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!

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. 

Join the ISPE Membership Committee for a festive night of networking and a fun Ugly Sweater Contest! Prizes will be awarded for the best ... oops we mean worst sweaters. Registration is free but only open to the first 20 registrants.

Tuesday, December 1, 2020
6:30 pm to 7:30 pm
Via Zoom link to be provided upon registration.

Missed the Fall Educational Summit? Not to worry - you can still register for access to the full library of 20+ educational webinars!

THANK YOU to our Platinum Fall Educational Summit Conference Sponsor 

PROGRAM SUMMARY:

The ISPE Boston Area Chapter Fall Educational Summit was the Chapter's first ever virtual conference and all educational webinar recordings are now available in our online library for easy, on-demand viewing. Educational tracks include Risk Management, ATMP, Facilities of the Future, Pharma 4.0, plus sessions on professional development, implicit bias, and more! Access to the full library is available to both members and non-members for the low price of $30!

Thank You to Our Gold Level Track Sponsors!
Boston Analytical
Burkert
Masy BioServices
NECI

LOG ON INFORMATION:

Once we process your registration, we will email you with your login information to the online recordings library. You can then watch the webinars at your convenience! 

REGISTRATION:

Members & Non-members: $30

Click here to register!

A month-long virtual conference featuring four tracks on industry topics, networking opportunities, and sponsored education throughout October!

THANK YOU to our Platinum Conference Sponsor

PROGRAM SUMMARY:

The ISPE Boston Area Chapter Fall Educational Summit will be the Chapter's first ever virtual conference and it will take place throughout the month of October.

This event will offer the educational sessions, normally presented in-person at the Annual Product Show, in a virtual format. The Chapter's Product Show committee and Educational Programs committee have been hard at work re-formulating these sessions for the virtual education space and are excited to bring you a new way to learn about industry topics and connect with colleagues both new and old. Registrants receive access to the full conference including every educational track. We'll also be bringing you special virtual sessions from the Women In Pharma (WIP) Committee, the Young Professionals Committee, and the Professional Development Committee, all included with your registration!

Thank You to Our Gold Level Track Sponsors!
Boston Analytical
Burkert
Masy BioServices
NECI

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

REGISTRATION NOW OPEN:
Member: $30
Non-Member: $60
Student Member: FREE

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

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the event platform, Homebase. This is where you'll be able to connect to the webinar sessions.

MEETING MANAGERS:
Megan Baillie, HP-NE
Janelle Carretero, NECI
Chris Ciampa, CAI
Kathleen Mihlbachler, YMC
Vineet Nair, CRB
Lokesh Shanmukha, Delta Project Management

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

Individual players can register online. If you are registering a foursome please click here for the registration form and return to office@ispeboston.org.

*Limit 2 Foursomes per company!

Pricing & Details:

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.

A month-long virtual conference featuring four tracks on industry topics, networking opportunities, and sponsored education throughout October!

THANK YOU to our Platinum Conference Sponsor

PROGRAM SUMMARY:

The ISPE Boston Area Chapter Fall Educational Summit will be the Chapter's first ever virtual conference and it will take place throughout the month of October.

This event will offer the educational sessions, normally presented in-person at the Annual Product Show, in a virtual format. The Chapter's Product Show committee and Educational Programs committee have been hard at work re-formulating these sessions for the virtual education space and are excited to bring you a new way to learn about industry topics and connect with colleagues both new and old. Registrants receive access to the full conference including every educational track. We'll also be bringing you special virtual sessions from the Women In Pharma (WIP) Committee, the Young Professionals Committee, and the Professional Development Committee, all included with your registration!

Thank You to Our Gold Level Track Sponsors!
Boston Analytical
Burkert
Masy BioServices
NECI

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

REGISTRATION NOW OPEN:
Member: $30
Non-Member: $60
Student Member: FREE

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

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the event platform, Homebase. This is where you'll be able to connect to the webinar sessions.

MEETING MANAGERS:
Megan Baillie, HP-NE
Janelle Carretero, NECI
Chris Ciampa, CAI
Kathleen Mihlbachler, YMC
Vineet Nair, CRB
Lokesh Shanmukha, Delta Project Management

**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 - September 24, 2020 from 12:00 pm - 1:00 pm

PROGRAM SUMMARY:

Join us on September 24th as two industry professionals present the below topics and we round out the program with a Question & Answer session.

Session I: Comparing Manual Manometer Testing to Room Pressure Monitors

Presented by: Michael Soper, Northeast Regional Sales Manager, Setra Systems Inc.

In Certified environments, HVAC systems are an important part of managing clean air to minimize airborne contaminants. Maintaining reliable and sufficient room differential pressure keeps people safe and processes clean. But can you trust the readings you see on room pressure monitors and building management systems? Are they accurate? When you test with a handheld manometer and it differs from wall-mounted units, which one do you believe? This session will get into detail about sensing technologies and calibration, and provide guidance to help you certify with confidence and report accurate room pressure numbers that are supported by published data.

Session II: Contamination Control Strategies: Case Studies

Presented by: Jim Polarine, Senior Technical Service Manager, STERIS Corporation

This webinar will cover a risk-based approach to a cleaning and disinfection program and case studies in contamination control.  Details will be provided on how to follow a risk-based approach for cleaning and disinfection using good science.  The most common causes of contamination will be conveyed in case studies with fungal spores, and bacterial spores.  Solutions will be discussed on how to proactively prevent contamination from reoccurring.

SPEAKERS:

Michael Soper, Northeast Regional Sales Manager, Setra Systems Inc.

Mr. Soper is one of the leading industry experts in room ventilation, differential pressure management, and mechanical systems for critical environments. His background includes innovation development, product management, and R&D at Schneider Electric, Phoenix Controls, and Setra Systems. Mr. Soper has more than 20 years’ experience providing global application engineering and consulting expertise to design engineers, building automation integrators, and end-users that operate regulated healthcare and laboratory spaces. He has a degree in mathematics from Boston College, and holds four US patents for hardware and software inventions.

Jim Polarine, Senior Technical Service Manager, STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years.  His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient.  He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants.   Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee.  Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course.  Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.  Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology.  He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois.  His main hobby is storm chasing and is very active in tornado research and tornado safety.

