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25th Anniversary Product Show Breaks Records!

by Mark Levanites, Product Show Committee Chair, with photos by David Fox Photography

The week leading up to the 25th Anniversary Boston Area Chapter Product Show set the stage. With the return of Tom Brady and the gorgeous 60-degree sunny day the mood had been set. A record-breaking 3100 attendees made the trip to Gillette Stadium and with plenty to do, see, and learn regardless of your professional expertise the 2016 Product Show did not disappoint.

Chapter President John Spohn greeted a packed house at the opening Plenary Session.

The Plenary Session started with an inspiring video documenting the past, present, and future of the Product Show along with Chapter President John Spohn, reporting that the Chapter is financially sound, continues to be the largest Chapter in the world, and has some very exciting programs and initiatives planned for the upcoming year. He concluded his presentation with the Annual Chapter Awards that recognize the contributions of outstanding Chapter volunteers:

  • Volunteer of the Year - Ying Cai, Membership Committee Chair
  • Volunteer of the Year - Howard Sneider, Educational Program Committee Chair
  • Student Chapter of the Year - Massachusetts Maritime Academy
  • Outstanding Achievement Award - Scholarship Committee
  • Hank Moes Lifetime Achievement Award - Doyle Johnson
Chapter Award winners (clockwise from top left) Doyle Johnson, Howard Sneider, Janet Tice (on behalf of the Scholarship Committee) and Mass Maritime Academy.

The first keynote address was delivered by Joseph Famulare, Immediate Past Chairman of the ISPE Board of Directors and Vice President, Global Quality Compliance and External Collaboration, Genentech/Roche, Pharma Technical Operations. Next up was U.S. Congressman Richard E. Neal, representing the 1st District of Massachusetts, who concluded his visit by opening the Product Show with a ceremonial ribbon-cutting and leading the assembled crowd into the Exhibit Hall. Soon to follow were 3100 attendees who visited the 375 exhibitors and the Career Fair's 44 hiring companies and set a new record for Product Show attendance.

Attendees enjoyed keynote presentations by (l to r) Joseph Famolare, Immediate Past Chair of the ISPE Board of Directors, and Congressman Richard E. Neal.


Congressman Neal opened the Product Show with a ceremonial ribbon-cutting (and a little help from his friends).

The full slate of educational programs offered throughout the day in the plenary session area thanks to the efforts of the Educational Program Committee attracted almost 400 attendees: "Implementing Lifecycle Process Validation Practices at CMOs" led by Rusty Morrison; "Unique Challenges of Executing Expansion and Retrofit Projects Concurrent with GMP Manufacturing" led by Joseph Musiak; "Project Delivery: Which Method of Contracting is Best?" led by Dean Poillucci; and "Biotech 101" led by Kamal Rashid. If you missed them, don't worry - you can view them on the  Product Show website .

On the Innovation Stage, showcasing their latest breakthrough technologies and techniques throughout the afternoon were: M+W Group, G&G Technologies, AutomaTech, Kneat Solutions, ClorDiSys Solutions, Environmental Systems Corporation, Harrington Pure/E&S Technologies and The Windshire Group. And the Student Development Program was a huge success with its session "How to Make the Most of Your Product Show Experience" led by Brian Hagopian.

Brian Hagopian had students prepare for the Product Show by practicing their elevator speeches.

The Career Fair, truly a "show within a show," was expanded this year to include 44 hiring companies eager to meet with potential new employees. Partnered with Career Builders to help source talent, the Career Fair attracted over 650 Product Show attendees - another record setting number. Many of the visitors took advantage of our professional photographer to get a new headshot - free of charge. Feedback on the Career Fair was overwhelmingly positive all around. So if you are a hiring company, contact us now at  office@ispeboston.org  if you're interested in next year's Career Fair.

We are excited to report that our Champions for Charity pavilion was a huge success once again. People generously donated over $2700 to the National Kidney Foundation and had their photo taken with Patriots alumni Jermaine Wiggins and Ronnie Lippett and Pats cheerleaders. These donations helped to support our team - the ISPE Nephronators - participating in this year's Boston Kidney Walk on October 16th.

