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

Pre-registration for this event is now closed. Walk-ins WILL be accepted onsite. If you have any questions please call the office at 781-647-4773 or email us at office@ispeboston.org prior to 5pm Friday, 2/17. Otherwise questions will be answered onsite.

The annual Student Career Workshop is being held at UMass Lowell, Lowell, MA. Join other students from local schools to learn the best interviewing skills, resume building, potential career paths, and hear personal success stories from young professionals and seasoned industry veterans.

If you will be graduating in the years 2023-2026, come to a workshop specifically designed to help you to hone your skills and improve your chances of getting that internship, co-op, or full-time position in the Life Science Industry!

Location:
UMASS Lowell
Health and Social Sciences Building
113 Wilder Street
Room HSS-140
Lowell, MA 01854

Program Schedule:
10:00 AM – 3:00 PM

Registration Fees:
This event is FREE for ISPE Student Members and includes all sessions, lunch, refreshments, and swag.
$30 for non-members (Join ISPE now at $29 and receive a year's worth of Membership Benefits as well as this program for free)

*Dress is Business Casual*

ISPE Boston has assembled an incredible group of industry experts to help you:

• Take Inventory of Yourself - What makes you unique?
• Get the Interview - Resume building & Effective emails / cover letters
• Get the Job - How to Make the Right First Impression, Interviewing Tips, & What do employers look for?
• Build Your Network - Why are networks important? How do I start?
• Build Your Career Path - Short- and long-term planning
• Learn from Industry Pros

Internship Survey: 
We are implementing a new program to make finding internships easier; please fill out THIS SURVEY to submit your information. More information will be provided on this during the workshop.

IMPORANT UPDATE: This event is SOLD OUT! Walk-in registrations will NOT be accepted onsite. Please contact the office if you have any questions, office@ispeboston.org. 

Thursday, February 16, 2023
4:00—6:00 PM

Location: 
Timberline Construction
300 Pine Street
Canton, MA 02021

ISPE Boston’s Women in Pharma Committee invites you to join us for a candle making class at Timberline Construction in Canton, MA! Use your imagination to create your own unique candle and catch up with friends and colleagues in the New Year.

Cost to attend includes:
• Candle class
• Food & beverages
• Happy vibes

Important Note: This event is limited to 25 attendees and will sell out so please register early. We hope to see you there! 

Registration Fees:
ISPE Members - $15
Non-Members - $20

Thank you to our event sponsor!

Registration for this event is closes on Wednesday at 10am. If you have any questions, please contact the office at (781) 647-4773 or office@ISPEBoston.org. 

Join Advantexe and ISPE Women in Pharma (WIP) on a digital simulation providing participants with the knowledge and new perspectives needed to develop their skills, careers, and earn a "seat at the table".  During the 3 sessions (2 virtual and 1 in-person), learners will be introduced to business acumen and leadership topics through simulations similar to how pilots hone their instincts and flying skills through a flight simulator.  You'll be learning how to "fly a business”!

Check out this quick video that explains the program:

 Advantexe simulations serve as a bridge between learning and real-life experience by applying new ideas and concepts in a risk-free environment that emulates a working environment to experience systematic consequences of your actions. There are two types of simulations in this program:
 

1.                  Business Acumen - simulation designed to show the cause and effect of strategy development and execution through cross-functional operational business decisions

2.                  Best Practical Leadership - decision-tree simulations where learners interact with characters in the realistic business situations and "the story" unfolds based upon learners' actions at critical decision points.