WHO SHOULD ATTEND THIS WEBINAR:
This program is geared towards professionals working in Validation, Quality Control or Quality Assurance, Operations, Cleanroom Management, Regulatory Affairs, or Production. Individuals who test and monitor cleanroom environmental conditions, airflow, and the accuracy of room pressure requirements. 

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

Registration Deadline is Wednesday, September 23rd at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGER:
Charlie Maher, CAI

Thank you to our Program Sponsors!

**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 - August 27, 2020 from 12:00 pm - 1:00 pm

PROGRAM SUMMARY:

Discussion of best practices, important considerations and the unique challenges of building flexibility into your cold storage solutions, including reach-ins, walk-ins and drive-ins. We will illustrate incorporating multiple redundancies, planning resourcefully for constant changing directives, and the importance of assessing and planning for unique current and future challenges.

SPEAKERS:

John Masiello, Co-Founder and Executive Vice President, Masy BioServices

John Masiello is the co-founder and Executive Vice President of Masy BioServices with over 30 years of experience in Validation, Calibration and cGMP best practices. His wide ranging expertise and innovative thinking has kept Masy BioServices raising the bar for excellence in BioPharma services. John holds a degree in Engineering from Wentworth Institute, and is a member of PDA and ISPE. In his free time John volunteers as a member of the local Economic Development Advisory Committee, and enjoys fostering the next generation of STEM professionals as a community educator.

Educated at Wentworth Institute in Boston, MA with a degree in Electrical Engineering, he is a lifelong resident of Massachusetts.  He is a member of several professional organizations such as the International Society of Pharmaceutical Engineers (ISPE), Instrument Society of America (ISA) and National Conference of Standards Laboratories (NCSL).  John volunteers in his hometown on the Economic Development Advisory Committee (EDAC) whose purpose is to stimulate business growth in the area. 

Christopher Masiello, Director of Facilities, Masy BioServices

Christopher Masiello has been the Director of Facilities at Masy BioServices for four years. Prior to this position, Christopher was Masy’s Biorepository Manager for four years and a Validation Project Lead for 12 years. He enjoys spending time with his family, hiking, volunteering as an Assistant Scout Master with the Boy Scouts, and coaching multiple basketball teams.

WHO SHOULD ATTEND THIS WEBINAR:
Anyone interested in understanding a multi-faceted storage design solution for today’s needs and tomorrow’s changing requirements.

PROGRAM FEES:
Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, August 26th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGER:
Janelle Carretero, NECI

Thank you to our Program Sponsors!

**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.**

PROGRAM SUMMARY:
Hear from two industry professionals as they discuss career development, both in terms of their personal paths as well as your own, and the best career advice they’ve ever received. We’ll dive into how to navigate unexpected turns in your career and how to invest in your personal strengths. 

SPEAKERS:
Haroon Hashmi, Senior Vice President, Regulatory Science, Ziopharm Oncology 

Haroon Hashmi is currently the Senior Vice President of Regulatory Science at Ziopharm Oncology where he oversees all regulatory functions and provide strategic support to company’s gene and cell therapy platforms. He has over 24 years of industry experience in global drug development in neurology, oncology, and hemophilia covering US, EU, and APAC regions. He played a key role in the expansion of Biogen business in the APAC region. Haroon obtained his Masters in Experimental Medicine from the University of Alberta, Edmonton, Canada and after obtaining his MPH in Epidemiology is in the process of completing his PhD in Public Health Epidemiology from Walden University.

Jane Rhodes, Chief Business Officer, Verge Genomics

Jane brings more than 20 years of drug discovery, company building and strategy leadership in the biotech industry. She spent 18 years at Biogen, where her notable achievements include founding the Value Based Medicine (VBM) Innovation Hub. Based on her work, she co-founded Qr8 Health, a software development company pioneering the development of patient assessment tools that are now used as standard of care in neurology clinics across the world. Most recently, she served as VP of Corporate Strategy and Business Development at Forma Therapeutics. Prior to her work in business strategy, she spent a decade leading discovery research culminating in more than 35 peer reviewed publications and 9 patent filings. Jane obtained her PhD in Neuroscience from the University of Manchester and MBA from Babson College.

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

Charlie is a trusted leader who enables life science firms achieve ambitious goals for the development and manufacture of biopharmaceutical products.  He works with clients to deliver innovative technical and business solutions that accelerate patient access to novel therapeutics and value creation for sponsors and investors.  Charlie has over 25 years of experience leading organizations in the life science industry and in the United States Navy, including director-level leadership of several multi-million biopharma projects and serving as the Commanding Officer of a nuclear-powered submarine.

WHO SHOULD ATTEND THIS WEBINAR:
Anyone interested in advice on their careers, how to achieve career goals, invest in personal strengths, and navigate unexpected career turns.

PROGRAM FEES:
Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, July 22nd at 9:00 am.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGERS:
Charlie Maher, CAI

Thank you to our Program Sponsors!

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

This is a Members Only event. The Educational Program Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 15^th at 5:30 pm as the 2021 educational season is developed. We are looking for program managers both experienced and new to join our team. Make sure to register if you are going to attend – a pre-meeting survey will be sent to confirmed registrants.

If you need help finding your ISPE Member number, contact Ask@ISPE.org or (813) 960-2105.

Log-On Information

One week prior to the meeting a confirmation e-mail will be sent with the unique registration link to the meeting room. 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. To test your system prior to the meeting go to the Zoom Test page.

Contact the office at Office@ISPEBoston.org or (781) 647-4773 if you have any questions.

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

There are clear applications and broad acceptance of augmented reality technologies in training departments, but the use of these systems as part of the inspection process has been limited.  Virtual inspections have the capability to revolutionize how both client and regulatory inspections are conducted, especially during times of crisis and interruption to business continuity. 

However, this technology (e.g. Microsoft HoloLens and Matterport 3D Mapping) is available today and can be widely used as the standard for inspections of the future.  Strategies for implementing on-site virtual inspections will be discussed during this presentation. 

SPEAKER:
Monica M. Commerford, Ph.D., Manager, Regulatory Affairs, Brammer Bio

Monica M. Commerford, Ph.D., is currently the Manager of Regulatory Affairs at Brammer Bio in Cambridge, MA, part of Thermo Fisher Scientific. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER and performed pre-license inspections of biological product manufacturing facilities. In addition, she has participated in writing policies and a draft guidance document. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health. 

