November 9-11, 2020 | Virtual Conference

SPEAKERS

Liang Zhao, PhD

Division Director, Division of Quantitative Methods and Modeling (DQMM), Office of Research Standard (ORS), OGD, CDER
FDA

Paul Thomas

Chief Commercial Officer, US
Biocon Biologics

Lei Zhang, PhD

Deputy Director, ORS, OGD, CDER
FDA

Judith Zander, M.D.

Director
Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA

CDR Leo Zadecky, RPh, MS

Senior Program Management Officer, Drug Shortage Staff (DSS), CDER
FDA

Sarah Yim, M.D.

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

Kimberly Witzmann, M.D.

Acting Deputy Director, OB, OGD, CDER
FDA

Molly Ventrelli

Senior Vice President, Regulatory Affairs
Fresenius Kabi

Siva Vaithiyalingam, PhD

Vice President, Regulatory Affairs
Cipla LTD

Rachel Turow, J.D.

Associate General Counsel, Regulatory Law & Policy
Teva Pharmaceuticals

Scott Tomsky

VP, North America
Regulatory Affairs, Generics, Teva

Eva Temkin, J.D.

Acting Associate Director for Policy, Office of Therapeutic Biologics and Biosimilars, CDER
FDA

CAPT Kendra Stewart, RPh, PharmD

Supervisor, Orange Book Staff, Office of Generic Drug Policy (OGDP), OGD, CDER
FDA

Adam Steinberg, PharmD

Manager, Regulatory Affairs
Apotex Corp.

Aloka Srinivasan, PhD

Principal and Managing Partner
RAAHA, LLC

Sara Skubikowski

Senior Director, Strategic Alliances
AAM

CDR David Skanchy, PhD

Division Director, DLCAPI, ONDP, OPQ, CDER
FDA

Christine Simmon

Senior Vice President, Policy & Strategic Alliances, AAM
Executive Director, Biosimilars Council

Edward Sherwood

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

Rachel Sher, J.D., M.P.H. 

Vice President, Policy and Regulatory Affairs
National Organization for Rare Disorders

David Rosen, J.D.

Partner
Foley & Lardner LLP

Niles Ron, PhD

Branch Chief, DPMA II, OLDP, OPQ, CDER
FDA

Christy Robinson

Principal
Matrix Global Advisors

Jonathan Resnick

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

Bhagwant Rege, PhD

Division Director, Division of Immediate and Modified Release Products III (DIMRP III), OLDP, OPQ, CDER
FDA

Andre Raw, PhD

Senior Scientific and Policy Advisor, Immediate Office (IO), OLDP, OPQ, CDER
FDA

Diane Raccasi, BS

Principal Consultant
Paraxel International

Alexandra (Alex) Pratt, M.D.

Chair of the Department of Critical Care
MedStar Washington Hospital Center

Robert “Bob” Pollock, MS

Senior Advisor, Outside Director to the Board
Lachman Consultant Services, Inc.

Laura Pethick, PharmD, MBA

Director, Patient Safety
Tolmar Pharmaceuticals, Inc.

Ranjana Pathak, DHA

President, Global Quality, Medical Affairs & Pharmacovigilance
Cipla Ltd.

Lisa Parks, RPh

Vice President of Sciences & Regulatory Affairs
AAM

Gerald Dal Pan, M.D., MHS

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

John O’Brien, PharmD, MPH

Managing Partner
South Capitol

Elizabeth Miller, PharmD

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

Thomas Metz

Associate Director, R&D Sourcing Lead – Generics
Hikma Pharmaceuticals

Suzanne McLeod

Manager, REMS and Drug Safety
Hikma Pharmaceuticals

Sean McGowan

Senior Director, Biosimilas
AmerisourceBergen

Brian McCormick

VP & Chief Regulatory Counsel, Head Global Regulatory Policy
Teva Pharmaceuticals

Julie Maréchal-Jamil

Director Biosimilars Policy & Science
Medicines for Europe

Arnaud Mahéas

Director, Public Affairs Europe
Director Public Affairs Europe Sandoz

Jennifer Maguire, PhD

Deputy Director, OQS, OPQ, CDER
FDA

Marcy Macdonald, RAC

Vice President, Regulatory Affairs
Tolmar, Inc.

Markham Luke, M.D., PhD

Director
DTP, ORS, OGD, CDER, FDA

Steven Lucio, PharmD, BCPS

Vice President, Pharmacy Solutions
Vizient, Inc.

Doug Long

Vice President of Industry Relations
IQVIA

Bing Li, PhD

Director
OB, OGD, CDER, FDA

Dan Leonard

President and Chief Executive Officer
AAM

Scott Lassman, J.D.

Principal
Lassman Law+Policy

Chad Landmon, J.D.

Partner
Axinn, Veltrop & Harkrider LLP

Kiran Krishnan, PhD

Senior Vice President, Global Regulatory Affairs
Apotex Inc.

Bill Kramer

Executive Director
Pacific Business Group on Health

Michael Kopcha, PhD, RPh

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

CAPT Craig Kiester, RPh, MS, RAC

Division Director, Division of Regulatory Business Process Management II (DRBPMII), Office of Program and Regulatory Operations (OPRO), OPQ, CDER
FDA

David Keire, PhD

Director, Division of Pharmaceutical Analysis (DPA), Office of Testing and Research (OTR), OPQ, CDER
FDA

Kurt Karst, J.D.

Director
Hyman, Phelps & McNamara, P.C.

Mamta Kapoor, PhD

Chemist/Quality Assessor, Division of Liquid-Based Products I (DLBP I), Office of Lifecycle Drug Products (OLDP), OPQ CDER
FDA

Vineet Kacker, PhD

Co-Founder, Managing Director and Global Technical Head
APCER Life Sciences, Inc.