Session Dates & Program Schedule:
Session 1: February 8, 2023 (5 – 6pm EST, virtual)
Session 2: February 15, 2023 (5 – 8pm EST, virtual)
Session 3: March 6, 2023 (3 – 8pm EST, in-person, Boston, MA, location TBD)

Rob Brodo is the President & CEO of Advantexe. In this role, Rob sets and executes Advantexe’s global business strategy. He has more than 25 years of training experience with a focus in healthcare and pharmaceuticals. Currently working with Merck, AstraZeneca, Pfizer, BMS, Gilead, Vertex, and Alnylam. Rob is an author and developer of Advantexe’s Strategic Business Selling™ content that integrates business acumen and strategic selling into a unique sales account management and sales leadership training solution. He is a graduate of the University of Pennsylvania's Wharton School of Business and currently resides outside of Philadelphia, Pennsylvania. Rob has frequent speaking engagements, having presented at ATD, Masie Learning Conference, Training Magazine’s learning conference, The Conference Board, as well as hundreds of sales meetings, company functions and events. He currently facilitates over 75 client programs a year.

Click here to visit the Advantexe website

Click here to connect with Rob on LinkedIn

Location/Platform: Virtual sessions via Zoom (you will receive a Zoom link once registered)

 Registration Fees*: Members: $750, Non-Members: $875

*PARTICIPANTS MUST REGISTER BY: 02/6/23

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER: 02/01/23 ARE SUBJECT TO BILLING

IMPORANT UPDATE: This event is SOLD OUT! Walk-in registrations will NOT be accepted onsite. Please contact the office if you have any questions, office@ispeboston.org. 

Thursday, February 2, 2023
5:30—7:30 PM

Location: 
Sam Walkers
1 Rainin Rd
Woburn, MA 01801

ISPE Boston’s Social Committee invites you to join us for a fabulous social event to ring in the new year! Prep for the Winter together, and plan with friends for the March 3rd ski trip!

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

Important Note: This event is limited to 125 attendees and will sell out so please register early. We hope to see you there! 

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

Thank you to our event sponsors!

Sponsorships for this event are now sold out!

Workshop Via Zoom

ISPE Boston’s Ethnocultural Diversity, Equity & Inclusion Committee invites you to our Webinar: Do the Work; Becoming an Accomplice. Understanding your privilege and identifying as an ally are a start, yet not enough. We have to do the work. This workshop covers the next steps in anti-racist work, past allyship into becoming an accomplice. We will examine the differences between these two concepts, learn to recognize performative allyship, share insight about what it means, and how to start the necessary work of becoming an accomplice. Segments of this virtual, interactive workshop will use breakout groups to enhance discussion and build community. The EDEI Committee has partnered with Change Cadet to provide this education to the ISPE Boston Area Chapter.

About Gitanjali Morris l Change Cadet Head of Strategy & Facilitator

Pronouns: she/her/hers

Gitanjali is dedicated to building and supporting inclusive and expansive communities that foster a deep sense of belonging. She has a demonstrated history of working in the architecture and planning industry, with nearly fifteen years of experience in the private and non-profit sectors. She is drawn to impact-driven companies and brands, and she has worked with clients in the fields of health and wellness, fitness, real estate, environmental planning, and urban design. Gitanjali's broad range of experience ranges from doing on-the-ground community organizing work in the housing field in Brooklyn, Manhattan, Fresno, and Merced, to running marketing and business development initiatives for architecture and planning firms.

Gitanjali believes the work each of us do 'on the side,' including diversity work, must be at the center. In addition to working in the private sector, Gitanjali teaches dance to large groups of women, which has underscored the importance of having women of color in leadership roles, building spaces where individuals feel they belong, and guiding a community through influential and change-making experiences. Her life experience and identity in white-dominated workplaces give her a unique perspective into the ways in which we must be mindful, intentional, and thoughtful about change.

Registration Fees:
Early Bird (Ends 1/5/2023)
Member: $25
Non-Member: $50
ISPE Emerging Leaders Member: $10
ISPE Student Members: FREE

After 1/5/2023
Member: $35
Non-Member: $60
ISPE Emerging Leaders Member: $20
ISPE Student Members: FREE

Sponsorship

Sponsorships are available for this program for $350 and include logo on event registration page & flyer, thank you & logo during welcoming remarks and closing remarks, and 5 free registrations for your colleagues or clients. Click here to complete a sponsorship form or contact the office at office@ISPEBoston.org. 

