2021 ISPE Annual Meeting & Expo: New ISPE Board Installed, 2020 & 2021 Awards Presented
The Membership and Awards Breakfast at the 2021 ISPE Annual Meeting & Expo on 2 November saw the traditional passing of the gavel in person for the first time in two years as Jörg Zimmermann became the Chair of the ISPE International Board of Directors. Awards were presented for both 2020 and 2021, since the 2020 awards were postponed from last year.
The Year in Review
Joanne Barrick, RPh, the 2020–2021 ISPE Board Chair and Advisor–Global Validation at Eli Lilly and Company, began the session with a look back at 2021 and the many challenges and achievements of ISPE and the industry.
“ISPE has been resilient, pivoting to virtual platforms faster than most other not for profits for conferences, webinars, and training,” Barrick said. “We have continued to deliver the pharma industry gold standard guidance documents and magazine. We are leading collaboration in interpretation and facilitating implementation of several new pharma regulatory expectations and also innovative technical solutions to manufacturing challenges. The ISPE Aseptic Conference and GAMP® have both very successfully reached the 30-year milestone. The lessons learned in 2021 position us to be even more impactful in the future.”
Barrick, who will continue on the Board in 2021-2022 as Immediate Past Chair, said over the last 18 months, “in the pharma industry, we saw unprecedented collaboration and have achieved speed and agility never thought possible. Vulnerabilities in supply chain were exposed, which must be resolved to assure a reliable supply of high quality medicines for patients we serve throughout the globe. Environmental sustainability has become a more and more important manufacturing consideration. Our industry continues to rise to the challenge, not only with development of the vaccines and treatments for COVID-19, but continued manufacture of drugs and treatments for many other illnesses while the pandemic raged, with very few disruptions in supply. I have never been more proud to be part of the pharma industry.”
She encouraged attendees to become more active in the Society. “As included in our newly revised value proposition, ISPE gives us a platform and a chance to advance and shape the pharma industry—and who won’t want to be part of that?”
Thomas B. Hartman, ISPE President and CEO, addressed the meeting and thanked all who have made the 2021 Annual Meeting & Expo a success, including the ISPE Boston Chapter for its assistance to ISPE staff in preparing and executing the conference. Hartman noted that the continued pandemic made preparation for the conference more complicated with a shorter lead time. He thanked ISPE staff for their contributions this year, noting several staff with long terms of service to the Society and several staff who have retired.
Hartman referred to the “bright light” on the pharmaceutical industry over the last 18 months of the pandemic as vaccines were developed and distributed. “The bright light revealed the critical importance of the industry, the art of drug discovery, and those who worked tirelessly” to discover and scale the vaccines for COVID-19, he said. This focus on the industry encouraged people to want to know more about the industry and to understand its challenges and how these are met. Hartman encouraged attendees to take the time to answer questions about the industry, since the answers may encourage people to join the industry.
Many challenges face the industry and Hartman noted that energy to drive change in facing these challenges is needed to make sure that there is no disruption or delay in making medications available to patients. “This is our call to action,” he said, noting that there has never been a better time to come together as an industry, realize its vision, and work on solutions.
Michael L. Rutherford, ISPE Board Treasurer and Executive Director, Computer Systems Quality & Data Integrity at Syneos Health, gave the financial report for the Society. He noted the pandemic has had impact on ISPE financial operations during 2021 and 2021, but said it is projected that the Society will break even by the end of 2021.
Antonio R. Moreira, ISPE Foundation Board Chair, and University of Maryland, Baltimore County, Vice Provost, Academic Affairs, gave an update on the ISPE Foundation. After a video about the Foundation programs, Moreira thanked the 2020–2021 Foundation Board and welcomed the 2021–2022 Foundation Board.
Moreira outlined the Foundation initiatives: workforce of the future/diversity and inclusion, Women in Pharma® (WIP), and global knowledge exchange. In 2021, the Foundation developed a three-year strategic plan, restructured its bylaws, and hired dedicated Foundation staff. In 2022, the Foundation plans to work with WIP, travel grants, emerging markets/document translation, and expanded outreach and leverage major gifts and corporate donations.
He reported on the two diversity internship initiatives in 2021 sponsored by Gilead and Nephron Pharmaceuticals. Over 100 applications from 17 states and six countries were received, he said. Five interns were placed at the two companies.
Moreira acknowledged the 12th Annual ISPE 5K Charity Run/Walk sponsored by Belimed, with all proceeds benefitting the Foundation.
Passing the Gavel
Barrick passed the gavel of the Chair to Zimmermann, Vice President, Vetter Development Service, External Affairs at Vetter Pharma-Fertigung GmbH & Co. Zimmermann, who served as Vice Chair during 2020–2021, welcomed all attendees to the meeting, and introduced himself: he is a pharmacist by education, and has spent over 26 years at Vetter with experience in production, site management, process and product development and now external affairs. His ISPE work started as a speaker in 2002 and increased to include his service on the Board.
“My mission as Chair is to bring us all together: we have different cultures and backgrounds, but working together, we can find the best way forward.” The goal of the industry is to get medicines to the patients who need them, he said.
