SPEAKERS

ALL SPEAKERS

Deborah Adams, PharmD

Regulatory Health Project Manager, ORO, DPM, OGD, CDER

FDA

Nick Adolph

Principal - US Market Access Strategy

IQVIA Institute for Human Data Science

Darshan Aigal, M.Sc, P.G.D.M

Director, Global complex Generics- Regulatory Affairs Department

Cipla Limited, India

Shawn Allwein, PhD

Vice President, Biologics CMC

Teva Pharmaceuticals

Vasilis Anagnostopoulos-King, MS

Management Analyst, GB, DUFM, OM, CDER

FDA

Kamaal Anas

Corporate Vice President, Regulatory Affairs

B. Braun Medical Inc.

Melissa Andel, MPP

Principal

CommonHealth Solutions

Donald Ashley, J.D.

Executive Vice President, Regulatory Compliance

Greenleaf Health, Inc.

Fouad Atouf, PhD

Senior Vice President, Global Biologics

U.S. Pharmacopeia

David Awotwe-Otoo, PhD

Senior Pharmaceutical Quality Assessor (SPQA), Division of Pharmaceutical Manufacturing Assessment II, OLDP, OPQ, CDER

FDA

Jaya Ayyagari

Head, Regulatory Affairs

Dr. Reddy's Laboratories Inc.

Christine Baeder, MBA

AAM Board Chair

Sandra Bai, PharmD

Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER

FDA

Michael Balon

Global Director, Regulatory Affairs New Product Development,

Apotex Inc.

Karen Bengtson

Supervisory Project Manager, ORS, IO, OGD, CDER

FDA

CAPT Christine Bina, RPh, MPH

Team Leader, Drug Shortage Staff, OCD, CDER

FDA

Megan Boals MPH, MS, CSM, CSPO, A-CSPO

Operations Research Analyst, DDQCSS, OBI, OSP, CDER, FDA

FDA

April Braddy, PhD

Division Director, Division of Bioequivalence III, OB, OGD, CDER

FDA

John Brooks, JD, MBA

Partner

South Capitol

Sarah Brown, PharmD

Associate Director, Regulatory Affairs Strategy and Science, Biosimilars

Sandoz

Michael Brzica, JD

Vice President, Government Affairs

Teva Pharmaceuticals

James Buening

Regulatory Health Project Manager, Division of Bioequivalence Process Management OB, OGD, CDER

FDA

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

Rebecca Cambronero, MBA, MSL, PMP

Senior Director, Regional General Manager, North America

U.S. Pharmacopeia

Peter Capella, PhD

Division Director, Division of Immediate and Modified Release Drug Products II OLDP, OGD, CDER

FDA

Mary Jo Carden, RPh, JD

Head, Policy, Corporate Affairs

Sandoz Pharmaceuticals

Fabricio Carneiro de Oliveira

General Manager, Medicines, APIs and Biological Products Office Chief

Brazilian Health Regulatory Agency

Virginia Carroll, PhD

Senior Pharmaceutical Quality Assessor, DBM, OPMA, OPQ, CDER

FDA

Shobha Reddy Chagam, M.S.

Interim Head Regulatory Affairs North America Generics

Dr. Reddy’s Laboratories Inc.

Theresa Chan, PharmD

Regulatory Health Project Manager, OB, DBPM, OGD, CDER

FDA

Cindy Chang, J.D., M.S.

Counsel, IP and Litigation

Hikma Pharmaceuticals USA Inc.

Somesh Chattopadhyay, PhD

Lead Mathematical Statistician, Division of Biometrics VIII, OB, OTS, CDER

FDA

Krishna Chimalakonda, M.S., PhD

Associate Director, Clinical Regulatory Affairs

Amneal Pharmaceuticals

Tom Ching, PharmD

Regulatory Health Project Manager, ORO, DPM, OGD, CDER

FDA

Sanjeeva Reddy Chinnakadoori, MS

Research Scientist III, Analytical R&D

Amneal Pharmaceuticals

Hillel Cohen, PhD

Executive Director, Scientific Affairs

Sandoz Inc.