WHO SHOULD ATTEND THIS WEBINAR:
Any person who participates in inspections including Quality, Regulatory, operations and management. Also, anyone interested in the use of emerging technologies including IT/OT specialists, Digital and Innovation leads.  

REGISTRATION FEES:
Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, July 8th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGER:
Megan Baillie, High Purity New England

Thank you to our Program Sponsors!

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

PROGRAM SUMMARY:
Join us on Thursday, June 25th at 12 pm ET for a live webinar on Business Continuity during the New Normal. COVID-19 has changed our lives and how business is conducted not only during the initial pandemic phase but also as we transition into the recovery/re-entry phase, and beyond. What will the new normal look like? What new practices will potentially be adopted and become mainstays?  

This cross-functional panel is comprised of members from engineering, operations, supply chain, finance and consulting background, working in startup environments to complex international organizations.  The panel will look at the impact of COVID on business processes from their respective lens and discuss methods on how organizational teams can work together to address the current situation, the re-entry, and beyond. They will explore the impact on productivity, warehousing, manufacturing verification, operating costs to organizations now required to do the same process with more PPE. Also, they will discuss the utilization of technology, social distancing, contact tracing, and agent-based modeling. The group will also touch on the second wave. How, can we prepare? 

Lastly, the group will explore deglobalization of resources and supply chain. How far and fast will the pendulum swing?  Please join us for this diverse panel of industry professional for an impactful discussion on navigating business continuity in the new normal.

SPEAKERS:
Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead
Kevin has over 27 years in the pharmaceutical and biopharmaceutical supply chain, distribution and transportation management world.  His primary focus has been on operational and quality improvements while also maintaining or achieving additional cost savings through gained efficiencies.  He has extensive experience setting up, qualifying, and overseeing the daily operations of in-house distribution centers & warehouses, as well as over 20 years of experience managing third party warehousing, transportation, cold-chain and contract manufacturing vendors and suppliers.  He has managed distribution & logistics operations and vendors for both domestic and international customers & partners.  Kevin has also qualified and implemented shipping lanes for all temperature ranges while using various active and passive solutions to meet all shipment size requirements from small parcel up to Sea Container.

For relaxation Kevin enjoys traveling, taking walks on the beach with is wife, and occasionally dusting off his art supplies to draw or paint something that catches his interest.

Pearlie Blaise, Senior Manager Cost Accounting, Bluebird Bio
Pearlie Blaise is the Senior Manager of Cost Accounting at bluebird bio leading the Accounting & Finance functions for bluebird Internal Manufacturing Organization. She has held positions of increasing responsibility in commercial manufacturing, including management accounting, cost planning, engineering, and COGS, inventory control, ERP Supply Chain and Financial Systems Implementation, and leading commercial organization’s financial forecasting and aligning operations strategies. She is an organized leader with focus on continuous improvements from a systems’ and financials lens while executing strategies that drive efficiency and profitability. 

Cory Siddons, Senior Director of Manufacturing, Alnylam Pharmaceuticals
Cory Siddons is the Senior Director of Manufacturing for Alnylam Pharmaceuticals and is site head for Alnylam’s manufacturing sites in Cambridge and Norton. In that role, he is responsible for cross functional plant start-up activities and operations including manufacturing, process sciences, validation, engineering, facilities, EH&S, and materials management. Cory was previously Director of Engineering at Alnylam, responsible for process engineering, plant engineering, and automation. Prior to joining Alnylam, he also spent more than 10 years in engineering consulting, supporting clients in the US and Europe. 

Niranjan Kulkarni, Director of Operations Improvement, CNiranjan Kulkarni, Ph.D., has over 15 years’ experience in business process and data modeling, process simulations, operations improvements, layout optimizations and supply chain management. He has worked with pharmaceuticals, biotech, food, chemicals, semiconductor, electronics assembly & packaging, manufacturing, and finance industries. At CRB, he leads a team of engineers, using modeling and simulations and other AI techniques to improve client outcomes.RB

MODERATOR:
Kathy Marini, Director of Business Development, CRB
Kathryn Marini is the Director of Business Development for CRB, a global design, construction, and consulting services firm with 16 offices worldwide.  Kathy is responsible for identifying new business opportunities in the Biotech, Pharmaceutical and Advanced Technology sectors and serves as the firm’s primary contact for both clients and prospects in the northeast region. She is also very involved in CRB’s technical staff recruiting efforts. Before joining CRB, Kathy held similar roles with both EG Life Sciences and NNE Pharmaplan. In addition to her life sciences industry experience, Kathy has worked in numerous roles in the aerospace manufacturing sector.  Kathy has been involved with ISPE for almost a decade and has volunteered to serve on the Product Show committee, the Student Development committee and most recently co-chaired the Women in Pharma® committee.

WHO SHOULD ATTEND THIS WEBINAR:
Everyone working in or supporting the life science/pharma manufacturing industry from facilities, engineering, operations, financials, management, quality control, inventory and manufacturing. All are welcome.

REGISTRATION FEES:
Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, June 24th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGERS:
Caren Jenkins, CRB

Thank you to our Program Sponsors!
DPS Group
ICQ Consultants

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

PROGRAM SUMMARY:
Join us on Thursday, June 18th at 11 am EST for a Tech Transfer webinar! Technology Transfer is a term used to describe the framework for the transfer of process and product development knowledge from development groups ("sending unit") to commercial groups ("receiving unit"). While the Tech Transfer process varies greatly depending on the type of product (e.g. parenteral, solid dosage, medical device, etc.) and the type of transfer (e.g. development to contract manufacturer, existing site to new site, etc.), there are fundamentals that remain the same from transfer to transfer that can be used to streamline the process. 

Our participants will present their role in Tech Transfer and discuss ways to streamline the process using case studies. At the conclusion of the webinar we will have a 20 min Q&A.

