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Speakers

Your Window into Emerging FDA and CMS Regulatory Policies Affecting Life Sciences

December 3-4, 2019
  • Arlington, VA

Sameer V. Awsare, M.D., FACP
Associate Executive Director
The Permanente Medical Group

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Ron Cohen, M.D.
Founder, President and CEO
Acorda Therapeutics

Thomas C. Conniff, Esq.
Assistant General Counsel
Johnson & Johnson;
Co-Chair
AdvaMed Legal Committee Working Group on Advancing Value-Based Health Care

Ron Cooper
President & CEO
Albiero Pharma

Cathy W. Critchlow, Ph.D.
Vice President, Center for Observational Research
Amgen, Inc.

Gregory Daniel, Ph.D., MPH
Head, U.S. Healthcare Policy Initiatives
Edwards Life Sciences

Maura Dickler, M.D.
Late Stage Development, Lilly Oncology
Eli Lilly & Company

Chris Garabedian
Chairman and CEO
Xontogeny

Pamela Goldberg
President & CEO
Medical Device Innovation Consortium (MDIC)

Jeet Guram, M.D.
Senior Advisor, Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

Eric D. Hargan
Deputy Secretary
U.S. Department of Health and Human Services

Nielsen Hobbs
Editor
Pink Sheet

Emil D. Kakkis, M.D., Ph.D.
CEO, President and Founder
Ultragenyx Pharmaceutical Inc.

Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)

David Martin
Associate Director, Real World Evidence Analytics,
Office of Medical Policy, CDER,
U.S. Food and Drug Administration (FDA)

Theresa M. Mullin, Ph.D.
Associate Director for Strategic Initiatives
FDA Center for Drug Evaluation and Research

Adora Ndu, PharmD, JD
Executive Director, Regulatory Affairs,
Policy, Research, Engagement (PRE), & Reg International
BioMarin Pharmaceutical Inc.

Darin Oppenheimer
Executive Director, Regulatory Device &
Digital Health Solutions
Merck

Denise M. Oppermann
Senior Director, RA Devices, RTG
Fresenius Medical Care

Bakul Patel
Director, Division of Digital Health, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)

Szymon Perkowski
Manager, Software Quality
Verily Life Sciences

Tejashri Purohit-Sheth, M.D.
Director, Division of Clinical Evaluation and Pharmacology/Toxicology (CBER / OTAT / DCEPT)
U.S. Food and Drug Administration (FDA)

Juliana M. Reed
Vice President, Corporate Affairs Lead – I & I and Biosimilars
Pfizer Inc.

James Reimann
Vice President, Global Head Oncology, Biostatistics
Genentech

Alan Sandler
Senior Vice President, Global Head of Product
Development, Oncology – Solid Tumors
Genentech

Anand Shah, M.D.
Senior Medical Advisor for Innovation, Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

Norman Sharpless
Acting Commissioner
U.S. Food and Drug Administration (FDA)

Peter Stein, M.D.
Director, Office of New Drugs, Center for Drug Evaluation and Research (CDER
U.S. Food and Drug Administration (FDA)

Dan Takefman, Ph.D.
Head, Regulatory Affairs
Spark Therapeutics

Eva Temkin
Acting Director for Policy, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER
U.S. Food and Drug Administration (FDA)

Tamar Thompson
Head, Federal Executive Branch Strategy & State Government Affairs
Bristol-Myers Squibb Company

Karin Van Baelen
Head, Global Regulatory Affairs
Janssen, Pharmaceutical Companies of Johnson & Johnson

Michael S. Weiss
Executive Chairman, President and CEO
TG Therapeutics

Michael Werner
Co-founder and Senior Policy Counsel
Alliance for Regenerative Medicine

Paul Westfall
Washington Counsel
American Medical Association

Matt Wetzel
Senior Counsel
Akin Gump Strauss Hauer & Feld LLP

Janet Woodcock
Director, Center for Drug Evaluation & Research (CDER)
U.S. Food and Drug Administration (FDA)

