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SPEAKERS

Susana Almeida, PhD

Clinical Development and Safety Director
Medicines for Europe

Melissa Andel, MPP

Principal
CommonHealth Solutions

Donald Ashley, JD

Director
Office of Compliance (OC), CDER, FDA

Michael Banks

Senior Vice President, Regulatory Affairs Research and Development
Teva Pharmaceuticals

Karthik Balasubramanian, PhD

Director, Generic CPD, US Development and Commercial
Teva Pharmaceuticals

Mike Balon

Global Director, Regulatory Affairs
Apotex Inc.

Lisa Bercu, JD

Regulatory Counsel, Division of Policy Development (DPD), OGDP, OGD, CDER
FDA

CAPT Christine Bina, RPh, MPH

Drug Shortage Staff, Office of Center Director, CDER
FDA

Ashley Boam, MSBE

Office Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
FDA

John Brooks, JD

Partner
South Capitol

Craig Burton

Vice President, Policy
AAM

Clare Butler, PhD

Head of IVIVC Global Inhalations
Teva Pharmaceuticals

Sally Choe, PhD

Director
Office of Generic Drugs (OGD), CDER, FDA

Lauren Ciurca, JD

Acting Director, Division of Legal and Regulatory Support, Office of Generic Drug Policy (OGDP), OGD, CDER
FDA

Hillel Cohen, PhD

Executive Director, Scientific Affairs
Sandoz, Inc

Jacqueline Corrigan-Curay, JD, M.D.

Principal Deputy Center Director
Center for Drug Evaluation and Research (CDER), FDA

Dawn Culp

Vice President, US Regulatory Affairs
Hikma Pharmaceuticals USA Inc.

Sandra D’Agostino-Ferlisi

Director, Global Regulatory Intelligence & Policy
Apotex Inc.

Gerald Dal Pan, M.D., MHS

Director
Office of Surveillance and Epidemiology (OSE), CDER, FDA

Robert Dorsam, PhD

Director, Division of Pharm Tox Review, Office of Safety & Clinical Evaluation, OGD, CDER
FDA

Sarah D’Orsie

Vice President Government Affairs and Policy
Fresenius Kabi, Inc.

Martin Ehlert, PhD

Global API R&D
Apotex Inc.

LCDR David Eng, PharmD

Team Leader, Division of Project Management, ORO, OGD, CDER
FDA

Lynne Ensor, PhD

Vice President, Regulatory Consulting Services Head of Global Compliance
Parexel International

Alison Falb

Regulatory Counsel, OTBB, OND, CDER
FDA

Emilija Fredro-Kumbaradzi, PhD

Associate Director, Biowaivers, Biocorrection, and Statistical Support
Apotex Inc.

Dhaval Gaglani, MS

Branch Chief, Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, OPQ, CDER
FDA

David Gaugh, RPh

Senior Vice President, Sciences & Regulatory Affairs
AAM

Kishore Gopu, MS, MBA

Senior Director, REMS Operations
Teva Pharmaceuticals

Laurie Graham

Division Director, Division of Internal Policies & Programs (DIPAP), OPPQ, OPQ, CDER
FDA

Kylie Grainger, PhD

Chemist, Division of Post-Marketing Activities II, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Keren Haruvi

President of Sandoz US
Head of North America, Sandoz Inc.

Karin Hessler, JD

Vice President, IP Policy and Deputy General Counsel
AAM

Sarah Ibrahim, PhD

Associate Director for Global Regulatory Affairs, Immediate Office, OGD, CDER
FDA

Bob Iser, MS

Senior Vice President, Global Quality Management
Amneal Pharmaceuticals

Aaron Josephson

Director, Regulatory Policy & Intelligence
Teva Pharmaceuticals

Kurt Karst, JD

Director
Hyman, Phelps & McNamara, P.C.

Paramjeet Kaur, PhD

Reviewer, Division of Bioequivalence II, OB, OGD, CDER
FDA

Kiran Krishnan, PhD

Senior Vice President, Global Regulatory Affairs
Apotex Inc.

Michael Kopcha, PhD, RPh

Director
Office of Pharmaceutical Quality (OPQ), CDER, FDA

Darby Kozak, PhD

Deputy Director, Division of Therapeutic Performance I, Office of Research and Standards (ORS), OGD, CDER
FDA

Emanuela Lacana, PhD

Deputy Director, OTBB, OND, CDER
FDA

Heidi Lee, PharmD

Branch Chief, Division of Regulatory and Business Process Management II, OPRO, OPQ, CDER
FDA

Dan Leonard

President and Chief Executive Officer
AAM

Robert Lionberger, PhD

Director, ORS, OGD, CDER
FDA

Markham Luke, M.D., PhD

Director
DTP, ORS, OGD, CDER, FDA

Marcy Macdonald

Vice President, Regulatory Affairs
Tolmar, Inc.

CDR Chitra Mahadevan, PharmD, MS, BCPS, PMP

Director, Division of Bioequivalence Process Management, OB, OGD, CDER
FDA

Claudia Manzo, PharmD

Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
FDA

Kristi Martin

Senior Advisor, Center for Medicare
Centers for Medicare & Medicaid Services

Tim Marzan, MS

Chemist, Division of Pharmaceutical Analysis, Office of Testing and Research, OPQ, CDER
FDA

Suzanne McLeod

Manager, REMS and Drug Safety
Hikma Pharmaceuticals USA Inc.