What: A retro-themed social gathering and celebration of 2022 with outdoor, fire-side free drinks, apps, and a raffle! Bring your retro ski gear (or just any festive holiday attire!) to celebrate with us.

Registration is now closed, but walk-ins are welcome!

Where: River Bar in Assembly Row, Somerville

When: 12/15 from 6-8pm

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

Thank you to our event sponsor CAI.

Our FREE prize raffle is sponsored by Boston Analytical.

Thursday, December 1, 2022
5:30 PM - 8:30 PM EST
450 Mass Ave, Cambridge, MA

ISPE Boston’s Ethnocultural Diversity, Equity & Inclusion Committee invites you to join us for a night of incredible dancing at La Fabrica Central in Cambridge, MA. Bring your dancing shoes and be prepared to learn moves from La Fabrica’s expert instructors. Registration includes heavy appetizers, two drink tickets, and dance lessons. During dance lessons, attendees can also expect to hear from experts on how learning skills in dance has impacted their professional experiences and can help build and improve inclusivity for us all. 

Location: 450 Massachusetts Avenue, Cambridge, MA 02139
Transportation: Save time and money – take the Red Line to Central
Parking: Cambridge Municipal Parking Lots 4, 5, and 6 within walking distance

Registration Fees:
Early Bird (Ends 11/28/2022)
Member: $20
Non-Member: $30
ISPE Emerging Leaders Member: $10
ISPE Student Members: FREE

After 11/28/2022
Member: $30
Non-Member: $40
ISPE ELs Member: $15
ISPE Student Members: FREE

Thank you to our Bronze Level event sponsors Boston Analytical and CAI.

Are you interested in sponsoring this event? Click here for more information!

Registration for this event is now closed. Email us at office@ispeboston.org if you have any questions.

Join us as we hear from Steve Flanagan about the power of LinkedIn and leveraging it to build your personal brand. Steve has helped many people in this area and continues to do so daily. He has over 18 years of experience in personal branding, and over 20 years of experience in business development.  Prior to that, he worked as a licensed architect and a construction manager. He has recently joined Consigli Construction in a Business Development role.

People perceive who you are based on how you present yourself. Steve will share how to show your passion, energy, and love to build an audience and create visibility on LinkedIn.  Visibility creates new opportunities. This approach is COVID-19, job loss, and health issues proof as well as many other things. 

Everything happens in parallel. You don’t need to wait years to see results. The progress builds on itself. Daria Bukesova from Ci Design will share LinkedIn's impact on her career in just under a year.

Location:
via Zoom (A personalized Zoom link will be sent to you closer to the program).

Registration Fees:
Members: FREE, Non-Members: $15

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.

Location: 
Castle Island Brewing Co.
10 Old Colony Avenue, South Boston, MA

Join over 100 of your fellow colleagues for a Halloween Costume Party to celebrate the season and Volunteer Appreciation Night! Wear your best costume for a chance to win the costume contest - Categories are Best, Scariest and Most Creative!

Registration Fees:
Volunteers - Free
ISPE Members - $15
Non-Members - $25

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, October 26, 2022
5:30—8:30 PM
Takeda
300 Shire Way, Room 1508
Lexington, MA 02421

Balance is B.S. reclaiming your life without compromise: tools and techniques for managing "busy" and having more of an impact at work and in your life.

PROGRAM SUMMARY:

Do you get to the end of the day and wonder “what did I even do today?” Do you feel like you’re in a constant state of tension between what you should be doing and what you want to be doing? 

In this session we’ll:

• Get centered on your values and how you can use them as a decision-making tool for when you’re faced with constant choices on how to spend your time.  
• Address the very practical elements of your meeting calendar - so bring that with you!
• Talk about and get comfortable with setting boundaries - saying “no” so you can say “yes” to the things that matter most.

