This event is sold out. Walk-ins will not be accepted onsite. If you have any questions, contact the us at office@ispeboston.org. 

WHEN: Thursday, December 11, 2025

              5:30 - 8:30 PM

WHERE: Takeda
               55 Hayden Ave, Lexington, MA

**Pre-Registration is closing at 12PM on Tuesday, December 9th. Walk-ins will not accepted on-site**

With increasing capability and decreasing cost of internet of things (IoT) and automation, there are many opportunities to improve predictive maintenance and continued process verification. These opportunities provide numerous benefits, including decreased maintenance costs, reduction of deviations, prevention of material loss, decreased downtime, etc.  

Join fellow IT, validation, automation, and Quality professionals for two presentations featuring case studies from the perspective of pharmaceutical manufacturers and IoT service providers. Specific examples of IoT and AI Agent implementation will be provided to demonstrate CPV improvements across manufacturing operations, as well as in predictive maintenance of cold chambers. Benefits of the case studies will be presented, along with limitations and cautions, to improve success and actionability, should attendees be interested in implementing similar strategies at their own facilities. 

The evening will begin with light dinner and refreshments, followed by both presentations (each 20 minutes), a 20-minute Q&A, and additional networking opportunities.

*Please note that due to security reasons, walk-ins will not be accepted on-site*

SPEAKERS:

Laurie Masiello
Laurie Masiello is the Co-Founder and Chief Executive Officer of Predictive Monitor®, a company dedicated to empowering organizations through predictive analytics and strategic foresight. Under her leadership, Predictive Monitor has become synonymous with integrity, excellence, and the philosophy that "early warnings predict success." Before Predictive Monitor, Laurie co-founded and served as CEO of MASY BioServices, a biopharma company focused on validation, calibration, bio storage, and predictive monitoring experiences, and grounded in the principles of quality and integrity. With her dedication to “Raising the Bar for Excellence”, she led MASY BioServices to achieve ISO-9001 certification and NIST / NVLAP ISO-17025 accreditation, solidifying its reputation for operational and industry excellence and competency. 

Laurie, a long-term ISPE member and Product Show Chair, continues to champion quality-driven decision-making, combining her decades of expertise and unwavering passion for excellence to lead organizations toward continued success and a sustainable future.

Ed Sanderson
Ed Sanderson is the Global Lead of Reliability Engineering at Takeda, where he leads the adoption of advanced technologies and best practices to enhance the reliability and performance of manufacturing equipment across the Takeda Global Manufacturing network. With a career that spans Front End Engineering Design (FEED), detailed design, commissioning, qualification and validation (CQV), and both reliability and risk engineering, Ed has contributed his expertise to leading organizations including Amgen, Baxter, Fluor, and Raytheon. Ed holds master’s degrees in chemical engineering and engineering management, and is a licensed professional engineer (PE). 

REGISTRATION FEES:

Registration by EOD Wednesday, December 3, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, December 4, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER DECEMBER 4 ARE SUBJECT TO BILLING**

Thursday, December 04, 2025 | 5:30 - 8:30 PM Joyful Garden, Watertown, MA https://joyful.boston/

**Pre-registration is closed however walk-ins will be accepted on-site**

The EDEI Committee invites you to a Winter Solstice Celebration! Let's gather as the season turns, share in the spirit of community, and embrace the return of the light. Come connect with colleagues and enjoy an evening of warmth and festive cheer!

Members: $25
Non-Members: $45
Emerging Leaders Members: $20
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER NOVEMBER 27 ARE SUBJECT TO BILLING**

This event is sold out. Walk-ins will not be accepted onsite. If you have any questions, contact the us at office@ispeboston.org. 

When: Wednesday, November 19th, 2025
           5:30 PM - 8:30 PM EST

Where: MilliporeSigma M Lab™ Collaboration Center
             400 Summit Drive
             Burlington, MA 01803

Program Details:
The ISPE Emerging Leaders Committee invites students, recent graduates, and young professionals to the third installment of the Biotech 101 Series—an evening dedicated to learning and networking. This session focuses on downstream bioprocessing, offering insights into the foundational technologies, equipment, and practices that drive the pharmaceutical industry. Attendees will also enjoy an exclusive tour of MilliporeSigma’s M-Lab™ Collaboration Center, gaining a firsthand look at biomanufacturing excellence. Whether you’re just entering the field, exploring career options, or looking to strengthen your understanding of downstream processes, this event provides valuable knowledge, industry connections, and opportunities to engage with peers—all while enjoying food and refreshments.

Agenda:
5:30-6:00 - Arrival and Dinner 
6:00-7:00 - Presentation and Q/A
7:00-8:30 - M-Lab Tours

*Closed-toed shoes are required to enter the M Lab Collaboration Center. Please dress appropriately.

Registration includes: Presentation, tour, mingle, drinks, and delicious appetizers!

Registration Fees:
ISPE Student Members: $5
Emerging Leaders: $20
Members: $40
Non-members: $50

Transportation: line 350 bus from Alewife to Burlington Mall, or plenty of parking available.
If you are a student and having trouble affording travel to this event, please reach out to office@ispeboston.org to see if you are eligible for the Student Transportation reimbursement program! 

Important Note: This event is limited to 50 attendees and walk-ins will NOT be accepted onsite, so please register early. We hope to see you there! 

Speakers:

Angelica Welch
Angelica Welch is a MSAT consultant at ValSource with 15 years of biopharmaceutical experience. She is a subject matter expert in manufacturing sciences and technology, specializing in design and support of downstream biologics operations. Angie's experience includes the full spectrum of process development, characterization, transfer, validation and operations support.  Throughout her career Angie has supported operations in the lab and on the manufacturing floor. Angie earned her B.S. in Biochemistry from Worcester Polytechnic Institute.

Adam Sokolnicki
Adam Sokolnicki is Director of the MSAT-Downstream group of Biomanufacturing Engineers at MilliporeSigma. His team assists biomanufacturers across North America in establishing robust, reliable, and reproducible downstream processes through hands-on application training, characterization and scaling studies, on-site support for facility startup, and the development of best practices utilizing MilliporeSigma technologies. He has a passion for and expertise in bioprocess equipment and single-use technologies, as critical components in downstream manufacturing. Prior to joining MilliporeSigma, he spent his early career conducting process development, process engineering, and technology transfer for clinical and commercial manufacturing at the biotech Altus Pharmaceuticals.  Adam has 20 years of industry experience in biopharmaceuticals and life science.  He obtained a BS and a MS in chemical engineering from Tufts University in Medford, MA. 

Online is closed. Registration will be available onsite. 

WHEN: Saturday, November 15, 2025
            1:00 - 6:00 PM

WHERE: Tufts University, Joyce Cummings Center
             177 College Ave, Medford, MA 

PROGRAM DETALS:
It was a dark and stormy night ... and the something about the mAbs has gone amuck! Now, by the light of day, intrepid teams of students and emerging leaders are invited to gather in teams, open a deviation investigation, and follow the trail of clues to a solution.  

AGENDA:
1:00 PM - Hackathon
4:00 PM - Networking
5:00 PM - Dinner 

REGISTRATION INCLUDES:
Dinner

REGISTRATION FEES:
ISPE Student Member: FREE
ISPE Emerging Leaders: $20
Members:$30
Non-members:$30

TRANSPORTATION:
The University is accessible via the MBTA Green Line; Medford/Tufts stop. Visitor Parking is also available.

**Registration is now closed. Walk-ins will NOT be accepted on-site**

WHEN: Thursday, November 13th
              5:30 - 8:30 PM

WHERE: BMS, Cambridge Crossing
               250 Water Street, Cambridge, MA

As automation and digitalization reshape pharmaceutical manufacturing, success depends on more than technology—it relies on critical thinking and human judgment to drive smarter, risk-based decisions.  Join fellow IT, CSV/CSA, and Quality professionals for an interactive GAMP Community of Practice workshop exploring how critical thinking strengthens validation, assurance, and compliance in GxP environments.

The evening will begin with light dinner and refreshments, followed by a short presentation setting the stage for critical thinking through the lens of GAMP 5 Second Edition and CSA principles. Participants will then move into small breakout groups, each focusing on a unique discussion topic.  Afterward, the full group will reconvene for roundtable report-outs, open Q&A, and additional networking opportunities.

Walk away with practical perspectives and fresh ideas for enhancing your approach to validation and quality.

Hosted at BMS’s Cambridge Crossing facility. Light dinner and refreshments provided. *Please note that due to security reasons, walk-ins will not be accepted on-site*

SPEAKERS:
Bonnie Neuhardt 

Bonnie Neuhardt serves as Vice-Chair of the ISPE Boston Area Chapter GAMP Community of Practice and contributed to the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition).

As Associate Director of Digital Quality at ElevateBio, she oversees data integrity and computer system validation quality programs. With more than 30 years of experience in FDA-regulated industries, including senior roles at Sunovion Pharmaceuticals and Averion International, Bonnie has developed and led validation frameworks and quality systems that meet evolving regulatory expectations. She is especially passionate about applying GAMP principles through critical thinking to strengthen validation outcomes.

Attrayee (Atty) Chakraborty
Attrayee (Atty) Chakraborty is a Quality Systems Engineer at a Digital Healthcare division and is involved in regulatory and quality management system. 

Attrayee has previously spoken on AI integration in healthcare systems, drug misinformation, quality culture, and international regulations at 30+ national and international conferences. She is also a working member of FDA-recognized collaborative and IEEE P3396 standards for AI risk management. 

Attrayee is recognized as an AI community leader by the Regulatory Affairs Professional Society (RAPS) and is a recipient of the RAPS Rising Star Award and Quality Rookie Award.

REGISTRATION FEES:

Registration by EOD Wednesday, November 5, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, November 6, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER NOVEMBER 6 ARE SUBJECT TO BILLING**

Tuesday, October 21, 2025

Indian Pond Country Club
60 Country Club Way
Kingston, MA 02364

All Net Proceeds to Benefit the ISPE Boston Area Chapter Scholarship Foundation

SCHEDULE:
9:30 AM         Registration, Driving Range, Pick up Boxed Lunch
11:00 AM       Shotgun Start – Scramble Format
4:00 PM         Cocktail Hour
5:00 PM         Reception, Dinner and Silent Auction (Come prepared to bid on some great prizes!)

PLEASE NOTE:
There is a one foursome per company maximum. Spaces will be filled on a first come, first served basis. Foursomes will not be confirmed without payment. Cancellations/Refunds will only be granted if your space can be filled. ISPE Boston will request your team member names two weeks prior to the tournament.

FEES:
$1600 per foursome
Each foursome includes lunch, dinner, golf, attendee gift for four players, as well as a tee sign for the purchasing company.

*This Event is Sold out. Please contact the office at office@ispeboston.org to be put on a Waiting List*

Join us for an insightful panel featuring three influential women in the New Hampshire life science market. We are honored to have speakers from Lonza, Vertex, and the CEO of New Hampshire Life Sciences, moderated by the VP of Life Sciences of C&W Services. Discover firsthand how these professionals leverage allies and collaboration to propel their expertise and achievements forward. 

WHEN:
Thursday, October 16, 2025                                                                      
4:00 pm – 7:00 pm                                                                              

WHERE: 
Lonza, 101 International Dr. Portsmouth NH 03801

REGISTRATION FEES:
ISPE Members: $25
Non-Members:$40

SPEAKERS:
Kerri Edwards, Interim Head of MSAT, Lonza
Andrea Hechavarria, President & CEO, NH Life Sciences (NHLS)
Varija Verma, Executive Director, Analytical Science & Technology, Vertex Pharmaceuticals

MODERATOR:
Dorrian Fragola, Vice President, Business Development, Life Sciences, C&W Services

Kerri Edwards, Interim Head of MSAT, Lonza

Current Interim Head of MSAT at Lonza-Portsmouth, BS in Molecular, Cellular, Developmental Biology and certified professional coach both through UNH. 15 years industry experience, specializing in leadership, manufacturing sciences, and technology transfer. Mom to 3 kids ages 5-7. 

Andrea Hechavarria, President & CEO, NH Life Sciences (NHLS)

Andrea Hechavarria is President & CEO of NH Life Sciences (NHLS), the statewide life sciences association—built by the industry, for the industry. Alongside co-founders Cindy Conde and John Whelan, Andrea established NHLS in 2023, successfully building membership from the ground-up with the backing of founding member companies and attracting broad interest from life sciences companies across the state. NHLS’ arrival in New Hampshire represents an exciting new chapter in the state’s economic history, as the industry is a priority growth sector for the Granite State with significant opportunity for further expansion. NHLS’ mission is to foster growth and awareness of the life sciences industry in New Hampshire and to attract and retain world-class talent and innovation. Under Andrea’s leadership, NHLS works to connect, convene, and facilitate the advancement of the life sciences industry in the Granite State through member programs and events, policy advocacy, industry intelligence, and education. 

Andrea is a proud NH native with an extensive career in government, policy and industry.  Most recently she built and led the Global Government Affairs function for Terumo Blood and Cell Technologies, a global leader in blood component, therapeutic apheresis and cellular technologies. Prior to Terumo BCT, Andrea served as Chief of Staff to the CEO and as VP of Government Affairs at Butterfly Network, a highly innovative and disruptive handheld ultrasound technology start-up.

Andrea began her work in the medical device industry at 3M Company where she worked closely with the White House COVID-19 Task Force and 3M business leaders to respond to the pandemic and the unprecedented global demand for N95 respirators. While at 3M she also worked closely with the global medtech association, AdvaMed, to successfully repeal the medical device tax.

Andrea is passionate about advocating for the life sciences community and the impact R&D, science, and innovative technology have on patients and our healthcare system at large. She has a strong reputation within the highest ranks of government and our nation’s leading business trade associations.

Varija Verma, Executive Director, Analytical Science & Technology, Vertex Pharmaceuticals

Varija Verma is Executive Director of Analytical Sciences & Technology at Vertex Pharmaceuticals, based in Boston, Massachusetts. At Vertex, Varija leads teams advancing analytical science across small molecules, protein therapeutics, oligonucleotides, cellular and genetic therapies, directly supporting the company's mission to deliver life-changing medicines for serious diseases and contributing directly to the commercialization of several transformative therapies.

She brings over two decades of biopharmaceutical experience, having held senior leadership roles at Kiniksa Pharmaceuticals, Bristol Myers Squibb, Selecta Biosciences, Nitto Denko Avecia, and Abbott Labs. Her career highlights include leading a multidisciplinary team responsible for analytical development, method validation, and control strategy development in support of pivotal clinical trials and commercial programs.

Varija has shaped analytical and CMC strategies and is particularly passionate about bridging scientific innovation and regulatory expectations, ensuring product quality, quality management, and sustaining knowledge management to accelerate access to life-changing medicines for patients. Her commitment to rigorous science and effective teamwork has helped her teams meet global excellence standards, achieve multiple regulatory approvals (BLA and NDA), and launch products to the market while delivering impactful results across diverse therapeutic modalities.

Varija earned her MS. in Analytical Chemistry from Illinois Institute of Technology, Chicago, and an MS in Organic Chemistry from India.

MODERATOR:

Dorrian Fragola, Vice President, Business Development, Life Sciences, C&W Services

Dorrian Fragola is a seasoned leader with nearly 20 years of experience in life science facility services, currently serving as Vice President of Business Development for Life Sciences at C&W Services. Since joining the company in October 2024, Dorrian has spearheaded strategic growth initiatives, driving client acquisition and expanding market presence across the Life Sciences sector. Her deep-rooted connections in the New England region and prior leadership roles with organizations such as the Boston Business Journal and Janitronics Building Services underscore her expertise in strategic planning, corporate partnerships, and sales leadership. Dorrian is also a recognized industry contributor, actively serving on boards and committees for ISPE, BOMA Boston, MassEcon, and Building Impact, and has earned accolades including the BOMA Boston Affiliate Member of the Year. She is committed to lifelong learning and continuous improvement furthering her education and certifications in life sciences and facilities management. Her dynamic approach and commitment to excellence make her a trusted partner to clients and a driving force in the industry.

Registration for the 2025 ISPE Boston Product Show is officially open—and this is your chance to be part of the biggest life sciences event in the Northeast.

With 450+ exhibitors, hands-on demos, technical sessions, career resources, and thousands of industry professionals under one roof, this is more than just a show—it’s where connections happen and innovation takes center stage.

The show is free to attend, and registration takes just a minute—don’t miss out on your chance to experience the best show of the year.

Click here to REGISTER NOW

Register Early for a Chance to Win!

Register by September 22 and you’ll be entered to win our Patriots Prize Pack, including two tickets to a home game, dinner for two at Davio's and a one-night stay at the Renaissance Hotel.

WHEN: Thursday, September 18, 2025
              5:30 - 8:30 PM

WHERE: Assembly Innovation Park
               188 Assembly Park Drive
               Somerville, MA 02145

The pharmaceutical and biotechnology industries are facing growing pressure to reduce energy consumption and carbon emissions in critical and regulated environments – such as cleanrooms and cGMP manufacturing facilities. These spaces often have intense HVAC demands and strict environmental control requirements.

This session explores how sustainable design and operational strategies can be successfully implemented in high-performance, high-risk environments without compromising safety, compliance, or research. Speakers will present real-world examples and technical insights that showcase sustainable HVAC design strategies such as embodied carbon reduction, decarbonization, demand-based ventilation, and smart environmental monitoring. Attendees will come away with actionable ideas to drive energy performance, reduce emissions, and support long-term operations in regulated facilities.

SPEAKERS: Patrick Kelly - Director of Life Science Solutions, Aircuity Executive leader with over 25 years of experience in sales, product management, and business development. I have a passion for helping life science and higher-ed clients achieve strategic carbon reduction, energy efficiency, and healthy building goals, using data and technology to optimize their R&D facilities. As the Director of Life Science Solutions at Aircuity and Thrive Buildings, I lead the go-to-market strategy and strategic account management. I build worldwide engagements with partners and stakeholders, leveraging my skills in technology evangelism and customer relationship management. I am a forward-thinking and highly adaptable leader who creates a culture of success and delivers impactful results. Steve Lahti, P.E. – Associate Principal, Vanderweil Engineers Steve Lahti, P.E., LEED AP BD+C, is an Associate Principal and Project Manager at R.G. Vanderweil Engineers with 18 years of experience delivering complex life science projects for national and global clients. He specializes in cGMP manufacturing and laboratory facilities, with deep expertise in sustainable HVAC design and high-performance mechanical systems. Steve leads multidisciplinary teams through new construction and renovation projects, ensuring systems meet stringent regulatory, energy, and operational standards. His leadership emphasizes early planning, cross-functional collaboration, and technical precision, making him a trusted partner in the delivery of critical biotech and pharmaceutical environments. 

Yaju Chauhan – Senior Principal Engineer Mechanical, Energy and Sustainability, Moderna Highly experienced Mechanical Engineer with over 23 years of proficiency in HVAC design and construction. Demonstrated leadership in managing mechanical workgroups, coordinating with external design engineers, and making pivotal design decisions for capital projects. Adept at collaborating with diverse teams to develop HVAC designs from Basis of Design (BOD) to Issue for Construction (IFC). With a broad experience in the facilities, HVAC, energy, and climate technology industry, I have established a reputation as a subject matter expert in energy-efficient HVAC design, energy efficiency, net-zero building electrification technologies, renewable energy technologies, and sustainability. REGISTRATION FEES:

Registration by EOD Wednesday, September 10, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, September 11, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER SEPTEMBER 10 ARE SUBJECT TO BILLING**

THIS EVENT IS SOLD OUT. If you would like to be added to a waitlist, please contact the office at OFFICE@ISPEBOSTON.ORG.

WHEN: Thursday, September 11, 2025
               5:00 - 8:00 PM

WHERE: Takeda Pharmaceuticals
                300 Shire Way
                Lexington, MA 02421

Join us for the first installment in the Biotech 101 Series, designed to educate students and young professionals (0-3 years of experience) about the foundational aspects of the pharmaceutical industry. This event is perfect for those newly entering pharma, considering a career in the field, or working in non-manufacturing roles. Gain insight into the upstream bioprocessing space with an engaging presentation and an exclusive Window Tour of Takeda’s state-of-the-art bioprocessing equipment. Attendees will learn about key technologies and essential equipment that drive the upstream manufacturing process in biopharma. Network with industry professionals, connect with peers, and enjoy refreshments as part of this interactive ISPE event! Whether you’re curious about pharma or looking to deepen your understanding of upstream processes, this session has something valuable for everyone.

AGENDA:
5:00 - 6:00 PM -Arrival and Dinner
6:00 - 7:00 PM - Presentation and Q/A
7:00 - 8:00 PM - Window tour and networking

Fees:
Emerging Leaders: $20
Students: $5
Members: $40
Non-members: $50

Speakers:
Minhazuddin Mohammed, Sr Manager Process Engineering at Takeda 
Minhaz Mohammed is the Senior Manager of Process Engineering at Takeda’s Massachusetts Biologic Operations site. With over 12 years of industry experience, he leads a team of bioprocess engineers responsible for designing, operating, and continuously improving biomanufacturing equipment. Over his 8.5 years at Takeda, Minhaz has driven operational innovations while progressively expanding his leadership scope. Before Takeda, Minhaz held roles at DuPont, Merck, and ValSource, including R&D process engineer, investigator, validation engineer, and quality assurance specialist. He earned bachelor’s and master’s degrees in chemical engineering from Drexel University, where he collaborated on designing a two-phase bubble column reactor for biodiesel production and completed a thesis on reactor modeling and scale-up. Minhaz specializes in capacity modeling, equipment design, and techno-economic feasibility to tackle challenges in multi-product biomanufacturing. His work focuses on optimizing plant efficiency, planning for future growth, and building resilient operations while fostering a growth mindset within his team. Outside of work, Minhaz enjoys photography, traveling, swimming, and cooking with his partner. 

Grace Lee, Process Engineer V at CRB
Grace Is a Senior Process Engineer at CRB with more than 25 years of experience in the biotechnology field.  Grace specializes in developing process solutions and systems for biotechnology and bioprocess manufacturing facilities.  She has worked closely with process owners to lead a range of phases of project design and led teams of engineers for the conceptual, preliminary and detailed design of a variety of bioprocess facility designs.  Process systems designed include: bioreactors, harvest collection and clarification systems, media and buffer preparation, CIP Systems and downstream purification systems including viral inactivation, chromatography, ultrafiltration.  Grace also has experience with both large scale cell culture facilities, single use manufacturing facilities, mRNA facilities and ATMP facilities.

This event is sold out. Walk-ins will not be accepted onsite. If you have any questions, contact the us at office@ispeboston.org. 

WHEN:  Thursday, August 28th                                                                           
               5:00 pm – 7:00 pm                                                                              

WHERE: Sanofi
                49 New York Avenue
                    Framingham, MA 01701

Join the ISPE Boston GAMP COP for a dynamic session exploring the latest inspection trends of 2024. This discussion will unpack current regulatory expectations and provide actionable insights to help you keep your Data Integrity (DI) program inspection-ready. We’ll take a deep dive into emerging DI trends and examine their potential impact on validation strategies. Whether you're leading digital quality initiatives, managing validation programs, or simply navigating the evolving compliance landscape, this session offers a valuable opportunity to exchange ideas and network with peers across the industry.

