AGENDA
EXPO
HOTEL
FAQs
CONTACT
OCT 27-29, 2025
|
REGISTER
SPEAKERS
ALL SPEAKERS
David Awotwe-Otoo, PhD
Senior Pharmaceutical Quality Assessor, Division of Product Quality Assessment III, OPQA I, OPQ, CDER
Food and Drug Administration
CAPT Stacy Barley, RN, MSN, MHA
Lead REMS Coordinator, Division of Clinical Safety and Surveillance (DCSS), OSCE, OGD, CDER
FDA
CAPT Tara Gooen Bizjak
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
Food and Drug Administration
Megan Boals, MPH, MS, CSM, CSPO, A-CSPO
Operations Research Analyst, DDQCSS, OBI, OSP, CDER
Food and Drug Administration
Sarah Brown, PharmD
Associate Director, Regulatory Affairs Strategy and Science, Biosimilars
Sandoz
Maria Burkholder, MHA
Senior Director, Regulatory Affairs Global Biosimilars
Teva Pharmaceuticals
Craig Burton
Senior Vice President, Policy and Strategic Alliances, AAM
Executive Director, Biosimilars Council
Robert Califf, M.D., MACC
Commissioner
Food and Drug Administration
Arpitha Chepyala, M.Sc.
Lead, Regulatory Affairs
Dr. Reddy's Laboratories Inc.
Sanjeeva Chinnakadoori, PhD
Senior Research Scientist/Associate Director, Analytical R&D
Amneal Pharmaceuticals
Shana Christrup
Senior Director, Policy
AAM
Andrew Clerman, M.D., PhD
Acting Lead Physician, Division of Therapeutic Performance I (DTP I), ORS, OGD, CDER
Food and Drug Administration
Adam Colborn, JD
Associate Vice President, Congressional Affairs
AMCP
Michelle Cope
Director, Federal & State Pharmacy & Regulatory Affairs
NACDS
Jacqueline Corrigan-Curay, JD, M.D.
Principal Deputy Center Director
Center for Drug Evaluation and Research (CDER), FDA
Michael Cottler, JD
Partner
Gemini Law LLP
Heather Crandall
Operations Research Analyst, DDMSS, OBI, OSP, CDER
Food and Drug Administration
Vince Crowley, PhD
Senior Pharmacologist, Division of Pharmacology/Toxicology Review (DPTR), OSCE, OGD, CDER
Food and Drug Administration
Alonza Cruse
Director, ORA
Food and Drug Administration
Aaron Cummings, JD
Partner
Crowell & Moring LLP
Aparna Dagar, PhD, RAC
Senior Director, Regulatory Affairs
Fresenius Kabi USA, LLC
John Derstine
Senior Director, Generic Regulatory Affairs
Teva Pharmaceuticals
Jason Flint, MBA, PMP
Deputy Director, Division of Medication Error Prevention and Analysis I (DMEPA), OSE, CDER
Food and Drug Administration
David Gaugh, RPh
Executive Vice President
AAM
Steven Gonzalez, JD
Associate
Hyman, Phelps & McNamara, P.C
Tarun Goswami, PhD
Senior Director, Complex Product Development
Amneal Pharmaceuticals
Andrew Graves, M.S., SCYM
Director, Immunogenicity Assessment
Teva Pharmaceuticals
Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S.
Sandoz Inc.
Srinivas Gurram
Senior Vice President of Regulatory Affairs & Corporate QA Lead, Americas
Zydus Pharmaceuticals
Laura Harner
Associate Director, Regulatory Affairs Biosimilars
Sandoz
Keren Haruvi
Board Chair
Association for Accessible Medicines (AAM)
Sarah Ibrahim, PhD
Associate Director for Global Regulatory Affairs, Immediate Office, OGD, CDER
Food and Drug Administration
Priti Jagani
Senior Director, Pharma R&D
Amneal Pharmaceuticals
Young Jhon, PhD
Senior Chemist, DPQAIV, OPQAI, OPQ, CDER
Food and Drug Administration
Nalin Karkra
General Manager
Sun Pharmaceuticals
David Kendall
Senior Fellow for Health and Fiscal Policy
Third Way
Johannes Keuschnigg, PhD
Regulatory Devices Portfolio Head
Sandoz
Vasiliy Korotchenko, PhD
Chemist, Division of Product Quality Assessment IV, OPQA I, OPQ, CDER
Food and Drug Administration
Darby Kozak, PhD
Deputy Director, OGD, CDER
Food and Drug Administration
Anita Krishnan, PhD
Associate Vice President and Head of Analytical Sciences
Biocon Biologics Ltd.
