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OCT 21-23, 2024
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Andy Aguanno, BSc.
Manager, Global Regulatory Affairs, Liquids & Specialty Dosage
Apotex Inc.
Sharon Ahluwalia, M.D.
Physician, Division of Clinical Review (DCR), OSCE, OGD, CDER
Food and Drug Administration
CAPT Tara Gooen Bizjak
Director, Manufacturing Quality Guidance and Policy Staff, OC, 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
Shobha Reddy Chagam
Head Regulatory Affairs
Dr. Reddy’s Laboratories Inc.
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
Andrew Clerman, M.D., PhD
Acting Lead Physician, Division of Therapeutic Performance I (DTP I), ORS, OGD, CDER
Food and Drug Administration
Jacqueline Corrigan-Curay, JD, M.D.
Principal Deputy Center Director
Center for Drug Evaluation and Research (CDER), FDA
Alonza Cruse
Director, ORA
Food and Drug Administration
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
Interim President & CEO
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)
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
Head, 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
Nicolette Louissaint, PhD
Senior Vice President, Policy and Strategic Planning
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
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
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
Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs
AAM
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 Regulatory Affairs, Office of Regulatory Affairs (ORA)
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.
Anand Saxena, M.Sc.
Director, Regulatory Affairs
Cipla LTD
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy
Sandoz
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.
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.
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
Matt Wetzel, JD
Partner
Goodwin Procter LLP
Cory Wohlbach
Global Vice President, Biosimilars
Teva Pharmaceuticals
Elena Wolff-Holz, M.D.
Vice President, Global Head Clinical Development
Biocon Biologics Ltd.
Janet Woodcock, M.D.
Former Principal Deputy Commissioner, FDA
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs (OND), CDER
FDA
