iSpeak Blog

2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives

Susan Sandler
2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives

The gavel passed to a new International Board Chair and ISPE leaders shared 2022 achievements and plans for 2023 at the 2022 ISPE Membership Meeting and Awards Lunch.

Michael L. Rutherford
Executive Director, Computer Systems Quality & Data Integrity
Syneos Health
Chair

The ISPE Membership Meeting and Awards Lunch on 1 November during the 2022 ISPE Annual Meeting and Expo saw the traditional passing of the gavel from International Board Chair Jörg Zimmermann to incoming Chair Michael Rutherford, board members taking up their new responsibilities, and reports on the year in review. Highlights were presented about what to expect in 2023 from ISPE leadership and Board members, and recipients of the 2022 ISPE International Honor Awards were announced.

The Year in Review

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Past Chair

Jörg Zimmermann, International Board Chair for 2021–2022 and Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co., opened the Membership Meeting with a look back at the year.

“A lot of work goes into being Chair, but it is also a lot of fun,” Zimmermann said. He noted that the International Board’s Executive Committee and the full Board worked hard on international initiatives and “a true representation of the membership,” including members from a range of organization types and locations.

Zimmermann outlined the two main projects of the Board during 2022.

One ISPE initiative is a work in progress, he said. Most Chapters and Affiliates have already adopted it. The initiative provides growth incentives for local groups and benefits the Society overall. Comments on the charter have been implemented into the 2023 version to be finalized by year end.

Strategic plan refresh for 2023–2025 involved an adaptation from the existing strategic plan, with the Society taking a “very confident position: Shaping the Future of Pharma and bringing quality medicines to patients worldwide.”

A video was screened about strategic objectives and desired outcomes for the strategic plan. Some highlights include:

Strategic objectives: Expand thought leadership; regular refresh of content priorities; a balanced portfolio of programs and services; diversity, inclusion, and social responsibility; foster partnerships and collaborations; strengthen member value through content and communications; attract and retain members and focus on regional needs; and digital transformation to improve industry leadership and member engagement.

Desired outcomes: Support of relevant therapeutic modalities in content; ISPE to remain a thought leader; evolve virtual and hybrid platforms to have global reach; grow and scale professional development programs; expand social responsibility impact; increase the ISPE Foundation donor base in programs; build partnerships that drive member value; foster regulatory interactions; grow membership to 25,000 by 2025; continue volunteer appreciation programs and elevate the value of volunteers to attract more volunteers; develop digital solutions and improve the digital experience; and increase agility to respond to current industry needs.

Zimmermann thanked the membership for “the trust and support” given him as Chair, and thanked the communities of practice (CoPs), Chapters and Affiliates, International Board, ISPE Staff, members and volunteers, Vetter, and his family.

He thanked the outgoing Board members for their contributions: Joanne Barrick, Sr. Director, TS/MS Validation, Eli Lilly and Company; Heather Bennett-Kelley, Project Manager/Engineer, ACCO Systems; Chris Chen, CEO, WuXi Biologics Co. Ltd.; David Doleski, Head of Global Quality Audit and External Engagement, Sanofi; and Lou Kennedy, CEO and Owner, Nephron Pharmaceuticals.

Joanne R. Barrick, RPh
Sr. Director TS/MS Validation
Eli Lilly and Company
Heather L. Bennett-Kelley
Project Manager/ Engineer
ACCO Engineered Systems
Chris Chen, PhD
CEO
WuXi Biologics (Shanghai) Co., Ltd.
David Doleski
Head of Global Quality Audit and External Engagement
Sanofi
Lou W. Kennedy
CEO and Owner
Nephron Pharmaceuticals

A Time of Change

Thomas B. Hartman
President and CEO
ISPE

Thomas Hartman, President and CEO of ISPE, welcomed attendees to the Membership Meeting and spoke of the “considerable change” that ISPE has undergone over the last few years; some changes were due to the pandemic, and others because of changing regional needs.

Membership is now over 20,000, with members in over 120 countries, Hartman said. The Society now has 39 Affiliates and Chapters in 90 countries, and will add two to three additional Affiliates in 10 new countries in multiple regions in the coming year.