SPEAKERS:
Derek Gallo, Director of Tech Transfer, Thermo Fisher
Derek Gallo is the current head of Technology Transfer (TT) for the Drug Product division across North America and Europe at Thermo Fisher Scientific.  He is passionate about developing best practices and tools for the global and site project management teams to improve and evolve how teams manage TT projects – both internally and for customers within the CMO space, process improvement, talent development, and improving patient’s lives through new medicines.  In this current role, Derek supports over 100 active tech transfer projects – successfully launching 30-40 new products annually with the successful transfer and launch of over 80 products past 3 years.  Prior to this role, Derek managed a tech transfer team responsible for the transfer and launch of 16 new products over three years at one facility.  Derek has experience in steriles, solid dosage, and biologics within the pharma industry and previously held positions including project management, validation engineering, R&D, and production operations within the Pharma industry

Kevin Turney, Director of Process Development, Amgen
Kevin Turney is a Director of Process Development who works with Technology Transfer Teams within Amgen and external parties to ensure effective method transfers for NPIs.  Kevin supports teams directly to transfer products (synthetic/biologic) globally and meet the business and patient needs for biopharmaceuticals.  Kevin currently works with Amgen’s Global Technology Transfer Network by leading the team responsible for analytical method implementations.  Kevin holds a PhD in Analytical Chemistry from the University of Florida and has over 15 years of biopharma experience. 

MODERATOR:
Jack Campion, Director of Business Development, Hart Design Group Ltd.
Jack is a long-time ISPE member and former president of the Boston Area Chapter.  He holds degrees in chemistry and chemical engineering from the College of the Holy Cross and Tufts University, respectively. Beginning his career in the environmental field, he moved to biopharmaceuticals, first as a validation specialist and process engineer with Hart Design Group Ltd., then with Massachusetts Biologic Laboratories and Sanofi (Genzyme).  He has held positions in process engineering, validation management, and project controls.  He then returned to Hart as Director of Business Development but often “wears other hats” in project management and C&Q management.  Jack is a registered Professional Engineer in Massachusetts.

Jack has served the Chapter in multiple capacities: twice as a board member and treasurer before becoming its president in 2017; however never more proudly than as Educational Program Chair.  (He encourages all to get involved and join the fun!)  Jack has managed or moderated numerous ISPE educational programs over the past 10+ years. 

WHO SHOULD ATTEND:
This educational webinar is intended for professionals in the pharmaceutical and biotechnology industry who have responsibilities or interests in the following areas of technology transfer, project management, manufacturing, technical sciences, engineering, validation, and quality. This combination presentation and Q&A style webinar will promote discussion of industry best practices for leading successful technology transfers and robust commercialization operations.

REGISTRATION FEES:
Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, June 17th at 5:00 pm.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGERS:
Shannon DeMello, CAI
Michelle Wang, Takeda
Jack Campion, The Hart Companies

Thank you to our Program Sponsors!
DPS Group
ICQ Consultants
Masy BioServices

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

PROGRAM SUMMARY:
Celebrate Women in Engineering Month! ISPE Boston Area Chapter Women in Pharma Committee is hosting a virtual poolside chat and trivia challenge on Wednesday, June 17 at 5:30 pm EST! We are holding a panel discussion with a myriad of industry professionals. Listen to colleagues advice and stories. 

Additionally, you have the chance to win fabulous fun and exciting prizes in our trivia challenge session.

Please join us for an evening of fun and light conversation to share ideas- professional as well as your quarantine quirks! Share virtual chardonnay, beer or lemonade with new and old friends both locally and internationally. 

BYOB. Light casual atmosphere no need to worry about kid, pet, or partner interruptions. All are welcome!

SPEAKERS:
Annelie King, Projects Manager, PMP, BWT Pharma and Biotech
Annelie has 20 years of experience of Project Management and Validation of Water Systems. Worked with water system projects in Europe, Asia, and USA. PMP Certified and a Sustainability Change Leader.

Katie Leitch, Director of Global Technical Operations, Alexion Pharmaceuticals
Katherine (Katie) Leitch currently serves as Director of Global Technical Operations at Alexion supporting both internal and external commercial manufacturing.  Katie has worked for Alexion since 2014 and has also held the positions of Director of Plant and Process Engineering and Director of Environmental, Health, and Safety (EHS) for North America Manufacturing. 

Prior to joining Alexion, Katie worked for Merck for 14 years with increasing levels of responsibility primarily in technical support roles for vaccine manufacturing.  The manufacturing experiences at Merck included working on three facility start-up projects as well as supporting multiple licensed vaccine manufacturing facilities. 

Katie is a co-chair and was a co-founder for the Boston Area ISPE Women in Pharma Subcommittee and is currently serving on the Board of the Boston Area ISPE Chapter.  Katie earned both of her engineering degrees from Virginia Tech.      

Patricia Rivera, Senior Manager, Regeneron Pharmaceuticals
Patricia is currently a Senior Manager with Regeneron Pharmaceuticals, leading multiple projects that includes new molecules to clinic and launching to market as well capital expenditures such as facility expansion. She is has 20 years of experience in project management, process engineering and automation in pharmaceutical industries such as Amgen, Genentech, BMS and now Regeneron. 

Patricia is a key contributor and workforce leader in a variety of manufacturing operations and projects including: Cell Culture, Aseptic Operations, Facilities Startups and Expansions, CMC Program Management, CMO and External Manufacturing relationships. Successful change agent who develop and lead strategies in cost and time constraint environment until full implementation. 

Patricia holds a bachelor’s degree in Chemical Engineering from the University of Puerto Rico – Mayaguez Campus, and a master’s degree in Manufacturing Engineering from the Polytechnic University of Puerto Rico. She volunteers as a Executive Director with a non-profit organization, Curando el Autismo (CEA) in Puerto Rico. She has been an ISPE member since 2018.

Haley Smestad, Project Engineer, Sequence Inc.
Haley Smestad is currently a Project Engineer working at Sequence Inc. For the past 4 years Haley has served on the consulting side of the industry and working with companies such as Alnylam, Immunomedics, Sanofi Genzyme, Agilent, Pfizer and Abbvie on various engineering projects in varying lifecycle stages. One of her favorite projects was while she was working at Hyde Engineering and Consulting on a project at Immunomedics as there was a huge variety of work preparing the facility for drug approval. Haley holds a BS and MS in Chemical Engineering from Worcester Polytechnic Institute. She is currently serving on the Women in Pharma Committee and Product Show Committee for the Boston Area ISPE Chapter. 