Ryan Conrad

Economist, Economics Staff, OPSA, OSP

FDA

LCDR Andrew Coogan, PharmD, BCPS

Drug Shortage Coordinator, Division of Legal and Regulatory Support, OGDP, OGD, CDER

FDA

Jacqueline Corrigan-Curray, JD, M.D.

Principal Deputy Center Director

Center for Drug Evaluation and Research (CDER), FDA

Heather Crandall

Operations Research Analyst, OBI, OSP, CDER

FDA

Michele Crawley, MS, RAC

Director, Regulatory Affairs

Cipla USA

Alonza Cruse, B.S.

Director, ORA

FDA

Michael Cutter, PhD

Chief Quality Officer

Biocon Biologics Ltd.

Ryan Daniel, J.D.

Vice President, Associate General Counsel, Corporate and Business Transactions, Biopharmaceuticals

Fresenius Kabi, LLC

CDR Cristina Dar, M.Eng.

Branch Chief, ECB, OC, CDER

FDA

Joe De Vito, PharmD

Senior Director, Global Quality Compliance

Teva Pharmaceuticals

John Derstine

Senior Director, Generic Regulatory Affairs

Teva Pharmaceuticals

Chris Downey, PhD

Division Director, Division of Biotechnology Manufacturing, OPMA, OPQ, CDER

FDA

Debashish Dutta

Senior Director & Head- Global Product Registrations & Regulatory Ops

Dr. Reddy’s Laboratories Ltd.

Sandra D’Agostino-Ferlisi

Director, Global Regulatory Intelligence and Policy

Apotex Inc.

Martin Ehlert, PhD

Vice President, Global API R&D

Apotex Inc.

Ileana Elder, PhD

Incidents, Recalls, and Shortages Branch Chief, ODSIR, OC, CDER

FDA

Jason Flint, MBA, PMP

Deputy Director & Associate Director for Human Factors (Acting), Division of Medication Error Prevention and Analysis I, OMEPRM, OSE, CDER

FDA

David Gaugh, RPh

Interim President & CEO

AAM

Francis Godwin, MBA

Director

Office of Manufacturing Quality, OC, CDER, FDA

CAPT Tara Gooen Bizjak, MS

Director, Manufacturing, Guidance and Policy Staff for Pharma Compliance at OC, CDER

FDA

Maria Gutierrez-Lugo, PhD

Review Chief, Division of Biotechnology Review and Research III, OBP, OPQ, CDER

FDA

Thomas Herndon, M.D.

Scientific Review Staff, OTBB, OND, CDER

FDA

Shannon Holden, PharmD, BCACP, CACP

Senior Clinical Manager, Pharmacy

Vizient Inc.

Desmond Hunt, PhD

Senior Principal Scientist

U.S. Pharmacopeia

Sarah Ibrahim, PhD

Associate Director for Stakeholder and Global Engagement, IO, OGD, CDER

FDA

Karen Ireland, MS, PMP, RAC-Drugs

Senior Regulatory Health Project Manager, Division of Regulatory Business Process Manager II, OPRO, OPQ, CDER

FDA

Yafei Jin, MS

Chemist, Division of Liquid-Based Products II, OLDP, OPQ, CDER

FDA

Ashley Jones-Mitchell

Director of Regulatory Innovation Strategy and Policy North America

Accumulus Synergy

Aaron Josephson, M.S.

Director, Regulatory Policy & Intelligence

Teva Pharmaceuticals

Kurt Karst, JD

Partner

Hyman, Phelps & McNamara, P.C.

