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

Michael Tarlov, NIST, Gaithersburg, MD

Michael Tarlov currently serves as the Acting Deputy Director of the Material Measurement Laboratory at the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland. Prior to that he served for over 10 years as the Chief of the Biomolecular Measurement Division at NIST. He also leads the NIST Biomanufacturing Program which develops measurement science and standards to support the development and manufacturing biologic medicines. He has conducted research in chemical/biological sensing, biomolecular films, and bioprocess measurements and has authored or co-authored over 90 publications. He received a B.A. in Chemistry from Colgate University and a Ph.D. in Analytical Chemistry from the University of Minnesota.

Kevin Macias, Eli Lilly and Company, Indiana

Kevin Macias, R.Ph., Ph.D., is an Executive Director-Engineering within Lilly’s synthetic molecule Process Design & Development Department. He and his team split their time between developing late-phase drug products, developing process analytical technology applications, and providing engineering support for a variety of oral solid dosage unit operations to enable smooth transitions toward commercialization. Kevin also serves as an internal champion for the development of continuous drug product manufacturing capabilities and is a strong advocate for talent development. Prior to joining Lilly in 2021, Kevin was a member of the Engineering Technologies group at Bristol Myers Squibb, where he gained extensive experience developing spectroscopic tools to aid process decisions and solve drug product performance issues. Kevin has a Bachelor of Science in Pharmacy from St. Louis College of Pharmacy and a Doctor of Philosophy in Industrial and Physical Pharmacy from Purdue University.

Ganeshkumar Subramanian, BMS, New Brunswick, NJ

Ganeshkumar (Ganesh) Subramanian is the leader of the Continued Process Verification (CPV) Program for Pharma products at Bristol-Myers Squibb (BMS), where he oversees BMS’s pharmaceutical product portfolio, orchestrating data integration, analysis, and complaint management across both internal operations and external manufacturing sites (CMOs). With nearly 25 years of diverse pharmaceutical experience, Ganesh has excelled in commercial manufacturing support, product transfer, scale-up, and formulation development. As a certified lead investigator and Lean Six Sigma Green Belt, Ganesh provides expert guidance on CMO investigations, quality events, change controls, scale-ups, and product transfers. His career began in R&D as a formulation scientist, where he successfully developed numerous products—spanning pediatric powders, capsules, and immediate- and sustained-release tablets—from concept through to commercialization. Ganesh is recognized for his scholarly contributions, including multiple publications in formulation design and co-authoring a book chapter on wet granulation. He holds a Master’s in Chemical Engineering from West Virginia University and an MBA from Rutgers University.

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
Geng (Michael) Tian, FDA, CDER, OPQ, OTR, Silver Spring, MD
Tim Stevens, Bristol-Myers Squibb, New Brunswick, NJ
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!