January / February 2023

ISPE Celebrates the 2022–2023 Board, Honor Award Winners, at Annual Meeting

Beau Castro
ISPE Celebrates the 2022–2023 Board, Honor Award Winners, at Annual Meeting

The 2022–2023 ISPE International Board took their places and the gavel passed to a new Chair during the 2022 ISPE Membership Meeting and Awards Lunch on 1 November during the 2022 ISPE Annual Meeting & Expo in Orlando, Florida.

Incoming Chair Michael L. Rutherford, Executive Director, Computer Systems Quality & Data Integrity at Syneos Health, began his year as Chair. Outgoing Chair Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co., moves into the Past Chair position of the International Board’s Officers.

The Membership Meeting included presentations by Zimmermann, Rutherford, and Thomas Hartman, ISPE President and CEO, as well as reports on the financial health of the Society and an update on the ISPE Foundation.

Looking Back, Looking Ahead

Zimmermann opened the Membership Meeting with a look back at the year, outlining the two main projects of the Board during 2022:

  • One ISPE initiative provides growth incentives for Chapters and Affiliates and benefits the Society overall. Comments on the charter have been implemented into the 2023 version.
  • Strategic plan refresh for 2023–2025 adapted the existing strategic plan to encompass the Society’s “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, including:
    • 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 acknowledged outgoing Board members for their contributions: Joanne Barrick, Senior 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.

Zimmermann passed the Chair’s gavel to Rutherford, ISPE International Board Chair for 2022–2023. Rutherford spoke about the year ahead, recalling his first participation with ISPE 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,” Rutherford said.

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 website, social media platforms, knowledge products, conferences, and

The 2022–2023 ISPE International Board of Directors


Michael L. Rutherford
Retired, Computer Systems Quality & Data Integrity
Scott W. Billman
Vice President of Global Engineering, Real Estate, and Facilities
Vice Chair
Jeffrey A. Biskup, PE
Executive Board Chairman/Co-Founder
Vivianne J. Arencibia
Vice President, Global Quality Systems and Compliance
Jörg Zimmermann
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Past Chair
Thomas B. Hartman
President and CEO
Ex Officio Non-voting Member


Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
David Churchward
Head of Operations Quality, Compliance and External Affairs
Norman A. Goldschmidt
Genesis AEC
Board Appointed Director
Ylva Ek
Robur Life Science Advisory AB
Sarah C. Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, Inc.
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Georg Singewald, PhD
SVP, Global Head of Engineering, Technology & Sustainability
Roche / Genentech
Hirofumi Suzuki, PhD
Product Supply Japan, Head of Product Supply Coordination
Bayer Yakuhin Ltd.
Timothy J.N. Watson, PhD
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences

Ex Officio

Zen-Zen Yen
Head of Engineering At Supply Center Grenzach
Bayer AG
Board Emerging Leaders Representative (Non-voting)

2022 International Honor Awards

The 2022 ISPE Honor Awards were distributed to the recipients by Hartman, Rutherford, and Zimmermann.

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]

  • 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