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January / February 2022

Celebrating the 2021–2022 ISPE International Board of Directors & Award Winners

ISPE
Celebrating the 2021–2022 ISPE International Board of Directors & Award Winners

The traditional passing of the gavel took place in person at the 2021 ISPE Annual Meeting & Expo on 2 November. The ISPE International Board members were seated, and ISPE distributed awards for both 2020 and 2021 since the 2020 awards were postponed due to the pandemic.

Joanne Barrick, RPh, the 2020–2021 ISPE Board Chair and Advisor–Global Validation at Eli Lilly and Company, passed the gavel of the Chair to Jörg Zim-mermann, Vice President, Vetter Development Service, External Affairs at Vetter Pharma-Fertigung GmbH & Co. Zimmermann served as Vice Chair during 2020–2021.

The 2021–2022 ISPE International Board of Directors


Officers

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Chair
Michael L. Rutherford
Executive Director, Computer Systems Quality & Data Integrity
Syneos Health
Vice Chair
Scott W. Billman
Vice President, Engineering, Pharmaceutical Services
Thermo Fisher Scientific
Treasurer
Jeffrey A. Biskup, PE
CEO and Chairman of the Board
CRB
Secretary
Joanne R. Barrick, RPh
Advisor, Global Validation
Eli Lilly and Company
Past Chair
Thomas B. Hartman
President and CEO
ISPE
Ex Officio Non-voting Member

Directors

Vivianne J. Arencibia
Independent Consultant
Arencibia Quality Compliance Associates
Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
Chris Chen, PhD
CEO
WuXi Biologics (Shanghai) Co., Ltd.
David Doleski
Compliance Head for Biologics Quality Operations
Sanofi
Board Appointed Director
Ylva Ek
Chief Quality Officer (CQO)
KeyPlants AB
Lou W. Kennedy
CEO and Owner
Nephron Pharmaceuticals
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Georg Singewald, PhD
Global Head MSAT & Engineering
Genentech, A Member of the Roche Group
Hirofumi Suzuki, PhD
Product Supply Japan, Head of Product Supply Coordination
Bayer Yakuhin Ltd
Timothy J.N. Watson, PhD
Executive Director & Team Leader, CMC Advisory Office
Pfizer Inc

Ex Officio

Heather L. Bennett-Kelley
Project Manager/ Engineer
ACCO Engineered Systems
Board Emerging Leaders Representative (Non-voting)

Awards were announced for both 2020 and 2021 at the 2021 ISPE Annual Meeting & Expo since 2020 awards were postponed due to the pandemic.

2020 And 2021 Awards

Affiliate and Chapter Excellence Award

2020

The Greater Los Angeles Area, San Francisco Bay Area, and San Diego Chapters received the award as a group due to their efforts to ensure members stayed informed and engaged through the pandemic, while adding 12 more events and 36 webinars; some done jointly, some individually, some with other industry groups.

2021

Philippines Affiliate, which engaged in multistakeholder activities to address a variety of areas during the pandemic including supply chain, vaccine development and regulatory requirements, and pharmacovigilance and adverse event monitoring, as well as increasing student and Emerging Leaders participation.


Committee of the Year

2020

ISPE Aseptic Conference Program Committee, which pivoted to a fully virtual event and exceeded attendance expectations, and ISPE Brazil Affiliate and the Women in Pharma® Brazil Covid 19 Project, which received a $2,500 support match grant to fund efforts to create hygiene kits and provide portable showers for the homeless of Sao Paolo.

2021

Emerging Leaders Virtual International Hackathon, because the committee demonstrated strong leadership in creating the fully global, virtual hackathon, which had 60 participants, 10 coaches, 5 judges, making it the biggest hackathon to date.


Pharmaceutical Engineering® Article of the Year

2019

Regulating Online Pharmacies and Medicinal Product E-Commerce” (November–December 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan

2020

Implementation of a Formal Energy-Efficient Design Process” (March–April 2020) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane


Max Seales Yonker Member of the Year Award

2020

Eamon P. Judge
Global Engineering Advisor - European FM Leader
Eli Lilly and Company

Eamon P. Judge, Global Engineering Advisor–European FM Leader, Eli Lilly and Company, in recognition of his work with the Ireland Affiliate for over 17 years, and his work as President of the Affiliate to form and lead the Irish COVID Alliance beginning in April 2020.

2021

Eleanor F. Small, Ph.D.
Principal Scientist
Johnson & Johnson Consumer Inc

Eleanor F. Small, PhD, Principal Scientist, Johnson & Johnson Consumer, Inc., for her leadership and commitment to the Delaware Valley Chapter, where she helmed the financial management and move to fully virtual programming, started subchapter initiatives, and the Chapter maintained the highest member retention of any US Chapter through the pandemic.


Richard B. Purdy Distinguished Achievement Award

2020

Christopher John Potter, Ph.D.
CMC Pharmaceutical Consultant

Christopher John Potter, PhD, CMC Pharmaceutical Consultant, for his years of service to ISPE, rst as a member and now as an advisor and consultant; his contributions included building PQLI®, raising ISPE’s profile with global regulators, work on ICH Q8, 9, 10, and 11, work on the quality metrics, ICH Q12, Advancing Pharmaceutical Quality (APQ) program, and regulatory programs on ATMPs and breakthrough therapies.

2021

Mario Brenga Giampietro
ISPE Brazil Affiliate

Mario Brenga Giampietro, ISPE Brazil Affiliate, who was the Brazil A liate President and a member of the GAMP Global Steering Committee; he made significant contributions with these initiatives and fostering relationships with regulators, interactions with other Chapters and Affiliates, and built Communities of Practice within the Affiliate. The award was given posthumously as he passed away in 2021


Company of the Year Award

2020 and 2021

The award recognizes the entire industry including ISPE membership for their unprecedented level of collaboration, dedication, tireless efforts, innovation, and speed; not only companies directly contributing to COVID-19- related vaccines, detection, and treatments, but all companies and regulatory authorities who supported and continue to support all pharma- and patient-related needs during the pandemic.


Facilities of the Year Awards (FOYA) Overall Winner

2021

Janssen Science Ireland Ringaskiddy, Ireland, BioCork2–Large Scale Fed Batch Facility, a project initiated to add new drug substance fed batch capacity at 15,000 L scale to the existing biologics facility.

Janssen Sciences Ireland