Registration Fees:
ISPE Members: $25
Emerging Leaders: $15
Students: $5
Non-Members:$35

Speaker:
Lizzandra Rivera

Lizzandra Rivera is a pharmaceutical professional with over 20 years of experience in validation and quality compliance.  A Chemical Engineer graduate from the University of Puerto Rico, she has provided strategic leadership and tactical implementation to establish a wide range of computerized systems and equipment through their computer systems validations assuring regulatory compliance is maintained throughout the systems’ lifecycles.  She has a well-rounded background encompassing manufacturing, IT and quality assurance.

Mrs. Rivera joined Alexion Pharmaceuticals (New Haven, CT) in 2014 where she currently holds the position of Director, Digital & IT Quality and is the CSV Program Manager.  She leads a global team that provides quality oversight, strategic direction and pragmatic tactics for the establishment and management of GxP computerized systems throughout Alexion. 

This event is sold out. If you would like to be put on a wait list, email us at office@ispeboston.org.

Thank you to our Sponsors!

• Stellix Global Services: Putting Contest
• WMFTS: Hole in One
• BWT Pharma & Biotech: Closest to the Pin - Men
• AHA Consulting Engineers: Closest to the Pin - Women
• Paul Mueller: Longest Drive - Men
• Performance Contracting: Longest Drive - Women
• SteelcoBelimed LifeScience: Straightest Drive - Men
• WB Engineers: Straightest Drive - Women
• Arcadis: Tee Sign
• Ci Design, Inc.: Tee Sign
• Commodore Builders: Tee Sign
• Consigli Construction: Tee Sign
• Cumming Group: Tee Sign
• DECCO: Tee Sign
• P+H Electric: Tee Sign
• PIDC Construction: Tee Sign
• RW Sullivan: Tee Sign
• Triumvirate Environmental: Tee Sign

LOCATION:

Blue Hill Country Club
23 Pecunit Street, Canton, MA 02021

Tentative SCHEDULE:

10:00 AM - 10:45 AM Registration and Buffet Lunch
11:00 AM -Shotgun Start – Scramble Format
5:30 PM: Buffet Dinner 

PLEASE NOTE

There is a one foursome per company maximum. Most sponsorships come with one foursome. Spaces will be filled on a first come, first served basis. Sponsorships and foursomes will not be confirmed without payment. Cancellations/Refunds will only be granted if your space can be filled. ISPE Boston will request your team member names 1 month prior to the tournament.

This is event is sold out. If you have any questions, contact us at office@ispeboston.org. 

Monday, July 28, 2025
Windham Country Club, Windham, NH

Time: 7am Registration, 8am Shotgun, 11:30 Lunch and Awards

Cost: $200/single

Registration for each Golfer Includes: Breakfast -Coffee and Donuts, One Mimosa or Bloody Mary at the turn, Lunch buffet and of course GOLF!

***A RULE THIS YEAR*** 50% of each foursome MUST be female. 

The Educational Programs Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 23rd as the 2026+ educational season is developed. We are looking for program managers both experienced and new to join our team.

Please REGISTER ahead of time so we can order enough food for everyone. 

This is open to all ISPE members and is FREE to attend.

**This Event is SOLD OUT and Walk-ins Will NOT be accepted**

Wednesday, July 9, 2025
5:30 PM - Social at the Lansdowne Pub**
7:00 PM - Boston Red Sox vs. Colorado Rockies

Join the ISPE Emerging Leaders for a fantastic night out on Wednesday, July 9th, to see the Boston Red Sox battle the Colorado Rockies at iconic Fenway Park. Before we head into the stadium for the 7:10 PM first pitch, we'll be kicking off the evening with a pre-game gathering at the Lansdowne Pub (9 Lansdowne St., Boston, MA 02215) starting at 5:30 PM. It's the perfect opportunity to network and socialize before the game. We can't wait to see you there!

Registration includes food and two free drinks at the Lansdowne Pub, as well as a ticket to the ball game. Space is limited to 50 people so sign up quickly!

** Please note:
The Lansdowne Pub is a 21+ only venue. 

Registration Fees:
Members: $60
Emerging Leaders: $40
Students: $20
Non-Members: $80

** Pre-Registration is closed. Walk-ins will be accepted on-site**

Join Us for the ISPE Boston Summer Social & Volunteer Appreciation Event on Thursday, June 26!

The ISPE Boston Social Committee is thrilled to invite you to our Summer Social & Volunteer Appreciation celebration! Come enjoy an evening of refreshing drinks, coastal vibes, and delicious bites at ReelHouse—a waterfront gem in Boston offering scenic views and a vibrant atmosphere.

Your registration includes:

* Fresh Raw Bar
* Two Drink Tickets
* Light Snacks
* Exciting Door Prizes

Registration Fees:

ISPE Members: $20
Non-Members: $30

Don't miss this chance to unwind, connect with fellow industry professionals, and celebrate the incredible contributions of our volunteers!

Pre-Registration is now Closed. Walk-in registrations will be accepted onsite. Contact the us at office@ispeboston.org with questions.

WHEN:  Tuesday, June 24th                                                                           
             5:00 pm – 7:30 pm                                                                              

WHERE: Egan Center, Northeastern University
               120 Forsyth Street 
                    Boston, MA 02115

Join us at Egan Center, Northeastern University on June 24th for an engaging networking event where we’ll connect with industry peers and discuss: Automated Testing for GMP Compliance with SaaS Applications in Life Sciences. This event will explore the role of automated testing in achieving GMP compliance for SaaS applications in life sciences.

RASO is proud to sponsor the venue for this event. As part of this collaboration, RASO members will receive free entry to the event.

Why This Matters

Automated testing ensures consistent validation of SaaS platforms used in regulated environments. It supports compliance with Good X Practice (e.g., GMP, GCP, GLP, GDP, GvPV) by reducing manual errors and audit risks. This approach enhances efficiency, traceability, and data integrity across the software lifecycle.

For RASO members, this session offers firsthand exposure to real-world regulatory technology applications, highlighting the intersection of automation, quality, and compliance. Understanding these systems is critical for future regulatory professionals navigating evolving digital frameworks in pharma and medtech.

The Power of Automation

The shift to SaaS applications in GxP-regulated environments is changing compliance management for life sciences organizations. IT quality professionals and application owners face strategic and operational challenges in ensuring these platforms meet FDA and GMP requirements.

This presentation will explore how automated testing supports GMP compliance for SaaS applications. It will align testing with GAMP 5 principles, maintain data integrity, and ensure traceability in a cloud-based ecosystem. Attendees will learn to design risk-based testing strategies, integrate testing with change management, and collaborate with vendors to keep systems validated.

Focused on practical implementation, this session will provide actionable insights for building resilient, audit-ready testing frameworks that enable compliance while fostering innovation.

This event is great for professionals involved in quality, validation, and IT who want to gain actionable insights to build resilient, audit-ready validation frameworks that support both compliance and innovation. 

Don’t miss this opportunity to engage with industry peers and experts. Mark your calendar for June 24th from 5:00-7:30pm at Northeastern, Boston campus — we look forward to seeing you there!

Registration Fees:
ISPE Members: $25
Emerging Leaders: $15
Students: $5
Non-Members:$40

**Online Pre-Reg is closed but WALK-INS will be accepted!**

Thursday, June 19, 2025
4:30 - 7:30 PM                                                          
At Work Collaborative
101 Arch St, enter on the Summer Street Side
Boston, MA 02110

The ISPE Boston Ethnocultural Diversity, Equity, and Inclusion (EDEI) Committee cordially invites you to join us for a Juneteenth Celebration and insightful panel discussion. The panel discussion will feature thought leaders who will share their perspectives on fostering ethnic diversity and advancing equity within our professional landscape. Come prepared to learn, share, and connect as we work together to build a more inclusive future.

Event Schedule: 
4:30 pm  Arrival and Registration
5:00 pm  Registration and Networking
6:00 pm  Panel Discussion and Q & A
7:00 pm Additional Networking

Your registration includes the following:

• Cocktail/Networking Hour
• Flavorful small bites

Celebrate, learn, and connect with us at this significant and inspiring event.

Registration Fees:

ISPE Members - $35
ISPE Emerging Leader Members - $25
ISPE Student Members - $10
Non-Members - $45

PANELISTS:

Richard Harris - Associate Dean of Diversity, Equity, and Inclusion in the Northeastern University College of Engineering 
Harris has contributed to and oversees grants including the NSF Northeast Louis Stokes Alliance for Minority Participation Program; the NSF INCLUDES Engineering PLUS Alliance; the S-Power Scholarships for STEM partnership with historically Black colleges and universities; and the LSAMP Bridge to the Doctorate.  Harris’s honors include the 2020 College of Engineering Dean’s Meritorious Award; 2019 NSBE Minority Program Director of the Year; 2019 NSBE Boston Professional STEM Advocate Award; 2016 Omega Psi Phi Fraternity, Inc. Carter G. Woodson Bowties & Pearls Higher Education Award; 2015 National GEM Consortium University Representative of the Year; and 2014 Raytheon, Patriots, Boys & Girls Clubs of America Science of Sports Science Fair Award. He is a volunteer leader with the Society of Hispanic Professional Engineers; National Society of Black Engineers; National GEM Consortium; Good Sports; Mass General Brigham Community Advisory Board; Empower Yourself youth-based STEM program; and the Concerned Black Men of Massachusetts, Inc., which oversees the Paul Robeson Institute for Positive Self-Development Program for urban males in grades 3–12.

Saraswathy (Sara) V. Nochur, Ph.D. – Retired Chief DEI Officer at Alnylam Pharmaceuticals
Sara serves on the Board of Directors of City Therapeutics and on the Board of two non-profit organizations: Biomedical Science Careers Program that aims to increase the representation of underrepresented minority and disadvantaged individuals in all facets of science and medicine, and of Hospitality Homes, an organization that provides free/low-cost housing for patients and caregivers from all over the world who seek specialty medical care in Boston area hospitals.

Cassie Ramos – Director for MOSAIC, Biogen’s multicultural employee resource network.
Cassie is an agile compliance counsel focused on employee lifecycle issues with exceptional leadership and organizational skills. She is recognized as particularly effective at analyzing complex issues; creating practical solutions to unusual fact patterns; presenting complex information across disciplines; and developing long-term strategies for streamlined operations.

MODERATOR: 

Lateffa Curry – Marketing Associate with the S/L/A/M Collaborative 
Lateffa Curry, a Marketing Associate with 18 years of experience at the S/L/A/M Collaborative in Boston, MA, will moderate the DEI panel discussion at the upcoming ISPE Juneteenth Event on Thursday, June 19th, 2025. With S/L/A/M Collaborative having a strong presence in the life science market sector, Lateffa brings a passion for fostering DEI awareness not only within the AEC industry but also in the broader science and research community.

ONLINE PRE-REGISTRATION IS CLOSED; WALK-INS WILL BE ACCEPTED ONSITE.
WHEN:
Thursday, June 12, 2025
5:30 PM - 8:00 PM

WHERE:
Assembly Innovation Park
188 Assembly Park Dr
Somerville, MA 02145

PROGRAM DETAILS:
The Evolving Role of AI in Quality 
Join ISPE Boston for an engaging program focused on the evolving role of AI in Quality. Hear from Industry leaders from Takeda and Moderna as they share real-world insights on integrating AI into quality systems and navigating the journey to identify high-impact use cases.

The session will also include a high level of the current AI landscape in Life Sciences. Attendees will gain practical knowledge and strategic perspectives on how AI is shaping the future of Quality.

AGENDA:
5:30 PM - Arrival and Networking
6:15 PM - Presentations Begin
8:00 PM - Program Concludes

SPEAKERS:
Full List of Speakers to Be Announced
Carmen Araujo, Head Global Quality Audit and Supplier Quality, Takeda

REGISTRATION FEES:

Registration by EOD Wednesday, June 4, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, June 5, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER JUNE 4 ARE SUBJECT TO BILLING**

Sunday, June 8, 2025

8:00AM—3:00 PM
John W. Weeks Bridge, Cambridge, MA 02163

Join Us for the 2025 Boston Hong Kong Dragon Boat Festival! 

The Ethnocultural, Diversity, Equity, and Inclusion Group is gearing up for our third year at the Annual Boston Hong Kong Dragon Boat Festival—and we want YOU to come cheer us on!

Our team would like to invite supporters to cheer them on to Victory! Bring your colleagues, family and friends for a fun day n the sun while showing your support!

**Last year, we powered our way to a 2nd place finish in the D Minor Division. This year, we’re aiming even higher—Gold in a Major Division!

Registration Fees:
This event is FREE  to all. Register now to to show your support!

We're currently seeking volunteers to help make this year's festival even more memorable. We need assistance with taking photos of the event and ensuring our team stays hydrated and energized throughout the day. Last year was fantastic, but with your help, we can make this year even better! If you're interested in spectating or volunteering, please contact us at office@ispeboston.org.

All paddler spots are taken but spectators are free to join us and cheer on the team and to enjoy the festival!

Click here for the spectator RVSP link:
https://www.ispeboston.org/events/?eventID=1438

Saturday, June 7, 2025
Sunday, June 8, 2025

8:00AM—3:00 PM
John W. Weeks Bridge, Cambridge, MA 02163

Join Us for the 2025 Boston Hong Kong Dragon Boat Festival! 

The Ethnocultural, Diversity, Equity, and Inclusion Group is gearing up for our third year at the Annual Boston Hong Kong Dragon Boat Festival—and we want YOU on our team!

**Last year, we powered our way to a 2nd place finish in the D Minor Division. This year, we’re aiming even higher—Gold in a Major Division!

We’re assembling 20 dedicated paddlers who are ready to compete, have fun, and build an unforgettable team experience on the beautiful Charles River.

Here’s what you need to know:

• Attend at least one practice session between late April and early June
•  Race weekend:
•  June 7 – Seeding race
•  June 8 – Festival day & main race

This is more than just a competition—it’s an exhilarating challenge and an amazing way to connect with an inclusive and passionate community. Whether you're a seasoned paddler or new to the sport, if you’re ready to push your limits and have a blast, we want you on board!

💥 Are you in? Sign up to secure your spot! 💥

Racing Registration Fees:

ISPE Members – FREE!
Non-Members - $20

Participants will be required to complete a waiver with ISPE Boston.

We're currently seeking volunteers to help make this year's festival even more memorable. We need assistance with taking photos of the event and ensuring our team stays hydrated and energized throughout the day. Last year was fantastic, but with your help, we can make this year even better! If you're interested in spectating or volunteering, please contact us at office@ispeboston.org.

Pre-registration is closed, but Walk-in Registrations will be accepted onsite. If you have any questions, contact us at office@ispeboston.org.

Wednesday, June 4, 2025

Smart Labs
40 Guest Street
Boston, MA  02135

PROGRAM SUMMARY:
AI has been around for decades, but only recently has it come into fashion—come see what’s trending! This session covers AI’s history, types, and must-know generative AI tools. Learn how to use AI safely, including regulations, industry standards and best practices. Experience live demos and interactive exercises that make AI feel as effortless as picking the perfect pair of shoes. Join speaker Julie Caccamise, AIGP and the Boston Women in Pharma with your device for a practical, engaging discussion tailored for women in pharma!

AGENDA:
4:30-5:30pm           Registration
5:30-6:30pm           AI Presentation 
6:30-7:00pm           Wrap-up and Networking

REGISTRATION FEES:
Members: $15.00
Non-Members: $25.00

SPEAKER:

Julie Caccamise, AIGP is an accomplished industrial engineer and quality professional with over 20 years of experience in regulated computer systems validation (CSV/CSA) within the life sciences sector. As one of the first certified Artificial Intelligence Governance Professionals (AIGP) and recently ISO 42001 trained, Julie has been at the forefront of aligning compliance strategies with cutting-edge technologies. Her expertise spans project management, system implementation life cycle, global health authority regulations, and industry standards, enabling her to successfully validate GxP systems used across all areas of the regulated pharmaceutical industry, including custom-built AI/ML solutions.

Julie is dedicated to driving innovation while maintaining agile and compliant operations. Her career highlights include leading 125+ digital transformation initiatives, optimizing governance programs, and ensuring client success in regulatory inspections. A natural communicator and collaborator, Julie excels at uniting cross-functional stakeholders, navigating ambiguity, and driving solutions that balance business needs with compliance.

A lifelong learner and passionate advocate for responsible AI adoption, Julie brings a welcoming and dynamic presence to every discussion. As a sought-after speaker, she empowers professionals to harness AI responsibly for both personal and professional transformation.

This event is sold out. If you would like to be put on a waiting list, please email the us at office@ispeboston.org. 

LOCATION:
Renaissance Golf Club
377 Kenoza Street, Haverhill, MA  01830

SCHEDULE:
10:00 AM - 10:45 PM Registration and Buffet Lunch 
11:00 AM -Shotgun Start – Scramble Format
5:30 PM: Buffet Dinner 

Please contact the office at (781) 647-4773 if you have any questions about this event.

This program is SOLD OUT! The venue is at capacity and walk-ins will NOT be accepted. If you have any questions, please contact us at office@ispeboston.org

WHEN:
Thursday, May 15, 2025
5:30 PM - 8:00 PM EDT

WHERE:
DPR Construction
950 Winter Street
Waltham, MA 02451

PROGRAM DETAILS:
Accelerating Speed to Market for GMP Facilities – A Multifaceted Approach
Bringing GMP facilities online quickly and efficiently is a critical challenge in the pharmaceutical and biotechnology industries. Speed to market is no longer just a competitive advantage—it’s essential for meeting patient needs and business goals. This interactive panel discussion will explore a multifaceted approach to accelerating GMP facility readiness, featuring insights from experts in Engineering Design, Procurement/Construction Management, Capital Project Management, Quality Assurance, and Validation.

The discussion will focus on key enablers of speed, efficiency, and compliance, including:

• Technology & Digital Tools: What innovative technologies (e.g., digital twins, cloud-based collaboration, AI-driven scheduling, and paperless validation) are supporting faster project execution?
• Information Sharing & Collaboration: How can real-time data exchange, integrated project platforms, and clear communication between disciplines drive efficiency and prevent bottlenecks?
• Contract Strategies for Success: Are there specific contract structures (e.g., risk-sharing agreements, early supplier engagement, or performance-based incentives) that help accelerate timelines while maintaining quality?
• Supply Chain & Equipment Fabrication: How can procurement and manufacturing strategies reduce lead times and ensure equipment readiness for commissioning?
• Regulatory & Validation Acceleration: What risk-based approaches, validation innovations, and regulatory engagement strategies can be leveraged to speed up approvals without increasing compliance risk?

This panel will provide real-world insights, case studies, and actionable strategies for navigating the complexities of GMP facility delivery. Whether you're managing capital projects, overseeing validation, or optimizing procurement, this session will offer practical takeaways for accelerating speed to market while ensuring compliance, cost control, and quality.

Join us for this dynamic discussion with industry leaders and gain the insights needed to streamline project execution, improve cross-functional collaboration, and leverage cutting-edge tools for faster GMP facility deployment.

AGENDA:
5:30 PM - Arrival and Networking
6:30 PM - Panel Begins
7:30 PM - Final Networking
8:00 PM - Program Concludes

SPEAKERS:
Steve Chapman, BW Design Group
Mike Forth, DPR Construction
Christian Giotas, ElevateBio
Melissa Stoudt, Lonza
Jack Schilling, Moderna
Brad Ebel, BA Sciences (Moderator)

REGISTRATION FEES:

Registration by EOD Wednesday, May 7, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, May 8, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER MAY 7 ARE SUBJECT TO BILLING**

JOIN THE 57th WALK FOR HUNGER, UNITING FOR CHANGE SINCE ’69!

We've joined Project Bread's The Walk for Hunger to help transform the landscape of food insecurity in Massachusetts. The in-person Walk on Sunday, May 4, 2025, is a family-friendly event that offers a 3-mile route on the Boston Common designed for every age and ability. Let’s make a difference together and build a hunger-free future!

Register now at https://give.projectbread.org/team/652901

Project Bread is committed to making sure that people in Massachusetts can afford enough to eat because hunger is an injustice. They seek out the expertise of those who experience hunger and make sure those voices are at the center of Project Bread’s strategy, research, and programs. This is essential to their policy work to build a system based on equity so that everyone gets what they need to thrive.

Your impact resonates deeply, especially in aiding the 1 in 4 families with children currently facing food insecurity, ensuring they have access to the nourishment they need. Thank you! 

Location & Parking:

Boston Common
Boston, MA

What to wear: sneakers or walking shoes, weather-dependent clothing

What to bring (all optional): water, pets, kids, mask, etc.

Eric Felz will be your host. Any questions, email: office@ispeboston.org

This program is SOLD OUT! The venue is at capacity and walk-ins will NOT be accepted. If you have any questions, please contact us at office@ispeboston.org

Date and Time:
Thursday, May 1st, 6:00 PM – 8:00 PM

Agenda:
6:00 PM - Arrival and Networking
6:30 PM - Panel begins
7:30 PM - Networking continues

Location:
The Great American Beer Hall, 142 Mystic Ave, Medford, MA 02155

Event Description:
We’re excited to bring together a dynamic group of panelists—pharmaceutical professionals with a wide range of experience (from 1 to 10+ years in the industry). They’ll be sharing their unique career journeys, discussing the challenges they’ve faced, and offering valuable advice to help emerging professionals navigate and thrive in the pharmaceutical industry. Speakers will be announced soon!

Registration Fees: Fee includes admission, two drink tickets, and food
Members: $25
Emerging Leaders: $20
Non-members: $30
Student Members: $5

Speakers:

Christopher Ciampa is an eighteen (18) year industry experienced Biopharma Consultant with a robust background including Facilities and Validation Engineering with involvement in GMP Facilities, Commissioning and Qualification, and Technology Transfer projects.  He received a Bachelor’s Degree in General Biology from University of New Hampshire (UNH) in 2007, as well as an M.B.A. in Management from Bentley University in 2014. Christopher specializes in ensuring regulatory compliance, particularly overseeing the adherence to Good X Practices (GLP, GMP) and applicable regulations, to uphold Patient Safety, Product Quality, and Data Integrity standards. He has expertise in ensuring compliance with FDA, GxP, 21 CFR Part 11, and other regulatory requirements. He is an “Out of the box” thinker, as well as flexible, with a collaborative mindset suited to dynamic environments. He is motivated, encouraging team collaboration across the CMC organization. Chris prides himself in being a lifelong learner and a creative problem solver.

Chris has been a proud member of the ISPE Boston Area Chapter since graduating from UNH and has served in various roles across many committees since 2008.  Most recently, he serves as Chapter Liaison for the Boston GAMP Community of Practice as well as contributing member of Emerging Leader’s Biotech Development Series.

Alexander (Alex) Hart is the Head of Quality and Compliance at Stevanato Group's US TEC Laboratory, bringing over a decade of dynamic leadership experience in pharmaceutical and biotechnology quality management. Alex specializes in developing robust Quality Management Systems (QMS), risk management strategies, and overseeing comprehensive lab and compliance investigations.

Throughout his career, Alex has successfully navigated complex environments across both small molecule and biologics sectors, with notable roles at industry-leading companies including Pfizer, Vertex, Sanofi, Agios, Mylan and Emergent Biosolutions.

In 2020 Alex was directly involved with the development, validation, and commercial release of Pfizer’s groundbreaking COVID-19 mRNA vaccine.

Alex is a certified ISO Lead Auditor for QMS and Medical Device standards, holds a Bachelor of Science in Biology, and has driven impactful transitions from traditional operational models to advanced digital systems.