Join us to get a handle on your "busy" so you can increase your impact at work and in your life - on your terms!

PROGRAM SCHEDULE:

5:30 – 6:30 PM     Registration & Networking Reception
6:30 – 8:30 PM     Presentation

SPEAKER:

Amy Paro is a dynamic executive coach, consultant and facilitator driven to help leaders and organizations achieve their maximum potential. She has been working in the BioTech industry for over ten years providing support to all functions from early discovery research to technical operations and commercial sales teams. She understands the nuances and complexity that live in this industry and works with her clients to find ways to navigate these nuances with authenticity and focus. Amy has a wide-range of expertise including leadership coaching and development, team effectiveness, culture and employee engagement, organizational development, onboarding, diversity and inclusion and talent management. She is the go-to person when there’s a problem that needs a creative solution, serving as trusted thought partner to leaders at all levels.

REGISTRATION FEES:

Early Bird (Ends 10/19/2022)
Member: $50
Non-Member: $95
ISPE Young Professionals Member: $20
Student: FREE

After 10/19/2022
Member: $60
Non-Member: $115
ISPE Young Professionals Member: $30
Student: FREE

Thank you to our wonderful sponsors:

When | October 13, 2022
Where | Technology Square, Cambridge
Time | 4:00 - 6:00 PM

Pricing | ISPE Women In Pharma Members - Free; Non Members - $35, Members - $18

Event Description | Join us on October 13 for a WWIRE + ISPE Women In Pharma COLLAB FIT event @ Technology Square in Cambridge! Grab your ticket today for #sweatworking with your fellow female CRE, AEC, Pharma + Biotech colleagues. We will be joined by Eliza Shirazi, owner and founder of Kick It By Eliza, for a 13 round, music driven, kickboxing class. Following the workout there will be networking with smoothies, juices and light bites.

This class is meant for all skill levels, NO PRIOR KICKBOXING EXPERIENCE NEEDED!

Register Here: https://clients.mindbodyonline.com/classic/ws?studioid=509080&stype=-7&sTG=22&sVT=5&sView=day&sLoc=1&sTrn=100000004&date=10/13/2

Use Code: ISPEFREE to receive free admission. 

SOLD OUT! We have reached capacity for this event - registration is now closed!

Fall Golf Tournament

Tuesday, October 11, 2022

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

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

Thank you to our wonderful sponsors:

Bala Consulting Engineers
Boston Analytical
CAI
Commodore Builders
Consigli Construction
DPS Group
Erland Construction
Fulcrum
Kinetics
Marguiles Perruzzi
Mettler Toledo
Neponset Controls
Northeast Engineering
Paul Mueller
PM Group
RW Sullivan Engineering
Sentrol
Sequence
Sterling Construction
Superior Controls / Etech Group
Timberline Construction
TRIA
ValSource, Inc
WB Engineers

WHEN: Monday, October 3, 2022

WHERE: Far Corner Golf Club
             5 Barker St
             Boxford, MA 01921
             https://farcornergolf.com/

 SCHEDULE:                 

             7:30-9:00am: Registration, Coffee & Doughnuts
             9:00am: Shotgun Start
             11:00am: Box lunches to be handed out at turn & by sponsors golf cart volunteer
             2:00pm: Networking, BBQ & Awards

REGISTRATION IS NOW OPEN!! Download the registration form, make your selections, and email to office@ispeboston.org

Thank you to our wonderful sponsors:

ahp Architects
Boston Analytical
CAI
Chapman Construction
Cotter Brothers Corp
JC Cannistraro LLC
Kynota
Margulies Perruzzi
Process Design Solutions
Repligen
STERIS Life Sciences
Wise Construction

**Interested in sponsoring this golf outing? Email us at: office@ispeboston.org**

SOLD OUT! We have reached capacity for this event - registration is now closed!