Looking ahead to the new year, Zimmermann predicted that hybrid conferences (offering a blend of in-person and virtual interactions) will continue, as will efforts to find the right balance for in office versus working at home, and work/life balance in general. He spoke about the many ISPE conferences that are already planned, including the 2021 ISPE Pharma 4.0™ and Annex 1 Conference on 8–9 December in Vienna, Austria; the 2022 Facilities of the Future Conference on 1–2 February in North Bethesda, Maryland; the 2022 ISPE Aseptic Conference on 14–15 March in North Bethesda, Maryland; and the 2022 ISPE Europe Annual Conference on 24–27 April in Madrid, Spain.
He noted that ISPE again has a footprint in China, and that the Society will be working on two major projects during 2022; the One ISPE Chapter and Affiliate Growth initiative and refreshing the ISPE Strategic Plan for 2023–2025.
Zimmermann encouraged Chapters and Affiliates to invite the Board to local meetings. “We want to hear from you and work with you. We are in this together!”
After thanking his family, company, the Executive Committee of the ISPE Board, and the full Board, he introduced the 2021–2022 ISPE Board and acknowledged the Past Chairs of ISPE.
Zimmermann then adjourned the business portion of the meeting.
2020 and 2021 Awards
Hartman and Barrick presented awards from both 2020 (these were postponed due to the pandemic) and 2021.
Affiliate and Chapter Excellence Award
The Greater Los Angeles Area, San Francisco Bay Area, and San Diego Chapters received the award as a group due to their efforts to ensure members stayed informed and engaged through the pandemic, while adding 12 more events and 36 webinars; some done jointly, some individually, some with other industry groups.
Philippines Affiliate, which engaged in multistakeholder activities to address a variety of areas during the pandemic including supply chain, vaccine development and regulatory requirements, and pharmacovigilance and adverse event monitoring, as well as increasing student and Emerging Leaders participation.
Committee of the Year
ISPE Aseptic Conference Program Committee, which pivoted to a fully virtual event and exceeded attendance expectations, and ISPE Brazil Affiliate and the Women in Pharma® Brazil Covid 19 Project, which received a $2,500 support match grant to fund efforts to create hygiene kits and provide portable showers for the homeless of Sao Paolo.
Emerging Leaders Virtual International Hackathon, because the committee demonstrated strong leadership in creating the fully global, virtual hackathon, which had 60 participants, 10 coaches, 5 judges, making it the biggest hackathon to date.
Pharmaceutical Engineering® Article of the Year
“Regulating Online Pharmacies and Medicinal Product E-Commerce” (November–December 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan
“Implementation of a Formal Energy-Efficient Design Process” (March–April 2020) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane
Max Seales Yonker Member of the Year Award
Eamon Judge, in recognition of his work with the Ireland Affiliate for over 17 years, and his work as President of the Affiliate to form and lead the Irish COVID Alliance beginning in April 2020.
Eleanor Small, for her leadership and commitment to the Delaware Valley Chapter, where she helmed the financial management and move to fully virtual programming, started subchapter initiatives, and the Chapter maintained the highest member retention of any US Chapter through the pandemic.
Richard B. Purdy Distinguished Achievement Award
Christopher Potter, PhD, for his years of service to ISPE, first as a member and now as an advisor andconsultant; his contributions included building PQLI®, raising ISPE’s profile with global regulators, work on ICH Q8, 9, 10, and 11, work on the quality metrics, ICH Q12, Advancing Pharmaceutical Quality (APQ) program, and regulatory programs on ATMPs and breakthrough therapies.
Mario Brenga Giampietro, who was the Brazil Affiliate President and a member of the GAMP Global Steering Committee; he made significant contributions with these initiatives and fostering relationships with regulators, interactions with other Chapters and Affiliates, and built Communities of Practice within the Affiliate. The award was given posthumously as he passed away in 2021.
Company of the Year Award
2020 and 2021
Hartman announced that no single company was selected as Company of the Year for 2020 or 2021. Instead, the award recognizes the entire industry including ISPE membership for “their unprecedented level of collaboration, dedication, tireless efforts, innovation, and speed; not only companies directly contributing to COVID-19-related vaccines, detection, and treatments, but all companies and regulatory authorities who supported and continue to support all pharma and patient related needs during the pandemic.”
Facilities of the Year Awards (FOYA) Overall Winner
Antonio Crincoli, Chair of the Facility of the Year Awards (FOYA) Judging Team, and Vice President of Global Engineering at Charles River Laboratories, Inc., announced the Overall FOYA Winner for 2021, the final award of the session.
Crincoli noted that this year, seven category awards were made and three honorable mentions during the banquet on Sunday 31 October. He acknowledged all judges participating in FOYA this year and thanked the FOYA Planning Committee.
“The FOYA program is all about promoting innovation and collaboration on a global scale–all for the benefit of patients,” Crincoli said. “Selected from a variety of submissions from around the world, these winning projects were standouts in their categories and exhibit the highest caliber of innovation and technological ingenuity taking place today in pharmaceutical engineering throughout the world.”
The overall winner for 2021 is Janssen Science Ireland for BioCork 2, an expansion of a biologics manufacturing facility in Cork, Ireland. In accepting the award, Jim Breen said, “At Janssen, we want to create a future where disease is a thing of the past; the industry is under a lot of pressure to fulfill the needs everybody wants in the world. It is very possible; we just have to work together.” He thanked the Irish team who were not able to attend the meeting in person, as well as the designer and builder on the project.
Hartman closed the session by announcing that the 2022 Annual Meeting & Expo will be held on 30 October–2 November in Orlando, Florida.