Beyond his technical expertise, Alex embraces a leadership philosophy grounded in altruism, actively mentoring and developing talent within his teams. He believes strongly in fostering growth, innovation, and professional fulfillment among colleagues and stakeholders alike.

At Stevanato Group, Alex oversees quality, compliance, and operational excellence across multiple laboratories, vendor management, regulatory interactions, and continuous improvement initiatives. His approachable style and unwavering dedication to ethical, people-centered leadership have positioned him as a rising voice in the biotech and pharmaceutical industry.

Sean Keenan is a Senior Engineer at Moderna based in Waltham. He brings nearly a decade of experience in the pharmaceutical and biotechnology industries, with a strong background in process engineering, laboratory and pilot plant operations, and organizational design for R&D and manufacturing environments. His work spans early-stage technology development through late-stage scale-up, with a focus on flow chemistry, continuous manufacturing, and strategic operations management.

Sean serves on the Board of Directors for the ISPE Boston Area Chapter and is passionate about bridging science, technology, and business. He holds a Bachelor of Science in Chemical Engineering from the University of Notre Dame and a Masters of Engineering Science in Biopharmaceutical Engineering from University College Dublin in Ireland.

Yolanda McLean is the Senior Director of Quality Strategy and Operations at Alnylam Pharmaceuticals with over 20 years of experience in the biopharma industry. Her passion for helping people began while working as an EMT during college - and has guided her path ever since. Yolanda is a strategic quality leader, team builder, and dedicated STEM advocate involved in workforce development through MassBioEd and ISPE.

Gearoid O'Sullivan serves as the Business Unit Manager at Wunderlich-Malec Engineering, Inc. for the Project Management Services Business Unit, for which he started back in 2022. He leads the Project Management and Project Controls services for life sciences clients nationwide while executing projects for clients in New England. With over 11 years of experience in the biotech and pharmaceutical industries, Gearoid has successfully managed and executed numerous complex capital projects and developed strong relationships with multiple industry leading Fortune 500 companies.

Registration is now closed. To comply with venue security policies, walk-in registrations will NOT be accepted. 

WHEN:
Thursday, April 17, 2025
5:30 PM - 8:00 PM EDT

WHERE:
Jacobs Offices, Copley Tower
Boston, MA 02116

PROGRAM DETAILS:
PFAS: Understanding “Forever Chemicals” and their potential impacts on pharmaceutical manufacturing
Join us for an informative evening program on Per- and polyfluoroalkyl substances (PFAS) and their potential impact pharma manufacturing. PFAS have been used industrially for decades, and due to their unique chemistry, they are resistant to degradation, leading to contaminated air, water, and soil. Certain PFAS have been detected in humans and animals through blood tests. While research on PFAS and their effects is ongoing, exposure to some PFAS has been linked to significant health concerns. Our speakers will discuss the science behind PFAS and share insights on how Takeda is accounting for the presence of these compounds in its operations.  

AGENDA:
5:30 PM - Arrival and Networking
6:45 PM - Presentations Begin
8:00 PM - Program Concludes

PRESENTATION 1*:
The Evolving PFAS Landscape: challenges and considerations for pharmaceuticals - Emily Pennoyer, PhD, MPH, Environmental Toxicologist
Per- and polyfluoroalkyl substances (PFAS) are synthetic fluorinated chemicals developed for their durability and water-resistant properties. Historically used in consumer goods, packaging, and industrial applications, many PFAS persist in the environment and accumulate in human serum. Some are bioaccumulative and toxic, with exposure linked to health effects such as increased cholesterol, immune system impacts, and cancer. PFAS regulations are evolving, with recent efforts to address them as a class rather than individually. However, broad PFAS definitions may include life-saving pharmaceuticals and other chemical products with essential uses, presenting challenges for regulation and environmental management. Understanding the evolving landscape of PFAS, their health effects, how they are defined and regulated is crucial for balancing environmental and public health concerns with the essential use of organofluorine containing pharmaceuticals. 

This session will provide an overview of PFAS, their uses, and their known health impacts. Using pharmaceuticals as an example, it will highlight differences across PFAS definitions used in regulatory and non- regulatory contexts and potential implications for pharmaceutical companies. Designed for professionals in bio/pharmaceutical manufacturing, environmental science, and policy, this talk will provide foundational knowledge about PFAS and their relevance to the pharmaceutical industry. 

PRESENTATION 2**:
Takeda’s Approach to Navigating PFAS Challenges - Kelly LaCarubba, Takeda Pharmaceuticals
This presentation delves into the impact of Polyfluoroalkyl substances (PFAS), known as ‘forever chemicals’ for their environmental persistence, on pharmaceutical manufacturing. With evolving global regulatory landscapes, such as the European Chemicals Agency’s (ECHA) proposed comprehensive ban on PFAS, the implications for bio/pharmaceutical manufacturing are significant. This presentation highlights how Takeda’s Global Material Qualification organization employs an agile, systematic approach to manage the risks associated with this evolving regulatory environment. Insights into Takeda’s comprehensive strategy are shared, focusing on data collection, digital tools, and a conceptual demonstration of the dashboard designed to tackle these challenges. 

This session provides actionable insights into how Takeda prepares for and responds to regulatory changes, ensuring the continued delivery of life-transforming products to patients. It is tailored for professionals in bio/pharmaceutical manufacturing, environmental scientists, regulatory affairs specialists and corporate sustainability officers. It is also relevant for senior executives responsible for strategic decision-making and suppliers involved in the bio/pharmaceutical sector who want to align with evolving regulations and data requirements.

SPEAKERS:

REGISTRATION FEES:

Registration by EOD Wednesday, April 9, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, April 10, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER APRIL 9 ARE SUBJECT TO BILLING**

Pre-registration is closed, but Walk-in Registrations will be accepted onsite. If you have any questions, contact us at office@ispeboston.org.

When: 
Thursday, April 10th, 2025
6:30-8:30pm

Where:
UMass Dartmouth
Room 149,Charlton College of Business (CCB) Building 

SEE BELOW FOR RIDE SHARE INFORMATION

Program Details:
The UMass Dartmouth Student Chapter invites 6 different Panelists with various backgrounds to have an in-depth discussion on career development. There is a primary focus on providing direction to young professionals who have the drive and are willing to solidify their spot in the industry. Each of the panelists will have their chance to share details of their own professional adventure, in hopes to inspire the next generation. Bring your open mind, a pen and paper, and a list of questions for a Q&A session after the discussion. Oh! And bring an appetite as well, food and beverages will be provided.

Registration:
Is free, and includes food, beverages, and the chance to network with other emerging leaders and professionals.

Agenda:

6:30 — Doors open, eat and network
7:00 — Intro to SDC and EL
7:15  — Panel Discussion
8:15  — Open Floor Q&A
8:30 — Event End

Parking/Travel Reimbursement:
Is free! Coming right off of Old Westport Rd, you'll head towards the school and take your first right over the speed bump, from there you will see signs of descending parking lot numbers. Lot 14 will be recognized as a vistor's parking lot and will be free for all visitors! From there you can follow the path down to the library signage will be posted as needed. 

Transportation stopping you from registering? You have options for reimbursement to help lighten the load! Both options require carpooling with at least 4 ISPE Student Members.

Reimbursement Available
* For groups of 4 or more traveling together via Uber/Lyft - up to $50 per foursome per way.
* All travelers must be current ISPE Student Members
* Pre-approval required by the Student Development Chair
*  Submit reimbursement form with receipt to Office@ispeboston.org

See three options below to help you attend the event. 

1. Uber Ride Share:
Use the UMassD May 1st ride share WhatsApp group to coordinate shared Uber rides to the event. Below is the link to the WhatsApp group and a QR code below for easy access:

WhatsApp Group: https://chat.whatsapp.com/Fbr1ef73n0lAFdX32k1DFB
QR Code: 

2. Train:
You can take the South Coast Rail line (formerly Middleborough/Lakeville Line) from South Station in Boston to either New Bedford or Fall River. UMass Dartmouth is centrally located between these stations, and you can then take Bus #9 directly to campus from either location or take a ride.

3. Peter Pan Shuttle/Bus:
Alternatively, you can take the Peter Pan Bus/Shuttle service from South Station to either New Bedford or Fall River. From there, you can take Bus #9 directly to UMass Dartmouth or take a ride.

If anyone has concerns or needs assistance with transportation, you can join UMassD May 1st ride share WhatsApp group to ask questions or feel free to email the UMass Dartmouth Industrial Advisor, Jenny Luo Yau (jluoyau@gmail.com) directly. 

Speakers:

Heather Longden:
Senior Marketing Manager for Pharmaceutical Regulatory Compliance, Waters Corporation
Heather Longden is an independent regulatory compliance consultant to the pharmaceutical industry. Heather specializes in data integrity, regulatory compliance, data management, GLP and GMP and computer system validation. She acts as an advisor to various regulatory groups, previously as a leader at GAMP® Americas steering committee and Boston Chapter Program Committee (EPC) and now serves on the ISPE Quality Control and Analytical COP and the Boston Area Chapter Board as well as founder of the Boston Chapter GAMP local COP.

Stacey V. Vega
Director of Business Development and Marketing, Connolly Brothers Inc.
Stacey has over 25 years of diverse business development, marketing, and sales experience. She started her career in the financial services industry, working as Marketing Associate for a private institutional investment firm in Connecticut. Her clients included Fortune 100 and 500 companies. In 2007 she made a career shift relocating back to her home state of Massachusetts and accepted a position as Business Development Manager at a design/manufacturing company where she developed critical lead generation strategies. She went on to become Marketing Director for the largest parking/transportation management firm in New England. During her tenure as Marketing Director, she was responsible for all internal and external client marketing programs with an emphasis on developing innovative and creative programs that drove both company and client profitability. After receiving an opportunity to join an engineering firm, she discovered her niche within the A/E/C industry. For the past 10 years she has worked for two of the most exemplary design-build construction firms in New England as Director of Business Development and Marketing. Her talents also include website design, SEO, social media marketing, copywriting, public relations, and graphic design. In 2019, she became Chairperson of ISPE Boston’s membership committee. Stacey is a Cum Laude graduate of Villanova University. She holds a Bachelors of Arts degree in Sociology and Communications. Stacey also has certification in social media marketing from Harvard University’s Executive Education Program. In 2021, Stacey was honored to receive the Janet Tice Distinguished Volunteer of the Year Award for the ISPE Boston chapter.

Tracy Mason
Division Manager, Biomedical Search
She has had a very non-linear career path. She received her degree in Microbiology from Sweet Briar College in Virginia. After graduation, she moved to Washington, DC, to work for the National Institutes of Health. She spent five years working for the NIAID under Tony Fauci, where, as a bench scientist, she primarily focused on oligonucleotide sequencing and synthesis for HIV research. Her career then shifted into the hospitality industry, where she spent the next 25 years in various roles, including restaurant assistant manager, catering director, and general manager. Shortly after the birth of her son, her career pivoted again, this time into a more traditional office manager position. Today, she describes herself as "life sciences adjacent," as she currently leads the Biomedical Search division of King & Bishop. In this role, she works with life science companies to source candidates for a wide variety of positions.

Lisa Conti
Principal Engineer, Sarepta Therapeutics
She attended Southeastern Massachusetts University in September 1988 as a Biology major with the goal of becoming a veterinarian. Four years later, she graduated from UMASS Dartmouth with two degrees—one in Biology and the other in Psychology. She added Psychology as a major during her second year after a meeting with her advisor, which led her to pursue a different career path.

 After graduating, she applied for jobs in various fields, initially focusing on hospitals, as she believed that was where someone with her educational background would find employment. Months later, she connected with a temp agency that was seeking someone to fill a temporary position at a biotech company while an employee was on leave for a few months. Biotech was an emerging field in the late 1980s and early 1990s. What began as a three-month assignment turned into a 33-year career in the biotech and biopharmaceutical industry. Over the years, she has worked at both private and public companies in various roles and capacities. Utilizing her background, she has witnessed the direct impact of her work on the lives of others, which has instilled in her a deep respect for science and the importance of developing life-saving medicines.

Martin Kockx
Principal Manufacturing Systems Engineer, Vertex Pharmaceuticals
I graduated from California State University Sacramento (CSUS) with a BS in Mechanical Engineering in 2010. This was toward the end of the Great Recession and the job market was still very difficult for new graduates. I had been working for an MEP Firm as a project engineer before graduating and we laid off shortly after due to the macro-economic climate. At the time, I was interested in machine design, product design, automotive, and aerospace. All natural outlets for an ME. After nearly 6 months of applying to things of interest and adjacent options with no success, necessity drove me to look outside the obvious options. I happened to have a great relationship with a professor and advisor who had been asked by a startup in the area for possible field engineers to join their company and she thought of me. That idiom of “who you know” really hit me from day one. This was somewhat lucky since that position was rooted in automation, where I would spend the rest of my career, but also because it let me travel extensively. I ended up living in Singapore and Hong Kong for the better part of my first 5 years out of university, which broadened my views in so many ways personally and professionally. That company was eventually acquired, and I had become less interested in that industry (Data Centers), so I looked to parlay that experience into more automation. I really liked the work and wanted to learn more. This led me to Life Sciences where I would stay until this day. I started at an A&E firm as a system integrator, moved to another firm when that one closed down, took a short detour to the wine & spirits industry before returning and working for an operating company. The first operating company was a CDMO and I was the lead automation engineer. I then went to a much larger and global role with a competitor where I did not enjoy the culture and mission. Finally, I ended up with Vertex as a Principal Engineer.

I have had to navigate tough times, events beyond my control, moves across continents and countries. I’ve worked for contractors, CDMOs, suppliers, and DSDP operating companies. I’ve mostly taken a self-taught approach vs formal training but do have experience with both. 

Jeffrey Heil
Discipline Manager, Process Engineering, DPS Group Global (Arcadis)
Dedicated, innovative and quality-conscious Professional Engineer (P.E.) with more than 18 years of process engineering and technical project management expertise in a diverse portfolio of engineering applications. Experienced in mRNA, oligonucleotide, and vaccine development projects. Also experienced in the design and validation of process safety systems, providing independent technical assurance of engineering work and working directly with clients to solve complex engineering problems in a variety of applications. I specialize in leading the execution of process projects with a background in hazardous materials, industrial processes and small molecule chemistry relating to the design, evaluation, optimization, and construction of process engineering systems. In the last 8 years I have been involved in a range of facility design and execution projects in the novel therapeutics space, including Oligonucleotide synthesis, mRNA vaccines, Viral vector / vaccine process development. One recent project has been leading an mRNA facility design for a pandemic scale vaccine. In addition to leading a diverse portfolio of projects, I lead the Process Engineering team at the Arcadis Framingham Office.

Pre-registration is closed, but Walk-in Registrations will be accepted onsite. If you have any questions, contact us at office@ispeboston.org.

WHEN:
Thursday, April 10, 2025
4:00 PM - 7:00 PM EST

WHERE:
Ultragenyx Pharmaceuticals
100 Chestnut Street
Somerville, MA 02143

PROGRAM DETAILS:
Unleash Your Power: Take Bold Steps Forward in Your Career
Managing the expectations of work, family, and life is a full-time job in itself. To find that sweet spot where all can be achieved and everyone can be happy, we find ourselves at the bottom of our own list. As a result, more than 80% of employees have noted that they are dissatisfied in some fashion with their current job.

How about you? Are you struggling with:

• Understanding and articulating your unique voice, skills, and superpowers.

• Knowing exactly what you want in your career and how to achieve it.

• Building the resources and network to support you in your career.

• Finding your voice to advocate for what you need.

You are not alone. In this two-hour interactive workshop, you will be guided through powerful exercises to help you see, broaden, and articulate your unique value and take stock in all that you have available to you to be successful.

You will leave the workshop with:

• Newfound awareness of your unique skills, superpowers, and key motivators.

• A framework for identifying your available resources.

• An action plan for getting to your goals.

• And simple tools to aid you in self-advocating for yourself in all settings.

If you are ready to take a front row seat in your career and begin to advocate for what you need now, then this is the workshop for you.

AGENDA:
4:00 PM - Registration and Networking
5:00 PM - Goal Setting Workshop
6:30 PM - Program Wrap-Up
7:00 PM - Program Concludes

SPEAKER:

REGISTRATION FEES:
ISPE Members: $40
Non-Members: $55

This program is closed for pre-registration. Walk-ins will be accepted onsite. If you have any questions, contact us at office@ispeboston.org. 

WHEN:
Thursday, March 27th, 2025
5:30pm-7:30pm

PROGRAM DETAILS:

Join us at Alkermes, 900 Winter St Waltham MA, 02451 on March 27th for an engaging networking event where we’ll connect with industry peers and discuss the complexities of 21 CFR Part 11 compliance when acquiring equipment with integrated computerized systems.

Why This Matters

As regulatory expectations continue to evolve, ensuring compliance with 21 CFR Part 11—which governs electronic records and electronic signatures—is critical for maintaining data integrity and meeting FDA standards. Acquiring new instruments that fall under this regulation requires a proactive approach to avoid compliance pitfalls that can delay instrument qualification and disrupt operations.

The Power of Early Assessment

A key takeaway from this session will be understanding the importance of conducting an early compliance assessment during the purchasing phase. By evaluating vendor certifications, data integrity controls, and Part 11 readiness upfront, organizations can streamline the qualification process, minimize unforeseen challenges, and ensure smoother implementation.

What You’ll Gain

• A clear understanding of 21 CFR Part 11 requirements in equipment acquisition
• Best practices for early compliance assessments to avoid qualification delays

Meeting Fees

To help offset event costs, the following registration fees apply:

• ISPE Members: $25
• ISPE Emerging Leader Members: $15
• ISPE Student Members: $5
• Non-Members: $40 

This event is great for professionals involved in quality, validation, IT, and equipment procurement who want to enhance their approach to regulatory compliance and risk mitigation.

Don’t miss this opportunity to engage with industry peers and experts. We look forward to seeing you there!

REGISTRATION IS CLOSED. WALK-INS WILL NOT BE ACCEPTED.

Friday, March, 21, 2025
6:00 – 10:00 PM

UMass Club Boston
1 Beacon St 32nd floor, Boston, MA 02108

ISPE Boston invites you to the "Around the World Gala" event. Experience a global celebration as we unite for an evening of connection, culture, and creativity! Enjoy exquisite international cuisine, signature cocktails, and music and cultural performances from around the world. There will also be special recognition awards for industry excellence and plenty of global networking with industry leaders. Wearing cultural attire is highly encouraged while black tie is optional. Join us for an unforgettable evening!

Your registration includes:

• Two (2) drink vouchers to sample exotic cocktails
• A delectable dinner
• An evening of fun dining, dancing, and mingling

Parking: the One Beacon Garage offers a discounted rate of $8 after 4pm. Visit the office in the garage prior to departure for more information.  There is additional parking in the Government Center Garage, or the PO Square Garage; all within walking distance of the Club.

Accommodations: A small room block at The Omni Parker House Hotel has been reserved for those who wish to extend their evening in the city.  Located at 60 School Street, it is a quick one minute walk to the Club. The group rate is $199 for single or double occupancy. Reservations can be made by calling: 617-227-8600 and referencing ISPE Annual Gala or clicking the following link https://bookings.omnihotels.com/event/boston-parker-house/2025-ispe-annual-gala-accommodations. This rate is available until February 21, 2025.

Registration Fees*

ISPE Members - $150.00
ISPE Members +1 - $210.00*
Board/PP - $25
Board/PP +1 - $100
ISPE Emerging Leader Members - $55.00
ISPE Student Members - $40.00
Non-Members - $195.00

*Members must register their +1 as a separate registration, please call the office at 781-647-4773 or email office@ispeboston.org to receive the discount code for special pricing. This code is only eligible for full ISPE Members. Emerging Leaders, Student Members, and Non-Members are ineligible to use the code.

Thank you to our Sponsors:

This virtual, online-only program is brought to you by the Women in Pharma (WIP) Committees but is open to all!

Part 3: Tuesday, March 18, 2025 - "Unconscious Bias Training: Helping Individuals Recognize and Address their Implicit Biases - Unconscious Attitudes or Stereotypes which Affect Understanding, Actions, and Decisions."                                                                                                                     Led by: Cassandra Dennis (Diversity, Equity and Inclusion Manager, SE; DPR Construction)

Meet the Moderator: Cassandra Perrymon

Cassandra Perrymon Dennis is a strategic and empathetic leader with 28 years of experience in the architecture, engineering, and construction (AEC) industry, specializing in diversity, equity, and inclusion (DEI). Combines a deep financial acumen with a people-first leadership approach to drive cultural transformation, foster belonging, and create high-performing teams. Proven expertise in unconscious bias training, inclusive practices, and developing equitable programs that align with business goals to produce measurable outcomes. Adept at integrating DEI strategies within organizational frameworks to enhance talent retention, engagement, and leadership development.

Click HERE to Register. 

Registration is closed; the ski lodge is at capacity.

Price Includes: Roundtrip bus ride, full-day adult lift ticket, lunch voucher, buffet dinner at T Bars, and fun with fellow ISPE members!

Bus Departures:

6:00 AM - Departure from Newton Marriott, Rte. 128
6:40 AM - Departure from Chateau Restaurant, Andover, MA
7:40 AM - Departure from LL Bean, Concord, NH
4:30 PM – Buses Depart Waterville Valley to Return to all drop-off sites

Individual Tickets $140 (ISPE Members) / $195 (non-members)

Note: All attendees will be sent a ski wavier which must be completed and returned to office@ispeboston.org

NOTE: Due to security restrictions at Alnylam, walk-ins will NOT be allowed onsite. Registration will close at midnight on 3/10.

WHEN:
Thursday, March 13th, 2025
5:30 PM - 8:45 PM EST

WHERE:
Alnylam Pharmaceuticals
675 West Kendall St
Cambridge, MA 02142

PROGRAM DETAILS:
Delivering Speed to Market……The Challenges Behind Program Execution

The Pharma and Biotech industries are continuing efforts across the Quality, Regulatory, and Process Development disciplines to enable product speed to patients and the market. Presentations and a panel discussion will explore the challenges and approaches employed to address some of these potential obstacles and how they may be addressed.

By sharing insights and strategies, this discussion aims to equip industry professionals across all the disciplines engaged in these  R&D and Licensure programs with the knowledge to better direct program plans and execution for product development and rapid delivery to patients in need.

AGENDA:

5:30 PM - Registration and Networking
6:45 PM - Welcome & Introductions
7:00 PM - Presentation 1*
7:30 PM - Presentation 2**
8:00 PM - Panel Discussion and Q&A
8:20 PM - Networking and program conclusion

PRESENTATION 1*: 
The Only Constant in Life is Change: Utilizing a Science-driven and Risk-based Approach to Speed Process Changes for ATMPs; Darius Pillsbury, Senior Consultant, ValSource
The only constant in life is change! This adage certainly does apply to the development and manufacture of the promising, new modalities like cell and gene therapies. How an organization manages and embraces change is paramount to the ultimate success of the commercialization of these novel products. In this presentation we will explore how to navigate various types of changes to cell and gene therapy manufacturing processes using key enablers like knowledge management and risk management in order to minimize delays. The recent draft guidance by the FDA “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products” will be reviewed. Process changes at all stages of the product lifecycle from the manufacture and testing of initial clinical trial materials to the commercialization and long-term management of the manufacturing process based on optimization of the Process Control Strategy (referred to by the FDA as the “Cookbook”) will be presented. This presentation is targeted to subject matter experts in CMC organizations (e.g., process and analytical development, quality systems, and production), who all have shared responsibilities to rapidly advance new and exciting therapies for patients desperately in need.

