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:

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

The ISPE Boston Area Chapter Women in Pharma (WIP) Committee is hosting a walk at Middlesex Fells Reservation in Stoneham, MA! 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 Middlesex Fells Reservation at 4pm at the upper parking lot.

- Dog, child, and family friendly! All are WELCOME!
- We will meet at the upper Sheepfold parking lot located in Middlesex Fells Reservation
  (please note, there is a lower parking lot too, we are meeting at the UPPER LOT).
- We will walk a 1.6-mile loop, rated as easy
- SNEAKERS or comfortable walking shoes are recommended

Location & Parking:
Upper Sheepfold Parking lot in Middlesex Fells Reservation
Stoneham, 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.!

Shannon Demello will be your host. Any questions, email: shannon.demello@cagents.com 

Join us for happy hour at Lord Hobo Brewing Company at 5 Draper Street, Woburn, MA after the walk! The brewery is ~3.4 miles away or a 10-minute drive.

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

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

Wednesday, June 29, 2022
6:00—9:00 PM

Night Shift Brewing | Lovejoy Wharf
1 Lovejoy Wharf #101 | Boston, MA

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

Cost to attend includes:

• Two drink tickets
  
• Light bites

Location: We will be at Night Shift Brewing - Lovejoy Wharf located in Boston, MA! There is plenty of metered parking on Causeway and local parking garages (TD Garden is the closest). There is also North Station T-stop which is a 5-minute walk to the venue.

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

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

The ISPE Boston Area Chapter Women in Pharma (WIP) Committee is hosting a walk at Breakheart Reservation in Wakefield, MA! 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 Breakheart Reservation at 4pm at the Wakefield Entrance (100 Hemlock Rd, Wakefield, MA)

- Dog, child, and family friendly! All are WELCOME!
- We will meet at the WAKEFIELD entrance (not the Saugus entrance) to Breakheart Reservation
- We will walk the paved 2-mile trail with hills
- SNEAKERS or comfortable walking shoes are recommended
- Breakheart outer loop features a lake and is rated as moderate. The trail is child and dog friendly primarily used for hiking, walking, running, bird watching and dog walking

Location & Parking:
Breakheart Reservation Wakefield Entrance
100 Hemlock Road, Wakefield, MA

Plenty of parking at the Northeast Vocational High School, 100 Hemlock Road, Wakefield, MA (Located right behind the Wakefield High School and athletic field at the end of Hemlock Street)
 

Breakheart Reservation Map: http://www.northshorenature.com/wp-content/uploads/Breakheart-Reservation-Trail-Map.pdf

What to wear: sneakers or walking shoes
What to bring: water, mask, snacks, that night’s winning lottery ticket numbers to share with your walking friends.

Brooke Cote will be your host. Any questions, email: brooke@elementalmachines.com

 
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!

Wednesday, June 8, 2022
5:00 PM – 7:30 PM EST

ElevateBio BaseCamp
200 Smith Street, Waltham, MA 02451

PROGRAM SUMMARY:

Join ISPE and our host ElevateBio, 2021 ISPE FOYA Category Award Winner for Operational Excellence, for an informative and fun filled evening of Facility Tours and a Panel Discussion with industry experts on June 8th at ElevateBio’s Basecamp facility in Waltham, MA. We will delve into the challenges of bringing manufacturing facilities to operational readiness and delivering life-saving therapies.

These days, it is critically important to think hard (but not too long) about your manufacturing strategy for advanced therapy medicinal products (ATMPs); should you focus your energy on site selection, design, construction and the challenges of achieving operational readiness and building an internal organization or enter into a partnership with a Contract Manufacturing organization capable of meeting your time to market, technical requirements and quality parameters?

Regardless of your chosen strategy, there is complexity and challenge throughout the project Lifecyle. At this Panel Discussion you will hear from a wide-ranging group of industry leaders with many years of experience in fields that play pivotal roles in the success of bringing a product to market in a fast-moving industry.

Learn about the perspectives and strategies of bringing a new multi-modal facility on-line from Mike Paglia (COO, ElevateBio BaseCamp); new process technologies, throughput modelling and designing for flexibility from Emily Heffernan (US Director, New Process Technology, DPS Group); the challenges that abound with site selection and leveraging local and state incentive programs from Bob Coughlin (Managing Director, JLL); and the considerations and planning required to develop manufacturing solutions in house from Brett Belongia (VP, CMC Operations, Oncorus Inc).

EVENT AGENDA:

Registration and Networking: 5:00 – 6:30 PM
Networking includes food and beverages
Facility Tours (Register for tour on-site, no pre-registration required):

• 5:30 PM: Josh Sorafine, SVP, Quality and Analytics, ElevateBio
• 5:30 PM: Tess Kitchener, VP, Business Development, ElevateBio
• 5:40 PM: Mario Miele, VP, Facilities and Engineering, ElevateBio
• 5:40 PM: Pete Gelinas, Head of Manufacturing and Technical Operations, ElevateBio

Opening Remarks and Intro to ElevateBio’s BaseCamp: 6:30 – 6:45 PM

• Andrew Sandford, President, ElevateBio, BaseCamp

Panel Discussion and Q&A: 6:45 PM

• Panel Moderator:
• Jim Grunwald, SVP, US Business Development, DPS Group
• Panellists:
• Michael Paglia, COO, ElevateBio BaseCamp
• Emily Thompson, US Director, New Process Technology, DPS Group
• Robert Coughlin, Managing Director US Life Sciences Practice, JLL
• Brett Belongia, VP, CMC Operations, Oncorus Inc.

Dessert Immediately Following Panel Discussion

WHO SHOULD ATTEND THIS WEBINAR:

Any individuals considering the manufacture of ATMP’s in today’s dynamic environment

DIRECTIONS AND PARKING:

Click here for door to door directions. Free parking is available onsite.

ONSITE COVID POLICY:

ElevateBio Covid Policy: All visitors are required to show proof of vaccination and masks are optional. 

REGISTRATION FEES:

Early Bird (Ends 6/1/2022)
Member: $50
Non-Member: $95
ISPE Emerging Leaders Member: $20
ISPE Student Members: FREE

After 6/1/2022
Member: $60
Non-Member: $115
ISPE ELs Member: $30
ISPE Student Members: FREE

Click here for the Flyer and Full Speaker Bios

MEETING MANAGER:

Amy Gusky, Director of Business Development, TRIA Architects

THANK YOU TO OUR PROGRAM SPONSORS:

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

ISPE Emerging Leaders presents a back-in-person meet and greet at Mighty Squirrel Brewery in Waltham, MA! Join us for an evening of socializing, networking, and meeting new members of the Emerging Leaders Committee. 

Date: Tuesday, May 24th
Place: Mighty Squirrel Brewing Company
411 Waverley Oaks Road, Waltham, MA 02452 --> plenty of parking available at the brewery!

Two (2) drinks are included with RSVP!

Please email EL@ispeboston.org with any questions. We hope to see you there!

The Spring Golf Tournament is SOLD OUT! If you have any questions contact us at office@ISPEBoston.org. 

COST:
$1500 for Foursomes - Includes name recognition in onsite program and signage on a hole
$300 for singles

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

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

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

Wednesday, May 18, 2022 - 4:00 PM 

The ISPE Boston Area Chapter Women In Pharma (WIP), Ethnocultural Diversity, Equity, & Inclusion (EDEI), and Veterans in Pharma (VIP) Committees are hosting another Walk! ALL ARE WELCOME!!!!  Grab your sneakers, mask, hand sanitizer, dog treats, and join us for a walk and networking. Or, just a walk or just networking! Registration is preferred for planning purposes.

Meet at Beaver Brook Reservation at 4pm at the Beaver Brook South Parking (free) 531 Waverley Oaks Rd Waltham, MA 02545.

Beaver Brook Reservation is 59 acres of open fields and woodlands. The ponds and waterfall make the park's north section a delightful place for a walk or picnic. The south section features athletic fields, a spray deck, and more. The spray deck might be a little chilly during our walk but is available for those of you who are adventurous.  This event is dog, kid, family, and squirrel friendly.

Afterwards we will head over to the Mighty Squirrel which is a dog-friendly facility (see dog policy).  Mighty Squirrel is located at 411 Waverley Oaks Rd Waltham, MA 02452.

Please wear comfortable shoes, bring a sweatshirt, and dress code is CASUAL.

Schedule
4:00 pm walk to 5:00 pm
5:15 pm to 7pm Mighty Squirrel Networking & FREE Trivia

Location & Parking:
Beaver Brook Reservation, the South Parking Lot
531 Waverley Oaks Rd Waltham, MA.

Registration Fees:
This is a FREE event!

Registration for this event is now closed. Walk-ins will NOT be accepted onsite. Email us at office@ispeboston.org if you have any questions.

Wednesday, May 11, 2022 at 5:30 PM

Location:
Craft Food Hall
Fifth Avenue at CityPoint
200 5th Avenue
Waltham, MA 02451

ISPE Boston’s Women in Pharma Committee invites you to join us for our long-awaited DIY Succulent Plant Party! This event will take place at Craft Food Hall at CityPoint in Waltham. We would like to thank DeAnna Murphy for securing the use of this space! Get ready to create some plant-life and spend time with your ISPE friends!

Brooke Cote will be our Succulent Pairing Expert for the evening and will lead the group through the DIY process!

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 - $40
ISPE Non-Members - $45

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

Wednesday, April 27, 2022

6:00 PM – 7:00 PM EST
Via Zoom

PROGRAM SUMMARY:

Join the ISPE Boston Education committee for our first virtual podcast club. Podcasts offer a unique opportunity for exposure to industry insights, community voices, and emerging technologies.  

We have curated some of our favorite episodes which will be shared a few weeks in advance for guided discussion at the meeting. This will be an interactive discussion, and in addition to discussing our favorites, we hope to gather some new and loved episodes from participants as well.