Sean Kassim, PhD

Director, Office of Study Integrity and Surveillance, OTS, CDER

FDA

CAPT Craig Kiester, RPh, M.S., RAC

Division Director, Division of Regulatory & Business Process Management II, OPRO, OPQ, OGD, CDER

FDA

Maria Kim, DPT

Management Analyst, GB, DUFM, OM, CDER

FDA

Sruthi King, PhD

Deputy Division Director, Division of Pharmacology and Toxicology OSCE, OGD, CDER

FDA

Michael Kleinrock

Sr. Research Director

IQVIA Institute for Human Data Science

Sara Koblitz, J.D.

Director

Hyman, Phelps, & McNamara, P.C.

Chaitanya Koduri

Director, International Government and Regulatory Engagement, Global External Affairs

United States Pharmacopeia

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

Kiran Krishnan, PhD

Senior Vice President, Global Regulatory Affairs

Apotex Corp.

Naomi Kruhlak, PhD

Scientific Lead, Division of Applied Regulatory Science, OCP, OTS, CDER

FDA

Vipra Kundoor, PhD

Pharmacologist, Division of Bioequivalence I, OB, OGD, CDER

FDA

Scott Kuzner, PhD

Senior Director, Sciences and Regulatory Affairs

AAM

Anthony Lakavage, J.D.

Senior Vice President, Global External Affairs

U.S. Pharmacopeia

Chris Lamanna, PhD

Head Regulatory Devices

Sandoz

Chad Landmon, J.D.

Partner

Axinn, Veltrop & Harkrider LLP

Jennifer Leaming, RAC

Principal Consultant

Lachman Consultant Services, Inc.

Devon Lee, PharmD

Regulatory Project Manager, Division of Project Management (DPM), ORO, OGD, CDER

FDA

Robert Lionberger, PhD

Director, ORS, OGD, CDER

FDA

Veeranna Lolla, M.Pharm., RAC

Senior Director, Regulatory Affairs

Teva Pharmaceuticals

Cindy Lombardy, MS, MBA, RAC-US

Senior Director, Pharmaceutical Regulatory Affairs

B. Braun Medical Inc.

Dongmei Lu, PhD

Policy Lead, Office of Policy for Pharmaceutical Quality, OPQ, CDER

FDA

Markham Luke, MD, PhD

Division Director, Division of Therapeutic Performance I, ORS, OGD, CDER

FDA

Jennifer Maguire, PhD

Director, Office of Quality Surveillance, OPQ, CDER

FDA

Brian Malkin, JD, MS

Associate General Counsel - Regulatory Law

Teva Pharmaceutical Industries

Samir Kumar Mandal, PhD

Senior Director, Regulatory Affairs

Dr. Reddy’s Laboratories Ltd.

Beena Mathew, PharmD, PMP

Senior Health Regulatory Project Manager, OB, DBPM, OGD, CDER

FDA

Rajeev Mathur

Head – Global Regulatory & Business Continuity

Sun Pharma

Christina Mazella

Vice President, Global Quality Compliance

Teva Pharmaceuticals

Brian McCormick, J.D., M.H.S.

Vice President, Chief Regulatory Counsel

Teva Pharmaceuticals

Katlin McKelvie Backfield, J.D.

Former Deputy General Counsel

U.S. Department of Health and Human Services (HHS)

Elizabeth Miller, PharmD

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

FDA

Ripen Misri, PhD

Senior Director, Liquids & Specialty Dosage Forms, Global R&D

Apotex Inc.

Maria Monroy-Osorio

Regulatory Health Project Manager, ORS, IO, OGD, CDER

FDA

Catherine Morales

Regulatory Health Project Manager, ORO, DPM, OGD, CDER

FDA

Utpal Munshi, PhD

Director, Division of Bioequivalence I, OB, OGD, CDER

FDA

Iilun Murphy, M.D.

Director

Office of Generic Drugs (OGD), CDER FDA

Mayank Nagar, M.S., MBA

Vice President & Head – Technical Services and New Product Launches (North America)

Dr. Reddy’s Laboratories Inc.

Martha Nguyen, J.D.

