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NOV 2-4, 2026
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Andy Aguanno, BSc.
Associate Director, Product Lifecycle Management (PLCM) Biosimilars and Liquid Products
Apotex Inc.
Matthew Andrews
Global Standards Director
GS1 US
Christine Baeder
President
Apotex Corp.
Michael Balon
Senior Director, Global Regulatory Affairs
Apotex Inc.
Scott Biggs
Director, Supplier Services
IQVIA
Bhupesh Singh Bisht, MPharm
Director, Regulatory Strategy and Labeling
Apotex Corp.
Nina Brahme, PhD
Senior Scientific Reviewer
OTBB, OND, CDER, FDA
Mary Jo Carden, RPh, JD
Founder and President
Carden Associates
Sharmista Chatterjee, PhD
Division Director, DPMA III, OPMA, OPQ, CDER
FDA
Nimi Chhina, PhD, JD
Vice President, Global Regulatory Affairs Policy & Intelligence, Digital, Compliance & Operations
Teva Pharmaceuticals
Julian Chun, PharmD, MBA, RAC
Lead Public Health Analyst with the Drug Registration and Listing, OUDLC, OC, CDER
FDA
Ariane O. Conrad, PharmD
Associate Director for Human Factors, DMEPAI, OMEPRM OSE, CDER
FDA
Aparna Dagar, PhD, RAC
Vice President, Regulatory Affairs
Fresenius Kabi USA, LLC
Dhaval Desai, MBA
Director, Regulatory Affairs and Supply Chain
Zydus Pharmaceuticals USA Inc.
Kyle Diamantas, JD
Acting Commissioner
FDA
Martin Ehlert, PhD
Vice President, Global API R&D
Apotex Inc.
Brian Folian, M.S., JD
Deputy Director, OSIS, OTS, CDER
FDA
Caitlin Frazer
Executive Director
National Security Commission on Emerging Biotechnology
Emilija Fredro-Kumbaradzi, PhD
Director, Biopharmaceutics and Statistics, R&D
Apotex Inc.
Jill Furman, JD
Director, Office of Compliance, CDER
FDA
Michael Ganio, PharmD, MS, BCSCP, BCPS, FASHP
Senior Director, Pharmacy Practice and Quality
ASHP
Jessica Greenbaum, JD
Senior Director, Regulatory Affairs Policy U.S.
Sandoz Inc.
Maria Gutierrez-Lugo, PhD
Supervisory Pharmaceutical Scientist, OPQ, CDER
FDA
Lara Hansen
Director, Regulatory Affairs
Sandoz
Keren Haruvi
President of Sandoz North America
Sandoz Inc.
Shannon Heine, PhD
Senior Pharmaceutical Scientist, DPMA I, OPMA, OPQ, CDER
FDA
Bob Hoffman
AAM Board Chair
Sarah Ikenberry, M.A.
Associate Director, Stakeholder Engagement and Education, OTBB, OND, CDER
FDA
Michael Isabell
Principal Engineer, RFID and Quality
CCL eAgile
Omar Jabri
Vice President, Intellectual Property Strategy
Apotex Inc.
Biljana Janković, PhD
Head of Pharmaceutical Research
Sandoz
Young Jhon, PhD
Senior Chemist, DPQAIV, OPQAI, OPQ, CDER
Food and Drug Administration
Arlene Joyner, MS, PMP, CSSGB
Director, Center for Industrial Base Management and Supply Chain
Administration for Strategic Preparedness and Response (ASPR)
Vickie Keck, MS, VMD
Acting Associate Director Generic Drug Stakeholder and Global Engagement, OGD, CDER
FDA
Alex Keeton
Executive Director of the Biosimilars Council
Senior Vice President, Policy, AAM
Johannes Keuschnigg, PhD
Regulatory Devices Portfolio Head
Sandoz
Craig Kiester, RPh, MS, RAC
Global Head, Regulatory and Quality Policy
Biocon
Michael Kopcha, PhD, RPh
Director
Office of Pharmaceutical Quality (OPQ), CDER, FDA
Darby Kozak, PhD
Acting Director, OGD, CDER
FDA
Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs
Apotex Corp.
Scott Kuzner, PhD
Senior Director, Sciences and Regulatory Affairs
AAM
Chad Landmon, JD
Chair, Hatch-Waxman & Biologics
Polsinelli
Sam Levin, PhD
Co-Founder & CTO
Neion BIO
Yiwei Li, PhD
Supervisory Pharmaceutical Scientist, OPMA, OPQ, CDER
FDA
Robert Lionberger, PhD
Director, ORS, OGD, CDER
Food and Drug Administration
Veeranna Lolla, MPharm, RAC
Senior Director, Regulatory Affairs
Sandoz Inc.
Markham Luke, M.D., PhD, FAAD
Director, DTPI, ORS, OGD, CDER
FDA
Rapti Madurawe, PhD
Division Director, DPQA XVI, OPQA III, OPQ, CDER
FDA
Gabriela Grasa Mannino, PhD
Senior Director, Advanced Supply Chain Solutions
USP
Kimberly Maxfield, PhD
Director, Regulatory Affairs, U.S.