Wednesday, September 28, 2022
7:10 PM - Boston Red Sox vs. Baltimore Orioles

Join the ISPE Emerging Leaders on Wednesday, September 28^th to watch the Red Sox take on the Baltimore Orioles at Fenway Park! First pitch is at 7:10 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 $30 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 35 people so sign up quickly!

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

Registration Fees:
$30 / person - limited to 35 people!

Thank you to our wonderful event sponsor, CAI

Registration for the ISPE Boston Area Chapter Product Show is NOW OPEN! Use the link below to sign up! Attendees who pre-register and join us at the show on September 21, 2022 at Gillette Stadium in Foxborough, MA will be entered into a pre-registration door prize drawing! As a reminder, attendee registration, parking, food, and educational sessions are always FREE!

Click here to launch attendee registration form or paste the following link into your browser: https://ispe.swoogo.com/2022ProductShow

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

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

Click here to view the floor plan and list of exhibitors: https://ispebos22.mapyourshow.com/8_0/#/

Click here to view the agenda!

Interested in the Career Fair? Click here for more information and to see the participating companies!

See you at Gillette Stadium!!

The ISPE Boston Area Chapter Women in Pharma (WIP) Committee is hosting a walk at Cushing Park in Framingham, MA at 4:00pm! Join us and walk, skip, prance or whatever moves you. Grab your sneakers, bring your mask, hand sanitizer, water bottle and join us for a socially distanced walk. Meet at the parking lot at 80 Dudley Rd, Framingham, MA. Everyone is welcome to join us afterwards for happy hour at Samba Steak & Sushi at ~5:30pm!

- Dog, child, and family friendly! All are WELCOME!
- We will meet at the parking lot located at 80 Dudley Rd, Framingham, MA at 4pm
- We will walk a 1.4-mile loop, rated as easy
- SNEAKERS or comfortable walking shoes are recommended

Location & Parking:
80 Dudley Rd
Framingham, MA (see map link with directions, here)

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

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

Aaron Bober will be your host. Any questions, email: aaron.bober@crbgroup.com or 508-808-3688.

Join us for happy hour at Samba Steak & Sushi at 1138 Worcester Rd in Framingham, MA after the walk! The brewery is ~2.2 miles away from Cushing Park in Framingham.

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

This event is completely sold out! Please call the office with any questions at 781-647-4773. No walk-ins will be accepted!

LOCATION:

Kernwood Country Club, Salem, MA 01970

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

Thank you to our event / contest sponsors:

A/Z Corp - Closest to the Pin (Women)
Bowdoin Construction - Tee Sign
BWT Pharma & Biotech - Closest to the Pin (Men)
CAI - Tee Sign
Commodore Builders - Putting Contest
DPS - Straightest Drive (Men)
ESS - Tee Sign
Exposure 2 Lighting - Tee Sign
Gerflor USA - Longest Drive (Women)
Middlesex Gases - Tee Sign
New England Labs - Hole in One
PIDC Construction - Tee Sign
Precision Cleanrooms - Tee Sign
RW Sullivan Engineering - Longest Drive (Men)
Sentrol - Tee Sign
STV - Tee Sign

ISPE Boston's Good Automated Manufacturing Practice (GAMP) 5 Forum Program

NEW SPEAKERS JUST ANNOUNCED FROM THE FDA!!

WHEN:   August 18, 2022 | 1:30pm - 7:00pm

WHERE: Courtyard by Marriott Boston Cambridge
             777 Memorial Drive
             Cambridge, MA 02139

PROGRAM DETAILS:

After celebrating GAMP’s 30th anniversary in 2021, the GAMP Global Steering committee and ISPE are proud to present the Second Edition of GAMP® 5 which will be available Summer of 2022.  GAMP 5 Guide–A Risk-Based Approach to Compliant GxP Computerized Systems was initially published in 2008. A GAMP 5 Second Edition has been developed based on comprehensive reviews of GAMP 5 content performed in 2017 and early 2020 by the GAMP CoP Global Steering Committee and the GAMP CoP ERB (Editorial Review Board).