Division Director, OGDP, OGD, CDER

FDA

Kristen Nickens, PhD

Product Quality Team Leader Office of Biotechnology Products, Division of Biotechnology Review and Research-I, OPQ, CDER

FDA

Elisa Nickum, PhD, PMP

Senior Regulatory Business Process Manager, OPRO, OPQ, CDER

FDA

Marie Angeline O’Shea, RN, MBA

Associate Director, OPRO, IO, OPQ, CDER

FDA

Oluwakemi Odesina, PharmD, BCPS, CPH

Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER

FDA

Raveendra Pai, MPharm, PhD

Senior Vice President – Formulation Development

Glenmark Pharmaceuticals Ltd.

John Pakulski, RPh

SVP Regulatory Affairs

Kashiv BioSciences, LLC

Harshil Parikh, M.S.

Principal Product Development Scientist, Formulations

Teva Pharmaceuticals

Nitin Patil, PhD

Head – API R&D

Biocon Limited

Gisa Perez, MBA

Generics Branch Chief, GB, DUFM, OM, CDER

FDA

Andrei Perlloni

Branch Chief, IBC, OC, CDER,

FDA

Charlene Peterson, PharmD

Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER

FDA

Ronald Piervincenzi, PhD

Chief Executive Officer

U.S. Pharmacopeia

James Polli, PhD

Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics

University of Maryland School of Pharmacy

Sunny Pyon, PharmD

Labeling Project Manager, ORO, DLR, OGD, CDER

FDA

Giuseppe Randazzo

Vice President, Sciences and Regulatory Affairs

AAM

Andre Raw, PhD

Associate Director, Immediate Office, OLDP, OPQ, CDER

FDA

Anupama Reddy, M.S.

Head, Quality Function Program Management Office

Biocon Biologics Limited

Bhagwant Rege, PhD

Division Director, Division of Biopharmaceutics, ONDP, OPQ, CDER

FDA

Ke Ren, PhD

Deputy Division Director, Division of Bioequivalence III, OB, OGD, CDER

FDA

Jonathan Resnick, PMP

Project Management Officer, DDMSS, OBI, OSP, CDER

FDA

Stacey Ricci, M.Eng., Sc.D.

Director, Scientific Review Staff, OTBB, OND, CDER

FDA

Peter Richardson, PhD

BMWP Scientific Secretary

European Medicines Agency

Alberto Rivalta, M.S.

Senior Director, Generics Regulatory Affairs

Teva Pharmaceuticals USA

Fabrice Romanet

Senior Vice President, Head of Program Leadership, Regulatory and Governmental Affairs

Fresenius Kabi Biopharma

CDR Lana Rossiter, PhD

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

FDA

Rhonda Rowell, RPh

Project Manager, Division of Filing Review, ORO, DFR, OGD, CDER

FDA

Partha Roy, PhD

Director, Office of Bioequivalence (OB), OGD, CDER

FDA

Anil Sachdeva

Global Vice President, Regulatory Affairs

Biocon Pharma Inc.

Caliope Sarago, MHSA

Senior Project Manager, ORS, IO OGD, CDER

FDA

Anand Saxena, M.Sc

Director Regulatory Affairs

Cipla Limited

Allison Schaefer, B.S., M.S., RPM

Regulatory Project Manager, ORO, DPM, OGD, CDER

FDA

Martin Schiestl, PhD

Global Head Regulatory Affairs Policy

Sandoz

Mark Schweitzer, PhD

Principal, Mark Schweitzer Consulting, LLC

Chair, USP Microbiology Expert Committee

Seyoum Senay

Program Manager & Supervisory Operations Research, DDMSS, OBI, OSP, CDER

FDA

Priya Shah, PharmD

Labeling Project Manager, ORO, DLR, OGD, CDER

FDA

Diaa Shakleya, PhD

Senior Research Scientist, DPQR, OTR, OPQ, CDER

FDA

Ali Shariati, MPS

Lead Management and Program Analyst, GB, DUFM, OM, CDER

FDA

Edward “Ted” Sherwood

Director, Office of Regulatory Operations (ORO), OGD, CDER

FDA

Rashmi Shetty

Director, North America- Regulatory Affairs Department

Cipla Limited, India.

CAPT Aaron Sigler, PharmD, BCPS, PMP, RAC, CPH

Deputy Director, Division of Project Management, ORO, OGD, CDER

FDA

Manina Singh, PharmD, PMP, RAC

Deputy Division Director, OB, DBPM, OGD, CDER

FDA

Bhupesh Singh, MPharm

Director, Regulatory Affairs

Apotex Corp.

Gina Sirianni, MSc

Director, Global Regulatory Affairs - Co-Development

Apotex Inc.

Howard Sklamberg, J.D.

Partner

Arnold & Porter Kaye Scholer LLP

CDR Hyun Son, PharmD, PMP

Senior Program Management Officer, DSS, OCD, CDER, FDA

FDA

Soumi Saha, PharmD, J.D.

Senior Vice President of Government Affairs

Premier

Olivia Souweine, PMP

Management Analyst, GB, DUFM, OM, CDER

FDA

Salma Srour, PharmD

Regulatory Business Process Manager, OPRO, DII, OPQ, CDER

FDA

Monét Stanford

Director, Policy

AAM

Adam Steinberg, PharmD

Associate Director, Regulatory Affairs

Apotex Corp.

Nilufer Tampal, PhD

Associate Director for Scientific Quality, OB, OGD, CDER

FDA

LCDR Nuri Tawwab, PharmD, MPH

Regulatory Business Process Manager, OPRO, DII, OPQ, CDER

FDA

Alan Thompson

Director, Regulatory Affairs

Teva Pharmaceuticals

Shashi Tiwari

Head of Analytical Research for API & Formulations

Biocon Limited

Maryll Toufanian, J.D.

Senior Vice President, Regulatory Strategy and Government Affairs

Amneal Pharmaceuticals

Kalpana Vanam, MBA

Senior Vice President, Regulatory Affairs

Lupin Pharmaceuticals Inc.

Janet Vaughn

Vice President, North America Generic Regulatory Affairs

Teva Pharmaceuticals USA

Kishore Velaga, M.S.

Director, Regulatory Affairs

Cipla USA

Molly Ventrelli

Senior Vice President, Regulatory Affairs

Fresenius Kabi USA

Diana Vivian, PhD

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

FDA

Thuyanh (Ann) Vu, RPh

Regulatory Health Project Manager, OPRO, DII, OPQ, CDER

FDA

Rong Wang, PhD, PharmD

Associate Director, Division of Bioequivalence I, OB, OGD, CDER

FDA

Joel Welch, PhD

Associate Director for Science and Biosimilar Strategy, OB, OPQ, CDER

FDA

Kristin Willemsen

Vice President, Scientific & Regulatory Affairs

Canadian Generic Pharmaceutical Association

Cory Wohlbach

Global Vice President, Global Biosimilars Regulatory Affairs

Teva Pharmaceutical Industries Ltd.

Elena Wolff-Holz, M.D., PhD

Vice President, Global Head Clinical Development

Biocon Biologics Ltd

Marta Wosińska, PhD

Senior Fellow, Schaeffer Initiative on Health Policy

The Brookings Institution

Chyong-Yi Wu, PhD

Regulatory Health Project Manager, Division of Bioequivalence Process Management OB, OGD, CDER, FDA

FDA

Xiaoming Xu, PhD

Division Director, Division of Product Quality Research, OTR, OPQ, CDER

FDA

Sarah Yim, M.D.

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

FDA

Lei Zhang, PhD

Deputy Director, ORS, OGD, CDER

FDA

Hongling Zhang, PhD

Division Director, Division of Bioequivalence II, OB, OGD, CDER

FDA

Liang Zhao, PhD

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

FDA

Hongfei Zhou, PhD

Pharmacologist, Division of Bioequivalence III, OB, OGD, CDER

FDA