Changes to the Board

Incoming Chair Scott W. Billman, Vice President of Engineering for Pharmaceutical Services at Thermo Fisher Scientific, began his year as Chair. Outgoing Chair Michael L. Rutherford, Executive Director of Computer Systems Quality and Data Integrity at Syneos Health, moves into the Past Chair position of the International Board’s officers.

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

Sharing that ISPE was in a strong position for growth, Rutherford gave an overview of ISPE’s accomplishments in 2023, which include a new website that allows members to more easily access their benefits, increased engagement with emerging leaders, the formation of a new student grant program, the implementation of the 2023–2025 Strategic Plan, and continued execution of One ISPE.

ISPE membership has increased nearly 30% from mid-2020. ISPE now has more than 21,000 members in over 120 countries.

“The goal of One ISPE is to make sure that we are connecting with all the affiliates and chapters. In 2023 we added our 40th chapter—the Southwest Chapter, who are hosting this event.” Rutherford also thanked outgoing board members Jörg Zimmermann, Vice President of Vetter Development Service and External Affairs at Vetter Pharma-Fertigung GmbH & Co. KG, and Zen-Zen Yen, Head of Engineering at Bayer AG, for their contributions as they step off the board.

Hartman welcomed attendees to the Membership Meeting and spoke about the ways ISPE members are helping shape the future of the pharmaceutical industry: “All of our accomplishments are thanks to you.”

“ISPE membership has increased nearly 30% from mid-2020. ISPE now has more than 21,000 members in over 120 countries and our goal is to have 25,000 by 2025. This year we increased the number of Communities of Practice (CoPs) from 19 to 22 and we have plans to create an additional three, focusing on artificial intelligence, sustainability, and pharma compounding.”

“We have increased the number of guidance documents we publish. Conference attendance is increasing in numbers when compared to pre-pandemic levels. We have a very active, productive, and industry-relevant regulatory steering council. It is all thanks to you, our subject matter experts. You are the lifeblood of ISPE,” said Hartman.

Billman introduced the 2023–2024 board and presented ISPE’s goals for 2024. “Looking ahead, we want to engage more students and emerging leaders, expand our global reach through engagement and inclusion, continue to drive technical innovation through CoPs, and continue to have more interaction with global regulatory experts. We are committed to continue to evolve and grow ISPE, deliver value to our members, and celebrate the successes of our industry.”

THE 2023–2024 INTERNATIONAL BOARD OF DIRECTORS

Officers

Scott W. Billman

Senior Vice President Global Engineering, Technology, & Facilities

Solventum

Jeffrey A. Biskup, PE

Executive Chairman of the Board

CRB

Vivianne J. Arencibia

Vice President, Global Quality Systems and Compliance

Moderna

Ylva Ek

Founder

Robur Life Science Advisory AB

Michael Rutherford

Principal, Computer Systems Quality & Data Integrity

Rutherford Consulting, LLC

Thomas B. Hartman

President and CEO

ISPE

Directors

Nina S. Cauchon, PhD

Director Regulatory Affairs - CMC

Amgen Inc.

David Churchward

Head of Operations Quality, Compliance and External Affairs

AstraZeneca

Liz M. Dooley, MSc

Senior Director, Global Engineering & Technology

Johnson & Johnson

Norman Goldschmidt

President

Genesis AEC

Michael Martin

CEO

CAI

Sarah C. Pope Miksinski, PhD

Executive Director, CMC Regulatory Affairs

Gilead Sciences, Inc.

Teresa Minero

Founder & CEO

LifeBee - Digitalizing Life Sciences

Georg Singewald

Global Head of Quality & Compliance

Roche / Genentech

Hirofumi Suzuki, PhD

Regulatory Affairs CH Japan, Manager

Bayer Yakuhin Ltd.

Timothy J.N. Watson, PhD

Vice President – Head of CMC Regulatory Affairs

Gilead Sciences

Ex Officio

Monique L. Sprueill, PMP

Director, GCP Quality Lead

Bristol Myers Squibb

2023 INTERNATIONAL HONOR AWARDS

The 2023 ISPE Honor Awards were distributed to recipients by Hartman, Rutherford, and Billman.

2022 ISPE Roger F. Sherwood Article of the Year Award

“Supporting Cell and Gene Therapy through Multimodal and Flexible Facilities” (November/December 2022)

Authors

• Stephen Judd, Arcadis DPS Group
• William G. Whitford, DPS Group (pictured)

2023 ISPE International Emerging Leader Hackathon Winning Team

Hack O’ Lantern

Team members

• Alma Navarro Carmona, Operations Rotation Development Program Analyst II from Genentech
• Christian Harper, Regional Sales from Stilmas Americas
• Saurav Jain, chemical engineering student from North Carolina State University
• Evangeline Colarossi Keiss, Formulation Scientist II from Tolmar Inc.
• Isabella Tobin, pharmacy student from Purdue University
• Anna Sun, Process Simulation Engineer from CRB
• Filipp Voronov, QC Chemistry I from Fujifilm Diosynth Biotech
• 2023 Company of the Year Award

2023 Company of the Year Award

Roche

2023 ISPE Affiliate and Chapter Excellence Award

Ireland Affiliate

2023 ISPE Committee of the Year

Advancing Pharmaceutical Quality (APQ) Initiative Team

2023 ISPE Max Seales Yonker Member of the Year Award

Diane L. Hustead

Executive Director, Regulatory Affairs

Merck & Co Inc.

2023 ISPE Richard B. Purdy Distinguished Achievement Award

Lorrie L. Vuolo-Schuessler

GAMP Americas Steering Committee

Retired, GSK and Syneos Health

2023 ISPE Joseph X. Phillips Professional Achievement Award

Frances M. Zipp

President and CEO

Lachman Consultant Services

2023 ISPE Facility of the Year Award

Genentech South San Francisco Clinical Supply Center