The Gavel Passes to the New ISPE Board Chair at 2020 ISPE Annual Meeting & Expo

Susan Sandler
ISPE Member Meeting at the 2020 ISPE Annual Meeting & Expo

The 2020 ISPE Member Meeting included most of the usual components of live Member Meetings: Outgoing ISPE International Board of Directors Chair Frances Zipp passed the gavel to incoming Chair Joanne Barrick, new Board members began their terms, Board members completing their terms departed, and ISPE members received a report on the state of the Society’s business. 

ISPE Member Meeting

Thomas Hartman, ISPE President and CEO, opened the Member Meeting at the 2020 ISPE Annual Meeting & Expo by noting that the virtual meeting would address most of the usual topics covered in prior Member Meetings. He did note as announced earlier this year that ISPE leadership decided to defer the 2020 membership recognition awards to the 2021 Annual Meeting & Expo, so that those awards could be given face to face with proper recognition. Hartman noted that the 2020 Facility of the Year Awards (FOYA) did proceed without being deferred, and he congratulated all of the winners.

Hartman gave an overview of the changes this year at ISPE due to the pandemic and its impact. These changes were implemented by ISPE staff, the International Board of Directors, and volunteers, including transforming face-to-face events to a robust catalog of online learning solutions (technology courses, webinars, and global conferences). He noted “significant efforts in ensuring ISPE continued to deliver technically relevant content while remaining financially solvent.” 

“Though we are not able to be together in person, I am proud and excited how much we have been able to accomplish in this year’s Annual Meeting,” Hartman said. He thanked all participants and the ISPE community for their hard work and dedication to making this year’s conference a success. 
“It has been an unusual year, to say the least,” Hartman said, but he said that despite the challenges presented by the COVID-19 pandemic, ISPE’s financial state remains strong. At the start of the pandemic, senior leadership of ISPE regrouped, realized face-to-face activities needed to change significantly, took a hard look at expenses and revenue, and made “difficult and courageous” decisions that included a full shift to virtual platforms and cost reductions but unfortunately also included some staff reductions. 

Hartman reported the financial results indicate a decline in gross revenue of about 30%, but with an almost equal drop in expenses, due to the pandemic and changes in operations that were made in response to it; both net assets and reserve funds remain strong while net income has been essentially flat. 

A Time of Transition

Hartman introduced Frances Zipp, who completed her year as Chair of the Board and now moves to the Immediate Past Chair position on the Board. “Fran has proven to be an incredible leader in a difficult year,” Hartman said. He thanked her for her dedication and years of service to ISPE. 

Zipp, who is President & CEO, Lachman Consultant Services, Inc., reminisced about her speech a year ago at the 2019 ISPE Annual Meeting & Expo Membership Breakfast, where she began her year as Chair. In her speech, she said, “I used a car analogy. I really did think this was a road was well known and well-travelled—then the road suddenly changed.”

2020 has been “a year like no other year. 2020 has been unprecedented.” Zipp noted the amazing challenges, but also the unprecedented collaboration among regulators, industry, and ISPE members, “with companies coming together as never before to help develop diagnostics, vaccine candidates, and potential therapeutic solutions” to COVID-19. 

ISPE and its members regrouped, and “came together to serve our Society, our industry, and most importantly, our communities. The road was different but we were steadfast.” Zipp credits ISPE’s 39 Chapters and Affiliates for this, noting that she had been able to visit 12 of them before travel stopped in March, but was able to connect virtually and also to keep Chapter and Affiliate leads abreast of information after each Board meeting. 

To illustrate the work of ISPE’s Chapters and Affiliates, Zipp provided a brief overview about some activities this year: 