Scott Kuzner, PhD
Senior Director, Sciences and Regulatory Affairs
AAM
Emanuela Lacana, PhD
Deputy Director, OTTB, OND, CDER
Food and Drug Administration
Chris Lamanna, PhD
Head Regulatory Devices
Sandoz
Sam Leo
Sr. Director, U.S. Biosimilar Operations
Teva Pharmaceuticals
Elizabeth Gallenagh
General Counsel and Senior Vice President, Supply Chain Integrity
Healthcare Distribution Alliance
Melissa Mannion, PharmD, JD
Regulatory Counsel, OGDP, OGD, CDER
Food and Drug Administration
Rajeev Mathur
Senior Vice President & Head Of Global Regulatory & Business Continuity
Sun Pharma
Christina Mazzella, MSc
Vice President, Global Quality Compliance
Teva Pharmaceuticals
Diane McCarthy, PhD
Senior Director, Science and Standards, Global Biologics
USP
Elizabeth Miller, PharmD
Assistant Commissioner For Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA)
FDA
Iilun Murphy, M.D.
Director
Office of Generic Drugs (OGD), CDER FDA
John Murphy III
President and CEO
AAM
Mayank Nagar
Vice President & Head – Technical Services and New Product Launches (North America)
Dr. Reddy’s Laboratories Inc.
Carrie O’Donel
Senior Principal Device Engineer
Teva Pharmaceuticals
Jayani Perera, PhD
Senior Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ, CDER
Food and Drug Administration
Sonia Oskouei, PharmD
Vice President & U.S. Head of Biosimilars and Specialty
Sandoz
Keduo Qian, PhD
Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ
FDA
Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs
AAM
Jonathan Resnick, PMP
Project Management Officer, DDMSS, OBI, OSP, CDER
Food and Drug Administration
Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER
Food and Drug Administration
Alberto Rivalta
Senior Director, Regulatory Affairs
Teva Pharmaceuticals
Michael Rogers, MS
Associate Commissioner for Inspections and Investigations, Office of Inspections and Investigations (OII)
FDA
Sarah Rogstad, PhD
Senior Scientific Advisor, Office of Pharmaceutical Quality Research, OPQ, CDER
Food and Drug Administration
Joshua Salsi
Head of North America Commercial
Biocon Biologics Ltd.
Michael Sargent
Senior Director, Policy
AAM
Anand Saxena, M.Sc.
Director, Regulatory Affairs
Cipla LTD
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy
Sandoz
Seyoum Senay
Supervisory Operations Research, DDMSS, OBI, OSP, CDER
Food and Drug Administration
Rakhi Shah, PhD
Associate Director, OPMA, OPQ, CDER
Food and Drug Administration
Rashmi Shetty
Director, Regulatory Affairs
Cipla LTD
Martin Shimer, II, RPh
Executive Director
Lachman Consultant Services, Inc.
Bhupesh Singh, MPharm
Director, Regulatory Affairs
Apotex Corp.
Adam Steinberg, PharmD
Associate Director, Regulatory Affairs
Apotex Corp.
John Strom, JD
Special Counsel
Foley & Lardner LLP
Alisha Sud
Director, Policy
AAM
CDR Emily Thakur, RPh
Team Leader, Drug Shortage Staff, OCD, CDER
Food and Drug Administration
Alan Thompson
Director, Inhalation Regulatory Affairs
Teva Pharmaceuticals
Stephanie Trunk, JD
Partner
Arent Fox LLP
Mustafa Unlu, PhD, JD
Policy Staff Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
Food and Drug Administration
Kalpana Vanam
Senior Vice President, Regulatory Affairs
Lupin Pharmaceuticals Inc.
Diana Vivian, PhD
Associate Director, Division of Bioequivalence II (DB II), OB, OGD, CDER
Food and Drug Administration
Yan Wang, PhD
Acting Deputy Director, Division of Therapeutic Performance I, ORS, OGD, CDER
Food and Drug Administration
CDR Silvia Wanis, PharmD, MS, BCPPS
Senior Regulatory Officer, Incidents, Recalls and Shortages Branch, Office of Drug Security, Integrity, and Response (ODSIR), OC, CDER
Food and Drug Administration
Polly Webster, JD, MPH
Senior Health Counsel
Senate Committee on Finance
Cory Wohlbach
Global Vice President, Biosimilars
Teva Pharmaceuticals
Elena Wolff-Holz, M.D.
Global Head Clinical Development
Biocon Biologics Ltd.
Arlene Wolny, PhD
Global Head of Regulatory Affairs
Biocon Biologics Ltd.
Janet Woodcock, M.D.
Former Principal Deputy Commissioner, FDA
CDR Geoffrey Wu, PhD, PMP, CPH
Acting Office Director, Office of Pharmaceutical Quality Assessment I (OPQA I), OPQ, CDER
Food and Drug Administration
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs (OND), CDER
FDA
Hongling Zhang, PhD
Director, Division of Bioequivalence II, OB, OGD, CDER
Food and Drug Administration