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. He noted Pharmaceutical Engineering’s APEX Award win for the third year in a row, and acknowledged the expertise and work of the Regulatory Steering Committee and the Drug Shortages Team’s work to develop a new drug shortages prevention document. The ISPE Foundation continues its work in support of the next generation in the industry, improved exhibitor experience including participation in education events, and the Society continues to have a healthy balance sheet.

Hartman said that these achievements happened against the backdrop of the pandemic, without any increase in membership fees and without increasing the number of staff beyond pre-pandemic levels.

“At the end of the day, it is all about members” in an industry that will be remembered from this pandemic for the lives that were saved. “ISPE members value the things I mentioned today, and they value making an even greater difference in our industry,” Hartman said. “As members of ISPE, we continue in our efforts to bring solutions to industry’s most complex problems.”

Financial Report

Scott W. Billman

Vice President, Engineering, Pharmaceutical Services
Thermo Fisher Scientific

Scott Billman, 2021–22 ISPE International Board Treasurer and Vice President, Engineering, Pharmaceutical Services, Thermo Fisher Scientific, gave the financial report.

He noted that the Society experienced about a 3% growth in membership this year. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong. Expenses for documents and conferences have been higher this year.

Net income is reinvested into ISPE programs, Billman said. Some of these investments included a $100,000 investment into One ISPE to fund some new areas for Chapters and Affiliates, and an annual donation to the ISPE Foundation.

Through the pandemic, the Society reduced staff and conferences, and did not need to use reserve funds. “We are in good financial health,” Billman concluded.

Foundation Update

Antonio R. Moreira, PhD
Vice Provost, Academic Affairs
University of Maryland

Antonio Moreira, ISPE Foundation Board Chair and Vice Provost, Academic Affairs, University of Maryland, Baltimore County, provided an update on the ISPE Foundation . He thanked the 2021–2022 Foundation Board for their work and welcomed the 2022–2023 Foundation Board.

He said that the ISPE Foundation tries to develop activities that benefit patient lives around the world. Its work focuses on three areas:

  1. ISPE Knowledge Without Borders: Technology Without Borders is a new initiatives, which is receiving generous support from Gilead. It will make documents available and training corresponding to those documents in areas of the world where there is a need. The program will begin in Brazil with translations into Portuguese.
  2. Workforce diversity: The internship program has three participating companies so far: WuXi, Nephron, and Gilead. Women in Pharma® is another initiative supported by the Foundation.
  3. Scholarships and grants: The Foundation hopes to start an academic scholarship fund and continues with its professional development grants (travel grants).

Moreira reported that five interns were placed in 2022, the Foundation awarded 31 travel grants, and it secured funding for the Technology Without Borders program.

The Foundation aims to raise $40,000 by year end with contributions to recognize the more than 40 years of ISPE’s contributions to the industry.

Looking Ahead

Zimmermann passed the Chair’s gavel to Michael Rutherford, ISPE International Board Chair for 2022–2023. He is Executive Director, Computer Systems Quality & Data Integrity, at Syneos Health.

Rutherford spoke about the year ahead, starting with his entrance to the stage accompanied by “I’m Alright,” the theme from the movie Caddyshack. He drew an analogy between the movie that helped launch the career of actor and comedian Bill Murray to his own opportunities through ISPE. Those began 20 years ago when he was involved in a major FDA inspection by Robert Tollefsen and Thomas Arista that significantly changed computer system validation in the industry.

“As a result, I was asked to present learning points and outcomes of that inspection at a GAMP Forum in San Francisco in January 2003. I would have never imagined that presentation, and becoming an active member in GAMP and ISPE, would have such an impact on my career and would result in me standing here as your new ISPE Board Chair. But that is what ISPE can do for its members: provide technical development and knowledge, provide the opportunity to build strong industry networks, provide a chance to give back to our industry and the patients we serve, and open up career opportunities beyond what you think are possible.

“I am the example of how ISPE has continued to Improve the volunteer experience; to attract, retain, and develop new talent and future leaders of ISPE. I strongly encourage you to take full advantage of your ISPE membership and volunteer opportunities. You will get back as much as, if not more, than what you put into it. Who knows where it will lead—maybe to this stage in the future.”