MODERATOR:
Kathy Marini, Director, Business Development, CRB
Kathryn Marini is the Director of Business Development for CRB, a global design, construction, and consulting services firm with 16 offices worldwide.  Kathy is responsible for identifying new business opportunities in the Biotech, Pharmaceutical and Advanced Technology sectors and serves as the firm’s primary contact for both clients and prospects in the northeast region. She is also very involved in CRB’s technical staff recruiting efforts. Before joining CRB, Kathy held similar roles with both EG Life Sciences and NNE Pharmaplan. In addition to her life sciences industry experience, Kathy has worked in numerous roles in the aerospace manufacturing sector.  Kathy has been involved with ISPE for almost a decade and has volunteered to serve on the Product Show committee, the Student Development committee and most recently co-chaired the Women in Pharma® committee.

WHO SHOULD ATTEND THIS WEBINAR: 
All are welcome and encouraged to attend!

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

REGISTRATION FEES:
At this time the Boston ISPE WIP is happy to offer this complimentary event to all.  Please note you do need to register by June 16, 2020 at 5:00 pm EST.

MEETING MANAGERS:
Caren Jenkins, CRB

Thank you to our Program Sponsors!
G-Con Manufacturing

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

PROGRAM SUMMARY:

Biopharmaceutical innovation is moving ahead at a blinding pace.  Scientists and engineers are creating methods and technologies to develop products with unprecedented therapeutic benefit – and even cures to disabling genetic conditions.

Advances in manufacturing process design and technologies enable rapid introduction of these novel products, as well as improving the quality and reducing cost of biopharmaceutical products across the spectrum.

To take full advantage of innovation in biopharmaceutical product development and manufacturing, flexible regulatory frameworks are needed to rapidly translate innovation into expanded patient access. 

The COVID-19 pandemic has served to further spotlight the importance of a flexible regulatory framework that supports rapid innovation in response to a public health crisis. 

Our panel will discuss opportunities for enhancing the flexibility of our regulatory framework support the goals of patient access and public safety.

SPEAKER BIOGRAPHIES:
PANELISTS:
Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA
Dr. Baker received a bachelor’s degree in biochemistry and molecular biology at Northwestern University, doctorate in biochemistry from the University of North Texas and completed post-doctoral studies at the University of California, Berkeley.  He joined Eli Lilly & Co in 1988 and led the development of several first in class biologics from bench top purification to global launch, supported post-launch manufacturing process development activities, and established and led Lilly’s Global Validation Practices Team.   Dr. Baker received the Lilly President’s Award twice, once for work associated with the development and launch of Humalog, the first insulin analog and once of work associated with the development and launch of drotecogen alfa, the first protein therapeutic manufactured in human cells. After completing his certification as a Lean Six Sigma Black Belt, Dr. Baker led corporate initiatives related to control, capability, and functional governance in pharmaceutical manufacturing.  Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at MedImmune, a subsidiary of AstraZeneca and, in 2011, Dr. Baker was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research at the FDA.  Dr. Baker helped establish the Quality Management System used today in OBP and has been recognized with several CDER citations for leadership and program development.  He was a member of the team which conceptualized and stood up the Office of Pharmaceutical Quality and has participated in the development of regulatory guidances and operational policies for CDER and reporting offices.   In 2018, Dr. Baker received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.”  He is currently FDA liaison to the Advanced Manufacturing National Program Office at NIST where he engages with biopharmaceutical manufacturing stakeholders to advance the National Strategic Plan for Manufacturing in the United States.

Haroon Hashmi, PhD, Senior Vice President, Regulatory Science, Ziopharm Oncology
Haroon Hashmi is currently the SVP of Regulatory Science at Ziopharm Oncology where he oversees all regulatory functions and provide strategic support to company’s gene and cell therapy platforms. He has over 20 years of industry experience in global drug development in neurology, oncology, and hemophilia covering US, EU, and APAC regions. Haroon obtained his Masters in Experimental Medicine from the University of Alberta, Edmonton, Canada and after obtaining his MPH in Epidemiology is in the process of completing his PhD in Public Health Epidemiology from Walden University.

Warren Jaworowicz, Associate Vice President of CMC (Manufacturing, Supply Chain, Quality), TScan
Warren Jaworowicz, Associate Vice President of CMC at TScan Therapeutics, has spent his career developing small molecule, biologic, cell, and gene therapy products.   He has worked at both small and large organizations and has experience with all phases of development.  Prior to joining TScan, Warren headed Technical and Operations and Supply Chain for Editas Medicine, where he led CMC efforts for EDIT-101, the world's first in vivo CRISPR genome editing medicine.

Philip W. Wills, PhD., Chief Commercial Officer, Catalent Pharma Solutions
Philip Wills, Chief Commercial Officer at Catalent Gene Therapy, is a veteran business executive and scientist with nearly two decades of contract manufacturing experience, primarily focused in viral vectors and other complex biologics. After joining Paragon in 2002, Philip held positions of increasing scope and responsibility, including appointments as the Principal Scientist and Vice President of Business Development. His career began at the University of Maryland and he worked in a variety of scientific roles in both the School of Medicine and Cancer Center. Philip obtained a Bachelor of Arts in Chemistry from Johns Hopkins University and a PhD in Pharmacology from the University of Maryland Medical School.

MODERATOR:
Charlie Maher, Global Director, Process and Manufacturing Technology, CAI 
Charlie is a trusted leader who enables life science firms achieve ambitious goals for the development and manufacture of biopharmaceutical products.  He works with clients to deliver innovative technical and business solutions that accelerate patient access to novel therapeutics and value creation for sponsors and investors.  Charlie has over 25 years of experience leading organizations in the life science industry and in the United States Navy, including director-level leadership of several multi-million biopharma projects and serving as the Commanding Officer of a nuclear-powered submarine.

WHO SHOULD ATTEND THIS WEBINAR: 
This program will appeal to people across organizations developing or delivering manufacturing programs, supporting vendors and consultants.

Individuals or organizations involved in developing innovative manufacturing methods and technologies should attend. Be part of the discussion and share your ideas on ways to modernize regulatory frameworks to support manufacturing innovation. Learn how to gain regulatory approval for novel manufacturing technologies that can drive efficiency and quality in your manufacturing platform.