  • San Francisco Bay Chapter: worked on transforming a traditional biopharma and research and development campus into a modern CDMO; held seminars and webinars on pandemic-ready facilities and air handling; provided information on California OSHA fume hood requirements; and provided information about the Bay Area market and biomedical industry opportunities. 
  • Greater Los Angeles Area Chapter: offered virtual case studies with lessons learned from users/suppliers; sessions on microbial concerns in water systems; GAMP past/present/future sessions; and maintaining operations during COVID-19. 
  • San Diego Chapter: provided transformative technology webinars; facility and HVAC measures for safer environments during the pandemic; held the second annual Women of San Diego Executive Leadership Panel webinar; and a session on return to the workplace post-COVID-19, focusing on the office of future.
  • Chesapeake Bay Area: held a New Year’s Eve celebration; offered information on evolving commissioning and qualification practices using quality risk management and a risk-based approach.
  • Delaware Valley Chapter: provided basic US regulatory information and had lunch and learn sessions on various topics such as immunology for nonbiologists, vaccines, and additional regulatory topics.
  • New Jersey Chapter: held a Women in Pharma® (WIP) session: “Show up, Speak up, Step up”; provided information on leadership strategies; had a session on storytelling in business; a session on disruption in  the biopharma ecosystem through artificial intelligence and machine learning; and a session on establishing credibility in the workforce.
  • Boston Chapter: offered a Women in Pharma virtual pool-side chat; a session on pharma community realities on meeting the challenges of the COVID-19 pandemic; sponsored an FDA/industry discussion panel on biomanufacturing innovation; a session on virtual inspections and how to navigate new paradigm; and business continuity in the new normal.
  • Carolina-South Atlantic (CaSA) Chapter: provided the ISPE Women in Pharma webinar: Transform and Empower Yourself; had an Oktoberfest and the greater Atlanta golf tournament; and a lunch and learn Women in Pharma.
  • Netherlands Affiliate: provided sessions on impact and challenges in generics; vendor assessment: risk based approaches and trends and challenges; held a talent night; and a session on innovative product and production processes for pharmaceuticals.
  • Singapore Affiliate: offered a work from home series including how to handle Excel and online meeting tools and MS Teams; sessions on GAMP past/present/future; embrace the Annex 1 draft; sessions on containment control strategies and implementation approaches; and Technical Tuesdays on cell and gene therapy and automation.
  • Italy Affiliate: gave data integrity sessions and sessions on biotechnology and OT (operational technology) cybersecurity.
  • UK Affiliate: provided a lock down webinar series; focus on mental wellbeing and working effectively and efficiently in remote teams; focus on pillars of structure, trust, and communication; and partnered with AstraZeneca on case studies for a back to work webinar.
  • Ireland Affiliate: held a Women in Pharma session on navigating virtual work and building a personal brand and executive presence; held its annual General Meeting via Webex; and supported the community in many ways, as did many other affiliates.
  • India Affiliate: held many webinars and sessions and focused on Pharma 4.0™ advances in sterile manufacturing. 
  • Belgium Affiliate: had sessions on GAMP; data integrity best practices; operational excellence virtual roundtable; and an online project management café.
  • D/A/CH (Germany/Austria/Switzerland): activities included online workshops; addressing COVID-19 disruptions on clinical trial supplies; and automation with robotic technology.
  • Eurasian Economic Union Affiliate: this new Affiliate has been active in remote learnings and activities.
  • Brazil Affiliate: presented strategies for sustainable pharma management from suppliers.
  • Mexico Affiliate: the year-old Affiliate offered many sessions and partnered with industry to build and bring new therapeutic entities to market.

Zipp noted that Chapters and Affiliates, the “backbone” of ISPE, did not stop learning, sharing, and reaching out when they could not travel.

She thanked the Board, officers, continuing Board members, and Board members who have completed their terms of service: Gunter Baumgartner, Senior Vice President, Head of Global Engineering, Takeda Pharmaceuticals International A.G.; Caroline Rocks, Senior Program Manager, AbbVie, Inc.; Christine M.V. Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.; LeAnna Pearson Marcum (Young Professionals Board representative), Senior Project Manager, PharmEng Technology; and James A. Breen, Jr., PE, Immediate Past Chair and Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals. 

Despite the challenges of remote meetings for the Board this year, “we still remember our mission: to supply knowledge to the pharma industry. That’s what has driven every activity.”

The New Chair Takes the Gavel

Zipp introduced the incoming 2020-2021 Chair of the ISPE International Board, Joanne R. Barrick, RPh, Advisor, Global Validation, Eli Lilly and Company. “Joanne has been a leading star at knowledge sharing at ISPE for many years,” Zipp said, noting Barrick’s passion, enthusiasm, and attention to detail as a Board member “has raised us up.” Zipp passed the gavel to Barrick, who began her presentation by saying it is an honor to serve as ISPE’s Chair. 

“The year 2020 has been a time of unprecedented change and challenge and I have never been more proud to be part of the pharma industry,” Barrick said. “We have seen unprecedented, exceptional collaboration between scientists, engineers, and regulators and miraculous progress toward safe and effective treatments and vaccines to end the threat posed by the coronavirus. Going forward, ISPE may be able to play a significant  role in capturing and disseminating these collaborative learnings, thus helping to assure we are better positioned to address the ever increasing number of health care issues (remember Zika and Ebola just a few years ago)? Together, we can effectively address challenges in supply chain, product and process development, scale-up, and commercial manufacturing.”   