A case study will be provided with an example of a significant process change made to an autologous gene-modified cellular therapy. The case study will encompass the initial identification of the need for a change, the supporting activities to implement the change, and the design and execution of an analytical product comparability study, based on best industry practices including the use of risk assessment and compliance with the expectations of global regulatory agencies. The challenges will be highlighted with solutions provided to overcome any barriers and challenges to implementation, as well as the follow up activities also important post-change. 

PRESENTATION 2**:
Accelerating Process Scale-up through enhanced Contamination Control Strategy (CCS) and Vendor Management; Thomas C. Page, Ph.D., Pioneer GMP Consulting
Navigating the path to the market for pharmaceutical products requires a systematic approach to addressing business, technical, and regulatory risks. This presentation highlights the importance of gap assessments and resulting risk-based control strategies to streamline facility design, optimize validation timelines and assure quality metrics.

Key focus areas include leveraging closed processes to isolate operations from the environment using single-use systems to enhance contamination control strategies. We will discuss a different approach to generating user requirement specifications for standard packaged equipment, the effective use of vendor-provided documentation and the emerging role of vendor design risk assessments. Additionally, the session will explore innovative approaches to installation and operational Qualification, examining the potential for pre-shipment vendor-execution and out of place qualification to compress readiness timelines.   Finally, several common gaps in how users manage critical component suppliers with potential approaches to mitigating common issues that emerge between user and vendors (sometimes contentiously so).

This presentation offers actionable strategies for pharmaceutical manufacturing professionals to mitigate risks, enhance product quality, and accelerate project timelines, ensuring success in today’s demanding regulatory landscape.

SPEAKERS:

REGISTRATION FEES:
**Are you a member of PDA but not SPE? Reach out to the PDA New England office to receive your member pricing code**

Registration by EOD Wednesday, March 5, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, March 6, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER MARCH 5 ARE SUBJECT TO BILLING**

Pre-Registration is now closed however Walk-ins will be accepted!

Location: 
Puttshack
58 Pier 4 Blvd, Boston, MA
6:00 - 8:00 pm

The ISPE Emerging Leaders and Student Development Committees warmly invite you to an enjoyable evening of mini golf and networking in the Seaport. This event guarantees a relaxed environment where you can mingle with fellow professionals, forge new friendships, and savor delightful snacks, all included in your ticket price. Bring your competitive spirit and challenge your colleagues to a fun round!

Cost to attend includes:
Light bites

Registration Fees:
ISPE Emerging Leaders Members - $15
ISPE Student Members - $5
ISPE Members - $20
Non-Members - $30

PRE-REGISTRATION is CLOSED - WALK-INS WILL BE ACCEPTED ON-SITE

Thursday, February 27th, 2025

3:30—6:00 PM

Location: 
Labshares, 57 Chapel Street, Newton, MA 

Light up your evening by joining fabulous women in Pharma for a night of candle making while mixing and mingling! 

Your ticket to fun covers:

• Admission to a fun night of creativity!
• A delightful spread of tasty finger foods
• Your very own custom made candle!

Registration Fees*:
ISPE Members - $40
ISPE Emerging Leader Members - $40
ISPE Student Members - $40
Non-Members - $40

Important Note:
This event is limited to 30 attendees and will sell out so please register early. We hope to see you there! 

This program is SOLD OUT! The venue is at capacity and walk-ins will NOT be accepted. If you have any questions, please contact us at office@ispeboston.org. 

WHEN:
Thursday, February 13th, 2025
5:30 PM - 8:30 PM EST

WHERE:
Tulip Interfaces
Assembly Square
77 Middlesex Avenue, Suite A
Somerville, MA 02145

PROGRAM DETAILS:
Panel on Lessons & Opportunities in Digital Transformation 

The Pharma and Biotech industries are undergoing a profound digital transformation, reshaping how research, development, and manufacturing are conducted. This panel discussion will explore the lessons learned and opportunities identified during this ongoing digital transition.

From Quality to IT to Manufacturing, digitalization offers promises of operational efficiency, data management & sharing across the supply network. Come hear about successes and opportunities in implementing digital technologies such as modular tools, AI/ML, analytics and connectivity. Additionally, the panel will address the challenges faced including regulatory considerations, data security and the need for cultural shifts within organizations. The panel will save some time for live Q&A.

By sharing insights and strategies, this discussion aims to equip industry professionals with the knowledge to harness digital tools more effectively and to drive innovation in the rapidly evolving landscape of pharma and biotech. Attendees will leave with actionable takeaways to navigate their own digital journeys and capitalize on the transformative potential of the digital mindset.

AGENDA:
5:30 PM - Networking and Tech Tours (Composable MES, and Lab of the Future)
6:30 PM - Panel Discussion and Q&A
7:45 PM - Networking and Tech Tours (Tours by request)
8:30 PM - Program Ends

SPEAKERS:

REGISTRATION FEES:

Registration by EOD Wednesday, February 5, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, February 5, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER FEBRUARY 5 ARE SUBJECT TO BILLING**

This virtual, online-only program is brought to you by the Women in Pharma (WIP) Committees but is open to all!

Part 2: Tuesday, February 11, 2025 - "Navigating Career Transitions: Strategies for Leading During Career Transitions (such as promotions, job changes, or career shifts)."                                            

Meet the Moderator: Cory Amenta, Jamie White Moran, Lara Ionesco Silverman PhD

Cory Amenta 

Cory Amenta is the Director of Business Development at CCI Consulting. As a trusted expert in outplacement, executive coaching, training and development, and HR consulting, Cory has worked with clients across various industries to enhance their talent management strategies and leadership effectiveness. With a career that spans many years in life sciences recruiting, Cory has developed deep expertise in identifying and attracting top-tier talent for some of the most dynamic and evolving sectors. This strong foundation in life sciences has provided Cory with a unique perspective on the critical needs of organizations in highly regulated industries and the importance of aligning human resources strategies with business goals. Throughout Cory's career, a focus on results-driven solutions has been paramount, guiding organizations through transitions, leadership development, and workforce optimization. As a strategic partner, Cory helps clients develop tailored approaches that foster both individual and organizational growth, ensuring success in an ever-changing business landscape.

Jamie White Moran 

Jaymie White Moran is a Clinical Project Services Account Manager with a strong focus on client communication and business development within the Pharmaceutical, Biotechnology, CMO/CDMO, and Medical Device industries. With expertise in managing project services and professional services, Jaymie works closely with life sciences delivery teams to identify and implement tailored solutions across a range of key areas, including Technical Operations & Engineering Services, Quality Assurance & Regulatory Compliance, Product & Process Development, Clinical Operations, and Laboratory Support & Services. Jaymie excels in managing W2 consultant project performance, ensuring successful outcomes by mitigating turnover, incentivizing retention, and promoting project continuity. Through a strategic and results-driven approach, Jaymie fosters lasting relationships with clients while delivering high-quality project solutions that support the growth and operational excellence of organizations in the life sciences sector.

Lara Ionesco Silverman

Lara Ionescu Silverman, PhD has led key aspects of scientific development for cell therapy and gene-modified cell therapy products, with expertise spanning process design, analytical methods, raw materials, laboratory operations, intellectual property, regulatory interactions, and external communications. With extensive experience overseeing multi-functional and multi-layered teams, Lara has developed both short- and long-term strategic plans, successfully translating them into actionable objectives for team execution.

Lara has also played a crucial role in understanding the scientific, clinical, and commercial landscapes to guide the strategic direction of the organization, advising on critical decisions that shape the company’s future trajectory. Under her leadership, teams have published numerous peer-reviewed manuscripts and presented at a wide range of academic and industry scientific conferences. In addition to her professional achievements, Lara is the Founder and Host of the “I Wish I Had Known” Women in Sciences Webinar Series. She holds a PhD and MSE in Bioengineering from the University of Pennsylvania, and a BSE in Chemical Engineering and Materials Science Engineering from Princeton University.

Click HERE to Register. 

Pre-Registration closes at midnight between 1/30 and 1/31. Walk-ins will be taken onsite on Saturday for any registrations after that.

WHEN:     Saturday, February 1st, 2025 | 9:30 am – 4:30 pm

WHERE:   Northeastern University
               Boston, MA   

Get Ready to Jumpstart Your Career at ISPE’s 13th Annual Student Career Workshop!

Are you ready to take the next step in your life sciences career? The 13th Annual Student Career Workshop being held at Northeastern University on Saturday, February 1st is your opportunity to gain the knowledge, skills, and connections you need to land that job or internship you’ve been dreaming of!

This isn’t just another career event — it’s a potentially life-changing experience. You’ll meet and network with industry experts who are eager to help you succeed. Get valuable, actionable advice on how to build a standout resume, ace your interview, and launch a successful career in the life sciences field.

The workshop will cover key topics including: 

• Where to find the jobs in life sciences 
• How your experience can be more valuable than you think 
• Crafting a resume that stands out 
• Mastering the art of making a great first impression 
• The one skill that's more important than raw intelligence 
• Presenting yourself confidently in interviews 
• Managing your digital footprint for success 
• The hiring process - what really happens behind the scenes? 
• Choosing between big vs. small companies and remote, hybrid, and in-person roles 
• Building a career path and professional network that will open doors for you

This event has already helped hundreds of students jumpstart their careers, and we can't wait to help you next! Hear what past participants have said:

"I’ve never received such useful advice about my career before." — Megha S., UMass

"Nobody runs a program for students like ISPE does." — Ryan Mudawar, Executive Vice President of Educational Partnerships and Workforce Investments, Massachusetts Life Sciences Center

At this workshop, it’s not just the attendees who are excited — our speakers and mentors rave about the incredible quality of the event and are eager to return each year. With comments ranging from “incredible” to “spectacular” to “invaluable,” this is an event you don’t want to miss!

Join us for an interactive, hands-on experience that will energize and empower you to take control of your career. Get ready to make lasting connections and gain the tools you need to succeed in the life sciences industry.

Don’t miss out on the opportunity to set yourself up for a bright future. We can’t wait to see you there!  Register now, it’s free for ISPE student members. 

Pricing:
ISPE Student Members: FREE
Non-Members: $30

**Annual Student Memberships cost $29 through ISPE Global; Sign up as a member today to receive a discounted registration price, and all other benefits of ISPE membership**

This program is SOLD OUT! The venue is at capacity and walk-ins will NOT be accepted.

Thursday, January 30, 2025

5:30—8:30 PM

Location: 
Common Craft
75 Middlesex Turnpike, Burlington, MA  01803

Get ready to jingle and mingle at the ISPE Boston Winter Social at Common Craft in Burlington! Grab a glass, nibble on delicious bites, and let the good times roll!

Your ticket to fun covers:

• Admission to the festive frolic
• A delightful spread of tasty finger foods
• Two (2) drink vouchers to keep those spirits high
• A shot at winning the Door Prize Raffle – score one of two Bruins ticket sets and a Visa gift card!
  Raffles sponsored by DECCO and JVT Advisors

Registration Fees*:
ISPE Members - $20
ISPE Emerging Leader Members - $10
ISPE Student Members - $10
Non-Members - $30 

Important Note:
This event is limited to 100 attendees and will sell out so please register early. We hope to see you there!

This virtual, online-only program is brought to you by the Women in Pharma (WIP) Committees but is open to all!

Meet the Moderator: Adrianna Gabriel-Miller, Vice President, Executive Coaching, CCI Consulting

Adrianna Gabriel-Miller is the Vice President of Executive Coaching at CCI Consulting, where she partners with organizations to develop strategic talent solutions for today’s fast-evolving leadership landscape. With over 13 years at Johnson & Johnson, she brings a wealth of experience in guiding organizations through change while driving high performance. Adrianna is passionate about people and continuous development, bringing a blend of action-oriented leadership and coaching expertise. She designs customized coaching programs, ensuring quality and consistency, and specializes in fostering diverse, equitable, and inclusive cultures. Adrianna works with leaders to drive tangible results, using a holistic approach that combines assessment data and skill development to promote lasting change. Her compassionate, results-focused style creates a safe space for leaders to build confidence, maximize effectiveness, and embrace authenticity. She holds a B.S. in Industrial and Systems Engineering from Rutgers University, is an APICS Certified Supply Chain Professional, and earned an M.S. in organizational dynamics from the University of Pennsylvania, specializing in Organizational Consulting and Executive Coaching.

Click HERE to Register. 

THIS PROGRAM IS SOLD OUT! WALK-INS WILL NOT BE ACCEPTED ONSITE

WHEN:
Thursday, January 16th, 2025
5:00 PM - 8:30 PM EST

WHERE:
Alnylam Pharmaceuticals
20 Commerce Way
Norton, MA 02766

PROGRAM DETAILS:
Changing Paradigms in Pharmaceutical Water
While distillation remains the gold standard, most regulatory agencies now accept membrane-based water purification systems for WFI quality water production. With sustainability goals in mind, many companies are exploring ambient temperature membrane-based WFI systems, which often leads to considering ozone as a sanitizer instead of heat. However, there are several considerations, such as what needs to be sampled where and how to validate equipment functionality. Attend this session to meet, network with, and learn from industry experts, and tour Alnylam’s Norton facility, which features both distillation and membrane-based WFI systems. This event will sell out quickly!

AGENDA: (session order subject to change)
5:00 PM - Arrival, Networking, and Plant Tours*
6:30 PM - Membrane Based WFI Systems presented by Gary Zoccolante and Andrew Collentro
7:00 PM - Ozone Use in Pharma presented by Joe Manfredi and Brian Hagopian
7:30 PM - Alnylam's justification and thought process for using distillation and membrane based WFI, and their plans to add ozonated storage presented by Bill Frederick
8:00 PM - Process vs Quality Control Sampling, Instrumentation, Point of Use vs. Loop Outlet Valve, inline vs. grab sampling variations for TOC and conductivity and thoughts on validating instrumentation presented by Brian Pochini and Anthony Bevilacqua
8:30 PM - Presentations conclude

*Tours are member-only, and limited to 60 people. ISPE Boston will reach out to registered members to offer time slots*

SPEAKERS:

REGISTRATION FEES:

Registration by EOD Wednesday, January 8, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, January 9, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER JANUARY 9 ARE SUBJECT TO BILLING**

This event is now Sold out. Walk-ins cannot be accommodated. Email the office if you would like to be on a waiting list.

Location: 
MassBioHuB
700 Technology Square, Cambridge, MA
5:30 - 8:30 pm

The ISPE Emerging Leaders and EDEI Committees invite you to our festive Holiday Networking Fiesta, where we honor and celebrate the rich traditions and contributions of Latino culture within our industry. We will have the participation of members from Latinos in Bio who will be joining us, sharing their heritage and perspectives in a relaxed setting.

At the Holiday Networking Fiesta, we believe the best way to connect with a culture is to experience it firsthand—and what better way than through engaging conversations, authentic cuisine, and lively activities! This gathering promises to be an evening filled with music, joy, and an opportunity to celebrate and support the Latino community.

Come enjoy the flavors, sounds, and energy of Latino culture while connecting with professionals across the ISPE network and Latinos in Bio community. This is your chance to expand your network in an inclusive and celebratory environment.

Why attend?

• Celebrate Latino Culture: Immerse yourself in the unique traditions, music, and foods shared by members from Latinos in Bio.
• Network & Collaborate: Connect with ISPE members and Latinos in Bio professionals in a relaxed and welcoming atmosphere.
• Support Diversity: Show your commitment to diversity by supporting the Latino community and recognizing their contributions to life sciences and biotechnology.
• Win Exciting Prizes: Participate in interactive activities and have a chance to win fantastic prizes!

Whether you’re looking to grow your network, support an inspiring community, or simply enjoy a festive evening with friends and colleagues, the Holiday Networking Fiesta is the perfect way to close out the year on a high note. Let’s celebrate together!

We can’t wait to see you there!

Cost to attend includes:
Two free drink tickets (cash bar available after that)
Delicious appetizers 

Registration Fees:
ISPE Emerging Leaders Members - $15
ISPE Members - $20
Latinos in Bio - $20
Non-Members - $40
ISPE Student Members - $10

WHEN:
Thursday, November 14th, 2024
4:00 PM - 8:00 PM EST

WHERE:
Northeastern University Innovation Campus
Building 5
147 S. Bedford Street
Burlington, MA 01803

PROGRAM DETAILS:
Cell & Gene Therapy: Distinct Challenges in Commercializing an Autologous Therapy
Cell and gene therapies have distinct differences from monoclonal antibodies and vaccines. Autologous cell and gene therapies add another element to the uniqueness of these therapies. This presentation will inform those new to the topic on some of these differences and dig into three challenges and how they were addressed for Bluebird bio’s LYFGENIA™.

Come to Northeastern University’s Burlington Campus for an opportunity to experience insightful presentations and Q&A on the cutting-edge field of Cell & Gene Therapy. There will be a short introductory “course” offered on the basics of C&G therapies and how they are developed. 

The main presentation will showcase industry experts delving into challenges they encountered while ensuring product quality and navigating regulatory landscapes crucial for bringing novel therapies to market. 

AGENDA:

4:00 PM - "Introduction to Cell & Gene Therapy" Session - OPTIONAL 101 Session for those new to the field
5:00 PM - Arrival, Networking, Welcome Appetizers, and Tour of Makers Space Facility*
6:00 PM - Introductions by Moderators and University Representative
6:15 PM - Speaker Presentations
7:00 PM - Q+A Session
7:20 PM - Networking and Refreshments

*Tours are member-only*

SPEAKERS:

REGISTRATION FEES:

Registration by EOD Wednesday, November 6, 2024
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration Starting Thursday, November 7, 2024
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10 

**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER NOVEMBER 7 ARE SUBJECT TO BILLING**

This Program Has been CANCELED. If you have any questions, please contact the office at 781-647-4773.

Please join us at an upcoming program at Common Craft in Burlington!

Registration is now closed for this program. If you have any questions, please contact the office at 781-647-4773.

Grab your paint brush and join us for an evening of fun and planning. We will provide the pumpkins and paint. All you need to bring is your ideas and creativity.  The WIP Programs Committee would like YOUR help to develop the educational and social program content for the upcoming Chapter year. Please join us on Thursday, October 24 as the 2025+ season is developed.

Waters and juices along with light appetizers will be served.

Cost  
$15.00 per person

Location
Shawmut, 560 Harrison Ave, Boston MA
( Directly across from SoWa Power Station 550 Harrison Avenue Boston, MA)

Parking available at 560 Harrison lot, 500 Harrison Ave Lot, 460 Harrison Ave Lot and street parking. 

Indian Pond Country Club
60 Country Club Way
Kingston, MA 02364

Registration is now open. If you are interested in a foursome, complete the paper form or the online form.

PLEASE NOTE:

There is a one foursome per company maximum. Spaces will be filled on a first come, first served basis. Foursomes will not be confirmed without payment. Cancellations/Refunds will only be granted if your space can be filled. ISPE Boston will request your team member names two weeks prior to the tournament.

This year’s show will feature more than 450+ exhibitors, 4500+ professionals, seven educational sessions, seven communities of practice sessions, innumerable networking opportunities, an extensive career fair, events highlighting Emerging Leaders, Women in Pharma®, EDEI initiatives and more. Plus, our famous After Party will be back on the field at Gillette Stadium with opportunities to kick a field goal and meet two famous sports players (Names to be Announced)! 

Register today: https://ispe.swoogo.com/ISPEBostonProductShow

REGISTRATION IS CLOSED, walk ins are welcome!

The ISPE Boston Area Chapter Women in Pharma (WIP) Committee is hosting a walk at Horn Pond in Woburn, MA! Join us and walk, skip, prance, or whatever moves you. 

- Dog, child, and family-friendly! All are WELCOME!
- We will meet at 4:00 in the parking lot on Lake Ave (85-93 Lake Ave, Woburn, MA 01801)
- The walk will commence at 4:15
- Sneakers or comfortable walking shoes are recommended

Location and Parking:
Horn Pond, 85-93 Lake Ave, Woburn, MA 01801
Recommended parking: onsite asphalt lot

What to Wear: 
Sneakers or walking shoes, weather-dependent clothing

What to Bring (all optional):
water, pets, kids, a smile!

Registration Fees:
$0 - this is a FREE event!

This event is sold out. If you have any questions, or would like to be added to the wait list, email us at office@ispeboston.org. 

LOCATION:

Blue Hill Country Club
23 Pecunit Street, Canton, MA 02021

Tentative SCHEDULE:
10:00 AM - 10:45 AM Registration and Buffet Lunch 
11:00 AM -Shotgun Start – Scramble Format
5:30 PM: Buffet Dinner 

PLEASE NOTE

There is a one foursome per company maximum. Most sponsorships come with one foursome. Spaces will be filled on a first come, first served basis. Sponsorships and foursomes will not be confirmed without payment. Cancellations/Refunds will only be granted if your space can be filled. ISPE Boston will request your team member names 1 month prior to the tournament.

This event is SOLD OUT!

Get ready for an exciting 9-hole golf tournament hosted by ISPE Boston's Women in Pharma on July 29! This tournament is designed to be shorter, perfect for beginners looking to get started in golf! Limited sponsorship opportunities are open as well.

LOCATION:
Robert T Lynch Golf Course 
1281 W Roxbury Parkway
Brookline, MA 02467

SCHEDULE:
11:00 AM - Arrival/Registration Check-in, Warm-up at Driving Range/Putting Green and Boxed Lunch
12:00 PM - Shotgun start - Scramble format
3:30 - 5:00 PM - Buffet Dinner and Awards

WHEN:
Thursday, July 25th, 2024
5:00 PM - 8:00 PM EST

WHERE:
Azzur Cleanrooms on Demand
45 Jackson Road
Devens, MA 01434

PROGRAM DETAILS:
Users and Providers: A Workshop of Exploring the Dialogue of Documents
Join us for an exciting and interactive evening with a facility tour, presentation, workshop, and social at the newly opened Azzur Cleanrooms on Demand in Devens. The event will start with refreshments and a tour of the Azzur Cleanrooms on Demand facility. The evening will focus on a workshop led by Howard Sneider, where we will explore the interplay of user requirements specification and scope of work documents. We will explore what each document needs to convey, and the process of mapping, analyzing, and validating how each requirement is satisfied. The participants will break into groups, practice eliciting, analyzing, and writing requirements, and share the results at the end of the workshop so everyone can benefit from each group's expertise. We will conclude the evening at Sterling Street Brewing located next door.

AGENDA:
5:00 PM - Arrival, Networking, and Facility Tours
6:15 PM - Presentation and Workshop
7:30 PM - Optional Networking at Sterling Street Brewing

SPEAKER:

Howard Sneider is a Senior Process/Specialty Engineer in the Advanced Technologies and Life Sciences department at Fluor. Howard has over 25 years of experience in process design, modeling, simulation, and equipment design. He has worked on each side of the relationship between the operating company and the architecture, engineering, and construction firm.  Howard also has over 20 years of experience as a member of the ISPE Boston Area Chapter and volunteered as a member and leader of the Educational Program Committee and a general member of the Board of Directors.

