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January / February 2025

ISPE Announces the 2024–2025 International Board of Directors and Honor Award Winners

Marcy Sanford
Pictured from left are David Churchward, Jeffrey A. Biskup, PE, Mike Martin, Vivianne Arencibia, Vivien Santillan, Sarah Pope Miksinski, PhD, Shanshan Liu, Liz Dooley, MSc, Rebecca Roscher, Michael Rutherford (2024 ISPE Interim President and CEO), Timothy J.N. Watson, PhD, and Scott W. Billman. Not pictured: Ylva Ek, Norman Goldschmidt, James Grunwald, and George Singewald, PhD.

The new ISPE International Board of Directors was introduced, the gavel was passed to a new Chair, and Honor Award Winners were announced on 15 October 2024 during the 2024 ISPE Membership Meeting and Awards Lunch in Orlando, US, during the 2024 ISPE Annual Meeting & Expo.

ISPE Board of Directors Immediate Past Chair Scott W. Billman (right) passes the gavel to incoming Chair Je rey A. Biskup, PE, (left).

ISPE Board of Directors Immediate Past Chair Scott W. Billman (right) passes the gavel to incoming Chair Jeffrey A. Biskup, PE, (left). 

Changes to the Board

Incoming Chair Jeffrey A. Biskup, PE, Executive Chairman of the Board at CRB, began his year as Chair. Outgoing Chair Scott W. Billman, Senior Vice President, Global Engineering, Technology, and Facilities, Solventum, moved into the Past Chair position of the International Board’s officers. The Membership Meeting included presentations by Billman, Biskup, and Michael Rutherford, 2024 Interim ISPE President and CEO, as well as reports on the financial health of ISPE and an update on the ISPE Foundation.

Billman gave an overview of ISPE’s accomplishments in 2024, which included the following:

  • Distributing $154,785 to Affiliates and Chapters for local membership projects
  • Reaching 22,000 members
  • Starting new Communities of Practice (CoPs) for Sustainability and artificial intelligence (AI)
  • Expanding professional development and custom training offerings
  • Continuing engagement with regulatory agencies

“ISPE is positioned to drive expanded knowledge sharing across the industry,” Billman told attendees. He also thanked outgoing board members for their contributions as they stepped down from the board. Past members include:

Nina Cauchon
Director Regulatory Affairs - CMC
Amgen Inc.
Teresa Minero
Founder & CEO
LifeBee | a ProductLifeGroup Company
Monique Sprueill
Director, GCP Quality Lead
Bristol Myers Squibb
Hirofumi Suzuki, PhD
Regulatory Affairs CH Japan, Manager
Bayer Yakuhin Ltd.
Michael Rutherford
Principal/ CEO/ Owner
Rutherford Consulting, LLC

Highlights and Updates

Rutherford welcomed attendees to the Membership Meeting and spoke about the ways the 22,000 ISPE members in 120 countries are helping shape the future of the pharmaceutical industry. “Our subject matter expertise is growing with CoPs. Guidance documents have added new ways to subscribe through institutional and corporate licenses. Conferences continue to highlight the innovative advancements within the industry through key education sessions, and the ISPE Foundation continues to provide professional development grants to students and recent graduates.”

James A. Breen, Jr., ISPE Foundation Board of Directors Vice Chair, 2022–2024, Vice President, Global Engineering and Technology, Johnson & Johnson Innovative Medicines, introduced the ISPE Foundation Board and gave an overview of the ISPE Foundation’s accomplishments for 2024, including the Technology without Borders Program, which will provide essential ISPE guidance documents and delivered nearly $250,000 worth of training in Portuguese to individuals in Brazil, and the Workforce Diversity Pillar, which awarded a scholarship through the Women in Pharma® program.

He also thanked the ISPE Delaware Valley Chapter for establishing the Delaware Valley Chapter Scholarship Fund. The largest Affiliate/Chapter gift in the Foundation’s history, the Fund provides academic scholarships to aspiring students in the Mid-Atlantic region. This enables them to concentrate on their education and career development in the pharmaceutical industry.