Barrick noted the challenges that ISPE has worked to surmount during 2020.“Due to travel restrictions, this has been a year of uncertainty, unprecedented challenges, and pivoting for ISPE. We have pivoted to virtual conferences, reinvented our training courses to include virtual interactions, and increased our webinar offerings.” She recognized Zipp’s contributions as Chair during the changes that came as the pandemic took hold, and said she is looking forward to her continued contributions as Immediate Past Chair. Barrick also thanked Tim Howard, Vice President, Human Resources Development, for his service as Interim President and CEO and his leadership through the start of the pandemic and necessary short-term changes. Barrick also thanked the ISPE staff for its dedication this year. 

“ISPE is very important to me and I have always been inspired by the way ISPE leads our industry forward,” Barrick said. She recalled in 2008, when ICH Q8 (Quality by Design) was introduced, ISPE took the lead in facilitating implementation. That initiative changed how the industry develops, manufactures, and discusses pharmaceutical manufacturing, she noted. Barrick joined the ICH Q8 process criticality task force and contributed to a quality by design (QbD) implementation Good Practice Guide. She presented at the 2009 Annual Meeting & Expo in San Diego, describing the impact of QbD on process validation. Next came leadership of the ISPE Team efforts to facilitate practical implementation of the lifecycle approach to process validation, which she said was a very rewarding and meaningful experience and resulted in several conferences and publications. 

“I am inspired by ISPE’s own culture of excellence, which consistently results in development and publication of our highly regarded guidance documents,” Barrick said. “But mostly, ISPE is important to me because of the people. Those invaluable ISPE member experts who consistently interrupt their day jobs to assist fellow ISPE members with questions. ISPE has been a tremendous opportunity for me to develop technical skills, regulatory awareness, and most important, a synergistic network.”

In 2021, Barrick said, implementation of the second year in ISPE’s current Strategic Plan will continue.   “While we are changing the ‘how’ we deliver the strategic plan, the plan and our content priorities remain a solid foundation for our Society,” she emphasized. Digitization will enhance content and information availability, and Women in Pharma and workforce development training programs will remain strong. The Society will continue to seek to expand its impact by increasing its global footprint, noting the recent addition of the Mexico and Eurasian Affiliated. Barrick said the ISPE Foundation is now poised for significant growth as a result of the leadership of Mike Arnold, and will include the pursuit of initiatives targeted at increasing diversity in the pharmaceutical industry.    

In addition, ISPE will continue to emphasize integration of conference, training, and guidance document offerings and place more emphasis on regulatory topic impact and activities, she said. Opportunities for more interface with the ISPE Board through conferences and participation in Chapter and Affiliate events can be expected. “I invite each of you to reach out to me at any time and share your thoughts on advancing ISPE’s support for the pharma industry and the patients we serve,” Barrick said.       
Barrick introduced the 2021 Board:

2020-2021 ISPE International Board of Directors

Officers

Joanne R. Barrick, RPh
Advisor, Global Validation
Eli Lilly and Company
Chair
Joerg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Vice Chair
Michael L. Rutherford
Executive Director, Computer Systems Quality & Data Integrity
Syneos Health
Treasurer
Scott W. Billman
Global Head of Engineering
Biogen
Secretary
Frances M. Zipp
President & CEO
Lachman Consultant Services, Inc.
Past Chair

Directors Elected to a Second Term

Vivianne J. Arencibia
Independent Consultant
Arencibia Quality Compliance Associates
Chris Chen, PhD
CEO
WuXi Biologics (Shanghai) Co., Ltd.

New Directors:

Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
David Doleski
Compliance Head for Biologics Quality Operations
Sanofi
Board Appointed Director
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Hirofumi Suzuki, PhD
Senior Regulatory CMC Adviser
Bayer Yakuhin Ltd

Continuing Board Members

In addition to those named above, the following Directors were elected in 2019 to serve a two-year term and will continue their service on the Board:

Ylva Ek
Chief Quality Officer (CQO)
KeyPlants AB
Lou W. Kennedy
CEO and Owner
Nephron Pharmaceuticals
Stephen C. Mahoney, JD
Senior Director, Global Quality & Compliance
Genentech, A Member of the Roche Group
Alice Redmond, PhD
Vice President, European Operations
CAI

Young Professionals Representative (Ex Officio)