ISPE and Chapter VIPs join the fun with Pats greats Jermaine Wiggins and Ronnie Lippett (not to mention the Pats cheerleaders).

The Young Professionals held a Networking/Educational Social hour which was highlighted by a panel of industry experts who provided resume reviews. And when the exhibitor floor closed at 6:30pm, both attendees and exhibitors made their way to Splitsville/Howl At The Moon to relax, bowl, dance, and socialize with new and old friends and meet special guest, Patriots defensive end Rob Ninkovich. A great end to a tremendous day!

The After Party at Splitsville/Howl at the Moon offered the opportunity to socialize with friends, plus photos with Rob Ninkovich and a chance to show off your bowling skills.

The Boston Area Chapter is pleased that this event continues to be offered free of charge, supported in full by our generous exhibitors. This includes free parking, free admission, free food, free soft drinks, free educational seminars, and free autographs. This show is our Chapter's flagship event and the revenue generated funds the Chapter and allows us to bring many worthwhile benefits to our Members.

With over 3000 attendees, the Product Show continues its 25-year reign as one of our industry's premier annual events.

So on behalf of the Chapter, thank you to all of our exhibitors for your continued support. We look forward to your participation next year and encourage you to pre-register. To make it easy, you can preregister now and pay your deposit online on our  Product Show website  so don't delay - half of the booths and tables are already reserved for 2017!

It goes without saying that a Show like this doesn't happen without a lot of help from many people. Our volunteers are the backbone of our Chapter and we are grateful for their help in making the Product Show the success that it is, year after year. The Product Show Committee is already hard at work planning how to top this year's tremendous result and we are always looking for enthusiastic, imaginative, and fun people to help us run this event. If that is you and you would like to join us, please contact the Product Show Committee at  office@ispeboston.org .

So mark your calendars - October 4, 2017 at Gillette Stadium - and watch this space throughout the coming year to learn what we have planned. Thanks for your support and see you at the Show in 2017.


by Jack Campion, The Hart Companies

The 2016 ISPE Annual Meeting of the international membership took place in the sunny city of Atlanta September 17-21 with over 1400 attendees from around the world. Many, MANY activities were jam-packed into 4 ½ days.

To start with, international governance gatherings, comprised of Affiliate representatives from around the world, were attended by your Chapter officers John Spohn, Jack Campion and Steve Kennedy, and Chapter Manager Amy Poole. These were great opportunities to share ideas and learn about the new directions of the ISPE internationally - all very encouraging.

Chapter Officers had a chance to share best practices with their peers from North and South Americas during the NASAAC conference at Annual Meeting in Atlanta.  

Keynote and Plenary Addresses Something that made the Annual Meeting especially memorable were the inspiring words delivered to audiences of over 1000 by a pharma CEO, a doctor, and the mother of a patient - a spectrum of pharma stakeholders including its ultimate stakeholders.

Joseph Jimenez, CEO of Novartis, presented a talk entitled "Reimagining Medicine." He predicted that the next decade will bring more new medicines than the last 50 years and discussed his company's technical innovations including:

  • Restoration of hearing using a viral vector to "turn on" the production of intra-aural hairs necessary for hearing.
  • Cartilage replacement by stimulating stem cells via an injection into knee joints.
  • Collaborations with technology companies, such as with Google to develop a microchip- embedded contact lens that can autofocus like the eye.
  • Capacity expansion and productivity improvements using continuous manufacturing, single-use systems and high-density perfusion

Joseph also recognized the need for greater worldwide access to the benefits delivered by the drugs we make - even in countries with no system of health coverage. Novartis is responding with a new brand called "Novartis Access." The program provides 15 medicines in the 30 lowest income countries at a cost of $1 per month per patient - a price almost anyone can afford. Kenya was the first beneficiary of the new program.

Nicole Pierson, the mother of Gavin, a pediatric brain tumor survivor, shared their personal story of how compassionate use contributed to saving Gavin's life. Gavin was diagnosed at age five with a rare brain tumor. He was the first pediatric patient to receive compassionate use for the Pfizer drug Palbociclib, before it had received FDA approval. Nicole is an advocate for pediatric brain tumor research and is also the author of "Be Strong and Brave," a memoir about how Gavin's faith and hope helped save his life.

Other distinguished keynote speakers included:

  • Flemming Dahl, Senior Vice President and Head of Quality, Novo Nordisk, who spoke about innovations in the industry's workforce.
  • Stephan Grupp, MD, PhD, Children's Hospital of Philadelphia, who gave a FACINATING presentation on a new Leukemia treatment, now in trials, that uses autologous cell therapy. 

Attendees can view videos of the presentations on the ISPE Annual Meeting website,  http://www.ispe.org/2016-annual-meeting . (Hint: If you didn't attend, find someone who did. The videos are worth seeing!)

There were nearly 70 sessions over the course of four days within six tracks - from "End-to-End Supply Chain Management" to "Facilities and Equipment" to "Regulatory Compliance and Quality Systems." Speakers from the Boston Area Chapter included Paige Kane, John Spohn, Brian Hagopian, Rick Kotosky, Doyle Johnson, Andre Gill and others.

A seventh track focused on Women in Pharma, part of a broader initiative within ISPE. Key female executives in pharma shared their journeys with attendees from both a personal and a professional perspective. A round table discussion focused on the challenges and opportunities each embraced as they progressed though their careers. In addition to the education sessions, the Women in Pharma initiative raised $3,555 towards a scholarship for women pursuing careers in the pharmaceutical industry.

Facility of the Year (FOYA) Awards Prior to the Annual Meeting, awards had been presented in six categories:

  • Equipment Innovation
  • Facility Integration
  • Operational Excellence
  • Process Innovation
  • Project Execution
  • Sustainability

From among these, the overall FOY Award was announced at the Wednesday Awards Breakfast. It was presented to the Roche-Genentech, Vacaville CA site for its "CCP2 Manufacturing Facility and Return to Service (RTS)" project. Notably the Equipment Innovation Award went to our Chapter's own Pfizer, Groton facility for its Portable Continuous Miniature and Modular (PCMM) collaboration. Congratulations to Boston Area Chapter Member Jeff Silcox of Hallam-ICS and the entire project team!

The Annual Meeting was also punctuated by numerous networking sessions in the vendor exhibition, and the famous Tuesday night party, held this year at the VERY STUPENDOUS Georgia Aquarium. Talk about pump capacity! (Not to mention some amazing aquatic life forms! Ever see an albino alligator?)

Next year's Annual Meeting will be held in San Diego, 29 October - 01 November. Time to make plans for next Halloween! Visit  http://www.ispe.org/2017-annual-meeting  for more information and add it to your calendar for 2017.


by David Sun, Genzyme, with photos by Howard Sneider, CRB

On September 8 the Young Professionals hosted their annual boat cruise aboard the Samuel Clemens leaving from Rowe's wharf in Boston's financial district. The event was a huge success with a record-high 75+ attendees consisting of both the young and young at heart. From 6:30 to 9:30, most guests had a general plan laid out for their evening. First and foremost, they filled their empty stomachs with the catered sandwiches, wings and more, then grabbed a drink from the bar and settled in for an evening of socializing.

This year's Harbor Cruise provided live music, great food and the Boston skyline in the background - what's not to like?

With hunger satisfied, attendees were treated to a live band filling the night air with jazz/swing music. With great music in the background and a beautiful view of the Boston skyline, people grouped up into small circles and began getting to know one another. With so many guests, there was plenty of networking and chit-chat to go around. Another popular option was taking selfies with Boston in the background.

Whether topside or below decks, the Samuel Clemens provided comfortable spaces for casual socializing.

