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NOV 2-4, 2026
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Michael Balon, BSc
Senior Director, Global Regulatory Affairs
Apotex Inc.
Scott Biggs
Director, Supplier Services
IQVIA
Dhaval Desai, MBA
Director, Regulatory Affairs and Supply Chain
Zydus Pharmaceuticals USA Inc.
Martin Ehlert, PhD
Vice President, Global API R&D
Apotex Inc.
Caitlin Frazer
Executive Director
National Security Commission on Emerging Biotechnology
Jill Furman, JD
Director, Office of Compliance, CDER
FDA
Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S.
Sandoz Inc.
Lara Hansen
Director, Regulatory Affairs
Sandoz
Bob Hoffman
AAM Board Chair
Young Jhon, PhD
Senior Chemist, DPQAIV, OPQAI, OPQ, CDER
Food and Drug Administration
Alex Keeton
Executive Director of the Biosimilars Council
Senior Vice President, Policy, AAM
Michael Kopcha, PhD, RPh
Director
Office of Pharmaceutical Quality (OPQ), CDER, FDA
Chad Landmon, JD
Chair, Hatch-Waxman & Biologics
Polsinelli
Yiwei Li, PhD
Supervisory Pharmaceutical Scientist, OPMA, OPQ, CDER
FDA
Veeranna Lolla, MPharm, RAC
Director, Regulatory Affairs
Sandoz Inc.
Markham Luke, M.D., PhD, FAAD
Director, DTPI, ORS, OGD, CDER
FDA
Elizabeth Miller, PharmD
Acting Deputy Associate Commissioner for Inspections and Investigations (DACII)
FDA
Piyush Modi
Director, Regulatory Affairs (CMC)
Amneal Pharmaceuticals
Iilun Murphy, M.D.
Director, Office of Generic Drugs, CDER
FDA
John Murphy III
President and CEO
AAM
Mayank Nagar, MS, MBA
Vice President & Head – Technical Services and New Product Launches (North America)
Dr. Reddy’s Laboratories Inc.
Anthony Narisetty
Associate Director, Regulatory USA Biosimilars
Sandoz Inc.
Umesh Pai, MPharm
AVP, MSTG, Regulatory & Business Continuity
Sun Pharma
Eunjung Park, PhD
Lead Pharmacologist Division of Bioequivalence II Office of Bioequivalence OGD, CDER
FDA
Sam Park, JD
General Counsel
Hikma Pharmaceuticals
David Pennington, RN, BSN, MBA
Chief Executive Officer
Dr. Evidence
Giuseppe Randazzo, M.S.
Senior Vice President, Sciences and Regulatory Affairs
AAM
Sam Raney, PhD
Associate Director for Science and Chief Scientific Advisor, ORS, OGD, CDER
FDA
Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER
Food and Drug Administration
Brandon Rockwell
President and COO
PAI Pharma
CDR Lana Rossiter, PhD
Supervisory Project Manager, OPRO, OPQ, CDER
FDA
CAPT Vincent Sansone, PharmD, BS, PMP, CPH, MS
Director, Division of Project Management, Office of Regulatory Operations (ORO), OGD, CDER
FDA
Anand Saxena, M.Sc.
Director, Regulatory Affairs
Cipla LTD
Martin Shimer, BS
Executive Director, Regulatory
Lachman Consultant Services, Inc.
Gina Sirianni, MSc
Senior Director, Global Regulatory Affairs, New Product Development
Apotex Inc.
Eric Twum, PhD
Regulatory Specialist, DQI-II, OQS, OPQ, CDER
FDA
Janet Vaughn
Senior Vice President, Regulatory Affairs, North America
Sandoz Inc.
Arun Verma
President
Fresenius Kabi
Yan Wang, PhD
Acting Deputy Director, Division of Therapeutic Performance I, ORS, OGD, CDER
Food and Drug Administration
Cory Wohlbach
Global Vice President, Biosimilars Regulatory Affairs
Teva Pharmaceuticals
Gillian Woollett, MA, DPhil
Vice President, Head Regulatory Strategy and Policy
Samsung Bioepis
Chaoju Xiao, PhD
Director, Formulation Research and Development
Fresenius Kabi USA, LLC
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER
FDA