Sameer V. Awsare, M.D., FACP
Associate Executive Director
The Permanente Medical Group

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Ron Cohen, M.D.
Founder, President and CEO
Acorda Therapeutics

Thomas C. Conniff, Esq.
Assistant General Counsel
Johnson & Johnson;
Co-Chair
AdvaMed Legal Committee Working Group on Advancing Value-Based Health Care

Ron Cooper
President & CEO
Albiero Pharma

Cathy W. Critchlow, Ph.D.
Vice President, Center for Observational Research
Amgen, Inc.

Gregory Daniel, Ph.D., MPH
Head, U.S. Healthcare Policy Initiatives
Edwards Life Sciences

Maura Dickler, M.D.
Late Stage Development, Lilly Oncology
Eli Lilly & Company

Chris Garabedian
Chairman and CEO
Xontogeny

Pamela Goldberg
President & CEO
Medical Device Innovation Consortium (MDIC)

Jeet Guram, M.D.
Senior Advisor, Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

Eric D. Hargan
Deputy Secretary
U.S. Department of Health and Human Services

Nielsen Hobbs
Editor
Pink Sheet

Emil D. Kakkis, M.D., Ph.D.
CEO, President and Founder
Ultragenyx Pharmaceutical Inc.

Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)

David Martin
Associate Director, Real World Evidence Analytics,
Office of Medical Policy, CDER,
U.S. Food and Drug Administration (FDA)

Theresa M. Mullin, Ph.D.
Associate Director for Strategic Initiatives
FDA Center for Drug Evaluation and Research

Adora Ndu, PharmD, JD
Executive Director, Regulatory Affairs,
Policy, Research, Engagement (PRE), & Reg International
BioMarin Pharmaceutical Inc.

Darin Oppenheimer
Executive Director, Regulatory Device &
Digital Health Solutions
Merck

Denise M. Oppermann
Senior Director, RA Devices, RTG
Fresenius Medical Care

Bakul Patel
Director, Division of Digital Health, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)

Szymon Perkowski
Manager, Software Quality
Verily Life Sciences

Tejashri Purohit-Sheth, M.D.
Director, Division of Clinical Evaluation and Pharmacology/Toxicology (CBER / OTAT / DCEPT)
U.S. Food and Drug Administration (FDA)

Juliana M. Reed
Vice President, Corporate Affairs Lead – I & I and Biosimilars
Pfizer Inc.

James Reimann
Vice President, Global Head Oncology, Biostatistics
Genentech

Alan Sandler
Senior Vice President, Global Head of Product
Development, Oncology – Solid Tumors
Genentech

Anand Shah, M.D.
Senior Medical Advisor for Innovation, Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

Norman Sharpless
Acting Commissioner
U.S. Food and Drug Administration (FDA)

Peter Stein, M.D.
Director, Office of New Drugs, Center for Drug Evaluation and Research (CDER
U.S. Food and Drug Administration (FDA)

Dan Takefman, Ph.D.
Head, Regulatory Affairs
Spark Therapeutics

Eva Temkin
Acting Director for Policy, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER
U.S. Food and Drug Administration (FDA)

Tamar Thompson
Head, Federal Executive Branch Strategy & State Government Affairs
Bristol-Myers Squibb Company

Karin Van Baelen
Head, Global Regulatory Affairs
Janssen, Pharmaceutical Companies of Johnson & Johnson

Michael S. Weiss
Executive Chairman, President and CEO
TG Therapeutics

Michael Werner
Co-founder and Senior Policy Counsel
Alliance for Regenerative Medicine

Paul Westfall
Washington Counsel
American Medical Association

Matt Wetzel
Senior Counsel
Akin Gump Strauss Hauer & Feld LLP

Janet Woodcock
Director, Center for Drug Evaluation & Research (CDER)
U.S. Food and Drug Administration (FDA)