The 2024–2025 International Board of Directors

The 2024–2025 International Board of Directors

Pictured from left are David Churchward, Je rey A. Biskup, PE, Mike Martin, Vivianne Arencibia, Vivien Santillan, Sarah Pope Miksinski, PhD, Shanshan Liu, Liz Dooley, MSc, Rebecca Roscher, Michael Rutherford (2024 ISPE Interim President and CEO), Timothy J.N. Watson, PhD, and Scott W. Billman Not pictured: Ylva Ek, Norman Goldschmidt, James Grunwald, and George Singewald, PhD.

Officers

Jeffrey A. Biskup, PE
Executive Chairman of the Board
CRB
Chair
Vivianne Arencibia
Vice President, Global Quality Systems and Compliance
Moderna
Vice Chair
Ylva Ek
Founder
Robur Life Science Advisory AB
Treasurer
Scott Billman
Senior Vice President Global Engineering, Technology, & Facilities
Solventum
Immediate Past Chair
Mike Martin
President and CEO
ISPE
Ex Officio Non-voting Member

Directors

David Churchward
Head of Operations Quality, Compliance and External Affairs
AstraZeneca
Liz Dooley
Senior Director, Global Engineering & Technology
Johnson & Johnson
Norman Goldschmidt
President
Genesis AEC
James Grunwald
Senior Vice President US Business Development
Arcadis
Shanshan Liu
Technical Director
No Deviation Pte Ltd
Sarah Pope Miksinski
Executive Director, CMC Regulatory Affairs
Gilead Sciences, Inc.
Vivien Santillan
Regional Director, Asia
Novatek International
Georg Singewald
Global Head of Quality & Compliance
Roche / Genentech
Timothy J.N. Watson, PhD
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences

Ex Officio

Rebecca Roscher
Project Manager
Bayer AG (Supply Center Grenzach)

2024 International Honor Awards

The 2024 ISPE Honor Awards were distributed to recipients by Michael L. Rutherford, Jeffrey A. Biskup, PE, and Scott W. Billman.

2023 ISPE Roger F. Sherwood Article of the Year Award

2023 ISPE Roger F. Sherwood Article of the Year Award

Winners were awarded for Pharmaceutical Engineering® content published during 2023.

“Comparability Considerations for Cellular and Gene Therapy Products,” published in the November/December 2023 issue by Andrew Chang, PhD, Katherine Donigan, PhD, Kathleen Francissen, PhD, Sam Gunter, MPP (pictured), and Emily Hernandez, PhD

2024 ISPE International Emerging Leader Hackathon Winning Team

2024 ISPE International Emerging Leader Hackathon Winning Team

Milton Engineering

Team members

  • Bonnie Brown
  • Denzel Dollano
  • Marcella Ayala
  • Susan Gamboa
  • Tiffany Lee

2024 Company of the Year Award

2024 Company of the Year Award

Takeda

2024 ISPE Affiliate and Chapter Excellence Award

2024 ISPE A liate and Chapter Excellence Award

Chesapeake Bay Area Chapter

2024 ISPE Committee of the Year

2024 ISPE Committee of the Year

Pharma 4.0™ Baseline Guide Team

2024 ISPE Max Seales Yonker Member of the Year Award

2024 ISPE Max Seales Yonker Member of the Year Award

Niranjan S. Kulkarni, PhD — Senior Director, Consulting Services, CRB

2024 ISPE Richard B. Purdy Distinguished Achievement Award

2024 ISPE Richard B. Purdy Distinguished Achievement Award

Roger Nosal — Head of Global Regulatory Strategy and Submissions, NGT Biopharma

2024 ISPE Joseph X. Phillips Professional Achievement Award

2024 ISPE Joseph X. Phillips Professional Achievement Award

Antonio (Tony) R. Moreira, PhD — Vice Provost, Academic Affairs, University of Maryland; 2020–2024 Chair, ISPE Foundation.

The award was granted posthumously. Members of the Moreira family, pictured above, accepted the award on behalf of Tony.