Podcasts to listen to prior to attending:
Our theme is around Technologies to Support the Future of Pharma and Biopharma Manufacturing

Augmented podcast - industrial conversations that matter: Trends in the Manufacturing Software Market on Apple Podcasts

• Episode 71
• Host Trond Undheim speaks with Ralph Verrilli, Managing Director, Madison Park Group, about how “technology will restore the agility of frontline workers” in pharma manufacturing and operations.

Bioprocess With The Bozenhardts: 016: Bioprocessing Facilites Of The Future on Apple Podcasts

• Episode 16
• Host Louise Hall leads a discussion with Herman and Erich Bozenhardt about what the future demands for manufacture of the wide array of biologics in development.

PODCAST CLUB HOSTS:

Jesse McLaughlin, BioPharma Regional Account Manager, Aqua-Chem and Host and Founder of Modern Biopharma Podcast

I get excited about my job. Sure, I get to work with some of the biggest and most technologically advanced companies in the world every day...but more importantly, I get to help deliver the most common ingredient used in the making of medicines so that we can all count on getting the most safe, effective, and impactful remedies possible when our Doctor gives us that prescription slip.

A LOT goes into making pharmaceuticals, and while no one thing is the most important thing, I love knowing that the water that I provide plays a hugely pivotal role in ensuring a quality product. Aqua-Chem provides solutions for the production of purified water, water-for-injection, and pure steam for the Pharma Industry. So when lives depend on it, companies turn to us.

Listen in on the Modern Biopharma Podcast at www.modernbiopharma.com or by searching "Modern Biopharma" on your favorite podcast player.

Kelly Doering, Aspen Technology

Kelly Doering leads the marketing team for the Pharmaceuticals Business Unit at AspenTech and has held numerous roles in product management, technical marketing and business development since 2007. She completed a postdoctoral fellowship at Boston Children's Hospital and holds an MS and PhD in Nutritional Sciences & Molecular Biology from the University of Connecticut, and a BS in Health Sciences and Natural Sciences from Worcester State University.

PROGRAM FEES:

Member: FREE
Student Member: FREE
Emerging Leader Member: FREE
Non-Member: $15

LOG-ON INFORMATION:

A confirmation email will be sent one day prior to the webinar with the Zoom login information. Should you have any questions or concerns, contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org. The webinar can be accessed through phone, online, or through the Zoom app. 

THANK YOU TO OUR SPONSORS!

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

Tuesday, April 19, 2022
5:30pm – 7:30pm
CRB offices, 101 Station Landing, Medford, MA

Just like cherry blossoms, Robert Downey Jr., Kesha, and Matthew McConaughey.

ISPE Boston’s Women in Pharma EPIC in person networking events are making a comeback! ISPE Boston’s Women in Pharma JOYFULLY invites you to join us for a special return to in-person Spring Networking event!

Time to ditch the zoom and get some face time!

Let’s get together for some light apps, laughs, and lots of fun as the mask mandates finally slip away!

We’ll have a ping pong table, corn hole, and other ice-breaker games to enjoy together at this live event.  As always ALL are welcome!

Registration Fees:
Members -- $10
Non-Members -- $15

PROGRAM SUMMARY:

Regulated laboratories often struggle with restrictions associated with ‘registered analytical procedures’ or methods. Despite encouraging a culture of continuous improvements, regulatory affairs groups are often reluctant to address the burden and cost of gathering pre-approval from regulatory health authorities for changes, even when these offer clear robustness improvements, or offer significant laboratory cost savings.

The ICH harmonization group issued a Quality guidelines Q12, in 2019, which offered a suite of tools to ease the regulatory burden of post approval changes. While the main focus of this was on manufacturing processes, one section plus an entire Annex was devoted to changes to analytical procedures. A separate ICH working group, specializing in analytical procedures, has been collaborating with a variety of global pharmacopoeia, on a lifecycle approach to analytical procedures, and devised an enhanced method development concept, to be published in ICH Q14,  to support the ICH Q12 overarching concept. This promises to be a game changer for regulated laboratories looking to regularly improve and modernize the sensitivity and robustness of their analytical procedures.

In addition, the EU and US pharmacopeia , again through the ICH harmonization process, plan to expand their scope for minor adaptations to chromatographic analyses, from purely restricted to isocratic separations to include well defined changes for gradient separations as well.

Both of these topics will be discussed in this webinar with time to ask questions for live answer, or post event responses.

SPEAKERS:

Shreekant Karmarkar, PhD

Dr. Karmarkar has over thirty years of leadership experience at analytical instrumentation and pharmaceutical companies. At Lachat Instruments (now a Danaher-Hach company), he led development of ion chromatography and flow injection analysis instrumental techniques. During his 16 years of career at Baxter Healthcare, he successfully implemented AQbD for chromatographic and non-chromatographic methods. Dr. Karmarkar led analytical development global teams on validation and transfer of hundreds of methods for excipients, drug substance, drug products at in-process, release, stability testing, and cleaning validation.

Now, as an independent consultant, Dr. Karmarkar provides analytical leadership to startup and mid-size Pharma companies, compliance issue resolution support, CMC sections submission services and technology transfer programs. One significant achievement was conceptualization of a new Analytical Center of Excellence for a major Indian CRO.

Jonathan E. Turner, Principal Product Marketing Manager, Analytical Columns

Jonathan E. Turner is the Product Marketing Manager for analytical LC columns at Waters Corporation.  He joined Waters Corporation in 2006 as a research chemist in the Chemistry Research and Development Group. In 2015 Jonathan transitioned from the laboratory to the Chemistry Product Management Group. In this new role he uses his expertise in chromatographic media to help design, develop, and commercialize new modern stationary phases. 

MEETING MANAGER:
Quincy Logan, Boston Analytical

PROGRAM FEES:
Member: FREE
Student Member: FREE
Emerging Leader Member: FREE
Non-Member: $15

Registration Deadline is Thursday, March 24 at 10:00 am EST.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

Thank you to our Sponsors!

Did you join us for our Power and Privilege workshop with Dr. Akilah Cadet last week? Looking to continue the conversation or share some thoughts? Missed the workshop but interested in hearing what others learned or are learning on their DE&I journey?

Join us for an informal, 1-hour listening circle where attendees can share their thoughts and feedback with the Chapter’s EDEI Committee and other colleagues. This event will be a great opportunity to network with others within the local life sciences industry and discuss ways to improve diversity, equity, and inclusion.

Program Fees:

This is a FREE event! And the first 15 people to register will receive a free $25 voucher for lunch during the sessioin.

Log on Information:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

SOLD OUT! The ski trip is completely sold out. We will NOT be able to accept any walk-in registrations or people driving themselves. The venue is completely full. Please email office@ispeboston.org with any questions.

ISPE Boston Area Chapter for the Annual Ski Trip on Friday, March 4, 2022 at Waterville Valley!

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 - SOLD OUT
6:40 AM – Departure from Chateau Restaurant, Andover, MA  - SOLD OUT
7:40 AM – Departure from LL Bean, Concord, NH  - SOLD OUT
4:30 PM – Bus Departs Waterville Valley to Return to all drop-off sites

Individual Tickets $120 (ISPE Members) / $160 (non-members)

Books of 4 Tickets are available for $450.  Contact the office at office@ispeboston.org or 781-647-7222.

To register for an individual ticket, use this online registration form. To purchase a book of 4 tickets, use this form and send back to office@ispeboston.org.

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

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

ISPE Boston’s Women in Pharma Committee invites you to our March 1st Webinar: Conquer Impostor Syndrome to Advance Your Career, presented by women’s leadership coach, Kim Meninger.

• Do you hesitate to speak up because you worry that you’ll sound foolish?
• Do you question whether you have what it takes to successfully perform your role?
• Do you worry that the people around you are so much better qualified than you are?

If so, you likely struggle with Impostor Syndrome, a term for the feelings of self-doubt and inadequacy many professionals face, particularly as we advance our careers. In this session, you'll learn common triggers of Impostor Syndrome, including feeling different from the dominant culture around you. This is why Impostor Syndrome is so pervasive among women in traditionally male-dominated fields. You’ll also learn strategies to build your confidence and manage these disruptive feelings so that you can effectively achieve your professional goals.

About Kim Meninger

As a women’s leadership coach, Kim Meninger is passionate about empowering women to become more confident, visible, and influential leaders. Having spent over 10 years in the high-tech industry, she experienced first-hand the unique challenges and opportunities facing women in traditionally male-dominated environments. She strives to be the resource to women that she did not have during her own corporate career.

Kim has a BA in psychology and an MBA from Boston College. She is an ICF Associate Certified Coach and CCE Board Certified Coach with certifications in career, executive and leadership development coaching.

Registration Fees:
ISPE Members: FREE
ISPE Emerging Leaders Member: FREE
ISPE Student Members: FREE
Non-Member: $5

Log-On Information:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

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

Workshop Via Zoom

White privilege is a thing, but not the only thing. We all have power and privilege. This workshop examines the many forms of power and privilege in the workplace, given our ethnicity, social economic status, education level, and more. We will explore how to use our power and privilege to better ourselves, to support others, and journey towards becoming an accomplice. This interactive workshop will use breakout groups to enhance discussion and build community.

SPEAKER:  Dr. Akilah Cadet

Dr. Akilah Cadet is the Founder and CEO of Change Cadet consulting firm, which offers a broad array of anti-racism and diversity services for companies and global brands. Dr. Cadet has 15+ years in management and building successful projects, teams, and leaders in the public and private sectors. She is a 2021 Forbes Next 1000 Honoree and honored as one of Staffing Industry Analysts’ (SIA) 2021 Diversity, Equity, and Inclusion Influencers. Forbes and the Wall Street Journal Diversity and Business Newsletter have featured her work. She has worked on federal, state, and privately funded multimillion-dollar projects ranging from public health/healthcare to education. She has spent an extensive part of her career designing training, coaching executives, and informing systematic change to improve the workforce experience for large organizations. Dr. Cadet holds a Bachelor of Science in Health Education in Community Based Public Health, a Master of Public Health, and a Doctorate of Health Sciences in Leadership and Organizational Behavior. She lives in/loves Oakland, has a rare heart condition, and is a proud Beyoncé advocate.