Brian McCormick, JD

Vice President & Chief Regulatory Counsel Head, Global Regulatory Policy
Teva Pharmaceuticals

LCDR Cassandra Metu, PharmD, MS, PMP, RAC

Senior Regulatory Project Manager, Division of Project Management, ORO, OGD, CDER
FDA

Elizabeth Miller, PharmD

Assistant Commissioner for Medical Products and Tobacco Operations
Office of Regulatory Affairs (ORA), FDA

Thomas O’Connor, PhD

Division Director, Division of Product Quality Research, Office of Testing and Research, OPQ, CDER
FDA

Oluwakemi (Kemi) Odesina, PharmD, BCPS, CPH, RAC

Reviewer, Division of Labeling Review, Office of Regulatory Operations (ORO), OGD, CDER
FDA

Anil Okay

Chief Commercial Officer
Alvotech

Olugbenga “Gbenga” Okubadejo, PharmD

Division Director, Division of Regulatory and Business Process Management III, Office of Program and Regulatory Operations, OPQ, CDER
FDA

Anshuman Patwardhan, PhD, MBA

Senior Vice President, Global Licensing & Business Development – Biologics
Lupin Pharmaceuticals

Ronald Piervincenzi, PhD

Chief Executive Officer
United States Pharmacopeia

Kimberly Raines, PhD

Branch Chief, Division of Biopharmaceutics, Office of New Drug Products, OPQ, CDER
FDA

CDR Mahesh Ramanadham, PharmD, MBA

Associate Director Scientific Operations, OPMA, OPQ, CDER
FDA

Andre Raw, PhD

Senior Science and Policy Advisor, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Jonathan Resnick

Project Management Officer
Electronic Submissions Capability Team, DDMSS, OBI, OSP, CDER, FDA

Stacey Ricci, MEng, ScD

Director, Scientific Review Staff, OTBB, OND, CDER
FDA

Allison Schaefer, MS

Title: Regulatory Project Manager, Division of Project Management, ORO, OGD, CDER
FDA

Rakhi Shah, PhD

Branch Chief, Division of Pharmaceutical Manufacturing Assessment I, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER
FDA

Michael Shumsky, JD

Director
Hyman, Phelps & McNamara, P.C.

Christine Simmon

Executive Vice President, Policy and Strategic Alliances, AAM
Executive Director, Biosimilars Council

Howard Sklamberg

Partner
Arnold & Porter

Aloka Srinivasan, PhD

Chief Executive Officer
RAAHA, LLC

Adam Steinberg, PharmD

Manager, Regulatory Affairs
Apotex Corp.

Eva Temkin, JD

Partner, FDA and Life Sciences
King & Spalding LLP

Paul Thomas

Chief Commercial Officer – United States
Biocon Biologics Inc.

Eric Tichy, PharmD, MBA

Vice Chair, Pharmacy Supply Solutions
Mayo Clinic

Scott Tomsky

Associate Vice President, Global Regulatory CMC
Organon

Rachel Turow, JD, MPH

Associate General Counsel, Regulatory Law & Policy
Teva Pharmaceuticals

Obinna Ugwu-Oju, MS

Division Director, Division of Quality Data Science, Office of Quality Surveillance, OPQ, CDER
FDA

Janet Vaughn

Vice President North America Generics Regulatory Affairs
Teva Pharmaceuticals USA

Daniela Verthelyi, M.D., PhD

Chief, Laboratory of Immunology, Division of Biotechnology Review and Research III, Office of Biotechnology Products (OBP), OPQ, CDER
FDA

Jude Vethanayagam

Global Director, Corporate Quality Audit & Global Supplier Quality
Apotex Inc.

Diana Vivian, PhD

Acting Associate Director, Division of Bioequivalence II, OB, OGD, CDER
FDA

Veda Walcott

Vice President, Global Regulatory Affairs and Compliance
Catalent Pharma Solutions

Massey Whorley

Associate Principal
Avalere Health

Cory Wohlbach

Global Vice President, Biosimilar Regulatory Affairs
Teva Pharmaceuticals

Janet Woodcock, M.D.

Acting Commissioner
FDA

Larisa Wu, PhD

Acting Associate Director of Science and Communication, Office of New Drug Products, OPQ, CDER
FDA

Sarah Yim, M.D.

Director
Office of Therapeutic Biologics and Biosimilars, CDER’s Office of New Drugs (OND), FDA

Miyoung Yoon, PhD

Acting Team Leader, Division of Quantitative Methods & Modeling, ORS, OGD, CDER
FDA

CAPT Leo Zadecky, RPh, MS

Senior Regulatory Review Officer, Drug Shortage Staff (DSS), CDER
FDA

Lei Zhang, PhD

Deputy Director, ORS, OGD, CDER
FDA

Liang Zhao, PhD

Director, Division of Quantitative Methods & Modeling, ORS, OGD, CDER
FDA

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