REGISTRATION FEES:
Registration by EOD Thursday, July 18, 2024
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, July 18, 2024
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER JULY 18 ARE SUBJECT TO BILLING**

The Educational Programs Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 17th as the 2025+ educational season is developed. We are looking for program managers both experience and new to join our team.

SCHEDULE:

5:00 – 6:00 Networking Reception with ISPE Boston Board of Directors
6:00 – 6:15 Introductions & Agenda
6:15 – 6:25 Review of 2023-2024
6:25 – 6:45 Chair goals for 2024-2025
6:45 – 7:45 Completing 2025+ Meeting Grid

LOCATION:

DPR Construction, 950 Winter Street, Waltham, MA

THIS EVENT IS SOLD OUT!! Walk-ins will NOT be accepted onsite. If you have any questions, please contact office@ispeboston.org.

Thursday, July 11, 2024
5:30 PM - Social at the Lansdowne Pub**
7:00 PM - Boston Red Sox vs. Oakland Athletics

Join the ISPE Emerging Leaders on Thursday, July 11 to watch the Red Sox take on the Oakland As at Fenway Park! First pitch is at 7:00 pm. Before the game starts, we will be hosting a pregame at the Lansdowne Pub starting at 5:30 pm (located at 9 Lansdowne St., Boston, MA 02215).

Registration is $40 a person and includes food and two free drinks at the Lansdowne Pub, as well as a ticket to the ball game. Space is limited to 50 people so sign up quickly!

** Please note:
The Lansdowne Pub is a 21+ only venue. 

Registration Fees:
$40 / person - limited to 50 people!

A Big Thank You to Our Sponsor, BWT, for Making this Event Possible!

Online, pre-registration for this event will close on 6/26 at noon. Walk-in registrations onsite are welcome!

ISPE Boston’s Social Committee invites you to a fabulous Summer Social & Volunteer Appreciation bash! Get ready for cool drinks, great vibes, and tasty treats at River Bar in Assembly Row. This spot boasts a hip setting with a variety of street food, a cozy patio with fire pits, and picturesque views of the Mystic River.

The cost of attendance covers:

• Two Drink Tickets
• Light Snacks

Registration Fees:

ISPE Members - $15
Non-Members - $25

Registration is closed. Walk-ins are welcome!

Wednesday, June 19, 2024 
4:30 - 8:00 pm
Museum of African American History
46 Joy Street, Boston, MA  02114

Join us for our 2nd Annual Juneteenth Celebration—an evening where culture, education, and networking converge in a historic setting. Dive deep into the rich narratives and pivotal moments of African American history, guided by a knowledgeable historian who brings the past to life.

Event Schedule:

4:30 - 5:00 pm        Arrival and Registration
5:00 - 6:00 pm        Welcoming Reception with Light Bites and Refreshments 
6:00 - 6:30 pm        Guided Museum Tour by a Historian- Explore the museum's most impactful exhibits, enriched with insights and stories shared by an expert in African American history.
6:30 - 8:00 pm        Extended Networking Opportunity - Engage with industry peers in a meaningful discussion about the past, present, and future impacts of diversity and inclusion within our community.

Your registration includes the following:

• Exclusive access to the museum with a professional historian-led tour
• Complimentary soft drinks
• A selection of gourmet light bites
  

Why this Celebration Matters:
This Juneteenth, elevate your understanding of African American contributions and struggles through an immersive educational experience. The event is designed not only to commemorate this historic day but also to provide a platform for professional growth and community building. Whether you’re seeking to enrich your knowledge, meet like-minded professionals, or contribute to discussions on cultural equity, this evening promises to be an invaluable addition to your calendar.

Celebrate, learn, and connect with us at this significant and inspiring event.

Registration Fees:

ISPE Members - $30
ISPE Emerging Leader Members - $20
ISPE Student Members - $20
Non-Members - $40

If you have any questions, please contact (office@ispeboston.org) 

THANK YOU TO OUR SPONSORS FOR MAKING THIS EVENT POSSIBLE!

Pre-registration for this event is closed. Walk-in registrations will be accepted onsite. Payment is due at the registration desk. If you have any questions, please contact the office at Office@ISPEBoston.org. 

WHEN: Thursday, June 13, 2024 | 4:00 – 6:30 PM

WHERE: 100 Chestnut Street, Somerville, MA 02143- 1st Floor Café

This brand new building isn't featured on Google Maps yet. View the new building here: https://www.100chestnutstreet.com/

100 Chestnut Street is easily accessible by MBTA Green Line Extension- East Somerville & Somerville Community Path. Complimentary public garage parking & onsite street parking within 100 Chestnut.

PROGRAM DETAILS: 
Do you find yourself thinking most peoples’ careers are linear and yours is a windy road? Are you wanting to embrace other areas of interest but not sure how to change your path? Join a panel of life science professionals sharing different perspectives of navigating the planned & serendipitous trajectories-- and how they ended up in the positions they are in! 

AGENDA:
4:00-4:30 Arrival and Tour/ Networking
4:30-5:30 Panel 
5:30-6:00 Networking

REGISTRATION FEES:
Members: $30
Non-Members: $50
Emerging Leaders Members: $20
Student Members: FREE  

PANELIST:
Michele Picard, Sr. Director, Facilities and Laboratory Operations at Kymera Therapeutics
Divya Krishnamurthy, Sr. Director Workplace Operations at Lyndra Therapeutics
Gianna Ferron, New England Biopharma Sales Executive at 10x Genomics
Moderator: Jennifer Reilly, President at Safety Partners

PANELIST BIOGRAPHIES:

Michele Picard, Kymera Therapeutics
As Sr. Director of Facilities and Lab Operations Michele oversees daily internal operations at Kymera including capital projects, facilities, laboratory, and operations.

During her 30 years in research both at the bench and in leadership positions she has managed laboratory buildouts, relocations and supervised laboratory and vivarium operations in addition to her research responsibilities. Her experience building two start-up companies and establishing operational programs and policies were the catalyst for her transition into operational roles.

Michele began her career at Boston University Medical Center and Avant Immunotherapeutics studying infectious diseases and Immunology. She was a founding scientist at Momenta Pharmaceuticals and later at Genocea Biosciences where began the transition to a fully operational role.

Michele holds a Bachelor of Science degree in Biology from Clark University and a Master of Science degree in Public Policy from the Tufts Cummings School of Veterinary Medicine.

Divya Krishnamurthy, Lyndra Therapeutics
Divya Krishnamurthy is currently Senior Director, Workplace Operations and Safety at Lyndra Therapeutics where she oversees all aspects of health and safety, GMP and n-GMP Facilities Operations, and DEA controlled substances compliance across all Lyndra sites.

Divya obtained her Ph.D. in Chemistry from Johns Hopkins University and began her career in academia as Research Assistant Professor at the University of Utah and the Harvard School of Public Health. She then made a transition to a career in EHS in roles with increasing responsibility and leadership, most recently as Director Global EHS at Ultragenyx, where she seamlessly integrated best practices, optimized EHS operations, and maintained the highest standards of safety and efficiency across all Ultragenyx sites. Before Ultragenyx, Divya was at Alkermes where she led the development and management of EHS programs ranging from pilot, kilo lab and large-scale chemistry and biology.  Prior to that she was a safety consultant at Safety Partners.

Leveraging over 20 years of diverse experience across biotech and pharma, as both a scientist and seasoned environmental health and safety (EHS) leader, Divya is passionate about creating and sustaining fully integrated, fit- for-purpose programs that keep people safe and healthy with a positive impact to our environment, while ensuring efficient operations.

Gianna Ferron, 10x Genomics
Gianna received her B.A. in Biology from Boston University in 2020 with a hands-on focus in neuroscience. After graduating, she joined a small biotech company as an associate scientist and moved into a scientist role. Gianna then took a project management focus to work directly with many pharmaceutical companies, catalyzing her transition to a business development position within the same company. She began an evening MBA program and transferred to a biotech and pharmaceutical sales executive role at 10x Genomics shortly before receiving her master’s degree at the end of 2023. In a few short years, Gianna has built both an expansive professional network and deep foundational knowledge across both science and business.

Moderator: Jennifer Reilly, Safety Partners
As President and Chief Operating Officer, Jennifer manages the daily operations of the company, including client service, service delivery, recruiting, sales, Quality, Research and Training and daily business operations. Leveraging over 25 years of experience in health and safety and lab operations, Jennifer has developed, managed, and implemented client programs specializing in radiation, chemical, and biological safety while taking on increasing operational responsibilities at Safety Partners.

Prior to joining Safety Partners in 2007, Jennifer spent five years at Alnylam Pharmaceuticals in Cambridge, MA, where she served as Senior Laboratory & Safety Manager for the laboratory facility.  She developed and maintained its environmental health and safety program as well as managed the animal care facility.  Prior to Alnylam, Jennifer held research positions at Biogen, Inc., Curis, Inc. (formerly Ontogeny, Inc.), and Brigham and Women’s Hospital in Boston, MA. Jennifer received a Master of Liberal Arts degree in Biology from Harvard University, and a Bachelor of Arts degree in Biology from Saint Anselm College.

<sup>All paddler spots are taken but spectators are free to join us and cheer on the team and to enjoy the festival! 

*More information on spectator and volunteer opportunities below!</sup>

Saturday, June 8, 2024
Sunday, June 9, 2024 

8:00AM—3:00 PM
John W. Weeks Bridge, Cambridge, MA 02163

Join the Ethnocultural, Diversity, Equity, and Inclusion Group as we gear up for the Boston Hong Kong Dragon Boat Festival! We're seeking 20 dedicated paddlers who are eager to compete alongside our vibrant community. Last year, we proudly secured second place in our category, and this year, our sights are set on the Gold.

To join, you'll need to attend at least one practice session between late April and early June, held on the picturesque Charles River. The festival itself takes place on June 9th, preceded by our first race for seeding on June 8th. It promises to be an exhilarating and rewarding team bonding experience. Are you ready to paddle your way to victory with us?

Important Note: The team is limited to 20 paddlers, please register early! 

*Join us for a day of excitement at the Boston Dragon Boat Festival on Sunday, June 9th! Bring your family and experience everything we have to offer. Indulge in delicious Asian cuisine, enjoy captivating performances, and cheer on the ISPE team as they race to victory!

We're currently seeking volunteers to help make this year's festival even more memorable. We need assistance with taking photos of the event and ensuring our team stays hydrated and energized throughout the day. Last year was fantastic, but with your help, we can make this year even better! If you're interested in spectating or volunteering, please contact us at office@ispeboston.org.

Registration Fees:

ISPE Members – FREE!
Non-Members - $20

Participants will be required to complete a waiver with ISPE Boston.

Due to onsite security requirements, registration for this program closed at 3:00PM on Monday, June 3rd. Walk-in registrations will NOT be accepted.

WHEN:
Thursday, June 6th, 2024
12:00 PM - 6:00 PM EST

WHERE:
Alkermes
900 Winter Street
Waltham, MA 02451

PROGRAM DETAILS:
GAMP 2024 Forum
Join the Educational Programs Committee and GAMP Steering Committee for an afternoon of all things GAMP! We've invited speakers from the FDA to join us for this half-day program. 

AGENDA:
12:00 PM - Arrival and Networking
                Includes food and beverages
1:00 PM - Welcome and Introductions
                Christopher Ciampa & Kathy Marini
1:30 PM - Overview of upcoming GAMP Global publications
                Lorrie Schuessler
2:00 PM - Panel Discussion with FDA on critical thinking and risk-based approach to computer system validation
                Geetanjali Abbi, Stephen Ferrell, Heather Longden, Lorrie Schuessler, Brandi Stockton, & Seneca Toms
3:00 PM - Vendor qualification and quality agreements for cloud PaaS/IaaS/SaaS suppliers
                Geetanjali Abbi & Stephen Ferrell
3:40 PM - Networking break
                Includes food and beverages
4:20 PM - Challenges with implementing AI
                Brandi Stockton
5:00 PM - Fireside chat with the FDA
                Heather Longden & Seneca Toms
6:00 PM - Event close
                Geetanjali Abbi & Christopher Ciampa
6:15 PM - Optional networking at the Craft Food Hall in Waltham
                This post-event meetup is self-sponsored

SPEAKERS:
Geetanjali Abbi
Stephen Ferrell
Heather Longden
Lorrie Schuessler
Brandi Stockton
Seneca Toms

REGISTRATION FEES:
Registration by Thursday, May 30, 2024
Members (Early Bird): $125
Non-Members (Early Bird): $195
Emerging Leaders Members (Early Bird): $65
Student Members: FREE

Registration after Thursday, May 30, 2024
Members: $135
Non-Members: $210
Emerging Leaders Members: $75
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER MAY 30 ARE SUBJECT TO BILLING**

This event is sold out. If you would like to be placed on a wait list, contact the office at office@ispeboston.org.

LOCATION:
Renaissance Golf Club
377 Kenoza Street, Haverhill, MA  01830

SCHEDULE:
10:00 AM - 10:45 PM Registration and Buffet Lunch 
11:00 PM -Shotgun Start – Scramble Format
5:30 PM: Buffet Dinner 

Please contact the office at (781) 647-4773 if you have any questions about this event.

This event is sold out; walk-ins will not be accepted onsite. If you'd like to join the waitlist, please email office@ispeboston.org.

WHEN:
Thursday, May 16th, 2024
5:00 PM - 8:00 PM EST

WHERE:
Takeda
650 Kendall Square
Cambridge, MA 02141

PROGRAM DETAILS:
AI in Manufacturing: Bridging Human Expertise and Technological Innovation
Join the Educational Programs Committee for three expert panels on AI in the BioPharma world! 

AGENDA:
5:00 PM - Arrival and Networking
• Includes food and beverages
6:00 PM - Presentations with Q+A
• How Generative AI is Changing the Way We Think About Manufacturing
Norma Levya (Takeda)
• Generative AI and its application to the exploration of pharmaceutical data sets
Andrew Fiordalis (Takeda)
• Adapting to Technological Change: Integrating AI into Science and Engineering Curricula at WPI
Dr. Robert Dempski (Worcester Polytechnic Institute)
7:30 PM - Networking

SESSION ABSTRACTS:
How Generative AI Is Changing The Way We Think About Manufacturing
GxP manufacturing has historically relied on the application of tribal and systemic knowledge to ensure the safety, purity, and efficacy of a product.  Floor personnel apply these knowledge domains to resolve deviations and investigations or to expand their process understanding (e.g. continuous process verification).  Recent advances in the application of large language models such as GPT are poised to create a human-AI interface that significantly increases the efficiency of operators and subject matter experts as they execute CMC lifecycle management activities such as process scale-up and technical transfers.  This talk will illustrate some of the ways large language models are being developed within Global Manufacturing Sciences to create human-AI partnerships that integrate GxP expectations.

Generative AI and its application to the exploration of pharmaceutical data sets
Join us for an immersive exploration of GenAI's transformative potential in revolutionizing the global investigations workflow. Delve into the depths of this innovative technology with Andrew as he elaborates on Paul's insightful examples. Discover the intricacies of prompt engineering, the seamless automation of ETL tasks, and the power of GenAI in conducting exploratory data analysis and modeling. Don't miss this opportunity to unlock the full spectrum of GenAI's capabilities.

Adapting to Technological Change: Integrating AI into Science and Engineering Curricula at WPI
In today's rapidly evolving technological landscape, seamlessly integrating artificial intelligence (AI) approaches into university curriculum has become more important than ever. By seamlessly integrating AI into curricula, universities can better prepare students for the demands of an AI-driven workforce, fostering innovation and equipping graduates with the necessary skills to tackle real-world challenges. However, implementing AI in education poses various challenges, including the need for faculty expertise, access to resources, and the development of appropriate pedagogical approaches. This presentation is intended to focus on ongoing efforts to better integrate AI tools into some of WPI’s ongoing research and teaching efforts.

SPEAKERS:

REGISTRATION FEES:
Registration by Thursday, May 9, 2024
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, May 9, 2024
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER MAY 9 ARE SUBJECT TO BILLING**

JOIN THE 56th WALK FOR HUNGER, UNITING FOR CHANGE SINCE ’69!

We've joined Project Bread's The Walk for Hunger to help transform the landscape of food insecurity in Massachusetts.  The in-person Walk on Sunday, May 5, 2024, is a family-friendly event that offers a 3-mile route on the Boston Common designed for every age and ability. Let’s make a difference together and build a hunger-free future!

Register now at https://give.projectbread.org/team/574880

Project Bread is committed to making sure that people in Massachusetts can afford enough to eat because hunger is an injustice. They seek out the expertise of those who experience hunger and make sure those voices are at the center of Project Bread’s strategy, research, and programs. This is essential to their policy work to build a system based on equity so that everyone gets what they need to thrive.

Your impact resonates deeply, especially in aiding the 1 in 4 families with children currently facing food insecurity, ensuring they have access to the nourishment they need. Thank you! 

Location & Parking:

Boston Common
Boston, MA

What to wear: sneakers or walking shoes, weather-dependent clothing

What to bring (all optional): water, pets, kids, mask, etc.

 Eric Felz will be your host. Any questions, email: office@ispeboston.org

Pre-registration for this event closed on Monday, April 29th at 5pm. Walk-ins will be accepted onsite.

Please join the ISPE Boston GAMP Community of Practice for our second social networking event of the year! 

Thursday, May 2, 2024
5:30 pm to 7:30 pm
Lily Ps
50 Binney Street, Cambridge, MA 02142

This no-charge meet-up will be at Lily P’s in Cambridge.  It is an informal event with a chance to get to know more about your local GAMP community of practice and share your CSV or Data Integrity successes and challenges with like-minded GAMPers.

Although attendance is free, PLEASE register when you know you can definitely attend. Registration helps with the planning and name tags, etc.

This event is strictly capped due to the space Lily P’s are offering. If something happens and you can’t make it - PLEASE email office@ispeboston.org so that someone else might be able to attend.

ISPE Boston Area Chapter will kindly provide light appetizers. 

The GAMP Boston CoP Steering Committee will be in attendance and encouraging enlightening conversations as well as your ideas for future interactions the CoP can facilitate! What can you offer along the way? Do you want to become more active in the committee?  Let us know!

THIS EVENT IS SOLD OUT. Walk-ins will NOT be accepted onsite. If you have any questions, please contact the office at office@ispeboston.org. 

WHEN:     Wednesday, April 24th | 6:00 pm – 8:30 pm

WHERE:   MilliporeSigma M Lab™ Collaboration Center
                 400 Summit Drive, Burlington, MA 01803

PROGRAM DETAILS:
Join the ISPE Emerging Leaders Committee and learn about Bioprocessing Modalities and the advanced testing and bioprocessing technologies that enable them. Brandon Musitano (Lonza) will present an overview of bioprocessing followed by two hands-on tours in a state-of-the-art bioprocessing suite where MilliporeSigma experts in MS&T will discuss key technologies. The agenda is:

6:00 - 6:15             Grab a drink (included), mingle, and settle in

6:15 -6:45              Bioprocessing 101

            Brandon Musitano, Lonza Biologics

6:45 - 7:30             Rotation 1 Tour (25 guests) / Rotation 2 Dinner

                                                  Evan Gates, MilliporeSigma

                                                  Greg Voyta, Millipore Sigma

7:30 - 8:15             Rotation 2 (25 guests) / Rotation 1 Dinner

                                                  Joel Ngoje, MilliporeSigma

                                                  Kevin Calnan, MilliporeSigma

                                                  Patrick McGee, MilliporeSigma

8:15 - 8:30             Social

Attendees will be able to select from one of the following tour sessions on a first-come first-served basis. Closed-toed shoes are required to enter the suite. Please dress appropriately.

REGISTRATION FEES:

Registration by April 17th
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE                                                           

Registration After April 17th
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE

THIS EVENT IS SOLD OUT. Walk-ins will NOT be accepted onsite. If you have any questions, please contact the office at office@ispeboston.org. 

WHEN:     
Thursday, April 11, 2024 | 4:30 pm – 6:30 pm

WHERE:   
PM Group, 200 Summit Dr., Suite 105, Burlington MA 01803

PROGRAM DETAILS: 
Join us for an exciting and interactive networking workshop led by Jayne Mattson, where you'll discover the keys to boosting your confidence, effectively engaging with others, and cultivating long-lasting relationships. In the realm of business, the connections you forge play a pivotal role in shaping your career trajectory. These relationships not only bolster your success in your current position but also pave the way for advancement to higher levels of responsibility. ISPE Boston’s Women in Pharma is committed to equipping individuals with the skills necessary to thrive in this arena, and we warmly invite you to participate in this enriching experience on April 11th. Don't miss out on this valuable opportunity to enhance your networking prowess and propel your professional journey forward!

SPEAKER:
Jayne Mattson is an Author, Career Coach and Speaker in her own business working with early to mid-career professionals in all areas of career management. She has worked in the Career Management field in Outplacement for over 20 years coaching career professionals through a successful career transition and Higher Education working with college students as they enter the job market.

Jayne authored a book on how to build relationships titled You, You, Me, You The art of talking to people, networking, and building relationships. She is enthusiastic about helping professionals develop and understand the value of building and maintaining relationships as the key to career success.

Registration Fees:
Members: $15.00
Non-Members: $25.00

This event is now sold out and walk-ins will NOT be accepted onsite. If you would like to be put on a wait list, contact the office at office@ispeboston.org.

When:
Thursday, April 4, 2024
6:00 PM - 8:00 PM EST

Where:
Lucky Strike Somerville
325 Revolution DR, 1128, Somerville, MA 02145

Program Details:
The ISPE’s Student Development and Emerging Leaders Committees invite you for an exciting evening of bowling, fun, and networking! This event is exclusively designed for ISPE student members, recent graduates, and young professionals who are looking to expand their social and professional networks.

Registration includes networking, private bowling lanes, shoe rentals, one free drink ticket, and delicious appetizers!

Registration Fees:
ISPE Student Members: $5
Emerging Leaders: $15
Members: $20
Non-members: $30

Transportation:
Orange line T stop at Assembly Station, or plenty of parking available.

Important Note:
This event is limited to 50 attendees and will sell out so please register early. We hope to see you there!

This event is now sold out and walk-ins will NOT be accepted onsite. If you would like to be put on a wait list, contact the office at office@ispeboston.org or (781) 647-4773.

Friday March, 22, 2024
6:00 – 10:00 PM

UMass Club Boston
1 Beacon St 32nd floor, Boston, MA 02108

The ISPE WIP and EDEI Committees would like to invite you to the "Around the World Gala" event. This elegant soirée offers the opportunity to sample international cocktails, relish fine cuisine and indulge in delectable desserts. Wearing cultural attire is highly encouraged while black tie is optional. Join us for an unforgettable evening!

Your registration includes:

• Two (2) drink vouchers to sample exotic cocktails
• A delectable dinner
• An evening of fun dining, dancing, and mingling

Parking: the One Beacon Garage offers a discounted rate of $8 after 4pm. Visit the office in the garage prior to departure for more information.  There is additional parking in the Government Center Garage, or the PO Square Garage; all within walking distance of the Club.

Registration Fees*:

ISPE Members - $100.00
ISPE Members +1 - $175.00*
ISPE Emerging Leader Members - $55.00
ISPE Student Members - $55.00
Non-Members - $140.00

 *Members must register their +1 as a separate registration using your member ID and GALA25 in the discount code field to receive the special pricing. This code is only eligible for full ISPE Members. Emerging Leaders, Student Members, and Non-Members are ineligible to use the code.

Sold out! Email office@ispeboston.org to join the waitlist!