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

MEETING MANAGERS:
Janelle Carretero, NECI
Charlie Maher, CAI

Thank you to our Program Sponsors!
DPS Group
ICQ Consultants
Masy BioServices

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

Designed with the working professional in mind, this program can be accessed from your phone, tablet or desktop. This presentation will be an introductory to intermediate level session providing attendees with a basic understanding of water purification and will cover contaminants, treatment processes, distribution systems, and water quality standards. The session will cover several common misconceptions about water purification equipment and systems, control of bacteria and biofilm, and how to verify water purity, etc.

Deadline to pre-register is Wednesday, May 6 at 5 pm.

PROGRAM SCHEDULE: 
12:00 – 1:00 PM EST: Educational Program
*We suggest logging on at least five minutes prior to the program*

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

LOG ON INFORMATION:
Prior to the webinar you will receive a confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

PROGRAM SUMMARY:
This will be an introductory to intermediate level session providing attendees with a basic understanding of water purification and will cover contaminants, treatment processes, distribution systems, and water quality standards. The session will cover several common misconceptions about water purification equipment and systems, control of bacteria and biofilm, and how to verify water purity, etc.

We will start with the basics to get everyone on the same page. Water is the most commonly used material used in the manufacture and purification of many biotech and pharmaceutical products and medical devices. Water may be used as an ingredient, a solvent, a diluent, a cleaner, or for other purposes. We will cover why water needs to be purified and how dozens of different purification steps are typically integrated to get the right water purity for its intended use. The webinar will review the contaminants/impurities that exist in the incoming water supply and discuss why some of these materials need to be removed (while others do not) based on the intended use of the water. We will touch on different grades of water as identified by various pharmacopoeias and consensus standards (ASTM, CAP/CLSI, pharmaceutical, and microelectronics grades). We will present a broad overview of why different grades of water purity exist.

After covering the basics, we will discuss some of the common misconceptions about water purification, terminology, monitoring, sampling, bacteria, etc. Come ready to learn and have fun at this session!

SPEAKER BIOGRAPHY
Brian Hagopian, CPIP., Clear Water Consulting, Inc.
Brian Hagopian, CPIP is the President of Clear Water Consulting, Inc., a company offering consulting, design, engineering, validation, troubleshooting and training in both high purity water and wastewater treatment systems. Brian has over 35 years of hands on industry experience and is considered a high purity water subject matter expert. Brian is an instructor at Worcester Polytechnic Institute’s Biomanufacturing Education and Training Center and is also a Massachusetts certified instructor offering in-person, remote, and online courses for training and licensing of industrial wastewater operators. Brian is a charter member and Past President of the Boston area chapter. He is one of ten people to have received the Hank Moes Lifetime Achievement Award and is one of 150 people in the world to have attained the Certified Pharmaceutical Industry Professional (CPIP) certification. Brian continues to be actively involved with the Boston Chapter’s Student Development Committee and Mentoring Program. More globally, Brian is on the Steering Committee of ISPE Critical Utilities COP where he has led teams of experts and authored several ISPE technical documents including the ISPE Good Practice Guide on Sampling of Pharmaceutical Water and Steam Systems and the updated ISPE Baseline Guide on Pharmaceutical Water and Steam Systems.

MEETING MANAGER:
Janelle Carretero, NECI

Thank you to our Program Sponsors!
DPS Group
ICQ Consultants
Masy BioServices

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

Designed with the working professional in mind, this program can be accessed from your phone or while on the road. This presentation will discuss Industry has assembled in various ways to fight the pandemic, how the community has worked together to quickly react and overcome challenges, and discuss ways the industry might be better enabled in the future. Hear from Leaders in the Industry on the progress we’ve made and what we can expect over the months to come. Sign up today!

The CDC Foundation, a U.S. based nonprofit, has launched a crowdfunding campaign to help combat coronavirus. You can donate to the cause by clicking here.

Deadline to pre-register is Thursday, April 22 at 5 pm.

PROGRAM SCHEDULE: 
12:00 – 1:00 PM EST: Educational Program
*We suggest logging on at least five minutes prior to the program*

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

LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you. 

The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.

PROGRAM SUMMARY:
The Pharmaceutical Industry is never stagnant. Over the past 5 years the evolution of Advanced Medicinal Therapy products shows a constant dedication to innovation in science, dedication to patient health and continual drive for not just a remediation but a cure to rare diseases. However, the world is facing a challenge now that impacts the lives of every person across the world, and the response of the Life Science Community has been overwhelming. People are pooling together to get supplies to our healthcare workers, manufacturers are shifting production to meet the demand of supplies that ensure safety. Equipment is being evaluated and re-purposed; and new patient tests are being developed. Within months, there are multiple companies that have already advanced COVID-19 vaccines in clinical stages with the overall goal of helping people keep safe and healthy. Join ISPE’s upcoming webinar to learn about how the Industry has assembled together in many different ways to fight the pandemic, how the community has come together to react quickly and the challenges that have been overcome and ways the industry as a whole might be better enabled in the future. Hear from Leaders in the Industry on the progress we’ve made and what we can expect over the months to come. Hear more about the efforts underway at Takeda, CRB, and J&J to rapidly develop and bring to market vaccines and treatments in the fight against coronavirus.

SPEAKER BIOGRAPHY
Steve Fadden, P.E., Senior Director Technical Operations, J&J
Stephen is Senior Director of Process Engineering for Johnson & Johnson -GPSG.  He has over 39 years experience in Pharmaceutical and Biotech industries. During his career he has been involved with several major projects in US, Netherland and Ireland totaling $1.5 billion.  His roles include process engineering, design engineering and project management.

Georgia Keresty, PhD., MPH, R&D Chief Operating Officer, Takeda
Georgia Keresty joined Takeda Pharmaceuticals in December 2017 and is R&D Chief Operating Officer.   She has oversight of the R&D integration for the Shire acquisition, portfolio strategy, management for governance forums such as Portfolio Review Committee (PRC), the Center for Operational Performance (CoOP), the Partnership Office and Takeda’s Regional Development Centers in Zurich, Osaka and Shanghai.  Additionally, the COO office will serve as the principal R&D liaison with key enterprise partner functions such as Quality, Procurement, Legal, IT, Intellectual Property (IP), Facilities and Investor Relations and ensure that these key capabilities are optimally integrated into the day-to-day R&D operations.  