John Clarke
Operations Lead
Pfizer
Board Young Professionals Representative (Non-voting)

“I hope you will join me in approaching the new year with renewed hope and inspired by the goodness of humankind,” Barrick said, thanking those working on COVID-19 treatments and vaccines “for your tireless efforts to complete several years of work in a matter of a few months.” She thanked members for donations to support COVID-19 relief, “and any kind word or deed you have offered to someone who is discouraged or isolated. We have again demonstrated the resilience of the human spirit as demonstrated by exhausted first responders and front-line healthcare workers who just keep going.  Thanks to those who held encouraging signs like ‘you are not alone’ or ‘praying for you’ to nursing home windows or worked at food banks or made masks or hand sanitizer or delivered groceries for at-risk neighbors, put teddy bears in their windows, or wrote encouraging notes on the sidewalks.”  

She encouraged members to “take full advantage of the benefits of being a member of the ISPE family.  Please consider volunteering and/or getting involved in your Chapter or Affiliate, perhaps for a service project. Or consider contributing to a Community of Practice or writing a part of a Guidance Document, facilitating a conference session, or even just volunteering to record notes for a conference break out session. Please do something—just get started. You will undoubtedly feel more confidence in your role with the backing of an ISPE network of experts. And for those already heavily involved, please share the value proposition of ISPE with others, continue to share your expertise, and help us to integrate and maintain the relevance of our offerings.”  

Barrick is looking forward to the continued success of ISPE in 2021, despite ongoing challenges with travel and finding new ways of working. “Through the leadership of Tom Hartman, and working together, I believe a year from now, every member of ISPE will feel proud of our accomplishments, and proud of the way ISPE rose to meet these unprecedented challenges. We will emerge stronger than ever.” 

ISPE Foundation Update

Michael Arnold, RPh, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies and Past ISPE Board Chair, provided an update on the ISPE Foundation, for which he has served as Chair. 

Despite the challenges of 2020, Arnold reported that the Foundation has had a successful year and is on target to meet or even exceed the 2020 revenue goal of $200,000. He described how the support provided to the Foundation has allowed it to help others: Since July, $35,000 in grants have been made, $15,000 has been provided to support Women in Pharma, and $18,000 has supported continued development of the Foundation web site.

Among the grants made were $10,000 to the World Health Organization for the COVID-19 Solidarity Response Fund; $15,000 in travel grants to students and Young Professionals to attend ISPE events and trainings (both remote and live attendance); and $10,000 to fund member efforts to prevent, detect, and respond to the COVID-19 pandemic within their communities through the COVID-19 Matching Gift. Brazil Affiliate Women in Pharma group was the first recipient of $2,500 for their efforts in assisting the homeless in Sao Paolo.

In 2020, the Foundation established a Donor List with four leadership societies and three clubs for various levels of giving. These recognize all donors on the Foundation web site who have not requested anonymity. Arnold added that in honor of ISPE’s 40th Anniversary, the 1980 Founders Society was established. The Foundation website has information on this and other giving categories. 

Finally, Arnold shared that the Foundation received a substantial donation from Gilead Sciences, with which the Gilead-ISPE Scholars Program was established. This program will provide world-class internship opportunities to groups that are typically underrepresented in the pharmaceutical industry. Selected candidates will work on high priority, impactful projects and workstreams tied to the Gilead Corporate Operations 2025, which was developed to support Gilead’s long-term company strategy.

The Foundation Development Committee, led by Andrew A. Signore, PE,CPIP, Partner, PharmaBioSource, is working on a “go forward” campaign strategy, Arnold said. This strategy will be crucial to the Foundation’s  success in 2021 and beyond. He encourages all to contribute to and support the Foundation. 

Hartman thanked Arnold for his service to the Foundation and recognized the new Board of the Foundation, welcoming Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County, as the new Foundation Chair, with Signore continuing to serve as Vice Chair,  Rutherford as Treasurer (who also serves as Treasurer on the ISPE International Board), and Christopher J. Reid, CEO, Integrity Solutions, as Secretary. Hartman noted that many ISPE Board members also serve on the Foundation Board:  Zimmerman, Kennedy, Mahoney, Redmond, and Arencibia. In addition, Breen and Monique L. Sprueill, PMP, Senior Director, Global Quality and Compliance, Genentech, will serve on the Foundation Board in 2021. 

Barrick concluded the meeting, which was followed by a presentation by Stephen M. Hahn, MD, Commissioner, FDA. Coverage of this presentation will be included in a separate blog.