Price Includes: Roundtrip bus ride, full-day adult lift ticket, lunch voucher, buffet dinner at T Bars, and fun with fellow ISPE members!

Bus Departures:

6:00 AM - Departure from Newton Marriott, Rte. 128
6:40 AM - Departure from Chateau Restaurant, Andover, MA
7:40 AM - Departure from LL Bean, Concord, NH
4:30 PM – Buses Depart Waterville Valley to Return to all drop-off sites

Individual Tickets $140 (ISPE Members) / $195 (non-members)

Books of 4 Tickets are SOLD OUT available for $495.  Download the printable registration form to register or contact the office at office@ispeboston.org or 781-647-7222.

Note: All attendees will be sent a ski wavier which must be completed and returned to office@ispeboston.org

Pre-registration is closed.
If you have any questions, please contact the office at office@ispeboston.org or 781-647-4773

Join the ISPE Boston GAMP Community of Practice for our first social networking event of the year! 
Thursday, February 29th | 6:00 pm to 8:00 pm
Trillium Brewery, Canton, MA

This no-charge, informal meet-up event with a chance to get to know more about your local GAMP community of practice and share your CSV or Data Integrity successes and challenges with like-minded GAMP-ers.

While ISPE Boston is kindly providing a few appetizers, this is mostly a self-funded event for the cash bar and/or dinner options that Trillium provides. Don’t forget the takeout opportunity for their excellent beer offerings.

The GAMP Boston CoP Steering Committee will be holding court, ready to soak in your brilliant ideas for future events. Whether it's topics, locations, or event suggestions, we're all ears! And guess what? We've got some exciting plans for 2024 that we can't wait to spill the beans on. 

Register here so we get an idea of head count. See you there!

SOLD OUT! Registration is closed for this event!

WHEN:     Thursday, February 15th, 2024 | 4:30 pm – 6:30 pm

WHERE:   Tome Bioscience
                  100 Talcott Avenue
                  Watertown, MA 02472    

PROGRAM DETAILS: 
Trends in Cell and Gene Editing
CRISPR, mRNA, and LNP oh my! The field of cell and gene editing is rapidly evolving, spurring innovation across the manufacturing landscape. Come hear about the latest cell and gene editing technologies and their manufacturing strategies.

AGENDA:
4:30 pm Arrival & Networking

• Includes food and beverages (two drink tickets will be provided to each attendee)

5:00 pm Introduction by Tome, Panel Discussion, and Q+A
6:00 pm Networking 

SPEAKERS:

Matt Barrows, Chief Technology Officer, Tome Biosciences Matt brings over 20 years of senior leadership in chemistry, manufacturing and controls. He was most recently Executive Director, Commercial Manufacturing at Moderna Therapeutics, where he led the manufacturing scale-up of Spikevax, Moderna’s COVID-19 vaccine and Moderna’s Personalized Cancer Vaccine scale-out and production. Prior to that, Matt served as Upstream Manufacturing Lead & Head of Operational Readiness at Alexion Pharmaceuticals and held leadership roles at Genzyme/Sanofi in Manufacturing, Process/Automation Engineering and Consent Decree Remediation. He received his MBA from Northeastern University and BS in Biotechnology from Worcester Polytechnic Institute.

John Finn, PhD, Chief Scientific Office, Tome Biosciences John brings over 20 years of gene therapy experience with a focus on genome editing and delivery technologies. He was most recently Vice President of Discovery Research at Codiak Biosciences, where he led the development of a new class of therapeutics based on engineered exosomes. Prior to Codiak, John was Executive Director of Platform Biology and Liver Discovery at Intellia Therapeutics, where he was responsible for the development of viral and non-viral delivery systems and demonstrated the first in vivo systemic administration of CRISPR-based therapeutics. Previously, John served as Director of Research at Arthrogen, developing novel AAV and exosome-based therapeutics. He serves as an American Society of Gene and Cell Therapy Committee Member for Nanoagents and Synthetic Formulations; Genome Editing; and Metabolic and Inherited Disease. John trained with Pieter Cullis and Ian MacLachlan and received his PhD in Biochemistry and Molecular Biology from the University of British Columbia and BS in Molecular Biology and Genetics from the University of Guelph. He completed post-doctoral programs in Immunology and Vaccine research at McMaster University and Hematology and Gene Therapy with Katherine High at the Children’s Hospital of Philadelphia.

REGISTRATION FEES:  

Registration by Thursday, February 8, 2024
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, February 8, 2024
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER FEBRUARY 8 ARE SUBJECT TO BILLING**

Pre-registration has ended but walk ins will be welcome

WHEN: Thursday, February 8, 2024 | 6:00 – 8:00 PM

WHERE: Lamplighter Brewery, 110 N. First Street, Cambridge, MA 02139    

PROGRAM DETAILS: 
Panel Discussion: Navigating Your Way To Leadership And Early Career Management

Ever wondered how to get into early management in your career? Come talk to other early managers and learn about their successes, failures and how they ended up in the positions they are in! The panel will feature life science professionals who have worked their way into management positions, along with a career coach as the moderator. We will have time for questions and open networking all while sharing a beverage.

SPEAKERS:

I started my journey in the biotech industry as an intern at a small biotech company during my last semester of college. The exposure to different aspects of the organization really sparked my interest in the field. It was incredibly rewarding for me to be able to have direct influence in developing a novel therapeutic and its path to market. During my time with the organization I worked in process development, marketing, analytical development, and quality control. I had my first leadership role here overseeing a small team of lab technicians. As the company grew, so did my responsibilities and I took on several leadership roles within quality control where I was responsible for method qualifications, EMPQ, stability studies and implementation of cGMP lab. In 2021, I moved to Boston to continue working in the CDMO space where I am currently Director of Analytical Development. I absolutely love being in a position that allows me to foster a creative working and learning environment.  

I received my B.S. in Chemical Engineering, with a concentration in Biomolecular Engineering and minor in Theology, from the University of Notre Dame in 2018. Growing up with a brother with special needs, I have always felt connected to patients and families navigating the world of rare diseases and knew I wanted to use my Engineering degree to impact a similar patient population. I started my career in the biopharma industry at Takeda Pharmaceuticals (formerly Shire) in a rotational program, spending 2.5 years gaining broad industry experience in Safety Engineering, Global Quality in Device and Combination Product Development, and supporting the production of biologics as a Manufacturing, Science, & Technology Engineer. After spending some time getting hands-on in the lab as a Purification Development Engineer, I was presented with my first leadership opportunity to be a Manufacturing Supervisor in 2022. The combination of technical production support, employee engagement and professional development, and connection to patients has been incredibly fulfilling. I moved from Takeda to uniQure Pharmaceuticals at the end of 2022 and am currently a Manufacturing Senior Supervisor responsible for Bioreactor production and overseeing 7 technicians. When I'm not spending time with my husband, Mark, and our friends, I am working to progress in my M.S. in Engineering Management program through Tufts, which I hope to complete in 2025.

Eoin Kiely is a dedicated professional with over 10 years of experience in the biotech manufacturing industry. He holds a Bachelor's degree in Chemical Engineering from University College Cork, Ireland, and a Masters in Engineering Management from Tufts University. Currently, Eoin serves as the Program Management Site Head at ThermoFisher's Plainville site, where he is a member of the site leadership team.

Throughout his career, Eoin has held various roles, including Head of F&E, Senior Manager Automation, Manufacturing Manager, Operations Program Lead, and Automation Engineer. In his current position, he takes pride in leading a team that serves as the primary point of contact for customers, ensuring the site's commitment to customer satisfaction. Eoin's educational background and diverse professional journey reflect his genuine passion for the industry and a continuous willingness to adapt and grow in different roles.

Michael (Mike) Scarpone is a dynamic leadership and development coach. His deep understanding of corporate culture has enabled him to work with over 150 clients representing a diverse array of for-profit and non-profit organizations on a local, regional, and national level. Mike holds a bachelor’s degree in psychology as well as a Master of Science in counseling psychology and has completed graduate work in organizational behavior and administration.  His certifications include:

·         Certified Executive Coach
·         Board Certified Coach
·         Certified Master Facilitator
·         Black Belt in Lean/Six Sigma process
·         Emotional Intelligence
·         Myers-Briggs Type Indicator
·         Positive Intelligence

He has served as CEO for three different organizations and currently has his own coaching and leadership development practice.

REGISTRATION FEES: 
Registration by Thursday, February 8, 2024
Members: $25
Emerging Leaders Members: $20
Non-Members: $30
Student Members: FREE

*Your ticket includes a drink and appetizers. 

LOCATION: The Lamplighter Brewery at Cambridge Crossing is easily accessible by MBTA Green Line E. The brewery is 2 blocks from Lechmere. There is limited street parking.

**PLEASE NOTE: CANCELLATIONS RECEIVED ATER TUESDAY, FEBRUARY 6, 2024 ARE SUBJECT TO BILLING**

WHEN:     Saturday, February 3rd, 2024 | 9:00 am – 4:30 pm

WHERE:   Ultragenyx Office
               16 Crosby Drive
               Bedford, MA 01730      

PROGRAM DETAILS COMING SOON!

Join the ISPE Boston Student Development Committee for the 2024 Annual ISPE Career Development Workshop! We want our Students and Recent Graduates to feel confident entering the world of Biotech and have planned a Full Day with that mission in mind. Activities include a Panel Discussion, the Wheel of Workshops, and the Poster Session. Poster submission is limited and is first come first serve. Please indicate your preference on the registration form.

AGENDA

09:00 - 09:30 AM  |  Doors Open + Breakfast
09:30 - 10:30 AM  |  Welcome / Activity for Students Only
10:30 - 11:30 AM  |  Panel Discussion with Workshop Leaders
11:30 - 12:30 PM  |  Lunch Social
1:::012:30 PM111 |  Wheel of Workshops (25 min each)
111::01-1111:111 |  Poster Session
1::004:15 PM1:11 |  Thank You and Farewell

RESUME REVIEW
Are you interested in having your resume edited? Upload your resume HERE! Edited resumes provided before the event will be handed back with comments by the editor and time for follow-up questions will be included at the end of the day.

MORE SPEAKERS TO BE ANNOUNCED!

Jayne Mattson, Career Management Coach and Principal, Jayne Mattson Jayne is an Author, Career Coach and Speaker in her own business working with early to mid-career professionals in all areas of career management. She has worked in the Career Management field in Outplacement for over 20 years coaching career professionals through a successful career transition and Higher Education working with college students as they enter the job market.  A skilled facilitator and inspirational speaker, Jayne speaks frequently on topics that include “Building your Confidence for Career Success” and “Understanding Corporate Culture Before You Accept a Job Offer” and “Confident Women Setting Boundaries.” Jayne authored a book on how to build relationships titled You, You, Me, You The art of talking to people, networking, and building relationships. She speaks to early to mid-career professionals in organizations and professional associations such as MassBio and ISPE on her framework of You, You, Me, You. She is enthusiastic about helping professionals develop and understand the value of building and maintaining relationships as the key to career success.

THANK YOU TO OUR SPONSOR AND SITE HOST!

REGISTRATION IS CLOSED; THIS EVENT IS SOLD OUT!

Thursday, January 25, 2024
6:00—9:00 PM

Location: 
Night Shift Brewing
1 Lovejoy Wharf #101, Boston, MA  02114

ISPE Boston extends you a warm invitation to our Winter Social bash at Night Shift Brewing in Lovejoy Wharf, Boston. Let's clink our glasses and eat some yummy treats while we chat the night away! 

The door fee will cover it all:

• Admission to the merriment
• A spread of delicious finger foods
• Two (2) drink vouchers to quench your thirst

Registration Fees*:
ISPE Members - $20
ISPE Emerging Leader Members - $10
ISPE Student Members - $10
Non-Members - $30 

* If you are unemployed, email the office (office@ispeboston.org) for a discount code to attend the program for free. 

Important Note:
This event is limited to 80 attendees and will sell out so please register early. We hope to see you there! 

REGISTRATION IS CLOSED; THIS EVENT IS SOLD OUT! 

WALK IN REGISTRATIONS WILL NOT BE ACCEPTED ONSITE

Location: 
The Maharaja
57 John F. Kennedy St., Cambridge, MA
6:00 - 8:00 pm

Join ISPE Boston's Ethnocultural Diversity, Equity & Inclusion Committee for a memorable evening in Cambridge, MA. Dive into a world of delectable cuisines, engaging games and lively interactions designed to foster inclusivity and understanding among us all. Your registration includes appetizers, a sumptuous dinner, two complimentary drink tickets, and a series of enlightening games that aim to enhance inclusivity. Don't miss out on this opportunity to connect, learn, and have fun!

Cost to attend includes:
Two free drink tickets (cash bar available after that)
Delicious appetizers and dinner

Registration Fees:
ISPE Emerging Leaders Members - $15
ISPE Members - $30
Non-Members - $40
ISPE Student Members - Free

Registration is CLOSED. For any questions, please contact the office at office@ispeboston.org or 781-647-4773

WHEN:     Thursday, November 16^th, 2023 | 5:30 pm – 8:00 pm

WHERE:   Massachusetts Biomedical Initiatives
               17 Briden Street
               Worcester, MA 01605      

PROGRAM DETAILS:

Strategy and Innovation used for Building a Regional Biomanufacturing Cluster
Engage in a captivating panel conversation centered around concepts and subjects aimed at facilitating the introduction of bio manufacturing to a developing region like Worcester, MA! Discussion will revolve around strategies, technology, and innovation, all geared towards expediting the market entry of Biomanufacturing!

AGENDA:
5:30 pm Arrival & Networking

• Includes food and beverages (two drink tickets will be provided to each attendee)

6:15 pm Introduction by MBI, Panel Discussion, and Q+A

7:00 pm Networking

SPEAKERS:

	Ben Bradford, Head of External Affairs, Mass Bio Ben joined the MassBio team in 2017. As Vice President of Economic Development and Workforce, he oversees MassBio’s relationship with municipalities, international organizations, and the local real estate and development community.  He also works with member and non-member companies to support their decision-making on relocation or expansions. Through relationships with foreign economic development agencies, Ben works to connect foreign companies to the US market. Additionally, he serves as a resource for MassBio member companies as they look to grow their operations in Massachusetts from a personnel standpoint. Prior to MassBio, Ben worked as Director of Business Development and Regional Strategy at the Massachusetts Life Sciences Center where he was responsible for recruiting new companies to do business in Massachusetts and developing relationships with municipalities across the Commonwealth with the goal of expanding the industry state-wide. Ben has a B.A. in Political Science from Union College (NY). He lives in North Reading with his wife and two kids.
	Lily Fitzgerald, Senior Manager, Advanced Technology Programs, Massachusetts Technology Collaborative Lily Fitzgerald is the Senior Manager, Advanced Technology Programs at the Massachusetts Technology Collaborative, where she leads cluster development for bioindustrial manufacturing and additive manufacturing and helps manage the Massachusetts Manufacturing Innovation Initiative (M2I2) grant program. Prior to joining MassTech, Lily spent 7 years at Ginkgo Bioworks, where she worked as an early engineer in Ginkgo’s laboratories and later founded the Public Policy team, advocating for policies that grow the bioeconomy. She has an M.S. in Technology Policy from MIT and a B.S. in Environmental Science from UMass Amherst.
	Devin Gleeson, PMP, Vice President of Life Science & Technology, Timberline Construction Taking advantage of Timberline’s already robust life science and technology portfolio, Devin is responsible for bringing his industry knowledge, best practices, processes and standards to continue providing their clients with exceptional service while driving strategic growth with their leadership team.  Devin brings more than 20 years of project management, construction and engineering experience from top life science and technology companies. His career project experience is varied throughout the pharmaceutical, bio-pharmaceutical and semi-conductor industries and ranges from leading a $250 million GMP manufacturing facility expansion to the construction of a $1 billion semiconductor manufacturing facility.  Devin joined Timberline most recently from DPS Global Group where he was a Director of Project Management, responsible for over $75 million in projects for Ipsen Biopharma and Organogenesis. Prior to DPS he has worked with and consulted for several companies such as Entegris, Covidian, MannKind, Pfizer, ConocoPhillips, British Petroleum and Intel.
	Jon Weaver, President & CEO, Massachusetts Biomedical Initiatives (MBI) Jon is the President & CEO of Massachusetts Biomedical Initiatives (MBI).  MBI is the longest-running life science business incubator in the Commonwealth and focuses on supporting startups from Concept to Clinical Trials.  MBI also serves as the hub of the biotech ecosystem in Central MA and a leader in economic & workforce development policy. Jon received his Bachelors and MBA from Assumption University.  He previously served as Vice President, Real Estate at MassDevelopment and Senior Project Manager at the Worcester Business Development Corporation.  Prior to assuming the role of President & CEO, Jon served as the Chief Operating Officer of MBI for four years.  Jon is a current Board Member of Assumption University, the Worcester Regional Research Bureau, the Venture Forum, UMass Chan Clinical Translational Sciences Community Advisory Board, Berkshire Bank Central MA Advisory Board, Grafton Community Advisory Group, and Alumni Advisor to the Worcester Student Government Association.
	Caren Jenkins, Business Development Coordinator, CRB (Moderator) Caren is a Relationship Builder, Business Development, and Marketing professional in the Pharma/Biotech industry with 10+ years of experience in the A/E/C and cleanroom industries. She has a strong background in project management and client development. She is a founding member, past Co-Chair of Women in Pharma, and a Board of Directors Member for ISPE Boston Chapter. In 2017 Caren was awarded ISPE Boston’s prestigious Janice Tice Volunteer of the year Award for her contributions to the Boston chapter and in 2019 and 2022 ISPE Boston Women in Pharma was recognized as the committee of the year. Caren is passionate about mentoring, helping to empower and connect young professionals and women in the life science and pharma industry.

REGISTRATION FEES:

Registration by Thursday, November 9, 2023
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, November 9, 2023
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER NOVEMBER 9 ARE SUBJECT TO BILLING**

THANK YOU TO OUR SPONSOR!

This event is SOLD OUT! The venue is at capacity so walk-ins will NOT be accepted on-site.

Location: 
Tavern in the Square
300 Mishawum Road, C Unit 320, Woburn, MA
5:30 - 9:30 pm

Join your ISPE friends and colleagues for a fall social at Tavern in the Square in Woburn! We have the rooftop booked, so break out your best Fall sweaters. 

Cost to attend includes:
Two free drink tickets (cash bar available after that)
Yummy appetizers

Important Note: 
This event limit has been increased. So don't delay, sign up today. We hope to see you there!

Registration Fees:
ISPE Student Members - $10
ISPE Emerging Leaders Members - $10
ISPE Members - $20
Non-Members - $30

Fall Golf Tournament

Monday, October 23, 2023

Indian Pond Country Club
60 Country Club Way
Kingston, MA 02364

More details coming soon!

THIS EVENT IS SOLD OUT. Walk-ins will NOT be accepted onsite. If you have any questions, please contact the office at office@ispeboston.org. 

WHERE:     
Northeastern University's Raytheon Amphitheater
Egan Research Center
120 Forsyth Street
Boston, MA 02115

PROGRAM DETAILS:
Unleash your Potential: Dream, Explore and Achieve, an esteemed gathering dedicated to empowering young professionals.
During this event, panelists will share their personal experiences, expertise, and knowledge, offering students a unique opportunity to learn about different career trajectories and gain valuable industry perspectives. The event will foster an interactive environment where students could ask questions, engage in discussions, and network with professionals in their areas of interest such as how to get a full-time job in the industry, resume reviews, questions on how daily roles look like and so on. It will broaden the students' understanding of potential career options in the biotech, healthcare and pharmaceutical industry and facilitate meaningful connections between aspiring professionals and industry leaders.

This program is a collaboration between Northeastern University's Graduate Women in Science and Engineering, ISPE Boston's Ethnocultural Diversity, Equity, and Inclusion Committee, and ISPE Boston's Student Development Committee.

AGENDA:
6:00 pm Arrival, Networking (Includes food and soft drinks)
6:30 pm Panel Discussion, and Q+A

REGISTRATION FEES:
ISPE Student Members: FREE
ISPE Emerging Leaders and Industry Members: $15
Non-Members: $20

PANELISTS: 

	James Sinoimeri, Manufacturing Sciences & Technology (MSAT) Process Engineer, BioNTech James is a Process Engineer in the Manufacturing Sciences and Technology (MSAT) group at BioNTech, focused on T-cell therapy manufacturing industrialization. He graduated from Northeastern University with a Bachelor's and Master's degree in chemical engineering. While a student at Northeastern, James served as the President of the ISPE Northeastern University Student Chapter for two years, and was awarded the Joel Goldenberg Scholarship from the ISPE Boston Area Chapter. Prior to his current role, James worked in process development research roles at Moderna and Indigo Ag.
	Marisa Sposato, Engineer II, Moderna Marisa holds a master of science degree in manufacturing engineering from Worcester Polytechnic Institute, where she also earned a BS in chemical engineering. In 2017, she received the Joel Goldenberg Scholarship from the ISPE Boston Area Chapter and is a member of the Women in Pharma group at ISPE. Currently, Marisa works as an engineer in Drug Product Development at Moderna. Marisa previously worked at Vertex Pharmaceuticals in the Continuous Manufacturing and Preformulation groups. Additionally, Marisa volunteers as an Industry advisor for the ISPE Framingham State University Student Chapter and is a co-chair of the Student Development Committee at ISPE.
	Emily Ortega, Process Development Associate, Amgen Emily obtained a Bachelor of Science degree in Chemical Engineering from Rensselaer Polytechnic Institute. In 2019, she was the Chapter President of The American Institute of Chemical Engineers. During her Co-Op at Regeneron Pharmaceuticals in New York, she specialized in formulation development. Emily is proud of her Latina heritage from Cuba and Ecuador.
	Silas Tamufor, Quality Assurance in Research & Development, Sanofi Silas works in the Quality Assurance Department for Research and Development at Sanofi in Framingham. He's currently pursuing his Ph.D. in Public Health Epidemiology at Walden University, having already earned a Master's degree in biotech from Framingham State University and a B.S. from Worcester State University. Additionally, Silas volunteers for the ISPE Boston Area Chapter where he contributes to the Educational Programs and Product Show Committee Program.
	Victor Szeto, Manager or Regulatory Affairs, Takeda Victor currently serves as a manager in the Global Regulatory Affairs department at Takeda. Prior to this role, he gained experience as a Validation Engineer at Takeda and as a Quality Control Supervisor in Microbiology at Thermo Fisher. He also worked at the Shire as a Quality Control Technician and Validation Engineer. Victor holds a Master's degree in Bioscience Management from Worcester Polytechnic Institute.

Questions? Contact us at (781) 647-4773 or office@ISPEBoston.org.

THIS EVENT IS SOLD OUT. Walk-ins will NOT be accepted onsite. If you have any questions, please contact the office at office@ispeboston.org. 

WHERE:     
The Park at Assembly Row by Volo
30 Grand Union Blvd, Somerville, MA 02145

PROGRAM DETAILS:
Come join the ISPE Emerging Leaders on October 5th for a night of Boston's favorite sport, Pickleball! This will be a laidback event from 6-8pm with courts reserved for those who register, rotating every 20 minutes so everyone can give it a try! The courts and paddles are on ISPE, and there will be a cash bar available for those interested. Stop by to try out a new sport, and network with others from the group! 