Deborah Johnson, PhD

Branch Chief, DLCAPI, ONDP, OPQ, CDER
FDA

William Jay, J.D.

Partner, DC Litigation Leader and Co-Chair, Appellate Litigation
Goodwin Procter LLP

Edwin Jao, PhD

Director, Division of Pharmaceutical Manufacturing Assessment 3, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER
FDA

Kristi Muldoon Jacobs

Director, Regulatory and Compendial Affairs
United States Pharmacopeial

CAPT Katherine Jacobitz

Program Management, Office of Pharmaceutical Quality Operations (OPQO), Office of Medical Products and Tobacco Operations (OMPTO), ORA, CDER
FDA

Sarah Ikenberry

Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars (OTBB), CDER
FDA

Karin Hessler, J.D.

Assistant General Counsel
AAM

Jenna Hammer, M.D.

Physician/Primary Reviewer, Division of Clinical Review (DCR), OB, OGD, CDER
FDA

Stephen Hahn, M.D.

Commissioner
FDA

Annette Guarisco Fildes

President and CEO
The ERISA Industry Committee (ERIC)

Kishore Gopu, MS, MBA

Director, REMS Operations
Teva Pharmaceuticals

Laurie Graham, PhD

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

Daniil Graborov

Computer Scientist, DDMSS, OBI, OSP, CDER
FDA

Scott Gottlieb, M.D.

Former Commissioner, FDA

David Gaugh, RPh

Senior Vice President, Sciences & Regulatory Affairs
AAM

Ronny Gal, PhD

Analyst
Sanford Bernstein

Jeff Francer, J.D

Senior Vice President and General Counsel
AAM

Brian Folian, J.D., MS

Deputy Office Director, Office of Study Integrity and Surveillance (OSIS), CDER
FDA

Lynne Ensor, PhD

Vice President, Technical
Parexel International

Martin Ehlert, PhD

Vice President
Research and Development, Apotex Inc.

Candis Edwards

Senior Vice President, Regulatory Affairs
Amneal Pharmaceuticals LLC

Vipul Doshi

President & Global Quality Regulatory
Zydus Cadila

Robert Dorsam, PhD

Associate Director of Pharmacology/Toxicology, DCR, OB, OGD, CDER
FDA

Charlie DiLiberti

President
Montclair Bioequivalence Services, LLC

Joyce DelGaudio

Sr. Director, Regulatory Affairs, Generics
Teva Pharmaceuticals

Gary Deeb

Senior Vice President, Global Licensing & Business Development
Lupin Inc.

John Darby, MSc

Senior Director
Lachman Consultant Services, Inc.

Ryan Daniel, J.D.

Chief Patent Counsel
Fresenius Kabi USA

Heather Crandall

Operations Research Analyst, Electronic Submissions Capability Team, Division of Data Management Services and Solutions (DDMSS), Office of Business Informatics (OBI), Office of Strategic Programs (OSP), CDER
FDA

Jody Cox

Vice President
Biosimilars Canada

Thomas Cosgrove, J.D.

Partner
Covington & Burling LLP

Dave Coppersmith, J.D.

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

Denise Conti, PhD

Senior Staff Fellow, Division of Therapeutic Performance (DTP), ORS, OGD, CDER
FDA

Lina Cong

Regulatory Information Specialist, DDMSS, OBI, OSP, CDER
FDA

Hillel Cohen, PhD

Executive Director, Scientific Affairs
Sandoz, Inc

Sally Choe, PhD

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

Ee-Sunn (Joanne) Chia, PhD

Division Director
Division of New Drug Products (DNDPIII), Office of New Drug Products (ONDP), OPQ, CDER, FDA

Zhi Chen, MS, RAC

Associate Director of Regulatory Affairs
Glenmark Pharmaceuticals Inc., USA

Ethan Chen, PMP, MSE, MBA

Director
DDMSS, OBI, OSP, CDER, FDA

Alicia Chen, PharmD

Lead Pharmacist, Orange Book Staff, Division of Legal and Regulatory Support (DLRS), OGDP, OGD, CDER
FDA

Howard Chazin, M.D., MBA

Director, Clinical Safety Surveillance Staff (CSSS), IO, OGD, CDER
FDA

Patrizia Cavazzoni, M.D. 

Acting Center Director
CDER, FDA

Jim Carey

Executive Director, US Health Policy
Merck and Co., Inc.

Craig Burton

Vice President, Policy
AAM

Molly Burich, MS

Head of Public Policy
Boehringer Ingelheim, Inc.

John Brooks

Partner
South Capitol

Rob Brenner, M.D., MMM

President, Clinical Integration & Physician Enterprise
Valley Health System

Charles Bon, MS

President/Founder
Biostudy Solutions, LLC

Elaine Herrmann Blais, J.D.

Partner
Goodwin Procter LLP

Lisa Bercu, J.D.

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

Karthik Balasubramanian, PhD

Director, Combination Products and Semisolids, Generic CPD
Teva Pharmaceuticals

Tao Bai, PhD

Lead Pharmacologist, Division of Bioequivalence I, Office of Bioequivalence (OB), OGD, CDER
FDA

Christine Baeder

SVP, Chief Operating Officer, U.S. Generics
Teva Pharmaceuticals

Alex M. Azar, II

Secretary
United States Department of Health and Human Services

Jane Axelrad, J.D.

Principal
Axelrad Solutions LLC

Donald Ashley, J.D.

Director
Office of Compliance (OC), CDER, FDA

Lauren Aronson

Partner
Mehlman, Castagnetti, Rosen & Thomas
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