The primary purpose and objective of this revision is to provide updates, clarify the relationship between GAMP 5 and the GAMP® 5 Guide: Records and Data Integrity, acknowledgment of current FDA work on computer software assurance (CSA), and an updated, dynamic, and evolving set of Appendices. 

Join the ISPE Boston Chapter Educational Program on August 18th in Cambridge, MA to learn more about how volunteer experts and regulators from the ISPE family collaborate through GAMP on a range of software and computerized systems challenges in a highly quality driven and regulated space. Hear from contributing authors, reviewers, and the editorial team about the highlights of this second edition. 

We also hope to shortly confirm a lively panel discussion with two invited FDA speakers from CDER and CDRH, who are both passionate about risk-based Validation of software and have worked closely with the editorial team on the upcoming ISPE guide. 

AGENDA:

1:30pm Welcome
• Overview of the ISPE GAMP Community of Practice
• Overview of the ISPE GAMP® 5 Guide, 2nd Edition
• Panel Discussion on critical thinking and risk-based approach to computer system validation (FDA invited)
• ISPE GAMP® 5 Guide, 2nd Edition new chapters/appendices on critical thinking and risk-based testing
• How to be involved in ISPE GAMP, Special Interest Groups, and local Communities of Practice
5:30-7:00pm Networking Session

SPEAKERS:
Lorrie Vuolo-Schuessler is Senior Director of Computer Systems Quality and Data Integrity at Syneos Health providing support and consultation to internal and external business partners to assist them in meeting global regulatory and data integrity requirements for computerized systems. Lorrie has been involved with ISPE and the GAMP Community of Practice leadership since 2002. She is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global leadership team. She has contributed to the development of the GAMP 5 2ed A Risk-Based Approach to Compliant GxP Computerized Systems and the ISPE GAMP Good Practice Guide (GPG): Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is a co-leader of the recently formed Computer Software Assurance (CSA) Special Interest Group (SIG) and drove the data integrity efforts within GAMP as the co-chair of the recently sunsetted GAMP Data Integrity SIG. The Data Integrity SIG developed multiple GPG’s including: the ISPE GAMP RDI GPG: Data Integrity by Design, the GAMP RDI GPG: Data Integrity – Manufacturing Records, the ISPE GAMP RDI GPG: Data Integrity – Key Concepts, and the ISPE GAMP Records and Data Integrity Guide. Additionally, she has contributed to multiple ISPE/GAMP webinars, expert exchanges, and trainings.

Khaled Moussally, EVP Client & Regulatory Relations, Compliance Group Inc. Khaled is a Quality / IT executive who partners with clients from the Pharma, Biotech and Medical Device industries to deliver solutions to their IT / Engineering quality and compliance related challenges. After spending over 27 years in IT, Manufacturing and Quality, 19 years of which at Baxter Healthcare, Khaled understands the regulated environment and is able through his deep experience and valuable network to provide his expert advice. Khaled is a contributor to the MDIC “Case for Quality Initiatives” and an active member of the “FDA CSA Industry team” (FICSA), contributed countless recommendation to the FDA draft guidance on “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled has presented in numerous seminars along with the FDA & Industry leaders on how to reduce time and cost in validating software by applying CSA Draft guidance. Khaled is a member of GAMP Americas Steering Committee, contributor to both, Good Practice Guides on DI by Design and Enabling Innovation and GAMP 5 2nd Edition.