Registration Fees:
Early Bird (Ends 2/10/2022)
Member: $25
Non-Member: $50
ISPE Emerging Leaders Member: $10
ISPE Student Members: FREE

After 2/10/2022
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. 

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

PROGRAM SUMMARY:
Speed with Quality is essential to advancing innovative therapeutics from the bench through clinical and into commercial production. This webinar will highlight two perspectives of how digital tools can increase efficiencies for technology transfer in pharma, followed by discussion and Q&A.

Czarina Santos will present: In preparing for Technology Transfer, it is critical that each step is assessed up front, with goals and expectations set for all parties involved. Examples of tools used in collaboration and the must haves for a successful tech transfer project will be discussed.

Charlie Maher will present: We will also learn how Digital Twin technology can be applied to accelerate the product lifecycle while achieving step improvements in product quality and yield. Key objectives of a successful Digital Twin Technology initiative and how it can be used to significantly accelerate technology transfer and product realization will be presented.

SPEAKERS:
Charlie Maher, Project Director, Resilience
Charlie serves as the Project Director for the design, construction, and qualification of Resilience's gene therapy manufacturing facility in Marlborough, MA.  He is also the Resilience’s global business process owner for commissioning and qualification across network of manufacturing facilities.  Before joining Resilience, Charlie served as the Global Director of Process and Manufacturing Technology at CAI where he enabled life science firms achieve ambitious goals for manufacturing pharmaceutical and biopharmaceutical products.  Earlier in his career, Charlie served in the submarine force of the United States Navy where he commanded a nuclear-powered submarine and was the Chief of Staff of the Naval Undersea Warfare Center, the Navy’s R&D facility for undersea weapon systems

Czarina Santos, Head of Project Management, Delta Project Management
Relevant Accomplishments: Clinical Manufacturing Site Construction and Technology Transfer, Product and Process Tech Transfer from Product Owner (Sending Unit) to CDMO, CMO to CMO, Product Development/Scaleup to Clinical/Commercial MFG

Areas of Expertise: Project Management, Technology Transfer of Facilities and Product, Process Engineering, Equipment and Process Commissioning/Qualification/Validation (CQV)

Professional Philosophy: Make the process simple to be sustainable. Streamline information sharing for transparency. Be inclusive.

MEETING MANAGERS:
Christopher Ciampa, CAI
Kelly Doering, Aspen Technology

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, February 16 at 10:00 am EST.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

Thank you to our Sponsors!

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

ISPE Boston’s Women in Pharma Committee invites you to join us for a Virtual Book Club featuring Jayne Mattson, author of the book “You, You, Me, YOU: The Art of Talking to People, Networking and Building Relationships.”

How many times have you joined a book club and ended up not reading it because the book was too long, the story was not interesting, or you just didn't have the time? This book club is going to be different! Jayne Mattson, Career Coach and Author's book You, You, Me, You  is only 100 pages, easy to read and the subtitle of talking to people, networking and building relationships are essential topics to help us advance in our careers. You won’t want to miss this fun event where Jayne will facilitate the discussion and  introduce you to some of her characters in the book, such as "Hijack Harry" who takes over every conversation you start.

Click here to purchase the book on Amazon!

Registration Fees:
Members -- FREE
Non-Members -- $5

Join us over Zoom 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 2022-2025, come to this webinar 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! This event will take place over the first week of February, so you'll be able to find sessions that work into your schedule.

Platform: via Zoom. Once register for the event, you will receive a link to register into the Zoom system which will send you the link to join the presentations.

Registration Fees: This event is FREE for ISPE Student Members!
$30 for non-members (Note that ISPE Student Membership is $29 for a full year - we recommend putting your $29 towards your membership so you can leverage all that ISPE has to over for a full year)

Program Schedule:
Tuesday, February 1 - 4 to 6 PM
First Impressions and Elevator Speeches
Making the right first impression is more challenging these days because it all happens virtually.  Learn some of the secrets to make you stand out from the crowd

Mastering the Virtual Interview, and then how to virtually follow up
Interviews take on a whole new meaning because everything is virtual.  Learn the secrets of success to stand out during your interview

Wed., February 2 - 4 to 6 PM
What makes each of us Unique
Learn how to translate skills you learned in college to fit job descriptions 

Resume and Cover Letter Do’s and Don’ts
Learn how to make your resume and cover letter sing to prospective employers, and also learn what NOT to do

Thursday, February 3 - 4 to 6 PM
Opportunities at Pfizer
Learn about Pfizer’s Student Worker Program and their new Rotational Program, learn about what Carly looks for in a student prospect 

Hear from Local Industry Veterans about the Life Sciences Industry
Learn from Industry Vets about the inner workings of the area’s booming Life Sciences Industry and the career paths that led people to where they are today

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

Thursday, January 27, 2022
5:30—7:30 PM

Location: 
Lucky Strike Bowling
325 Revolution Drive #1128
Somerville, MA

ISPE Boston’s Social Committee invites you to join us for a special Winter Social event! Let’s get together for some fun bowling rounds and games of pool with good company, delicious food, & drinks!

Cost to attend includes:
• Private bowling lanes and pool tables
• One free drink ticket (cash bar available after that)
• Yummy appetizers

Important Note: This event is limited to 75 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:

Join ISPE Women in Pharma for a culinary adventure!

Chef Pietro will lead the class from his home kitchen studio in Milan, Italy, where he will teach and cook with us. We will be making Gnocchi with Pesto Genovese! The recipe can be made gluten free, dairy free, and/or vegan. The ingredients list will be included with the confirmation email.

Registration is limited to the first 50 people who sign up. This event sold out last year so make sure to register today!

Schedule: 
6:00 PM - 8:00 PM (the class might run a bit after 8:00 PM)

Log-On Information: 
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app. Chef Pietro recommends using a tablet or computer instead of a phone for this class. 

Registration Fees: 
ISPE Members: $15
Non-Member: $15
ISPE Emerging Leaders Member: $15
Student Members:$15

Registration Closes 12/9 at 9am. If you have any questions, please contact the office at Office@ISPEBoston.org. 

ISPE Boston’s Membership Committee invites you to join us for a special Network & Nosh event on December 9th at IL Massimo Ristorante, centrally located in Dedham, MA (at Legacy Place).

Let’s get together one more time before year-end for some great food and conversation!

Cost to attend includes:
• An abundant selection of delicious Italian hors d'oeuvres
• Two (2) drink tickets
• And fresh baked cannoli!

Location:
This event will be held at the award-winning IL Massimo Ristorante, centrally located in Dedham, MA (at Legacy Place).

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:
Members -- $10
Non-Members -- $20

Online registration for this event is now closed. If you have any questions, please contact the office at office@ispeboston.org. 

ISPE Webinar: Continuous Drug Substance Manufacturing - Coming of Age

WEBINAR - Wednesday, December 8, 2021 from 12:00 pm - 1:00 pm

PROGRAM SUMMARY:

Join us for a webinar on continuous manufacturing, featuring two of ISPE’s Annual Meeting speakers, Stephen Born and Thomas Ransohoff. This was a popular program at the Annual Meeting and Stephen and Thomas are returning to present their sessions for the ISPE Boston Area Chapter. See below for more details!

PROGRAM AGENDA:                         

• 12:00 pm – 12:05 pm – Welcome & Introductions
  
  
• 12:05 pm – 12:25 pm – Thomas C. Ransohoff, M.S. presents, “Implementation of Continuous Manufacturing for Monoclonal Antibodies”
  Significant progress has been made at demonstrating the feasibility and value of intensified and continuous manufacturing of monoclonal antibodies (mAbs) and other biologics at pilot scale. Furthermore, regulatory guidance and standards for continuous manufacturing are emerging. An overview of strategies for overcoming the challenges in GMP implementation of continuous biomanufacturing will be presented. Approaches for batch definition, microbiological control, process development and other topics will be reviewed. These strategies are based on a review of broad industry applications along with specific experiences related to development of a continuous manufacturing platform at Resilience.
  
  
• 12:25 pm – 12:45 pm – Stephen Born presents, “On-Demand Manufacturing of Pharmaceuticals”
  Session description coming soon!
  
  
• 12:45 pm – 1:00 pm – Q+A Session

SPEAKERS:

Thomas C. Ransohoff, M.S., Technical Head, Biologics Franchise, Resilience

Thomas C. Ransohoff, M.S. is currently Technical Head, Biologicals Franchise at National Resilience, Inc. (“Resilience”) and has over 30 years of experience in the biopharmaceutical industry. Mr. Ransohoff's areas of expertise include development and scale-up of biopharmaceutical processes; separations and purification technologies; cGMP manufacturing; and management of technology-based start-up ventures. Before joining Resilience, Mr. Ransohoff was a Managing Director at BDO and its precursor BPTC, a leading CMC consulting firm that he helped build over a 20 year period. Prior to that, he held senior level positions at TranXenoGen, Dyax, Repligen, and Xoma. He is also a co-founder of several successful start-ups, including 4th Dimension Bioprocess, Tarpon Biosystems and BioFlash Partners. He serves on a number of scientific and professional advisory boards and holds a Bachelor's degree from MIT and a Master's degree from the University of California, Berkeley, both in Chemical Engineering.

Stephen Born, Ph.D., Director of Scientific Affairs, CONTINUUS Pharmaceuticals, Inc.

Full biography coming soon!

WHO SHOULD ATTEND THIS WEBINAR:

This program will appeal to industry professionals interested in continuous manufacturing.

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, December 8th at 10:59 am EST.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGER:
Megan Baillie, Entegris Life Sciences

Thank you to our Program Sponsors!

Online registration for this event is now closed. If you have any questions, please contact the office at office@ispeboston.org. 

Don't miss out on our upcoming program, Success is Planned: Set Intentions for Your 2022 Career. This virtual panel is focused on strengthening your intentions for your career. Connect with other women leaders in the biotech industry while learning important takeaways about actively managing your career and brand.

The past year has challenged adaptability, flexibility and resilience skills in completely new ways. With continual changes to the workforce it can be overwhelming to prioritize personal needs for your professional path. 

Join Women In Pharma, Women In Bio, and Women Accelerators for a facilitated discussion on ways you can set intentions that will help you balance the organization's needs and your career needs as well!

Event Schedule:
Panel Discussion: 4:00 - 5:30
Networking: 5:30 - 6:30

Moderator: 
Caren Jenkins, CRB

Panelists:
Joanne Kamens, PhD, Executive Director 
Jayne Mattson, Author and Career Coach
Juliet Williams, PhD, SVP, Head of Biology at Kymera Therapeutics 

For full panelists biographies, please view the event flyer here.

Registration Fees:
ISPE Members: FREE
Non-Member: FREE
ISPE Emerging Leaders Member: FREE
Student Members: FREE

Log-On Information:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

Meeting Manager:
Brooke Cote, Elemental Machines

Thank you to our event sponsor!

This event is now closed. If you have any questions, please contact the office at office@ispeboston.org. 

Celebrate the holidays and connect with someone new!

Join the ISPE Boston Women in PharmaÒ (WIP) for the First Annual Holiday Card and/or Gift Exchange. Spread a little holiday cheer, meet new people, and connect! We are offering the option of swapping cards, gifts (minimum $25 in value) or both. Great opportunity to give a little and get a whole lot in return! ALL who would like to share the seasonal spirit are welcome to join in the fun!

It’s super easy. Just 11 simple steps:

1. Sign up to swap a holiday card or holiday gift or both.

2. Fill out the intake form before the deadline of Monday, November 29, 2021, at noon.

3. Receive your secret holiday swap info and preferences on November 29 by email.

4. Purchase gift, or card, or both that suits their preference. For those of you who are not shoppers, both card and gift can be electronic!

5. Send out card and or gift by December 15 to avoid any shipping delays. To avoid the high cost of shipping consider places that offer free shipping such as Amazon, Target, Walmart, etc.

6. Wait patiently for your card, or gift, or both.

7. Receive your swap and Celebrate!

8. Send thank you to your secret holiday cheer bringer and start a conversation.

9. Take picture of your card or present and share with WIP Boston so we can post our happy swappees on LinkedIn and Twitter.

10. Like, Reshare, Retweet the LinkedIn and Twitter Secret Holiday Cheerer posts and photos on ISPE Boston.

11. ENJOY VERY HAPPY HOLIDAYS!!!!!

Deadline to Participate:

Monday, November 29th at noon

ISPE VIRTUAL PANEL DISCUSSION

Fast Track Delivery: Balancing Capital Projects & Operations

WEBINAR - Thursday, November 18, 2021 from 12:00 pm - 1:00 pm

PROGRAM SUMMARY:

Fast Track Project delivery can be leveraged to expedite the project lifecycle and bring products to market more quickly and efficiently. However, Fast Track delivery is not a panacea; the process requires detailed planning, coordination and communication.  This session will provide an introduction into Fast Track Delivery, as well as the lessons learned from a large pharma expansion and renovation project.

SPEAKERS:

Rob Calvert, Design Manager, Jacobs

Rob Calvert has over 30 years of experience in Project Management/Project Engineering of Pharmaceutical Vaccine Facilities, Secondary Manufacturing/Fill-Finish Facilities, Pilot Facilities, Bulk Biotech Facilities, Medical Device Facilities, Laboratories, and Office Buildings.  Rob has led project teams through all facets of project execution from Conceptual Design through Construction and Process Validation.  Process validation experience includes on-site execution of IQ/OQ protocols for process equipment and utility systems in a solid dosage facility and parenteral manufacturing facility.

Most recently Rob was the Project Manager for a confidential client’s Formulation Center servicing both human health and animal heath production for clinical trial use. This 120K SF innovative facility maximized flexibility and reconfigurability, utilized LEAN execution strategies, and maximized modular/offsite construction methodologies. Rob led the design team and was key point of contact with client and construction manager.

Rob was also the Engineering Project Manager for Siemens Healthcare’s Diagnostic Products Capacity Expansion Project in Walpole, Massachusetts. He led a multi-office design team on a $300MM major capacity increase at an existing reagent manufacturing facility, which included over 45 manufacturing expansion and renovation projects. This complicated project included construction of a new building and renovations in five buildings while keeping the site operational. It impacted almost 700K SF of space.

Eric Karch, Senior Director Global Reagent Manufacturing, Laboratory Diagnostics / Supply Chain Management, Siemens Healthineers

Eric Karch is a Senior Director Global Reagent Manufacturing, Laboratory Diagnostics / Supply Chain Management. He has over 31 yrs in medical device industry with diverse background in operations and he has held numerous leadership roles in large capital projects, reagent manufacturing, technical operations, and quality control.

Eric’s role on the project was the Operations lead and subject matter expert (SME) for laboratory operations and reagent manufacturing. Siemens Healthineers is a global leader in medical imaging, laboratory diagnostics, and healthcare information technology.

Greg Keller, Project Executive, Columbia Construction

Greg Keller has been in the construction industry for 44 years and has been a member of Columbia Construction team for 24 of those years.  As Columbia’s Project Executive, Greg is highly regarded in the industry for his professionalism and analytical acumen. His diverse project portfolio includes clients in the institutional, corporate, R&D, and healthcare sectors. Throughout his career, Greg has served in variety of roles including project superintendent and project manager, always focusing on bringing best practices and passion to the team. 

Most recently, his notable management and execution of the highly complex Advanced Manufacturing and R&D facility for Siemens Healthineers in Walpole, MA, a fast track project which included intricate coordination and planning of more than 45 interdependent renovations and additions to five existing buildings, as well as a new office building, all coordinated around a fully functioning manufacturing operation.

Dennis Lucey, Managing Director – Northeast Pharma Team, PMA Consultants

Mr. Dennis Lucey brings 25 years of experience in the pharmaceutical, construction and engineering industries to solve complex program challenges. Expert at planning, building and managing project management and project controls teams and strategies to enable the successful completion of large and complex pharmaceutical projects. As a Managing Director in the Boston office, Dennis leads PMA’s Northeast Pharma Team.

Dennis has both project and program experience in project controls, design, construction management, and project management in public and private sectors.  With PMA, he provides project scheduling and planning, contract management, schedule and cost controls, time entitlement, project management system implementations and claims analyses services.  Industry sector experience includes residential, academic, biopharmaceutical, office/retail, highway, and waste/wastewater projects. His software knowledge includes Primavera P6, NetPoint, NetRisk, Microsoft Project, Power BI, eBuilder, and PM Web.

Dennis was the Project Controls Project Manager for the Siemens Healthineer’s Diagnostic Products Capacity Expansion Project in Walpole, Massachusetts.  He led the project controls team and supported Siemens Project Management team to help deliver over 45 manufacturing expansion and renovations projects.

WHO SHOULD ATTEND THIS WEBINAR:

This program will appeal to a wide variety of industry personas including Capital Project Managers, Facility and Operations Leads, Design Engineers and Construction Management professionals. Both individuals and organizations involved in life sciences should attend this presentation to gain new insights into how to accelerate the capital project delivery lifecycle and how to align project teams achieve the fast paced project delivery cycle required in today’s life sciences marketplace.  The expert panel of speakers shall provide new approaches and lessons learned to streamline and accelerate the time to market.   

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, November 17th at 11:59 pm EST.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGERS:
Janelle Carretero, NECI
Mohammad Riaz, Delta Project Management

Thank you to our Program Sponsors!

Wednesday, October 20, 2021 - 4:00 PM 

The ISPE Boston Area Chapter Veteran's in Pharma (VIP) and Women In Pharma (WIP) Committees are hosting another VIP & WIP Walk! ALL ARE WELCOME!!!!  Grab your sneakers, mask, hand sanitizer, dog treats and join us for a walk and networking. Or just a walk or just networking! Registration is preferred for planning purposes.

Meet at Beaver Brook Reservation at 4pm at the Beaver Brook South Parking (free) 531 Waverly Oak Rd Waltham, Ma.

Beaver Brook Reservation is 59 acres of open fields and woodlands. The ponds and waterfall make the park's north section a delightful place for a walk or picnic. The south section features athletic fields, a spray deck, and more. The spray deck might be a little chilly during our walk but available for those of you who are adventurous.  This event is dog, kid, family, and squirrel friendly.

Afterwards we will head over to the Mighty Squirrel which is a dog friendly facility. (see dog policy).  Mighty Squirrel is located 411 Waverly Oaks Rd Waltham Ma 02452.

Please wear comfortable shoes, bring a sweatshirt, and dress code is CASUAL.

Schedule
4:00 pm walk to 5:00 pm
5:15 pm to 7pm Mighty Squirrel Networking

Location & Parking:
Beaver Brook Reservation, the South Parking Lot
531 Waverly Oak Rd Waltham, Ma.

Registration Fees:
This is a FREE event!

This is the rescheduled summer golf tournament which was orignally being held on 8/23. If you have already registered, your spot will be transferred to the new date Monday, October 18th. Please contact us at office@ispeboston.org with questions.

Join your fellow colleagues for a reception and dinner at the Kernwood Country Club following the Summer Golf Tournament. Cost $75 for members and $90 for non-members. Registration/Cancellation deadline is Monday, Ocotber 4th. 

Thank you to our Golf Tournament Sponsors:

CAI - Putting Contest
Kinetics - Hole-in-One
RW Sullivan - Closest to the Pin - Men
Sequence - Closest to the Pin - Women
DPS Group Global - Longest Drive - Men
Superior Controls - Longest Drive - Women
Columbia Construction - Straightest Drive - Men
CI Design - Straightest Drive - Women

LOCATION:
Kernwood Country Club, Salem, MA 01970

SCHEDULE: 
5:30 PM - Reception/Cocktails/Dinner

The summer golf tournament has been rescheduled to Monday, October 18th. Please contact us at office@ispeboston.org with questions.

This event is SOLD OUT. Click HERE if you would like to register for Dinner Only. If you have any questions, contact us at office@ispeboston.org. 

Thank you to our Golf Sponsors:

CAI - Putting Contest
Kinetics - Hole-in-One
RW Sullivan - Closest to the Pin - Men
Sequence - Closest to the Pin - Women
DPS Group Global - Longest Drive - Men
Superior Controls - Longest Drive - Women
Columbia Construction - Straightest Drive - Men
CI Design - Straightest Drive - Women

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

ISPE Virtual Book Club

discussing Bottle of Lies by Katherine Eban

VIRTUAL DISCUSSION GROUP - October 13, 2021 from 6:00 pm - 7:00 pm

PROGRAM SUMMARY:

Join us for a virtual book club discussion of Bottle of Lies by Katherine Eban, this year's Product Show keynote speaker!

PROGRAM FEES:

Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: FREE

Registration Deadline is Tuesday, October 12 at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGERS:
Heather Longden, Waters Corporation
Aaron Hubbell, Delta Project Management

Fall Golf Tournament

Tuesday, October 12, 2021

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

There is 1 Foursome Left!

Click Here for a Downloadable Registration Form.

Join the Emerging Leaders Committee at Apex Entertainment on Thursday, September 30^th, for bowling, a buffet, cash bar, and a go-kart-filled night of fun. Come out and meet the Emerging Leaders and network in a relaxed atmosphere.

Date: 6PM-9PM, Thursday, September 30^th, 2021

Registration fee: $20 for members & $25 for non-members

More information about Apex Entertainment can be found by clicking here. 

THIS EVENT IS SOLD OUT. If you have any questions or would like to be put on a waitlist, please contact the office at office@ispeboston.org. 

Join Women in Pharma for a Golf Clinic & Networking!

Wednesday, September 29, 2021
4:30 to 6:00 pm Golf Clinic with Golf Pro
6:00 to 7:00 pm Networking, cash bar, and appetizers

Granite Links Golf Course
100 Quarry Hill Road, Quincy, MA

Granite Links is rated a Top 100 Golf Course by Golf Digest Magazine. It will be a great day to brush up on your golf while mingling with colleagues and enjoying the views from this beautiful course that overlooks the city of Boston.

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

Registration Fees:

o   ISPE Members                    $25
o   Non-members                    $35

Thank You To Our Event Sponsors:

Click HERE to register. Attendees who pre-register and join us at the show on September 15, 2021 at Gillette Stadium in Foxborough, MA will be entered into a pre-registration door prize drawing! Full information on the Show can be found on the new website at www.ISPEPS.org. Check is out today!

Click HERE for the day's agenda.

Click HERE for a list of the exhibitors.

As a reminder, attendee registration, parking, educational sessions, and food are always FREE!

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

Pre-Registration for this event has closed, but it is a FREE event - feel free to meet-up at the venue!

Thursday, August 26, 2021 - 5:00 - 7:00 PM 

The ISPE Boston Area Chapter Ethnocultural Diversity, Equity & Inclusion (EDEI) Committee is hosting another free networking meet-up, this time at the Mighty Squirrel Brewery in Waltham, MA! The Mighty Squirrel Brewery has a spacious outdoor Biergarten, as well as mobile-device ordering with delivery right to your table! There are also food trucks every evening. All are WELCOME – so feel free to invite your colleagues and join us for a summer afternoon of networking with other local life sciences professionals!

Additional info can be found on the “Visit Us” page on the Mighty Squirrel Brewery website: https://www.mightysquirrel.com/visit. 

Location:

Mighty Squirrel Brewery
411 Waverley Oaks Road
Waltham, MA 

Getting There: There is extensive free parking available at MSB. The brewery is also very close to Waverley Station on the Fitchburg commuter rail. The 73 Bus also stops nearby at the Church St @ Lexington St stop. The closest T Stop is Alewife, but you would have to take ride share or the bus the remainder of the way to Waltham.

Raindate: Since there is an outdoor area, we will move the social inside at the bar if there is inclement weather.

Registration Fees: This is a FREE event! 

**Pre-registration for this event is now closed and we are at capacity for the event, therefore we will not be able to take onsite registrations. If you have any questions, please contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org .**

Join us on Wednesday, August 18th at the Dorchester Brewing Company's beautiful roof deck for a social and educational event on the Biotechnology of Beer. Because education is important but beer is importanter.

Registration includes two free drink tickets and dinner from M & M BBQ.

Schedule:

5:30 to 6:30 pm – Networking
6:30 to 7:00 pm – Biotechnology of Beer Mini Course
7:00 to 8:30 pm – Networking

Location:

Dorchester Brewing Company
1250 Massachusetts Avenue, Dorchester, MA 02125
https://www.dorchesterbrewing.com/

Biotechnology of Beer Mini Course:
Take this opportunity to learn about the biologic process, how it has been harnessed by mankind to create beer. Learn what impacts the joy of beer taste, and do so with a beer in hand.

Brian Donovan, Program/Project Manager, Nitto Avecia
Brian Donovan has 25 years of experience in brewing, food processing, biotechnology, and industrial enzyme production, with specific experience with process design and optimization as well as maintenance and reliability. He has held positions in process engineering, project management, operations & maintenance management at such companies as Anheuser Busch, United Brewing Systems, Harpoon Brewery and Verenium.

Kevin Chronley, Vice President, A/Z Corporation, a Cianbro Company
Kevin M Chronley has a long history with ISPE and Beverage Consumption; which both contributed to surviving/serving on many committee and board positions for ISPE, currently a Past President of the Boston Area Chapter.  As a Chemical Engineer, I have long marveled at understanding the biotech process of producing the multitude of types and styles of beer. I have volunteered to introduce and support our subject matter expert and speaker Brian Donovan.

Registration Fees:

o      ISPE Members                                   $25
o      Non-members                                   $35

Thank you to our Event Sponsors:

Wednesday, August 4, 2021 - 5:30 PM 

Pre-Registration is closed for this event. If you would like to attend, please call the us at 781-647-4773.

The ISPE Boston Area Chapter Women In Pharma (WIP) Committee has decided to host another WIP Walk after the success of the June walk! This time around, attendees will gather at Horn Pond in Woburn, MA! So join us and walk, skip, prance or whatever moves you. Grab your sneakers, bring your mask and hand sanitizer (if you'd like), water bottle and join us for a social/networking walk!

• Dog, kid and family friendly! All are WELCOME!
• We will walk the paved 2.5 mile trail around the beautiful Horn Pond.
  
• SNEAKERS or Comfortable walking shoes and comfortable clothing are recommended. 
• The trail is kid and dog friendly primarily used for hiking, walking, running, bird watching and dog walking. 
• Your WIP Walk leader, Brooke Cote, will be there early at 5:00 pm to meet the walkers!

Location & Parking:

Horn Pond
85 Lake Avenue
Woburn, MA

Plenty of free parking at Horn Pond - just use address 85 Lake Ave in Woburn.

Registration Fees: This is a FREE event! 

Registration for this event is closed. Walk-ins will NOT be accepted onsite. If you have any questions please contact us at office@ispeboston.org or 781-647-4773.

The Educational Programs Committee needs YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 21st as the 2021-2022 educational season is developed. We are looking for ideas, speakers, and program managers both experienced and new to join our team. 

This MEMBERS ONLY FREE event starts at 5:00 pm with a networking reception with cash bar, followed by a light dinner and planning session. Special perk: anyone that joined ISPE over 10 years ago will get a free drink ticket! 

Contact the office at office@ispeboston.org or 781-647-4773 if you have any questions. 

SCHEDULE:
5:00 – 6:00 pm          Networking Reception with Cash Bar
6:15 – 6:45 pm          Light Dinner
6:45 – 8:30 pm          Planning Session

LOCATION:
Royal Sonesta's outside Riverside Terrace
40 Edwin H Land Boulevard
Cambridge, MA 02142

Thursday, June 24, 2021 - 5:00 - 7:00 PM 

The ISPE Boston Area Chapter Ethnocultural Diversity, Equity & Inclusion (EDEI) Committee is hosting a free networking meet-up at Lawn On D in Boston, MA! Lawn On D is a 2.7-acre outdoor interactive space on D Street, right next to the Boston Convention & Expo Center in the seaport district. The Lawn On D provides a colorful collection of public seating, interactive art exhibitions, assorted games such as bocce and ping-pong, and its signature swings. There is also a pavilion with food, a bar, and other concessions. All are WELCOME – so feel free to invite your colleagues and join us for a summer afternoon of networking with other local life sciences professionals!

Additional Info:

• Lawn On D does not allow pets, outside alcohol or outside food.
• Lawn On D concessions & drinks menu: https://www.signatureboston.com/lawn-on-d/community-activities#food 
• Access Lawn On D’s Frequently Asked Questions page here: https://www.signatureboston.com/lawn-on-d/community-activities#faq
• We will be sharing the meet-up point on the Lawn On D map in the event confirmation email

Location:
Lawn On D
420 D Street
Boston, MA 02210

Getting There: A self-pay parking lot and metered street spots are available. There is also the Silver Line nearby (get off at the World Trade Center T Stop). For more detailed information, go to the Lawn On D website at https://www.signatureboston.com/lawn-on-d/getting-here/public-access 

Raindate: There will be no rain date for this event. In the event of inclement weather, the office will contact registrants the morning of the event on whether it is cancelled.

Registration Fees: This is a FREE event! 

**Online pre-event registration for this event is now closed. Onsite registration will be available when you enter the event. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

Virtualization has become a critical communication tool during the pandemic.  As a result of public safety requirements, the biopharmaceutical industry has had to adjust by adopting virtual technologies and applications to continue making life saving medicines. This hybrid event will include 3 mini presentations that have been utilized during the pandemic, followed by a panel discussion where we'll discuss virtualization in the post-pandemic era. 

• Topic 1- Training: Integrated cloud-based virtual laboratories have allowed learners to perform authentic workplace tasks online, using highly accurate digital copies of real laboratory and industrial scale biomanufacturing equipment.  During this presentation we will model Advanced tools for e-learning that can be utilized for training purposes whether it’s for new hires, annual training, cross-training, or other. 
• Topic 2- FATs: During this presentation we will address the pros and cons of virtual FATs, virtual tools to optimize success, and lessons learned.
• Topic 3- Auditing: During this presentation we will discuss the advantages and opportunities of performing remote audits for third-party vendors and discuss the tools and policies to ensure a successful remote audit. Discuss a risk-based approach to determine the usage of remote access to manage CMO activities during manufacturing operations.

Location:
Gillette Stadium
Cross Insurance Pavilion
1 Patriot Place
Foxborough, MA 02035

Event Schedule:
Registration & Networking Reception: 5:00 - 6:00 
Panel Discussion: 6:00 - 7:00
Q+A: 7:00 - 7:30
Bonus Event courtesy of Gillette Stadium: 7:30 on (see below for more info)

Speakers:

MODERATOR: Sunny Tam, PhD, Director of Professional Science Master's Program in Biotechnology, Framingham State University

PANELISTS:

Yakov Cherner, President, Advanced Tools for e-Learning (ATeL)

Rusty Morrison, Director of Operations – Northeast, CAI

Paul Partovi, Associate Director of Quality Assurance, Sanofi

For full speaker biographies, please view the event flyer here.

Registration Capacity:

Please note that this event is limited to only 50 attendees and will be first come, first served! If you want to register, please do so as soon as possible. The ISPE Boston office cannot hold spaces.

Registration Fees:
Early Bird (Ends 6/9/2021)
Member: $50
Non-Member: $95
ISPE Emerging Leaders Member: $20
ISPE Student Members: FREE

After 6/9/2021
Member: $60
Non-Member: $115
ISPE Emerging Leaders Member: $30
ISPE Student Members: FREE

Meeting Manager:
Shannon DeMello, CAI

Thank you to our program sponsors!
DPS Group
Genesis
ICQ Consultants
Masy BioServices

Onsite Mask & Social Distance Policy:
As of June 1st, Gillette Stadium is not enforcing any mask mandate.

Bonus Event Courtesy of Gillette Stadium:
Following the program, attendees are welcome to stay for the New England Revolution soccer game against the New York Red Bulls, taking place on the Gillette Stadium field for FREE!

Join us for a great opportunity to use the Mentor Circle format to network with our colleagues in the Delaware Valley Chapter of ISPE! 

The WIP committees of Delaware Valley and Boston are working together to bring you another excellent opportunity to network virtually. Over the last year it’s been challenging to network, meet new people and connect. Join us for an engaging session that is sure to be a good use of your time!

Register at your earliest convenience! Attendance is limited to 25 participants from Boston and 25 participants from Delaware Valley - so secure your spot now!

To register, go to https://www.tickettailor.com/events/ispedvc/537197

Wednesday, June 9, 2021 - 5:00 PM 

The ISPE Boston Area Chapter Women In Pharma (WIP) Committee is hosting a walk at Breakheart Reservation in Wakefield, MA! So join us and walk, skip, prance or whatever moves you. Grab your sneakers, bring your mask, hand santizer, water bottle and join us for a social distanced walk.  

• Dog, kid and family friendly! All are WELCOME!
• We will meet at the WAKEFIELD entrance (not the Saugus entrance) to Breakheart Reservation.
• We will walk the paved 2 mile trail with hills.
• SNEAKERS or Comfortable walking shoes are recommended. 
• Breakheart outer loop features a lake and is rated as moderate. The trail is kid and dog friendly primarily used for hiking, walking, running, bird watching and dog walking. 

Location & Parking:

Breakheart Reservation Wakefield Entrance
100 Hemlock Road, Wakefield, MA

Plenty of parking at the North East Vocational High School, 100 Hemlock Road, Wakefield, MA
(Located right behind the Wakefield High School and athletic field at the end of Hemlock Street) 

Breakheart Reservation Map: http://www.northshorenature.com/wp-content/uploads/Breakheart-Reservation-Trail-Map.pdf 

What to wear: sneakers or walking shoes
What to bring: water, mask, snacks, that night’s winning lottery ticket numbers to share with your walking friends.
Raindate: Wednesday June 16th, 2021 at 5:00 PM

Meet at the trail head at the Wakefield entrance to Breakheart Reservation 

Registration Fees: This is a FREE event! 

This event has SOLD OUT! Email office@ispeboston.org if you'd like to be added to the waitlist!

Join the ISPE for 18 holes of Miniature Golf on Wednesday, May 26th at 4:00pm!

Get out of the house or office for a few hours and enjoy some fun networking outside in beautiful Holliston.

Teams of two will putt-it-out for $25 gift cards for the top three teams. Registration is limited to the first 20 people.  

Registration Fees:

ISPE Members $5
Young Professional Members $5
Student Members  $5
Non-Members $10

This event is SOLD OUT! If you have any questions, please contact the office at office@ispeboston.org. 

SCHEDULE:
11:00 AM - 11:45 PM Registration and Buffet Lunch 
12:00 PM -Shotgun Start – Scramble Format 

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

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

Join us for a great opportunity to use the Mentor Circle format to network with our colleagues in the Delaware Valley Chapter of ISPE! 

The WIP committees of Delaware Valley and Boston are working together to bring you an excellent opportunity to network virtually. Over the last year it’s been challenging to network, meet new people and connect. Join us for an engaging session that is sure to be a good use of your time!

Register at your earliest convenience! Attendance is limited to 25 participants from Boston and 25 participants from Delaware Valley - so secure your spot now!

To register, go to https://www.tickettailor.com/events/ispedvc/509343

Join us for an informal, 1-hour listening circle where attendees can share their thoughts and feedback with the Chapter’s Ethnocultural Diversity, Equity & Inclusion Committee. This event will be a great opportunity to network with others within the local life sciences industry and discuss ways to improve diversity, equity, and inclusion.

Program Fees:

This is a FREE event!

Log on Information:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

Wednesday, April 21, 2021

12:00 PM – 1:00 PM EST

The ISPE Boston Area Chapter Women In Pharma® (WIP) Committee is excited to present their Spring Stretch Yoga event on Wednesday, April 21^st from 12:00 pm – 1:00 pm. All are welcome to attend this 45-minute guided vinyasa stretching class (less-flow) incorporating longer holds, breathing, and lengthening to target specific body parts and increase your flexibility. We’ll do some networking in the last 15 minutes as well! Note that this event is free if you are registered for the ISPE Boston Area Chapter’s Virtual Spring Conference!

About Our Instructor:

Harrison Bramhall is the founder and developer of GoSpacing, a virtual class scheduling app for entrepreneurial yoga instructors.

Harrison has been a yoga teacher since 2015. Trained in CorePower’s heated Power Vinyasa, Harrison provides instruction that is energetic and easy to follow. After 3 years of studio experience, he began yoga entrepreneurship by creating a series of vinyasa classes accompanied by live musicians and painters, which were later featured in Boston Magazine. In recent years, Harrison has supported the yoga community with GoSpacing, an app he developed to help instructors transition from studio classes to yoga entrepreneurship.

Visit GoSpacing.com to teach or learn more about classes. Follow him on @GoSpacing!

*Registration Fees:

Members                                           $10
Young Professional Members             $5
Nonmembers                                     $10
Student Members                             FREE

*Note that this event is included with Spring Conference registration – if you have already registered for that event, there is no need to register separately for yoga!

Log-in Information:

One week prior to the event a confirmation e-mail will be sent with the unique registration link to the access the meeting room. Should you have any questions or concerns, contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org.

Virtual Spring Conference

Pharma Plant War Stories: Lessons Learned & Best Practices from Design to Operation

April 19-23, 2021

PROGRAM SUMMARY:
The ISPE Boston Area Chapter is pleased to present a virtual Spring Conference program focused on lessons learned and best practices. The topics covered in this conference will delve into the key ideas, strategies and implementation processes that attendees can utilize in order to achieve the greatest value at their own facilities. Attendees will receive access to on-demand webinar sessions – watchable on your schedule! Then, join us for live Q+A sessions with our program speakers to diver deeper into the subject matter. Browse the full conference brochure featuring session information and speaker biographies here!

WHO SHOULD ATTEND:
This virtual program will appeal to a wide variety of industry personas including Process & Automation Engineers, Quality Assurance, and Operations Professionals. Individuals or organizations involved in life sciences should attend as it shall provide insights into new ways of thinking about existing challenges in life science manufacturing. The expert assembly of speakers shall provide new approaches to streamlining manufacturing processes and cost savings.

Sponsorship Opportunities are available now - Click here to view the prospectus & registration form!

REGISTRATION NOW OPEN:
Members: $30
Emerging Leader Members: $25
Student Members: FREE
Non-Members: $60

ALL REGISTRANTS RECEIVE ACCESS TO THE WEBINAR LIBRARY FOR EASY, ON-DEMAND VIEWING!

LOG ON INFORMATION:
A confirmation email will be sent with information on how to access the conference Homebase system. From there, you’ll be able to watch on-demand content and join the live Q+A sessions via Zoom at the click of a button. You’ll also be able to browse our virtual exhibitor hall and connect with our sponsors, as well as virtually network with other attendees. Should you have any questions or concerns, contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org. Please note that it is recommended you access the conference Homebase system from a desktop or laptop computer, rather than a mobile device. 

MEETING MANAGERS:
Howard Sneider, Avecia
Catherine Stone, Skanska
Michael Bogan, ICQ Consultants

THANK YOU TO OUR SPONSORS & SUPPORTERS:

**Registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

WIP Boston is proud to present an encore, updated program with Mary Cheyne. Join us for a night of learning and fun! ALL ARE WELCOME! Mary will share some of her tips and tricks to better public speaking, as well engage the audience in some public speaking GROUP exercises.

AGENDA:

5:30 to 6:30 pm                Program
6:30 to 7:30 pm                Networking in break out rooms

PROGRAM SUMMARY:

As a professional woman, how do you speak with CONFIDENCE without feeling like a fraud?