Prior to joining Takeda, Georgia spent 16 years as a Vice President and executive leader at Johnson & Johnson. Her last role was leading the Pharmaceutical Development and Manufacturing Sciences (PDMS) group within Janssen R&D, overseeing a global team of more than 1,700 scientists, pharmacists and engineers.  Prior to J&J, Georgia spent the early part of her career at Novartis and Bristol Myers Squibb where she developed and executed engineering, operations, quality and supply chain strategies.  

Georgia is a member of the Board of Directors for Commissioning Agents, Inc., Aspen Technology Inc., and serves on the Board of Trustees for Clarkson University. 

Georgia received her BS in chemical engineering from Clarkson University, BS in computer science from Ramapo College of New Jersey, a MS in information systems from Pace University, a MBA from Rutgers University, a PhD in operations management from Rutgers University, and a MPH from the University of Southern California.   

Marc Pelletier, PhD., Director of Process Technology, CRB Consulting Engineers
Marc is Director of Process Technology at CRB Consulting Engineers. His roles include strategic planning, conceptual design, process engineering, risk assessments, compliance and validation for the Life Technologies sector. He has been with CRB for 14 years of his 35+ year career in biotech. 

Marc was the former Chair of the American Society of Mechanical Engineers BioProcessing Equipment (ASME BPE) Executive Committee. He is the author of the Closed Processing and Risk Assessment chapters of the ISPE Baseline Guideline on Biopharmaceutical Manufacturing Facilities. He is principal author of the new Biophorum BioProcess Closure Playbook. He is a contributor on the BPOG Room (de)Classification Team. Marc has served as adjunct professor at the University of Manitoba, Canada and Bemidji State University, MN. He is a frequent lecturer for the ASME, IBC, ISPE and ISBioTech.

MEETING MANAGERS:
Janelle Carretero, NECI
Caren Jenkins, CRB

Thank you to our Program Sponsors!
DPS Group
ICQ Consultants
Masy BioServices

Please note: the Student Poster Contest has been postponed due to concerns regarding the spread of COVID-19. The Board of Directors will be monitoring the situation and will reschedule this program as soon as is possible. If you have any questions please contact the office at office@ispeboston.org or (781) 647-4773.

Want to Show Off Your Work and Win $500.00? Register to Compete in the:

ISPE Boston Area Chapter

ANNUAL STUDENT POSTER CONTEST
on Thursday, April 2, 2020

Three winning student posters, one each from the graduate, bachelor, and associates degree categories will receive a $500 cash prize and a FREE TRIP to ISPE’s Annual Meeting in Philadelphia, PA on November 1-4, 2020.

Competitors will be given a ten-minute window to showcase their projects with the judges. Judging sessions will consist of a five-minute presentation given by the competitor plus a five-minute question-and-answer period.

Pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE to participate.  Join ISPE at www.ispe.org/join-or-renew.

Cost:
Free

Location:
The Westin Waltham-Boston Hotel
70 Third Avenue, Waltham, MA
Click here for directions and travel information.

Registration Deadline:
Monday, March 30, 2020 at noon

Posters Competition Rules and Guidelines:

View the registration form for more details.

Please note: the Spring Conference has been canceled due to concerns regarding the spread of COVID-19. The Board of Directors will be monitoring the situation and will reschedule this program as soon as is possible. If you have any questions please contact the office at office@ispeboston.org or (781) 647-4773.

The 2^nd annual ISPE Boston Area Chapter Spring Conference is pleased to present a 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. Attend concurrent educational sessions that expand upon the keynote presentation topics. 

Networking: Capitalize on opportunities to meet and connect with clients, develop new associations, and solidify existing partnerships. Meet with members and associates of the Boston area ISPE chapter. 

Vendors: Meet industry-leading solution providers and explore how their products and services can help you achieve project success.

Student Poster Contest: View the entries to the ISPE Boston Area Chapter Student Poster Contest. Learn about and discuss the research findings of local ISPE students at the undergraduate and graduate level.

Chapter Awards Presentation: Join us as we formally recognize and celebrate achievements within the ISPE Boston Area Chapter.

PROGRAM SCHEDULE:
11:30 AM - Registration & Networking
12:00 PM -  Luncheon Keynote
1:30 - 5:00 PM - Concurrent Educational Sessions
5:00 PM - Networking Reception and Awards Presentation

WHO SHOULD ATTEND:
This 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.

LOCATION:
The Westin Waltham Boston Hotel, 70 3rd Ave, Waltham, MA 02451

PRESENTATION ABSTRACTS:
Keynote:
Eric Schnake, Plasma OpU Lead, Capital Projects & Portfolio, Takeda Pharmaceuticals 
Takeda’s Georgia Manufacturing Facility – Sharing the Top Lessons Learned and Success Factors of a Greenfield Project 
Every year millions of patients depend upon plasma-derived therapies obtained through plasma fractionation processes. Takeda’s new 1.1 million square feet state-of-the-art Plasma Protein Manufacturing facility is the cornerstone of a global strategy ensuring patients world-wide have access to its medications. Takeda relied on a global team of experts and innovative risk management strategies to successfully plan, design, and construct a facility meeting current production requirements, that is also expandable for future needs. The Project’s award-winning safety program was a top priority, leading to the 2015 CURT Construction Industry Safety Excellence Award by the Construction Users Roundtable. The Education Session will explore many of the project success factors and lessons learned from such a complex initiative and share these with the participants.

Gilad Langer, Manufacturing Practice Lead, Tulip & PJ Geldenhuis, Sr. Solutions Engineer, Vertex Pharmaceuticals via JMA Engineering Solutions
A view into Pharma 4.0 technologies to support human activity
The promise of productivity gains from digital technologies don’t have to involve lengthy and complex implementation. There is a lot that can be gained by simply digitizing manual processes. This can be exemplified by how a leading pharmaceutical manufacturer used a no-code Manufacturing App Platform to guide employees through a complex line clearance and setup process. The elimination of paper-based SOPs for visual, interactive work instructions shortened the process from two weeks to two days – an 80% reduction in time. Join the session to learn more.