The event is held at The Park at Assembly Row by Volo. Assembly Row is located in Somerville and easily accessible by the Orange line, with the stop being "Assembly Row". Assembly also offers free parking for up to 3 hours in any of their parking garages. Can't wait to see you there!

REGISTRATION FEE:
Standard Fee: $10

Register today for our Annual Product Show at Gillette Stadium in Foxborough, MA! As a reminder, attendee registration, parking, educational sessions, and food are always FREE!

ATTENDEE REGISTRATION
Attendee registration can be found here: https://ispe.swoogo.com/23BostonProductShow

Want to learn more about the Product Show? Go to the Product Show website at https://productshow.ispeboston.org/

EXHIBITOR REGISTRATION
We are currently sold out of exhibit space. If you would like to be placed on a wait list, please submit your name here: https://productshow.ispeboston.org/exhibitor-wait-list-form/

Questions? Please email office@ISPEBoston.org or call +1-781-647-4773.

_{SOLD OUT!}

LOCATION:
Kernwood Country Club, Salem, MA 01970

Tentative SCHEDULE: 
11:00 AM - Registration, Lunch and Driving Range 
12:30 PM - Shotgun Start – Scramble Format 
5:30 PM - Reception/Cocktails/Dinner

This program has SOLD OUT! Walk-ins will NOT be accepted onsite.

Wednesday, August 9, 2023
5:30 PM - Social at Game On!
7:00 PM - Boston Red Sox vs. Kansas City Royals

Join the ISPE Emerging Leaders on Wednesday, August 9^th to watch the Red Sox take on the Kansas City Royals at Fenway Park! First pitch is at 7:00 pm. Before the game starts, we will be hosting a pregame at Game On! starting at 5:30 pm (located at 82 Lansdowne St., Boston, MA 02215).

Registration is $40 a person and includes food and two free drinks at Game On!, as well as a ticket to the ball game. Space is limited to 50 people so sign up quickly!

We look forward to seeing you all there and let’s go Sox!

Registration Fees:
$40 / person - limited to 50 people!

2022 Red Sox Event!

The WIP golf tournament is now SOLD OUT! See you at 12:00 PM (NOON) for arrival/check-in. Shot gun start in scramble format is at 1:00 PM!

LOCATION:
Robert T Lynch Golf Course (Brookline Golf Course) 
1281 W Roxbury Parkway
Chestnut Hill, MA 02467

SCHEDULE:
12:00 PM - Arrival/Registration Check-in, Warm-up at Driving Range/Putting Green
1:00 PM - Shotgun start - Scramble format
~5:00 PM - Networking/Cocktails/Dinner

THANK YOU TO OUR FABULOUS WIP GOLF EVENT SPONSORS!

Arcadis DPS Group 
Northeast Engineering
Process Design Solutions
RW Sullivan Engineering
Trane
Wise Construction

Pre-Registration is closed, but walk-ins are welcome

WHEN:       Thursday, July 20th, 2023  |  5:00 pm - 8:00 pm

WHERE:      PCI Cleanroom Contracting
                    150 Hopping Brook Road
                     Holliston, MA 01746

PROGRAM DETAILS:
Time is Money: Missteps to avoid and roadblocks to avert with increased speed to market

AGENDA:
5:00 pm Arrival, Networking, and Tours (Includes food and beverages (drink tickets provided for all attendees)) 
5:30 pm Introduction by PCI Cleanroom Contracting, Panel Discussion, and Q+A
6:45 pm Tours and Networking

PCI has opened their facility, offering tours of 3 newly constructed 300sf modular cGMP cleanrooms, featuring multiple cleanroom panel manufacturers, including a self-supported walkable ceiling system design.  Features also include various manufacturers of cleanroom doors, HEPA terminals, walkable light fixtures, interlock doors, pass thru cabinets, automatic doors, wall protection options, process utility panels, etc.  Construction, design and clean room experts will be on site to explain clean room functions, answer questions and provide insight.  This is a unique opportunity to learn about different products that can go into clean rooms to suit your MFG needs. 

PANELISTS: 

Victoria Cowan, Operations Manager, PCI Cleanroom Contracting

Victoria Cowan is a seasoned professional with 20 years of experience in the industry. Born and raised in Colorado, she maintains strong connections to New England, as her father hails from Arlington, MA, and she fondly recalls spending her childhood summers in Maine with her family.
Victoria has a background in civil/structural engineering. To begin her career, she worked for the foremost GC in the SF Bay Area who specialized in complex pharmaceutical projects as well as other complex projects. After 5 years, she made a successful transition to a specialty trade partner. Throughout her career, Victoria has contributed to numerous high-profile projects, collaborating with organizations such as Genentech, Gilead, Gladstone, Bayer, AGC Biologics, Umoja and several other NDA clients.
During her time on the West Coast, Victoria and her team spearheaded the establishment of a design group within PCI, collaborating on intricate projects with IPD, Design-Assist, and Design-Build delivery models.
In 2021, capitalizing on her extensive industry knowledge and entrepreneurial spirit, Victoria and her team started a new venture in Colorado, launching a ground-up business for PCI to cater to the pharmaceutical and other markets in the region.
Victoria's diverse experience, spanning multiple regions and sectors, ensures a unique perspective and valuable insights to the challenges facing our industry.

Chris Cody, Director of Design Operations, CRB

Chris is the Director of Design Operations for CRBs Boston office and a licensed architect with over fifteen years of experience working on complex projects for various life sciences clients. He is skilled in integrated designs that span biotechnology, R+D, mixed-use, and commercial typologies. Possessing a strong technical mind with experience on both large and small projects, Chris' project management and organizational skills also make him adept in handling a vast array of project scales and complexities to support any client.

David Howard, Vice President, P&H Electrical

David is the Vice President and Managing Partner of Piquette & Howard Electric Service.  After graduating from Worcester Polytechnic Institute in 1998, he began his career as an Electrical Engineer for a large MEP Engineering Firm designing a vast array of complex laboratory style projects for the Life Science and Higher Education sectors.  In 2003 he decided to take over the family business, P&H Electric.  Over the past 20 years, P&H Electric has grown significantly to now over 250 Engineers, Electricians and Control Specialists focusing on Life Science, Pharmaceutical, R&D, and Manufacturing types of projects.

With over 25 years of experience as a Licensed Professional Electrical Engineer and Master Electrician, David has been intricately involved with hundreds of Design Build, Design Assist, and traditional Design Bid Build style projects.  His experience leading projects from the preconstruction stage all the way through budgeting, scheduling, procurement, installation and closeout provides projects with a unique perspective to bring new facilities to market at an accelerated rate.  

Dennis Fischer, Senior Director of Project Delivery Services, CRB (Moderator)

Dennis is the Sr. Director of Project Delivery Services for CRB’s northeastern region and Canada. Offering over two decades of experience, he applies his varied field execution background as a project manager and superintendent on projects ranging from utility infrastructure programs to pharmaceutical manufacturing facilities to conceptualize project challenges, schedules, and rigging execution strategies. Preconstruction execution strategies, integrated planning and scheduling, estimation, and procurement services are Dennis’ priorities as projects are being developed with the overall buildout as his focus. 

REGISTRATION FEES:

Registration by Thursday, July 13, 2023
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, July 13, 2023
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER JULY 13 ARE SUBJECT TO BILLING**

MEETING MANAGERS: Caren Jenkins, Neena Shah, Silas Tamufor

THANK YOU TO OUR SPONSORS!

Questions? Contact us at (781) 647-4773 or office@ISPEBoston.org.

Registration is now closed. Walk-ins will not be accepted onsite as we have reached capacity. If you have any questions, please contact us at office@ispeboston.org

Please note: There are a limited # of spots available for those who are interested in the networking/social portion of this event but not the golf clinic. If you wish to sign-up but not participate in the golf clinic aspect, please call the office to pay with a credit card over the phone at 781-647-4773 or email us at office@ispeboston.org. $15 Members / $25 Non members

Wednesday, July 12, 2023
5:30 PM - 7:30 PM

Granite Links Golf Course
100 Quarry Hill Road, Quincy, MA
https://www.granitelinks.com/

Join Women in Pharma for an awesome Golf Clinic with Golf Pros, plus networking, drinks & appetizers!! Granite Links is rated a Top 100 Golf Course by Golf Digest Magazine. It will be a great day to meet and mingle with colleagues while enjoying the views from this beautiful course that overlooks the city of Boston. 

This year, there will be TWO golf pros providing instruction with dedicated range space, golf balls and clubs available for anyone who doesn’t have them!

Space is limited to the first 30 registrants. Register today!

PRICING: $25 Members / $35 Non member

Interested in sponsoring the WIP Golf Clinic? Sponsorships are $500 each and include the following benefits:

1. Logo on welcome signage at event
2. Logo on website event registration page
3. Logo included in email blast
4. Option to donate “swag” for attendees

Registration is now closed. Walk-ins will not be accepted onsite as we have reached capacity. If you have any questions, please contact us at office@ispeboston.org

Thursday, June 29, 2023
5:30—8:30 PM

Break Rock Brewing 
On Boardwalk, 534 Victory Rd, Quincy, MA 02171

ISPE Boston’s Social Committee invites you to join us for a fabulous Summer Social & Volunteer Appreciation Night event! Let’s get together for some cold drinks, good company, live music, and a bite to eat!

Cost to attend includes:

• Two drink tickets
  
• Light bites

Location: 

Break Rock Brewery  located a short walk down the boardwalk beneath the Meriel Apartments and just past Marina Bay Market.

PARKING: Best bet is the large DCR parking lot located directly behind our building. Signage indicates “no parking after dusk” but this is not enforced. Additionally, there is a large lot across the street from Marina Bay Market that allows for parking between 6pm-6am Monday - Friday and anytime on Saturday and Sundays. We also have one small shared parking lot at the entrance of the boardwalk with limited public spaces. Time limits in this area are enforced. There is also some on-street parking in the area. Break Rock Brewing is not responsible for any towing, ticketing, or damage to your vehicle.

PUBLIC TRANSIT: For public transit information, click here. The closest MBTA train stop is North Quincy Station, about 2.5 miles from the brewery.

FERRY: The Marina Bay Ferry, with service to Boston and Winthrop, is a partnership between the City of Quincy and the Town of Winthrop. Operating weekdays, it provides water transportation from Squantum Point Park/Marina Bay in Quincy to the Town of Winthrop, Boston Seaport, New England Aquarium, and the Boston Financial District. Click here for the schedule.

Registration Fees:

ISPE Members - $15
Non-Members - $25

The ISPE Boston Area Chapter Women in Pharma (WIP) Committee is hosting a walk at the Charles River Esplanade in Boston, MA! Join us and walk, skip, prance or whatever moves you. If walking isn't your thing, join us after for a beer at the Night Shift Beer Garden!

- Dog, child, and family friendly! All are WELCOME!
- We will meet at 5:30pm at Hatch Memorial Shell, 47 David G Mugar Way, Boston, MA 02108
- Walk will start at ~6pm and we'll end at the Night Shift Beer Garden pop-up on the Esplanade
- SNEAKERS or comfortable walking shoes are recommended

Location & Parking:
Esplanade in Boston, MA
Recommended parking garage: Boston Common Garage

What to wear: sneakers or walking shoes, weather dependent clothing

What to bring (all optional): water, pets, kids, a smile!

Marisa Sposato & Linda Lauzier will be your hosts. Any questions, email: msposato0412@gmail.com or LLauzier@ultragenyx.com

Join us for happy hour at Night Shift Brewing on the Esplanade after the walk!

Registration Fees: $0 - This is a FREE event!

Pre-registration is closed for this event. Walk-ins are welcome.

WHEN:     Wednesday, June 21^st | 5:30 PM – 8:30 PM

WHERE:   Creative Office Resources
                 44 Thomson Place
                    Boston, MA 02210

PROGRAM DETAILS:
Please join ISPE Boston Women in Pharma for a conversation about personal finance. The event will feature expert speakers who will provide valuable insights and tips on managing your finances, investing, and planning for the future. Whether you are just starting out in your career or looking to build your wealth, this event will have something for everyone. In addition to the informative presentation, there will also be opportunities to network with other like-minded individuals and to ask questions of the speakers.

AGENDA:

5:30 PM Arrival and Networking

6:15 PM Panel Discussion and Q+A

  ·         Panelists:

      o   Ben Hamblen, Managing Director, Commonwealth Financial Group

      o   Bill Moody, Financial Advisor & Planner, Commonwealth Financial Group

      o   Despoina Betaki, Head of Accounts & Relations, Sagax Team

7:30 PM Networking and Socializing

  ·         Includes heavy appetizers and delicious beverages!

PANELIST BIOS:
Ben Hamblen, Managing Director, Commonwealth Financial Group (CFG)  

Ben Hamblen is the Managing Director of Commonwealth Financial Group (CFG). Ben joined the agency in 2014 as an Investment Specialist. Ben then transitioned into working with senior advisors on development to streamline the firm’s planning process and philosophy. After running the training program for new financial professionals for a period of time, Ben has most recently transitioned into building, managing, and growing a team of new financial professionals in the firm, who will be a core part of CFG in the years to come.

Prior to joining CFG, Ben worked in the Financial Planning Department at Baystate Financial in Boston. In this role, he acted as a Senior Case Manager for fee-based financial planners, specializing in eMoney. Ben then took a position as an Agency Supervisory Officer at MassMutual Oregon in Portland, Oregon. In this role, he was able to expand his compliance knowledge within a highly regulated industry and obtain licensing as a Registered Principal.

Bill Moody, Financial Advisor & Planner, Commonwealth Financial Group (CFG)

Bill has over 15 years of experience in the financial services industry. He began his career in 2005 as an Internal Wholesaler at John Hancock before moving to MetLife in 2010, where he worked as a Case Consultant in their Financial Planning Department. He proudly works as a financial advisor and planner with Commonwealth Financial Group since 2018. He continued his financial planning work when he made the move to MassMutual in 2016. During his time at MetLife and MassMutual, Bill was responsible for developing comprehensive financial plans for over 1,000 clients and their families.

While Bill’s client base is diverse, he specializes in working with professionals in the life sciences, medical, technology, legal, and management consulting fields.

He is a CERTIFIED FINANCIAL PLANNER™ Professional, a Certified Investment Management Analyst® Professional, and a Chartered Life Underwriter® Professional. In addition, he holds a Life Insurance license, Accident & Health license, as well as FINRA Series 6, 7, 63, and 65 licenses.

Despoina Betaki, Head of Accounts & Relations, Sagax Team

Despoina is an experienced executive professional with global exposure from the UK to Germany to the US, a diverse background in biotech and pharmaceutical industries, and an additional history of working in capital markets, asset allocation, M&As, and funding. She served as the director of Global Strategies Council specializing in government relations, M&A services, business development and trade. She now heads the Accounts and Relations at Sagax Team, a boutique consulting company serving as one of the most trusted partners for Compliance and Lab Informatics in Life Sciences industry. Despoina has an Executive MBA, as well as graduate degrees in Regulatory Affairs, Pharmacoeconomics and Cybersecurity. She proudly serves the ISPE WIP Committee and is moreover actively volunteering for community projects, academic mentorship programs and activities that focus on the well-being and quality of life of fellow citizens in need.

This event is limited to 70 people and will likely sell out, so register early!

REGISTRATION FEES:

Members: $15
Non-Members: $25
Emerging Leaders Members: $15
Student Members: FREE

THANK YOU TO OUR VENUE SPONSOR!

LOCATION:
Pleasant Valley Country Club
95 Armsby Rd, Sutton, MA 01590

SCHEDULE:
10:00 AM - 10:45 AM Registration and Boxed Lunch 
11:00 AM -Shotgun Start – Scramble Format
4:00 PM: Buffet Dinner with Awards and Raffles
*There will be a silent auction to benefit Project Onramp

PRICING:
$300 per single golfer / $1200 per foursome 

To purchase a foursome, foursome + contest hole sponsorship, or register as a single golfer, please fill out the form online, HERE and send back to us at office@ispeboston.org to sign up.

Please contact the office at (781) 647-4773 if you have any questions about this event.

Pre-registration for this program is CLOSED; WALK-INS ARE WELCOME!

WHEN:     Thursday, June 15^th, 2023 | 4:30 pm – 8:30 pm

WHERE:   Landmark Bio                                                        City Works
               300 N Beacon St, Suite 201                &                  91 Arsenal Yards Blvd
               Watertown, MA 02472                                            Watertown, MA 02472

PROGRAM DETAILS:
Risk Awareness: A healthy way to assessing and managing risks in Computer System Lifecyle

Risk awareness is an essential aspect of assessing and managing risks in the computer system lifecycle. It involves developing a culture of identifying and mitigating risks at every stage of the system's development, deployment, and operation.

By implementing healthy risk awareness practices, organizations can better assess and manage risks throughout the computer system lifecycle. This leads to more secure and reliable systems, which in turn can help to minimize the potential for downtime, and other compliance incidents.

In this ‘workshop’ style event, attendees will discuss and learn from expert instructors and other attendees how to approach the four phases in a computer system lifecycle, with a risk-based mentality, to guide appropriate and efficient computer system validation requirements.

AGENDA:

4:30 pm Arrival, Networking, and Tours at Landmark Bio

• Includes food and beverages (one drink ticket will be provided to each attendee)
  

5:30 pm Presentation with Roundtables

• Presenter: Geetanjali “Geetu” Abbi, Director, Digital Quality Assurance, Alkermes

7:15 pm Presentation concludes, and the group moves to City Works

• Join us for the optional inaugural GAMP Boston Community-of-Practice (COP) social with self-sponsored food & drinks
  

SPEAKER BIO: 
Geetanjali “Geetu” Abbi, Director, Digital Quality Assurance, Alkermes 

Geetu is a pragmatic leader and a champion in Computer System Validation & Compliance with more than 16 years of experience. Geetu graduated from DIT University in India in 2002 with a degree in Information Technology. From the beginning she was more curious on the quality aspect of the software and started her journey as Testing Lead and transitioned to a career in CS Validation. Throughout her career, she has accomplished numerous projects in areas ranging from manufacturing, quality systems, clinical, Information Technology and Labs. Today, she leads a global team and heads Digital Quality Assurance at Alkermes. She is a big proponent of continuous learning and improvement and challenges herself and her team, to think outside the box and develop effective risk-based strategies that fits systems of all facets.  

Oh, and Geetu loves the outdoors. Why does that matter? Well, it means that she spends most of her summer afternoons either gardening or doing outdoor activities with family. She has 2 kids and maintains the title of the best Mom by being a bit mischievous, witty, and a little cheeky.

REGISTRATION FEES: 

Registration by Thursday, June 8, 2023
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE

Registration after Thursday, June 8, 2023
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE 

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER JUNE 8 ARE SUBJECT TO BILLING**  

MEETING MANAGERS: Heather Longden & Monika Zatek

THANK YOU TO OUR SPONSORS!
 

Registration is now closed for our Paddle Team! We are looking for volunteers to attend the festival to cheer on Team ISPE during the event! If you are interested, please email office@ispeboston.org!

Saturday, June 10, 2023
*Sunday, June 11, 2023 
*Pending results of Saturday’s Time Trial Races
8:00AM—3:00 PM
John W. Weeks Bridge, Cambridge, MA 02163

Attention all Ethnocultural Diversity, Equity, and Inclusion enthusiasts! Get ready to witness the spectacle of a lifetime as we celebrate the Boston Dragon Boat Festival! Sign up to paddle with ISPE Boston at the 2023 Boston Dragon Boat Festival!

Embark on a journey filled with vibrant colors, traditional music, and the spirit of competition as teams from around Boston gather to showcase their unique cultural heritage. Watch as they maneuver their intricately decorated boats in fierce competition, all while displaying their cultural pride through traditional costumes and music. 

The event will take place on the scenic riverbanks of the Charles River, offering breathtaking views and an unforgettable experience. There will also be food stalls featuring cuisines from different cultures, ensuring that you have a taste of the world's finest culinary delights. 

Don't miss out on this opportunity to experience the fusion of culture and sports! 

ISPE Boston will be paddling a dragon boat comprised of paddlers, a drummer, and a steerer. No experience is required to participate. Paddlers will be coached and provided all necessary equipment. Athletes must be competent swimmers, though the goal is to stay in the boat! Participants must agree to participate in a minimum of two 2-hour practice sessions, which will be scheduled up to 4 weeks prior to Race Day (June 10^th). Race lengths include 250m and 500m, equivalent to 2-3 or 4-5 minutes of intense exertion, respectively. Time trial races will take place on Saturday and qualifying teams will be invited back on Sunday to compete in final races.

Important Note: The team is limited to 20 paddlers and up to 6 alternates! Please register early! 

Registration Fees:

ISPE Members – FREE!
Non-Members - $20

Participants will be required to complete a waiver with ISPE Boston. 

Pre-registration for this program is CLOSED; WALK-INS ARE WELCOME!

WHEN:     Wednesday, May 24th | 6:00 pm – 8:00 pm

WHERE:   IPS (Burlington), 30 Corporate Drive, Suite 130, Burlington, MA 01803

PROGRAM DETAILS:

Join the Emerging Leaders and Educational Programming Committees for a joint Early Career Panel, where pharmaceutical industry leaders will share their tips and insights on furthering your career as a young professional. This is the second event in the 2023 ELC Professional Development Series and is sure to be an incredibly fun and educational event!Panelists include engineers with an average of 10 years of experience in the industry, covering all sectors of pharma, from small molecules and biologics, R&D and GMP operations, and startup/contracting/consulting/big pharma companies. Additionally, the panelists have a variety of educational backgrounds, including bachelors, masters, and PhDs, and have worked in Process Engineering, Quality, Project Management, and Operations. These industry leaders will be speaking about how they discerned their career path, how they upskilled and advanced over the course of their career trajectory, and what advice they have for young engineers looking to develop themselves within the pharmaceutical space. This is the perfect event for emerging leaders new to the industry who are looking for information and advice to help guide their early careers. 

AGENDA:

6:00 PM - Arrival and Mingling
6:15 PM - Introduction by IPS, Panel Discussion and Q+A
7:00-9:00 PM - Appetizers, Drinks (2 drink tickets provided), and Networking in IPS' Club House

Panel Moderator:

• Sean Keenan

Panelists:

• Luke Rogers, Vice President Innovation and Product Development, On Demand Pharma

Luke Rogers bio (VP Innovation for On Demand Pharmaceuticals) - Dr. Luke Rogers is currently the V.P. of Innovation for On Demand Pharmaceuticals working to commercialize their Pharmacy on Demand platform. He received his degree in Medicinal Chemistry from Trinity College Dublin. He also completed his Ph.D research in Trinity College on the synthesis and biomedical applications of Tetrapyrroles. 

After a stint within the Merck Manufacturing Division, working on a large scale GMP flow chemistry process step, he transitioned to MIT to lead efforts on multiple iterations of the Pharmacy on Demand project within the Department of Chemical Engineering. This work involved the development, optimization, and integration of miniaturized continuous manufacturing processes to produce Active Pharmaceutical Ingredients. 

After the successful demonstration of the manufacturing capabilities of such systems, he then transitioned to his current role where he is helping lead efforts towards regulatory submissions of a new processes for point of care manufacturing of patient-ready medicines.

• Jacklyn "Jackie" Chesny, QA Supervisor, Moderna

Jackie is a new supervisor in the Quality Assurance Department at Moderna’s Norwood location. Jackie has over 12 years of experience in various areas of the biotechnology industry. She has worked in a contract laboratory, for companies producing clinical and commercial phase products, and most recently, in a CMO. 