Whether you are speaking up in a virtual meeting, presenting an idea to your boss, facilitating a meeting with your team, or even giving a presentation to your superiors, you need to be able to speak with confidence to influence your listeners.

Despite popular belief, people’s top fear is NOT public speaking. That is a myth. For many people, especially women, the top fear is public JUDGMENT.

Key Takeaways from this virtual workshop:

• Learn how to stop overthinking & be present when you speak.
• How to speak powerfully & authentically under pressure.
• How to bypass the number one saboteur in public speaking, your inner critic.

WHO SHOULD ATTEND THIS WEBINAR:

ALL ARE WELCOME! Anyone who is interested in learning more about public speaking both in person and virtually.

SPEAKER:  

Mary Cheyne, MBA

Mary Cheyne, MBA, is a TEDx Speaker and Transformational Public Speaking Trainer & Coach, and the 2009 World Champion of Public Speaking first runner-up, out of 25,000 contestants from 14 countries. Mary has trained over 20,000 people in 30 cities world-wide, including those in Australia, Europe, Asia, Canada & the US. She is the best-selling author of the book “Present” Yourself in Public Speaking – Tell Your Inner Critic to SHUT UP! And the Real You to SPEAK UP! This vast experience has led Mary to one important, unvarnished conclusion: “To communicate and persuade effectively, the first person you need to convince is YOURSELF.”

MEETING MANAGERS: 

Caren Jenkins, CRB
Katie Leitch, Alexion
Kathy Marini, CRB

REGISTRATION FEES:                                           

Registration Deadline March 30, 2021 at 5:00pm

ISPE Members - $10
ISPE Emerging Leaders Members - $5
Student Members - $5
Nonmembers  - $15

**PLEASE NOTE: CANCELLATIONS RECEIVED AFTER MARCH 22nd  ARE SUBJECT TO BILLING**

LOG-ON INFORMATION:

A confirmation email will be sent one day prior to the webinar with the Zoom login information. Should you have any questions or concerns, contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org. The webinar can be accessed through phone, online, or through the Zoom webinar app.

SPONSORSHIP OPPORTUNITIES:

Sponsorship Opportunities for this event are available along with other upcoming WIP events in 2021!  Please contact the meeting managers or office@ispeboston.com if interested. Click here for a Sponsorship Form.

**Registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

ISPE Advancing Pharmaceutical Quality – What’s New, What’s Next?
The journey towards enhanced Quality Management Maturity

WEBINAR - March 18, 2021 from 12:00 pm - 1:45 pm

PROGRAM SUMMARY:

Join us for a panel discussion covering what’s new with ISPE’s Advancing Pharmaceutical Quality Program, FDA updates on quality metrics pilots and quality management maturity, insights on the latest pharmaceutical industry operational excellence benchmarks, and practical strategies for building cultural excellence to support enhanced quality outcomes. Our panel of speakers will address audience questions at the end.

SPEAKERS:

Nuala Calnan, PhD, CEO, BioPharm Excel

Nuala Calnan has over 20 years experience in the biopharmaceutical industry across operations, new product introduction and facility start-up and manufacturing. Nuala’s current focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient. 

Nuala works across the BioPharma and Medtech industries, as well as service providers to these industries, delivering research, consultancy and training that drives innovation. She works closely with industry in assisting organisations to deliver quality excellence, designing metrics that matter to the patient and the business, good data governance programs and implementing behaviour based quality through cultural excellence programs.

Nuala has led a recent Irish Industry research study examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA.  She is currently a member of the team conducting research on behalf of the FDA examining the role of Quality Metrics in driving enhanced quality performance. 

Nuala co-leads the ISPE Quality Culture Team that published the recent ISPE Cultural Excellence Report and the ISPE/ PQLI Task Team on Knowledge Management.  She was also lead editor on a recent knowledge management book entitled A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry, CRC Press 2017.

Nuala is currently an Adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she teaches and leads a number of patient-focused regulatory science research projects at Masters and PhD level.

Tami Frederick, Sr. Director, Corporate Quality and Cultural Excellence, Perrigo

Tami is Senior Director of Corporate Quality Systems and Cultural Excellence at Perrigo. She the Chair of ISPE's Advancing Pharmaceutical Quality team. Tami is a co-author of the 2020 ISPE APQ Series, Quality Management Maturity- CAPA Guide. Tami led the PDA/ISPE Culture Collaboration team authoring the Root Cause Analysis Guide in 2019 and co-authored ISPE Cultural Excellence report in 2017. She is a member of the ISPE Regulatory Steering Team. Tami is Global Quality Leader with 27 years of experience in the Pharmaceutical Industry. She is a chemical engineer by trade and cultural excellence consultant. Tami has held positions in Corporate Quality, QA & QC Operations, R&D, Operational Excellence, and Technical Engineering. She is a certified Lean Six-Sigma Blackbelt and a Certified Quality Engineer. She is also HACCP certified and a Safe Quality Food Practitioner. Her experience spans solid, semi-solid, and liquid drug dosage forms, API’s, Medical Device, and Infant Formula/Foods. Tami has led multicultural Quality teams in the implementation of global quality systems such as global change control, EDMS, SQM, quality investigation and CAPA, corporate quality metrics & governance, global technology councils, and auditing to support compliance. She is a strategic, global continuous improvement leader and change agent advancing the culture of quality throughout all levels in the organization.

Thomas Friedli, Director, Institute of Technology Management, St. Gallen University

Thomas Friedli is a Professor for Production Management at St.Gallen University in Switzerland. His main research interests are in the fields of managing operational excellence, global production management and management of industrial services. He is a lecturer in the (E)MBA programs in St.Gallen, Fribourg and Salzburg. He spent several weeks as Adjunct Associate Professor at the Purdue University in West Lafayette, USA. He leads the St.Gallen OPEX Benchmarking in the Pharmaceutical Industry, the largest independent Benchmarking in this field. He also is the editor, author or co-author of 15 books and various articles. Among his books are “Quality Control Lab”, published in 2020, “21c Quality Management in the Pharmaceutical Industry” published in 2018, “Leading Operational Excellence in the Pharmaceutical Industry”, published in 2013, "The Pathway to Operational Excellence in the Pharmaceutical Industry", published in 2010 and “Operational Excellence in the Pharmaceutical Industry”, published in 2006. Professor Friedli has been the Principal Investigator in a collaborative FDA research grant about quality metrics from 2016 – 2019.

Alex Viehmann, Director, Division of Quality Intelligence II, FDA, CDER, Office of Pharmaceutical Quality

Full biography coming soon!

WHO SHOULD ATTEND THIS WEBINAR:

This program is geared towards professionals and managers from Quality, Operations, and/or Strategy Development interested in quality metrics and quality management.

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, March 17th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGERS:
Heather Longden, Waters Corporation
Charlie Maher, Resilience

Thank you to our Program Sponsors!

**Registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

Join the Emerging Leaders for a night of trivia!

(previously Young Professionals Committee) 

Thursday, February 25, 2021
6:00 PM – 7:30 PM EST

Test your brainpower and recall of a wide variety of general knowledge topics! Registration is FREE but limited to the first 25 who sign-up online. Participants will be grouped into teams and play to the death for a $100 prize, and ultimate bragging rights. 

**Registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

On February 24th from 5:30pm to 7:00pm come hear a panel of speakers discuss the diversity of Pharma in what will be an engaging event that will highlight some of the challenges and solutions from academia through the corporate environment.  If you are looking to learn more about Diversity and Inclusion and what you can do, then you will walk away with a wealth of knowledge. This panel discussion will give you an opportunity to learn from some of the leading experts and to ask the difficult questions that you have. Many companies are looking to have a diverse workforce because diversity makes good business sense. A more diverse workforce is a more productive, competitive workforce. This time gives us an opportunity to make positive change. But it brings challenges that will require tools and support.

Although the shortage of diverse candidates within the engineering field is not a new challenge, the current climate has catalyzed opportunities to move the industry towards more inclusive representation of minorities. 

The Ethnocultural Diversity & Inclusion Initiative fosters diversity and inclusion within the broader ISPE community to represent and serve professionals of ethnically, racially and culturally diverse backgrounds by:

• Providing education and increasing awareness about racial disparities within the pharmaceutical industry;
• Enhancing the recruitment and retention of racially diverse pharmaceutical industry candidates during progression from K-12 to professional level; and
• Cultivating partnerships with organizations that support ERC minorities with education of experiential backgrounds in pharmaceuticals.

Find out how you can get involved. This group has a passion for helping underrepresented engineers and finding ways to give back. This can include individual contributors, managers, senior managers as well as HR professionals.

Who Should Attend this Webinar:
Anyone interested in learning more about diversity and inclusion and what they can do to help. 

Meeting Managers:

Eric Felz, Takeda 

Eni Adedokun, Takeda

Speakers: 
Click here for full speaker biographies.

Dr. John Armendariz, Vice Provost for institutional diversity & Inclusion (Northeastern University)

Dr. Elizabeth Zulick, Director Lowell Institute School at NU

Dean Richard Harris, Assistant Dean, Director of NU program in Multicultural Engineering (NUPRIME)

Dr. Richard O’Bryant, Director of John D. O’Bryant African American Institute

Moderated by Dr. Martin Kimani, Associate Director Process Sciences, Sarepta Therapeutics

Program Fees:
Members & Non-Members: FREE

Registration Deadline is Wednesday, February 24th at 3:00 pm.

Log on Information:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

Thank you to our Program Sponsor!

Sponsorship:
If you would like to sponsor this event, fill out this form and send to ISPE at office@ispeboston.org.

WEBINAR -February 18, 2021 from 12:00 pm - 1:00 pm

**Registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

PROGRAM SUMMARY:

In 2019, after many years of new guidance updates (which include ASTM E2500, ICH Q8, Q9, 10, as well as FDA Guidance for industry), ISPE updated its paramount baseline guide for Commissioning and Qualification. 

The purpose of this updated guidance is to define the Baseline® approach for the Commissioning and Qualification of facilities, utilities, and equipment regulated by the FDA. This will assist in optimizing the commissioning and qualification processes at regulated facilities. 

Despite this monumental effort, adoption in industry by end users is slow at best, and has not been widely accepted.  These presentations, and breakout panel discussions by the speakers, will address challenges in adopting the updated methodology, and will also include how to manage change to encourage adoption.  The discussion will also include testimonials directly from end users, and show how adoption can lead to more integrated qualification approach, allowing for faster project turnaround and cost savings.

SPEAKERS:

Michael Polansky, Director, Corporate Quality, AstraZeneca

As a Director of Corporate Quality at AstraZeneca, Mike is the Quality Process Champion for Premises and Equipment, functioning as the primary Quality liaison with Global Engineering in the development of Engineering standards and improved quality focus of Engineering processes.  Prior to working in Corporate Quality, Mike was the site lead of Quality Systems and Compliance at AstraZeneca’s biopharmaceutical bulk manufacturing facility in Frederick, MD.  Over his 23 years of pharmaceutical industry experience, Mike has also held various Quality and CQV roles at Sanofi Pasteur, Centocor, Inc. (now Janssen Biotech) and GlaxoSmithKline.  During his tenure at Sanofi Pasteur, Mike was responsible for the successful program development of Integrated Commissioning and Qualification, under the site Engineering function, as the Director of Commissioning and Qualification Best Practices.

Deborah Wild, President, DW BioPharma

Deborah Wild is the President of DW BioPharma and was previously Chief of Staff/Head Global Cell and Gene Therapy Business management for Catalent, Cell and Gene Therapy. Deb is an accomplished C-Suite Executive with over 30 years’ experience and has effectively lead large groups that include Quality Assurance, Quality Control, Validation, Regulatory Affairs, and Manufacturing departments throughout her career.  Deb was a key executive team member that transitioned a family owned business into a hyper growth Private Equity (PE) backed success, resulting in a $1.2B purchase by Catalent in 2019, delivering record returns for PE investment partners. She is a biotechnology and pharmaceutical leader with a proven record in bringing products to market and an entrepreneur’s perspective as an owner of a successful consulting business. 

WHO SHOULD ATTEND THIS WEBINAR:

This program is geared towards professionals interested in general equipment facilities validation.

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, February 17th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGERS:
Michael Bogan, ICQ Consultants, Corp.

Thank you to our Program Sponsors!

THIS EVENT IS SOLD OUT. If you have any questions or would like to be put on a waitlist, please contact the office at office@ispeboston.org. 

Monday, February 15, 2021
6:00 PM – 7:00 PM EST

COVID-19 has dramatically changed traditional forms of networking. Throughout this time, we have been challenged to find new ways to maintain relationships with our ISPE Boston community. ISPE Boston board member Caren Jenkins will join us for an engaging discussion about networking and insights about the impact ISPE Boston has had on her career. This event is FREE and open to both members and non-members, but limited to 20 people. So register today!

During this event you will: 

• · Learn some virtual networking tips & tricks
• · Be able to share feedback on any programs/events you want to see offered
• · Ask any questions you have about membership benefits

Guest Speaker:

Caren Jenkins is an experienced business development professional. Her professional “superpower” is that of being a connector. She enjoys talking with prospective new clients, learning about each company, why they exist, their goals and then finding ways to help them. Caren has built strong relationships and networks with key thought leaders and centers of influence in the Boston/New England area. Nine years ago, Caren made a career change and started her career within the life science industry, at that time she began her membership with ISPE Boston Chapter. During her tenure, she has worked on the ISPE Boston product show committee, she is part of the WIP leadership team which started the WIP Boston committee 2 years ago, she chairs the communications committee, and is a member of the ISPE Boston Board of Directors. Caren credits much of her professional success to the opportunities ISPE Boston has provided. ISPE Boston has allowed her to get actively involved with the industry, meet life science professionals, and continuously educate herself on the latest industry trends and issues. Caren views network development as a marathon scavenger hunt. She continuously invests time and effort into meeting new people or reconnecting with old friends to learn about their needs. She is constantly listening to see where she can provide value.

Caren is a part of the business development team at CRB Boston office. She is responsible for generating new business opportunities and growing CRBs client base by strengthening existing relationships. During COVID she has explored many ways of beating the isolation blues, including practicing yoga, learning to playing the ukulele, trying to improve her golf swing, rescuing a new puppy, and is currently planning their next get away to Costa Rica.

https://www.linkedin.com/in/caren-jenkins-08113912/

Log-in Information:

One week prior to the event a confirmation e-mail will be sent with the unique registration link to the access the meeting room. Should you have any questions or concerns, contact the office by calling (781) 647-4773 or e-mailing office@ispeboston.org.

THIS EVENT IS SOLD OUT. If you have any questions or would like to be put on a waitlist, please contact the office at office@ispeboston.org. 

Fight the winter blues by joining Women in Pharma for this live virtual experience: cooking with Pietro. Grab a glass of wine and cook along at home. Family members are welcome to join in!

Registration is limited to 30 people, be sure to sign-up and reserve your spot!

Registration Fee: $15

Thursday, January 28, 2021

6:00 pm

Via Zoom link to be provided upon registration.

The annual Student Career Workshop has gone virtual! Join us over Zoom 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 2021-2024, come to this webinar 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! This event will take place over the last two weeks of January, so you'll be able to find sessions that work into your schedule.

Platform:
ISPE Boston Homebase & Zoom
**Once you register, you'll receive access to the ISPE Boston Homebase platform where you'll be able to create your schedule and join webinars at the click of a button.**

Program Schedule:
Tuesday, January 26 from 4 to 7 PM
Thursday, January 28 from 4 to 7 PM
Tuesday, February 2 from 4 to 7 PM
Thursday, February 4 from 4 to 7 PM

Registration Fees:
This event is FREE for ISPE Student Members!
$30 for non-members (Note that ISPE Student Membership is $30 for a full year - we recommend putting your $30 towards your membership so you can leverage all that ISPE has to over for a full year)

**Pre-registration for this event is now closed. If you have any questions, please contact the office by calling (781) 647-4773 or emailing office@ispeboston.org.**

WEBINAR - January 21, 2021 from 12:00 pm - 1:30 pm

PROGRAM SUMMARY:

Single use technologies have been deployed in commercial pharma and biopharma operations for several years. These technologies promised gains and efficiencies in facility design, operational flexibility, reduced utility costs, and reduced changeover time. Single use solutions have largely delivered on these promises, but with these benefits there have also been unforeseen costs and possible downsides such as reduced supply chain robustness, being locked into single suppliers, and a dead-end waste stream where single use components’ ultimate destination is a landfill or incinerator. 

Alejandro Kaiser will discuss the current state of these unanswered questions as well as possible paths forward to allow single use technologies to fully realize their potential. This webinar and Q&A will be of interest to facility designers and engineers, pharma and biopharma operations professionals, supply chain professionals, environmental and waste stream engineers, and anyone interested in learning more about these unanswered single use questions.

SPEAKERS:

Alejandro Kaiser, PE, Process Engineer, CRB

Alejandro Kaiser, PE, is a licensed process engineer on CRB's biotechnology team. He has been with CRB for eight years.

WHO SHOULD ATTEND THIS WEBINAR:

This program is geared towards professionals interested in single use technology.

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, January 20th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGER:
Aaron Hubbell, Delta Project Management, Inc.

Thank you to our Program Sponsors!

WEBINAR - December 16, 2020 from 12:00 pm - 1:00 pm

PROGRAM SUMMARY:

With the onset of the COVID-19 pandemic, the pharmaceutical industry shifted into hyperdrive to develop, test and manufacture vaccines and therapeutic products needed to meet the public health crisis. To achieve these ambitious timelines, technology transfers moved forward on highly compressed timelines to advance hundreds of products from development labs to clinical manufacturing and then out to a broad network of large-scale commercial production sites around the world.

The urgency of responding to the COVID-19 crisis highlights the importance of excellence in Technology Transfer Program Management.

The webinar will be presented as a facilitated scenario-based format, highlighting the unique challenges of Technology Transfer in the era of COVID-19 and inviting participants to serve in the role of a Technology Transfer Project Manager. The scenario will involve the transfer of a notional COVID-related product from clinical scale into a plant for large-scale production.  As a group, we will plan a tech transfer, identifying best practices for each phase of the project.  Participants are encouraged to share their ideas and experiences with the group.

SPEAKERS:

Charlie Maher, Global Director, Process and Manufacturing Technology, CAI

As Global Director of Process and Manufacturing Technology at CAI, Charlie enables life science firms achieve ambitious goals for manufacturing pharmaceutical and biopharmaceutical products, particularly ATMP products. He leads strategic technology transfer and site start-up programs, delivering all aspects of operational readiness to achieve equipment qualification, process validation, regulatory approval, vertical startup, and continuous improvement. Charlie previously served in the submarine force of the United States Navy where he commanded a nuclear-powered submarine and was the Chief of Staff of the Naval Undersea Warfare Center, the Navy’s R&D facility for undersea weapon systems.

Eric Felz, Head of Facilities Engineering and Validation QMS, Takeda

Eric Felz is Head of Facilities Engineering and Validation QMS for Takeda. Prior to Takeda, Eric worked for Genzyme and Abbott Labs and has 22 years of experience in the BioPharma industry primarily focusing on Commissioning and Qualification. Eric has been an ISPE member since 2001. Eric has been part of the Commissioning and Qualification Community of Practice as well as a member of the Education Committee. He has served on the Board of Directors since 2015 as the liaison to the membership and social committees. Eric has served as the Treasurer, Vice President and is the current President of the Boston Chapter. Eric has a BS in Chemical Engineering from Cornell University as well as an MBA from Babson College. He enjoys hiking, photography, hockey, cooking and spending time with his wife and 3 children.

WHO SHOULD ATTEND THIS WEBINAR:
This program is geared towards professionals interested in tech transfer.

PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15

Registration Deadline is Wednesday, December 16th at 11:00 am.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.

MEETING MANAGER:
Aaron Hubbell, Delta Project Management, Inc.

Thank you to our Program Sponsor!