Charlie Maher, Global Director, Process and Manufacturing Technology, CAI
Quality by Design (QbD) in the era of Cell and Gene Therapy - Taking it to the Next Level
Since the publication of ICH-8 in 2006, Quality by Design (QbD) has been employed by the life science industry to improve pharmaceutical product quality, reduce regulatory risk and enhance patient access to novel products.   With the rise of cell and gene therapies, the use of QbD is even more important given the pace of innovation, the compression of the product development lifecycle, challenges in characterizing product and process, and rapid institutional learning by regulatory bodies.  This presentation will explore these drivers and highlight examples of how the disciplined use of QbD can enhance the product quality, success in regulatory approvals, reduced direct and indirect product lifecycle costs and improved regulatory flexibility for post-approval changes for cell and gene therapy products.

Forrest Brown, Engineering Services Manager, Sequence & Emily Petrelis, Validation Projects & Systems Leader, Thermo Fisher Scientific
Efficient Gene Therapy Facility Start-Up: Best Practices and Common Pitfalls
How will you ensure your next gene therapy start-up is executed compliantly AND efficiently?  Taking a new gene therapy facility/expansion from construction to production presents many challenges. While each project is unique, avoiding common pitfalls can significantly reduce risk to schedule and budget. This presentation will focus on optimizing the start-up process by utilizing a risk-based approach to focus on common areas of primary importance.

Manufacturer case studies will be provided with lessons learned, including an opportunity for questions from the audience. This presentation is intended for anyone challenged with delivering increased gene-therapy manufacturing capacity who also wants to provide the most efficient and effective solution possible.

William Deckert, Global Consult, CAI
Cell & Gene Therapy Facilities – How to renovate to save time and money
A very detailed discussion about how existing facilities can be renovated into Cell & Gene Therapy manufacturing suites with less cost and a shorter schedule. This will result in getting products to market quicker and creating more ROI for investors and for manufacturing companies. With 700 new products hitting the market within the next 24 months, it is critical to create manufacturing spaces that can produce these products quickly and safely.

Pietro Perrone, Automatic Process Engineer, GE Healthcare
Advanced Automation for the Flexible Manufacture of Therapeutics
Improvements in biopharmaceutical productivity and flexibility are achieved when unit operations in the production train perform in concert with each other. The architecture of the automation that supports the bioprocess operation defines the design of a flexible and effective manufacturing operation. Developing standardized automation modules enhances the applicability to multiple unit operations and improves the speed of implementation into manufacturing operations by applying software that is verified across multiple platforms.  This results in fast and cost-effective implementations for the manufacturers of therapeutics.

Connected manufacturing is to seamlessly link unit operations via both physical and digital connections throughout the process. Connected manufacturing integrates an overarching layer of automation across multiple steps in the bioprocess train extending from upstream to downstream. Aligned with the physical connections, the digital connections coordinate the individual unit operations with each other and minimize operator intervention.

This presentation highlights innovative production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply. Key factors for an industry that aims to maximize productivity, flexibility and quality in the manufacture of biopharmaceutical products.

Elizabeth Rivera, Technical Services Manager, STERIS
Stage 3 Maintenance of a Cleaning Validation Program
The recent shift from traditional cleaning validation to a 3-staged cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of a cleaning process. The main purpose of the third validation stage is continuous assurance that the cleaning procedure is performing as expected and remains in a state of control for the life of the product(s) being manufactured. As suggested in the FDA Process Validation Guidance, to accomplish continuous assurance a system (or systems) is essential for detecting unplanned departures from the validated process. Implementing a system to evaluate the performance of the cleaning process includes collecting and interpreting cleaning data that allows detection of undesired variability. 

When a process shows undesired variability actions must be taken to correct, anticipate, and prevent problems so the process remains in control. An ongoing program to collect and analyze product and process data that relate to cleaning acceptance criteria (and hence product quality) must be established. The information collected should verify that the critical cleaning attributes are being controlled throughout the process. Several concepts are discussed in the presentation provide guidance on the various ways to provide a high level of assurance that a cleaning process remains validated and in control such as Periodic Review, monitoring and data trending, preventive maintenance, non-routine soils and cleaning beyond validated, personnel retraining, change control procedures, deviations, OOS, among others.

Lindsay Smart, Managing Director, ZETA US Inc.
Single-Use Vs Stainless Steel – Are Hybrid Facilities the Best of Both Worlds?
The pharmaceutical industry is constantly facing severe time and cost pressures. Currently, in order to be able to react to new developments in the sector, as quickly as possible, the focus is ever increasingly centered on time-to-market as well as modular, highly flexible production concepts for new biopharmaceutical products. During the planning phase for so-called fast-track projects, single-use technologies (SUT) are also becoming increasingly more important. It is suggested, in search of the best possible solution, the industry should jointly rely more on hybrid solutions and customized single-use systems. 

SUT is often manufacturer specific and can often only be used in a limited way. In contrast, customized stainless-steel solutions, which do not have these disadvantages, can tend to be less flexible and require time-consuming cleaning and sterilization processes. State-of-the-art hybrid solutions are based on well-designed engineering concepts, combining SUT with high-end stainless-steel components. Therefore, benefits of both system types can be realized: low investment costs, high flexibility and shorter set-up times of SUT are combined with durable stainless-steel components, guaranteeing the highest level of automation and process safety, integrity and reproducibility. This presentation will detail: 1) How current assemblies can be customized and interconnected with highly sophisticated cross-functionality from a mechanical and automation perspective; 2) The advantages of next level single-use systems from recent case studies, which will show how dance floor concepts improve process clarity and ergonomics, operator safety and simplify maintenance and 3) Supplier agnostic concepts showing how a stainless steel backbone can handle generic single use bioreactors and other single-use assemblies to optimize facility design and layout.

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Attendee Registration Fees:
Early Bird Rates (End 3/26/2020)
Members: $125.00
Young Professional Members: $85.00
Non-Members: $195.00

Rates after 3/26/2020
Members: $135.00
Young Professional Member: $95.00
Non-Member Price: $210.00

EVENT SPONSORS & EXHIBITORS:
ABEC
BELFOR Property Restoration
DPS Group
Gerflor USA
ICQ Consultants
Masy BioServices
Siena Construction Corporation
T&C Stainless, Inc.

**Sponsorships are SOLD OUT!**