In the year ahead, Rutherford pointed to the importance of supporting the One ISPE program, reconfirming the International Board’s commitment to all Chapters and Affiliates including through the Board liaison program, which assigns individual Board members to each Chapter and Affiliate, and participation in local and regional events when possible. “Supporting each other and growing ISPE is the common goal for all of us.”

Initiatives such as partnerships and Technology Without Borders, and leveraging established brands including Emerging Leaders, Women in Pharma, GAMP, and Pharma 4.0 will continue to expand the Society’s global engagement, he said. New CoPs are being established, including compounding and quality. Enhanced digital solutions are coming including the web site, social media platforms, knowledge products, conferences, and professional development programs.

Rutherford said he is looking forward to working with ISPE leadership and staff and the International Board. “I am truly honored to be in this position and I look forward to this next year.”

He introduced the 2022–2023 Board:

Officers

Michael L. Rutherford
Executive Director, Computer Systems Quality & Data Integrity
Syneos Health
Chair
Scott W. Billman
Vice President, Engineering, Pharmaceutical Services
Thermo Fisher Scientific
Vice Chair
Jeffrey A. Biskup, PE
CEO and Chairman of the Board
CRB
Treasurer
Vivianne J. Arencibia
Vice President, Global Quality Systems and Compliance
Moderna
Secretary
Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Past Chair

Re-elected Directors

Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Hirofumi Suzuki, PhD
Product Supply Japan, Head of Product Supply Coordination
Bayer Yakuhin Ltd

New Directors

David Churchward
Global Head Sterility Assurance, Cell and Gene Technologies
Lonza Biologics
Norman A. Goldschmidt
President
Genesis AEC

Continuing Board Members:

In addition to those named above, the following Directors were elected in 2021 to serve a two-year term and will continue their service on the Board:

Ylva Ek
Founder
Robur Life Science Advisory AB
Sarah C. Pope Miksinski, PhD
Executive Director in CMC Regulatory Affairs
AstraZeneca
Georg Singewald, PhD
Global Head Technology & Engineering
F Hoffmann-La Roche AG
Timothy J.N. Watson, PhD
Executive Director & Team Leader, CMC Advisory Office
Pfizer Inc

Ex Officio

Zen-Zen Yen
Head of Engineering
Bayer AG

  • Poster Presentation
  • Team BioGatz
  • 2022 ISPE Affiliate and Chapter Excellence Award - Japan
  • 2022 ISPE Affiliate and Chapter Excellence Award - South Central
  • 2022 ISPE Committee of the Year
  • 2022 ISPE Max Seales Yonker Member of the Year Award
  • 2022 ISPE Richard B. Purdy Distinguished Achievement Award
  • 2022 ISPE Joseph X. Phillips Professional Achievement Award
  • 2022 FOYA Overall Winner

ISPE International Honor Awards

Hartman, Zimmermann, and Rutherford distributed the 2022 ISPE International Honor Awards to the following recipients:

2022 Professional Poster Display Award

2022 International Emerging Leader Hackathon Winning Team

Clair Delmas, Anne Lynch, Emanual Montanez, Shakti Nagpal, Silas Tamufor, and Team Coach Brandi Stockton

2021 ISPE PE Roger F. Sherwood Article of the Year Award

(awarded for content published during the previous calendar year)

Medical Device UDI Components Management in the European Union” (July-August 2021) by Laurence Azoulay, Marie Coulon, PharmD, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida-Marchand, Ye-Lynne Lee, Valérie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé

2022 ISPE Affiliate and Chapter Excellence Award

ISPE Japan Affiliate

ISPE South Central Chapter (Texas, Louisiana, and Oklahoma)

2022 ISPE Committee of the Year

GAMP® Global Steering Committee

2022 ISPE Max Seales Yonker Member of the Year Award

2022 ISPE Richard B. Purdy Distinguished Achievement Award

2022 ISPE Joseph X. Phillips Professional Achievement Award

2022 ISPE FOYA Overall Winner Award

Takeda Pharmaceuticals International AG TaSiVa [Pharma 4.0 category]