November 2016, Volume XXVI, No. 6

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Newsletter Archive

ISPE Annual Meeting Brings Worldwide Members to Atlanta

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, (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 for more information and add it to your calendar for 2017.


Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail:
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