Jackie started her career in the biotechnology industry in 2009 as a receptionist at BlueStream Laboratories in Cambridge. She then transitioned to work in manufacturing plants in the Greater Boston Area. Most notably, Jackie worked at Sanofi Genzyme while the company was under Consent Decree. 

One of the highlights of her career in the biotechnology industry is to be able to say she and her husband have been patients of two of the companies for which she has worked. 

Jackie received her BA in Spanish Language in 2008 from Brandeis University in Waltham. In 2021, Jackie completed a Certificate in Biotechnology at Quincy College and is currently taking prerequisite classes at Quincy College to transfer to a master’s program in biotechnology.

• Travis Maser, Senior Manager Upstream Manufacturing Technology, BMS

Travis Maser is currently the Senior Manager of Upstream Manufacturing Technology (MT) at Bristol Myers Squibb (BMS) in Devens, MA. He graduated from the University of New Hampshire in 2014 with a B.S in Chemical Engineering that included a biochemical engineering option. 

Travis started his career as a Validation Engineer for Masy BioServices then quickly changed to a Process Engineer for Barry Wehmiller Design Group. As a Process Engineer, he was involved in two facility commissioning and qualification projects (clinical and gene therapy), manufacturing engineering staff augmentation support for commercial manufacturing and a maintenance / piping technical evaluation. This was completed at several local biotech sites such as Pfizer, Novartis and BMS. 

He left Design Group in 2018 and went to BMS where he has further grown his career working in both clinical and commercial biologics manufacturing. In this current role, he manages a team of four engineers to ensure 25kL upstream commercial biologic processes run as designed. This includes technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls and preparation of regulatory filings. Additionally, he supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.

• Gearoid O'Sullivan, Business Unit Manager, Wunderlich-Malec Engineering

I graduated in 2013 with a Mechanical Engineering Degree from Cork Institute of Technology (now MTU) in Ireland. I got a job shortly after with DPS Group, an AE Firm specializing in the Semi-Conductor and Life Science industries.

About a year in I resigned to move to the US with a J1 Graduate visa. DPS, having opened an office in Boston, hired me for a shutdown coordinator role with Sanofi shortly after I relocated.

I worked as a Project Engineer with DPS for 5 years, working at 3 different clients in that time (Sanofi, Ipsen, Takeda). Then I received an opportunity to work with Turner & Townsend (T&T) as a Senior Project Manager, supporting Pfizer, their largest Life Science Client.

Within two years, I grew the T&T team at Pfizer to 5 people from 2 and added a new client to their portfolio. I also managed $75M capital budget for Pfizer, writing all of the Project Charters for 2022.

As of June 2022, I left T&T to start a new Business Unit with Wunderlich-Malec Engineering, focused on Engineering Project Management and Project Controls in the Life Science industry. I currently manage a team of 5 Project Managers/Schedulers.

REGISTRATION FEES:

Members: $15

Non-Members: $25

Emerging Leaders Members: $15

Student Members: FREE

THANK YOU TO OUR SPONSORS!

*THIS EVENT IS SOLD OUT*

LOCATION:
Blue Hill Country Club
23 Pecunit Street, Canton, MA 02021

Tentative SCHEDULE:
10:00 AM - 10:45 PM Registration and Buffet Lunch 
11:00 PM -Shotgun Start – Scramble Format
5:30 PM: Buffet Dinner 

Please contact the office at (781) 647-4773 if you have any questions about this event.

WHEN:     Thursday, May 18th | 5:30 PM – 8:00 PM

WHERE:   Takeda, 650 E Kendall Street, Cambridge, MA 02142

PROGRAM DETAILS:

The state of DE&I in the biotech/pharma industry is driven by several factors foundationally, and historically. In the last few years, like in other industries, pharma/biotech has steadily increased its awareness of and focus on building diversity, equity, and inclusion into the industry, starting with community and academia, where the challenges to access begin. This event aims to discuss the data, trends, and thoughts from various DE&I backgrounds including industry, academia and community-based efforts that work in conjunction to support the growth of DE&I spaces in the biotech/pharma industry.

• The event will feature a networking portion, followed by a brief interactive presentation, and a panel discussion with DE&I experts. Plus, enjoy heavy appetizers and delicious beverages!
• The objective of this event is to highlight significant trends, review best practices and discuss the industry's direction with the intent to provide a call to action for all members and allies.
• The benefits of the event include:
             - Increased collaboration and networking for professionals across industry, academia, and community
             - Better understanding of current state of DE&I actions that each organization can take to continue to drive DE&I efforts
             - Learning about existing resources in the industry or gaps identified as areas of opportunities

AGENDA:

5:30-6:15pm – Arrival & Networking 
6:15-6:30pm – Opening remarks and Data Presentation
6:30-7:30pm – Panel Discussion (3-4 panelists and moderator)
7:30-8:00pm – Closing remarks and Further networking 

PANELISTS:

Chris Haigh - Founder and Lead Consultant, True Change Associates
Ross Marshall - Head of Community Engagement, MassBio
Saraswathy (Sara) Nochur, PhD - Chief Diversity Equity & Inclusion Officer, Alnylam
Ramona Burress - Head of Patient Engagement & Insights, Takeda

Moderated by: Amina Lobban, Head of Culture, Engagement & HR Business Excellence, Takeda

SPEAKER BIOS:

Chris Haigh, M.Ed is the Founder and Lead Consultant for True Change Associates (TCA) and has over 25 years of experience working with academic institutions, corporations, and nonprofit organizations focusing on diversity and inclusion, equity and social justice, leadership development, and team building. TCA was established in 2015 with the mission of working in community with people and organizations to move through personal growth into creating lasting institutional and systemic change around equity and inclusion. 

In addition to TCA, Chris partners with global leadership development firms Canvas Leadership, MSM Global, and Impact International to deliver leadership development programs with a DEI lens to clients in all sectors.  Chris also serves as a Co-Lead Facilitator for the LeaderShape Institute, a national organization committed to creating “a just, caring, and thriving world where all lead with integrity and a healthy disregard for the impossible”, and as a Facilitator for Outward Bound Professional, the division of OB that focuses on transformative leadership development with corporate clients using experiential education in the outdoors.  Lastly, Chris is a former faculty member for Merrimack College in their Higher Education Graduate program, and for the Federal Executive Institute within the Federal Government.

Chris believes that a collaborative approach is necessary in DEI work and current and past collaborators include: Drizly, Takeda Pharmaceuticals, The Union of Concerned Scientists, Arrakis, Chronosphere, Tufts Medical Center, Taza Chocolate, Verité, Thompson Island Outward Bound Educational Center, Middlesex Community College, Penn State and Colby College. Chris is a certified administrator for both the Intercultural Development Inventory (IDI) and Intercultural Conflict Styles Inventory (ICS), as well as The Leadership Circle. Additionally, Chris has presented at national conferences such as SXSW, the Racial Justice Institute at Creating Change, and The White Privilege Conference. 

Prior to TCA, Chris’ experience includes professional roles at The University of Massachusetts - Amherst, Brown University, Rhode Island College, SpeakOut Boston (the nation’s oldest LGBTQ speakers’ bureau), City Year, Exploration Schools, and Wentworth Institute of Technology.

Chris is a skilled relationship builder, strategic planner, and team energizer, and loves helping people and organizations be their best selves while contributing to a socially just world. Chris holds a M.Ed. from the University of Massachusetts – Amherst in Social Justice Education, and a BA from Colby College in American Studies. Chris lives on the east coast of the United States in Rhode Island, with their wife Vanessa and rescue dog Nica.

Ross Marshall is a DEI strategist experienced designing, building and leading measurable and scalable D&I-focused programs and initiatives for complex organizations.

As Senior Director of Diversity Advisory, Ross is building, launching, and operating a DEI advisory enterprise for MassBio members that are seeking next-level DEI strategic consulting.  In addition, he will work in conjunction with the MassBio Edge team to build awareness and create opportunities for MassBio members to launch and scale their supplier diversity programs.  

Prior to joining the MassBio team Ross was a founding Partner of DEI Partners where he harnessed the power of analytics to empower a smarter, data driven DEI strategy.  

Ross brings experience articulating a vision, translating it into executable strategy and driving cross-functional teams to deliver in alignment with D&I strategy.  

Saraswathy Nochur has been Chief DE&I Officer at Alnylam Pharmaceuticals in Cambridge, MA since January 2021, where she works with various stakeholders globally to increase diversity, promote equity and foster inclusion, and also co-leads initiatives to increase diversity in clinical trials. Prior to this role, she was Chief Regulatory Officer at Alnylam for 15 years. In this role, she built an international team of over 65 Regulatory Affairs professionals, enabling the development and approval of four novel RNA interference therapeutics for rare diseases in multiple countries. Sara holds a Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology, Cambridge, MA.

Sara currently serves on the Board of Directors of Marinus Pharmaceuticals, a company developing innovative therapeutics to treat rare seizure disorders, and of Decibel Therapeutics, who are developing regenerative and gene therapy strategies to restore hearing and balance. She is also on the Board of Biomedical Science Careers Program (BSCP), a non-profit organization that aims to increase the representation of underrepresented minority and disadvantaged individuals in all facets of science and medicine. She is a host and member of the Board of Hospitality Homes, a non-profit organization that provides free/low-cost housing for patients and caregivers from all over the world who seek specialty medical care in Boston area hospitals. 

Sara and her husband are founding members and volunteers for All India Movement for Seva, a non-profit organization that provides support for school children in rural and tribal India.

Ramona Burress, PharmD, is Head of Patient Engagement and Insights, Center for Health Equity and Patient Affairs (HEPA) at Takeda Pharmaceuticals. She leads the Center’s work with internal Takeda teams to provide longitudinal patient insights and increased knowledge of patients’ needs, beliefs and expectations through engagement. Ramona is a licensed clinical pharmacist and accomplished leader with 20+ years of experience in advancing positive patient outcomes and equity within healthcare. 

Most recently, Ramona served as Director, Diversity & Inclusion in Clinical Trials, at Janssen Pharmaceutical Companies of Johnson & Johnson, where she designed external stakeholder partnerships critical to increasing participation of underrepresented and underserved populations in clinical research. Her results-driven approach was mastered in a former role as a Healthcare Specialty Supervisor with Walgreens Pharmacy in which she employed her extensive medical and business knowledge to serve the needs of patients with complicated health conditions.

Amina Lobban is Head of Culture, Engagement & HR Business Excellence, Global Manufacturing, Supply & Quality at Takeda. She joined Takeda through Shire, and in her 16 years at the company her career has steadily progressed from Engineering, Business Operations, Integration, and Program Management roles in Process Development and Global Manufacturing, Supply & Quality. She joined HR in 2021, further expanding her experience across the business. Amina began her professional career in her home country of Trinidad & Tobago as a Petroleum Engineer at the Ministry of Energy, where she worked with multinational energy companies operating in the region. Her transitions across industries and functions have brought her increasing experience leading global teams and working with colleagues internationally. 

Amina has demonstrated her passion and commitment to gender parity through her volunteer work internally at Takeda as Global Co-Lead of their Gender Parity Network ERG, and externally with the Healthcare Businesswomen’s Association (HBA) and The Boston Club. She has previously held local and regional roles with HBA New England, now Chairs HBA’s Global Ambassador program, overseeing leadership development programs at over 50 corporate partner locations worldwide, and is co-chair of The Boston Club’s Healthcare and Life Sciences Affinity Group. Amina was honored to be named a 2022 HBA Rising Star at Takeda in recognition of her leadership and impact.

Amina lives in Bedford, MA with her husband and two young children. 

REGISTRATION FEES:

Register by 5/11/23:

Members: $10
Non-Members: $15
Emerging Leaders Members: $10
Student Members: FREE

Register after 5/11/23:

Members: $15
Non-Members: $20
Emerging Leaders Members: $15
Student Members: FREE

THANK YOU TO OUR SPONSOR!

Registration is CLOSED, if you still want to participate, please email the organizer Eric Felz with any questions eric.felz@takeda.com

JOIN THE 55th WALK FOR HUNGER - HELP RAISE MONEY FOR HUNGER RELIEF IN MASSACHUSETTS

We've joined Project Bread's The Walk for Hunger to help get food relief to kids and families across Massachusetts. After being virtual for the last 3 years, one of Massachusetts' most iconic events is back in Boston! The in-person Walk on Sunday, May 7, 2023, will take the form of a fun-filled 3-mile walk around Boston Common.

In 1969, The Walk for Hunger was founded on the promise, by the people of Massachusetts, to provide relief to our neighbors struggling with food insecurity. We know that you agree no one should go without a meal, yet Project Bread estimates that 1 in 5 households with children across the Commonwealth are facing hunger right now. 

It's your donations, participation, and fundraising that has made The Walk for Hunger successful at achieving its mission for more than five decades. Thank you! 

Location & Parking:
Boston Common
Boston, MA

What to wear: sneakers or walking shoes, weather dependent clothing

What to bring (all optional): water, pets, kids, mask, etc.

Eric Felz and Yolanda McLean will be your hosts. Any questions, email: office@ispeboston.org

*This event is sold out! We are at capacity and will not be accepting walk-ins!* If you would like to be added to the waitlist please contact the office!

Tuesday, April 25, 2023
6:00 PM - 8:00 PM EST

ISPE Boston’s Emerging Leaders Committee invites you to join us for a Puttshack Social full of fun on April 25th in Boston, MA!

Registration includes networking, a round of mini golf, two drink tickets and delicious appetizers.

Location: Puttshack Boston, 58 Pier 4 Blvd., Boston, MA 02210

Cost: $15 members / $25 nonmembers

Thank you to our event sponsor!

*Online registration for this event is closed, but walk-ins will be accepted on-site*

WHEN:     Thursday, April 13 | 4:30 pm – 7:00 pm

WHERE:   STC Biologics, 330 Nevada Street, Newton, MA 02460

PROGRAM DETAILS:
Operational Readiness is critical to CDMO manufacturing lifecycles and the process can be arduous for startup teams to undertake themselves. Learn about how industry leaders are adopting their process and the benefits they are able to achieve by leveraging lessons learned to reduce risks.

AGENDA:
4:30 pm - Arrival and Networking
5:30 pm - Opening Remarks and Intro to STC Biologics
5:45 pm - Panel Discussion and Q+A

SPEAKERS: 

Magdalena Leszczyniecka, President/CEO, STC Biologics
Magdalena is the President and CEO of STC Biologics. STC Biologics, Inc. is a boutique CDMO located in Newton, MA that provides full CMC services and consulting to enable its partners to advance their biologic products from discovery to commercial approval. Magdalena started STC Biologics in 2009 with the goal to bring biosimilars to the market. Since 2012, STC changed its strategy and focused on CDMO services. STC Biologics strives to realize “Speed to Clinic” through integrated product development, technical rigor, and flexibility. Before STC she gained start-up experience working for two venture capital firms: Flagship Ventures and Atlas Ventures. Before that She led the development of MM-121, anti-HER3 antibody program, at Merrimack Pharmaceuticals. In 2002, she started her scientific career at Novartis Pharmaceuticals as a project leader for two oncology development products.  She received her Ph.D. from a joint program between Columbia University and NYU, an MBA from Babson College, and a B.S. in Biochemistry from Rutgers University.

Kelly O’Hare, SVP Operations, Lykan Bioscience
As Senior Vice President of Operations at Lykan Biosciences, Kelly oversees management of the day-to-day site operations, including Manufacturing, Supply Chain, Project Management, and IT. Kelly has more than 30 years of experience in various stage biopharmaceutical companies including biologics, small molecules, cell and gene therapies and diagnostic imaging agents, at both product-based companies and CDMOs. Kelly is inspired by leading teams and initiatives to success through the establishment of compliant, robust, and efficient processes. She is a champion of continuous improvement and risk-based decision-making, and of strong partnering within the Lykan organization and with our Partners and suppliers. Before joining Lykan Bioscience, she held various senior leadership roles in various Quality and Technical Operations disciplines with Solid Biosciences, OvaScience, Lantheus Medical Imaging, Vertex, Shire, and Lonza. Kelly is a proud contributor to the commercialization of three novel products, is a supporter of future women leaders in STEM, and a member of the Industry Advisory Board for the Northeastern University College of Science Biotechnology program.

Shawn Fitzpatrick, Head of Manufacturing-Marlborough, Resilience
Shawn Fitzpatrick is the Head of Manufacturing for Resilience, Marlborough site, which is in currently in construction and nearing completion. The facility, upon completion, will be focused on gene therapy and vaccines. Shawn has over 25 years of experience in Biotechnology primarily in Manufacturing related roles of increasing responsibility across small and large pharma companies including TKT, Shire, Takeda and Wuxi Biologics. In addition, Shawn is Board Member for the Just-a-Start Corporations, a non-profit which is focused on promoting equity by creating access to stable housing and building pathways to economic opportunity. One educational program includes biotechnology education.

David DiPietro, Senior Project Manager, CAI
Dave DiPietro is a Senior Project Manager with CAI, an expert in Program and Project Management who has led cross functional teams to deliver complex, high value projects on time and on budget. As a recognized leader in human performance and project management in the built environment, he has leveraged his varied experience in life sciences, shipbuilding, and military operations to achieve operational and organizational excellence. Most recently served as the Startup and Test Director for a 120,000 sf cGMP manufacturing and QC lab facility. At home he serves in a support ministry and as a project manager for various missions in the US and overseas.

MEETING MANAGER:
Ryan Dessert, LeftField PM

REGISTRATION FEES:

Registration by Thursday, April 6, 2023
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members (Early Bird): FREE

Registration after Thursday, April 6, 2023
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE

THANK YOU TO OUR WONDERFUL SPONSORS:

Pre-registration for this event is now closed. Walk-in registrations will be accepted onsite. Email us at office@ispeboston.org if you have any questions.

Wednesday, March 8, 2023
5:30-8:30pm                                                                                                        

Allsteel Showroom
200 State Street
4th Floor, Suite 4A
Boston, MA 02109                                                                                                           

This international women’s day, please join ISPE Boston Women in Pharma and our panelists for a discussion about Entrepreneurial Women Who Create Wealth in Biotech. We will have delicious food and beverages to enjoy, and it will be a wonderful networking opportunity to connect with industry professionals.

Key points for discussion will include:

• Benefits of investing in women led entrepreneurial companies
• Characteristics of publicly-traded women-led entrepreneurial companies
• Women-led companies focus more on ESG efforts
• Women are becoming much more active in HealthCare and Biotech 
• Innovations brought by women-led companies in Biotech
• Increase of women leaders in major companies in roles such as CEOs, COOs, CFOs, Directors, etc.
• Women Founders now taking more companies public through IPOs

Our panelists:

Despoina Betaki is an experienced executive professional with global exposure from the UK to Germany to the US, a diverse background in biotech and pharmaceutical industries, and an additional history of working in capital markets, asset allocation, M&As, and funding. She served as the director of Global Strategies Council specializing in government relations, M&A services, business development and trade. She now heads the Accounts and Relations at Sagax Team, a boutique consulting company serving as one of the most trusted partners for Compliance and Lab Informatics in Life Sciences industry. Despoina has an Executive MBA, as well as graduate degrees in Regulatory Affairs, Pharmacoeconomics and Cybersecurity. She proudly serves the ISPE WIP Committee and is moreover actively volunteering for community projects, academic mentorship programs and activities that focus on the well-being and quality of life of fellow citizens in need.

Eva Ados is the COO & Chief Investment Strategist of ERShares, where she leads ERShare’s global macroeconomic strategy and oversees investments in global, publicly-listed entrepreneurial equities. She is a Fulbright scholar from Europe and graduated summa cum laude with a Bachelor’s in Business Administration and Finance and a Master’s in Innovation and Technology. She has global leadership experience encompassing innovative and start-up organizations throughout the US and Europe. Ms. Ados regularly appears on CNBC, Bloomberg TV, FOX Business and Yahoo Finance and is often quoted in the financial press with her perspective on the global economy, financial markets, technology trends and entrepreneurial companies. She has developed and is managing two new investment strategies: Entrepreneur Innovation & Technology, as well as Female-led Entrepreneurial companies.

Dr. Joel Shulman is the Founder/Managing Director/CIO of ERShares. His 25+ years of research at Babson College (#1 in Entrepreneurship) and best business book written while at Harvard (Getting Bigger by Growing Smaller), led to the formation of a proprietary investment model and the Entrepreneur Factor. The formation of his money management practice followed the sale of the Shulman Review, a CFA test-prep company that trained over 12,000+ investment professionals in 110+ countries around the world. Dr Shulman appears frequently in the media including, Fox Business, CNBC, Bloomberg, Yahoo Finance, WSJ, Barrons, Forbes among others. He has been a consultant to many leading organizations as well as The World Bank in which he helped facilitate capital market development in Central Asian states. He has a Ph.D. and CFA designations along with an MPA from the Kennedy School of Government at Harvard University. 

Important Note: There are limited spots for this event, so make sure to register early!

Registration Fees:

ISPE Members - $15
Non-Members - $25

Thank you to our bar/drink sponsor and host sponsor:

This event is SOLD OUT. If you would like to put your name on the wait list, please email the office at Office@ISPEBoston.org. 

Price Includes: Roundtrip bus ride, full-day adult lift ticket, lunch voucher, buffet dinner at T Bars, and fun with fellow ISPE members!

Bus Departures:

6:00 AM - Departure from Newton Marriott, Rte. 128
6:40 AM - Departure from Chateau Restaurant, Andover, MA
7:40 AM - Departure from LL Bean, Concord, NH
4:30 PM – Bus Departs Waterville Valley to Return to all drop-off sites

Individual Tickets $125 (ISPE Members) / $175 (non-members)

Books of 4 Tickets are available for $495.  Contact the office at office@ispeboston.org or 781-647-7222.

Note: All attendees will be sent a ski wavier which must be completed and returned to office@ispeboston.org

This event is now SOLD OUT. Walk-in registrations will NOT be accepted onsite. Please contact the office if you have any questions, office@ispeboston.org. 

The Emerging Leaders Committee presents the first in a Professional Development Series. 

Single-Use Technologies and Life Cycle

Please join us on February 22nd at 6pm at the Craft Food Hall, Waltham, MA. Our speaker, Mark Maselli, Associate Director of Engineering & Technology at Tonix Pharmaceuticals, will speak to the topic of Single Use Technologies (SUT) and SUT life cycle in which he would be describing what SUT is, SUT adoption and application along with costing. Recent technological advances have revolutionized the bioprocess industry and are enabling manufacturers to move away from equipment that must be sterilized or consumables that are recycled or pose a risk with their transfer into cleanrooms, towards the adoption of disposable and single-use sterile items. 

Space is limited to 40 attendees, so don't delay.

REGISTRATION FEES:
Each registered attendee will receive entrance, TWO drink tickets and food.

$15 for ISPE Members
$25 for non-members

Mark Maselli
Associate Director of Engineering & Technology
Tonix Pharmaceuticals
Mark has a BS in Chemical Engineering from Northeastern and MS in Engineering Management from Tufts. He has been working in the Life Sciences industry for the last 12 years and he is one of the early adopters of single use technology at Shire (now Takeda). He has led engineering design and construction of two fully disposable clinical manufacturing sites.

THANK YOU TO OUR PROFESSIONAL DEVELOPEMENT SERIES SPONSOR