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