NEW CONFIRMED SPEAKERS:

Seneca D. Toms, National Drug Expert, Drugs, U.S. Food & Drug Administration (FDA)

Francisco Vicenty, Program Manager, Case for Quality, U.S. Food & Drug Administration (FDA)

REGISTRATION FEES:

Early Bird (Ends 08/11/2022)
Member: $125
Non-Member: $195
ISPE Young Professionals Member: $65
Student: FREE

After 08/11/2022
Member: $135
Non-Member: $210
ISPE Young Professionals Member: $70
Student: FREE

PARKING INFORMATION:

Courtyard by Marriott Boston Cambridge offers valet parking at a rate of $45 per night or you can park your car in the adjacent garage at a rate of $40 for 24 hours. If you are planning on taking your car in and out multiple times during your stay, then valet parking is the less expensive alternative. Street parking is free between 8pm and 8am and all day on Sundays.

Thank you to our wonderful sponsors:

THIS EVENT IS SOLD OUT. Please contact the office if you have any questions or would like to be put on a wait list, office@ispeboston.org. 

Thursday, August 4, 2022
6:45 PM – WooSox vs. Durham Bulls

The ISPE Boston Membership Committee invites you to attend the WooSox vs. Durham Bulls baseball game at the Polar Park at 6:45 PM on Thursday, August 4th. We are thrilled to be hosting what is sure to be one of the most memorable and fun networking events of the year at the new Polar Park in Worcester, MA!

Ticket price includes:
• Seating for 1 located in the Berm section of Polar Park
• $12 credit for food and beverages while at the game
• Parking is not included and ranges from $5-$20

Availability is limited, so register now!

Registration Fees:
Members (non-YP): $20
Non-Members: $25

We have reached capacity for this event - registration is now closed!

DATE:                       Monday, August 1^st

LOCATION:               Sagamore Spring Golf Club
                                  1287 Main Street
                                   Lynnfield, MA
                                   781-334-3151
                                   https://www.sagamoregolf.com/sagamore-spring-home

SCHEDULE:              8:00 AM – Coffee, Registration & Warm-up
                                  9:00 AM – Shotgun Start – Rainbow Scramble Format
                                  2:00 PM – 4:00 PM – BBQ at the Outdoor Grill, Beverages & Networking

Join us for the premiere Women in Pharma ISPE Boston Golf Outing.  You asked and we listened! 
A fun-filled day of golf, contests, PRIZES, and more fun at Sagamore Spring Golf Course in Lynnfield, MA. This is NOT your average golf tournament!! This tournament was designed with the ladies in mind focusing on finesse and fun vs. long drives and par fives. Sagamore Spring is a smaller course; however, it will challenge golfers middle and short game.

The tournament will feature a shot gun start and a rainbow scramble format including *sparkly ball* and other contests. Due to the nature of the event, we respectfully request that there be at least one female player per foursome. 

~ For every female golfer on your team, a stroke deduction will be taken from your final score ~

Please complete the printable registration form, specifying the item you wish to purchase and forward your non-refundable check or credit card payment to ISPE Boston at: office@ispeboston.org or 465 Waverley Oaks Rd, Ste. 421, Waltham, MA 02452. (781) 647-4773

Pre-registration for this event is now closed. Email us at office@ispeboston.org if you have any questions.

The Educational Programs Committee needs YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 20th as the 2022-2023 educational season is developed. We are looking for ideas, speakers, locations, and program managers both experienced and new to join our team. 

Meeting Details: Join the Educational Programs Committee and the Board of Directors at 5:00 pm for a networking reception with cash bar, followed by dinner. Special perk: everyone that attends gets two free drink tickets! After dinner we will have an informal agenda where we review ideas and begin to plan out the new year.

Location:
Newton Marriott Hotel
2345 Commonwealth Ave, Newton, MA  02456

Schedule:
5:00 - 6:00 pm   Networking Reception with Cash Bar
6:15 - 6:45 pm   Dinner
6:45 - 8:30 pm   Planning Sessions

Fees:
This event is FREE!

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

Tuesday, July 19, 2022
5:30 to 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 Pro, 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.

Space is limited to the first 25 registrants. Register today!

Thank you to our wonderful sponsors: