IFPAC Scientific Board

Every year, the IFPAC Scientific Board–composed of industry, regulatory, and academic leaders—works together to create a comprehensive program that addresses important mainstay topics; they touch base on the latest trends, technologies, and applications.

CO-CHAIRS

Sameer Talwar, GSK, King of Prussia, Pennsylvania

Sameer Talwar is a digital modeling lead at GSK, where he is leading the digital transformation for large molecule/biologics CMC space. His focus area is digital redesign of pharmaceutical CMC and commercial operations by embedding a predict-first and integrated agentic AI culture and solutions. Sameer obtained his PhD from Duquesne University building PAT models for small molecule drug product and he has been at GSK for 12 years now. He is also connected with knowledge management, self-driving labs, and enterprise data provisioning in the CMC space.

Paresma (Pinky) Patel, Gilead Sciences, Maryland

Paresma (Pinky) Patel, Ph.D. is Director of Regulatory CMC Policy & Advocacy at Gilead Sciences, where she leads chemistry, manufacturing, and controls (CMC) regulatory advocacy in support of global health authority filings. Prior to joining Gilead, Dr. Patel spent a decade at the U.S. Food and Drug Administration (FDA) (2015–2025), holding positions of increasing responsibility within CDER’s Office of Pharmaceutical Quality. Her roles included Reviewer, Branch Chief, and ultimately Division Director in the Office of Product Quality Assessment III. Earlier in her career, Dr. Patel worked as a medicinal chemist at the National Institutes of Health. She earned her Ph.D. in Organic Chemistry from The Scripps Research Institute (2010) and completed a postdoctoral fellowship at the California Institute of Technology (2012).

Members

Christian Airiau, Sanofi, Framingham, MA
Ahmad Almaya, Eli Lilly, Indianapolis, IN
Andrew Anderson, United Kingdom
Scott Armstrong, Phillips 66, Houston, TX
Bob Bear, Ametek, Pittsburgh, PA
Tara Gooen Bizjak, FDA, CDER, OC, OMQ, MGPS, Silver Spring, MD
Lucinda Buhse, FDA, CDER, OPQ, OTR, DPA, Silver Spring, MD
Brian Carlin, Consultant, Lawrenceville, NJ
Sharmista Chatterjee, FDA, CDER, OPQ, OPF, Silver Spring, MD
James Cheney, Celgene, Summit, NJ
Greg Connelly, Vertex, Boston, MA
Celia Cruz, Eli Lilly, Indianapolis, IN
Lawrence De Belder, Consultant, Beerse, Belgium
Ranjit Deshmukh
Greg Doddridge, Abbvie, North Chicago, IL
Bill Foley, Waters Corporation, Plymouth, MA
Celeste Frankenfeld Lamm, Merck, Rahway, NJ
Rick Friedman, FDA, CDER, OC, OMQ, Silver Spring, MD
Neal Gallagher, Eigenvector Research, Inc., Manson, WA
Sherine George, Dow Chemical, Freeport, TX
Robert Guenard, Biogen, RTP, NC
Steve Hammond, Steve Hammond Consulting
Doug Hausner, Thermo Fisher Scientific
Walter Henslee, JPAC, McDade, TX
Ernie Hillier, EJH Consulting
David Keire, FDA, CDER, OPQ, OTR, Silver Spring, MD
Mel Koch, Consultant, Seattle, WA
Evdokia Korakianiti, EMA
Theodora Kourti, Consultant
Steve Kozlowski, FDA, CDER, OPQ, OBP, Silver Spring, MD
Gulsad Kucuk, Bristol-Myers Squibb, New Brunswick, NJ
Bogdan Kurtyka, FDA, CDER, OPQ, OPF, Silver Spring, MD
Sau (Larry) Lee, FDA,CDER,OMPT,CDER,OPQ,SS, Silver Spring, MD
Lorenz Liesum, Novartis Pharma, Basel, Switzerland
Keven Macias, Eli Lilly, Indianapolis, IN
Rapti Madurawe, FDA, CDER, OPQ, OPF, DPAI, Silver Spring, MD
Sarah Pope Miksinski, AstraZeneca, Gaithersburg, MD
Charles E. (Chuck) Miller, Aspen Technology, Lansdale, PA
Christine M. Moore, Organon, Jersey City, NJ
Moheb M. Nasr, Consultant
Thomas O’Connor, FDA, CDER, OPQ, OTR, DPQR, Silver Spring, MD
Paresma (Pinky) Patel, Gilead Sciences, MD
Justin Pritchard, Vertex, Boston, MA
G.K. Raju, Light Pharma, Cambridge, MA

Manoharan Ramasamy, Merck & Co., West Point, PA
Saly Romero-Torres, Biogen, RTP, NC
Sonja S. Sekulic, Pfizer, Groton, CT
Robert E. Sherman, ISA Life Fellow, Consultant, Shorewood, IL
Ryan Simpson, Eastman Chemical Company, Kingsport, TN
Rakhi Shah, FDA, CDER, OPQ, OTR, Silver Spring, MD
Tim Stevens, Bristol-Myers Squibb, New Brunswick, NJ
Ganeshkumar Subramanian, BMS, New Brunswick, NJ
Michael Tarlov, NIST, Gaithersburg, MD
Geng (Michael) Tian, FDA, CDER, OPQ, OTR, Silver Spring, MD
J.D. Tate, Dow Chemical (retired), Freeport, TX
Gert Thurau, Hoffmann-LaRoche, Basel, Switzerland
Cenk Undey, Sanofi, Framingham, MA
Juergen von Frese, Da-Sol, Utting am Ammersee, Germany
Tony Wang, Amgen, Houston, TX
Martin Warman, Martin Warman Consultancy, Swalecliffe, UK
Xiaoyu Zhang, Eli Lilly, Indianapolis, IN

Organization Representatives

Stephen Byrn, CPPR/PTCC/CAMP, Purdue University, West Lafayette, IN
James Drennen III and Carl Anderson, DCPT, Duquesne University, Pittsburgh, PA
Brian Marquardt, Director, CPAC, APL, Univ. of Washington, Seattle, WA
Jose Cardoso de Menezes, IST, UTL, Lisbon, Portugal
Fernando Muzzio, Rutgers University, New Brunswick, NJ
Colm O’Donnell, University College Dublin, Ireland
Rodolfo Romañach, Ph.D., UPR, Mayagüez, PR,
Michael J. Tarlov, NIST, Gaithersburg, MD
Seongkyu Yoon, University of Massachusetts-Lowell, Lowell, MA

IFPAC

Robert S. Zutkis, Director, IFPAC, Grayslake, IL
Julie C. Kovach, Associate Director, IFPAC, Grayslake, IL

IFPAC would like to thank each board member for their contributions to the success of the IFPAC Annual Meeting over the years!