As the evening drew to a close, incoming Chapter President John Spohn thanked everyone for coming, advertised future events, and talked about the Chapter's upcoming year and new initiatives for 2017. Then the Samuel Clemens drifted back into the harbor, the chatter of the evening quieted and everyone finally headed home after a fun evening cruising the harbor.


by Stefan Tropsa, Design Group

The Boston Area Chapter educational program entitled "Accidental Project Manager, Now What?" was held on Thursday, September 15 at Alnylam Pharmaceuticals in Cambridge. This topic attracted approximately 70 attendees, both members and non-members alike.

Following the traditional networking reception, the evening began with opening remarks by Chapter President John Spohn and Meeting Manager Stefan Tropsa who captured the audience's attention with an overview of the challenges of project management. Stacy Price, Head of Operations, Process Development at Shire, followed Stefan's introduction. She described the core concepts of project management based on her 20 years managing commercial and clinical biotechnology operations at Shire. Stacy provided enlightening insights on common misconceptions, modes for project failure, and tips and tricks to ensure project success by honing management of stakeholder's, scope, communication, operations, and change. Furthermore, she provided a new perspective on aspects of project management that are often overlooked.

Alnylam hosted the Chapter for the September educational program and networking reception. 

Up next was Rob Beane, Director of Regulatory Compliance at Design Group. He concentrated specifically on communication and its importance to project success. He provided a solid foundation for why it is so important and discussed the many means of communication used throughout a project including Risk Management, Action Items List, Meeting Minutes, Status Reports and Dashboards, Earned Value or other Key Performance Indicators, Change Management, Plan Report, and Lessons Learned. Rob's lively performance clearly captured the hearts and minds of the audience.

Stacy and Rob shared a great deal of information during the course of the evening that provoked one of the most engaging and dynamic Q&A sessions the Chapter has seen this year! The questions ranged from how to become a project manager, to how to incorporate all team members while keeping the project on track for success. In sum, the program succeeded in delivering quality information on a topic of keen interest and relevance to Chapter members.

The Boston Area Chapter and Meeting Managers Stefan Tropsa and Thomas Vaughan would like to thank the speakers and audience members for their valuable contributions to this program; Alnylam Pharmaceutical for hosting the event; and sponsor Commissioning Agents for their invaluable support.


by Brian Hagopian, Clear Water Consulting, and Paige Kane, Merck, with photos by Brian Hagopian

The Product Show has always been a focus of the fall season for our Student Members and this year was no exception. The Chapter gave over 200 students the opportunity to attend the 25th Anniversary edition of the Product Show by sending buses to our 13 Student Chapters and transporting students to and from Gillette Stadium. Highlights of this year's Show included presentation of the coveted Student Chapter of The Year Award to Mass Maritime Academy during the plenary session. MMA was recognized for their excellent work over the past year in building membership and promoting ISPE around campus.

Proudly displaying their plaque are Student Chapter of the Year Mass Maritime Academy award recipients: (l-r) Faculty Advisor George Howe, President Ryan Galanti, Treasurer Lukas Smith and Vice President Benjamin Joyal.

To prepare for the Show, about 50 students attended a session entitled "How to Get the Most out of Your Product Show Experience" where they learned how to make the right first impression when meeting people. We surprised students by making them practice their "elevator speeches" during the session. At first they were a little hesitant but after a few minutes they were clearly enjoying themselves as they prepared to visit the exhibit area and the Career Fair.

Students practiced their elevator speeches as part of the educational session "How to Make the Most of Your Product Show Experience."

Student Development Committee members also took advantage of the Career Fair with its 44 hiring companies, meeting with as many HR representatives as possible and singing the praises of the Boston Area Chapter and its 300 Student Members. As a result of these efforts, the Chapter will be posting over 100 new positions on our website in the coming months!

Scholarship applications are due by November 1 for the next round of Chapter scholarships. Over its history, the Chapter has awarded scholarships to a whopping 50 percent of applicants. Take advantage of this great program and help pay for the cost of your education. Don't delay since a written reference is required - be sure to give your chosen reference time to write a glowing endorsement.   Click here  to learn more and complete your application on line.

Page last updated: 4 November 2016