Biocon Biologics
Brian McCormick, JD
Vice President and Chief Regulatory Counsel
Teva Pharmaceuticals
Elizabeth Miller, PharmD
Associate Commissioner for Inspections and Investigations, OII
FDA
Piyush Modi
Director, Regulatory Affairs (CMC)
Amneal Pharmaceuticals
CAPT Monica Muñoz, PhD, PharmD
Division Director, Pharmacovigilance I, OSE, 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
Eric Pang, PhD
Acting Team Lead, DTP I, ORS, OGD, CDER
FDA
Michael Parden
Chief Executive Officer
B. Braun of America Inc.
Eunjung Park, PhD
Lead Pharmacologist Division of Bioequivalence II Office of Bioequivalence OGD, CDER
FDA
David Pennington, RN, BSN, MBA
Chief Executive Officer
Dr. Evidence
Balaji Prasad, M.D.
Chief Strategy Officer
Alvotech
Ronald T. Piervincenzi, PhD
Chief Executive Officer
USP
Shanthi Rajendran, PhD
Associate Director, CMC – Biosimilars & Specialty, Global R&D
Apotex Inc.
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
Andre Raw, PhD
Associate Director, OPQA I, OPQ, CDER
FDA
Bhagwant Rege, PhD
Division Director, OPQA I, OPQ, CDER
FDA
Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER
Food and Drug Administration
Thomas Roades, MPP
Policy Research Associate
Duke-Margolis Institute for Health Policy
Brandon Rockwell
President
PAI Pharma
CDR Lana Rossiter, PhD
Supervisory Project Manager, OPRO, OPQ, CDER
FDA
Aileen Ryan
President & Chief Executive Officer
RAIN Alliance
CAPT Vincent Sansone, PharmD, BS, PMP, CPH, MS
Director, Division of Project Management, Office of Regulatory Operations (ORO), OGD, CDER
FDA
Martin Schiestl, PhD
Global Head Regulatory Policy & Intelligence
Sandoz
Martin Shimer, BS
Executive Director, Regulatory
Lachman Consultant Services, Inc.
Pahala Simamora, PhD
Division Director, DPQA IX, OPQA II, OPQ
FDA
Gina Sirianni, MSc
Senior Director, Global Regulatory Affairs, New Product Development
Apotex Inc.
Cameron Smith, PhD
Supervisory Pharmaceutical Scientist, DPQA IV, OPQA I, OPQ, CDER
FDA
Lolita Sterrett, PharmD
Associate Director for Human Factors, DMEPAII, OMEPRM, OSE, CDER
FDA
CDR Emily Thakur, RPh
Team Leader, Drug Shortage Staff, OCD, CDER
Food and Drug Administration
Scott Tomsky
Vice President and Global Head, Regulatory Affairs
Biocon
Maryll Toufanian, JD
Senior Vice President, Regulatory Strategy and Government Affairs
Amneal Pharmaceuticals
Kimberlee Trzeciak
Vice President, U.S. Government and Regulatory Affairs
USP
Eric Twum, PhD
Regulatory Specialist, DQI-II, OQS, OPQ, CDER
FDA
Mustafa Unlu, PhD, JD
Policy Staff Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
Food and Drug Administration
Siva Vaithiyalingam, PhD
Vice President, Regulatory Affairs
Cipla LTD
Kalpana Vanam
Senior Vice President, Regulatory Affairs, U.S.
Lupin Pharmaceuticals Inc.
Janet Vaughn
Senior Vice President, Regulatory Affairs, North America
Sandoz Inc.
Krishna Venkatesh
Global Head, Integrated Product Development Organization
Dr. Reddy’s Laboratories Ltd.
Gwen Volpe, RPh, Executive MBA, LSSBB, DPLA, FASHP
Senior Director, Medication Technology Programs and Strategic Partnerships
Fresenius Kabi USA
Tracy VonBriesen, RN, M.S.
Senior Director, Human Factors
Fresenius Kabi USA, LLC
Yan Wang, PhD
Deputy Director, Division of Therapeutic Performance I, ORS, OGD, CDER
FDA
Kristin Willemsen, MSc
Vice President, Scientific & Regulatory Affairs
Canadian Generic Pharmaceutical Association
Kimberly Witzmann, M.D.
Deputy Director, Office of Safety and Clinical Evaluation (OSCE), OGD, CDER
FDA
Cory Wohlbach
Global Vice President, Biosimilars Regulatory Affairs
Teva Pharmaceuticals
Arlene Wolny, PhD
Global Head of Regulatory Affairs
Kashiv Biosciences
Gillian Woollett, MA, DPhil
Vice President, Head Regulatory Strategy and Policy
Samsung Bioepis
Fang Wu, PhD
Senior Pharmacologist, DQMM, ORS, OGD, CDER
FDA
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
Andrew Zacher, JD, MS
Senior Director, Regulatory and Public Policy
Amneal Pharmaceuticals
Hailing Zhang, PhD
Division Director, OPQA II, OPQ, CDER
FDA
Ahmed Zidan, BPharm, M.S., PhD
Senior Research Scientist, DPQR V, OPQR, OPQ, CDER
FDA
