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Agenda

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

December 3-4, 2019
  • Arlington, VA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, December 3, 2019

7:30

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

8:45

OPENING KEYNOTE ADDRESS

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

9:15

CDER KEYNOTE ADDRESS2019 and the Year Ahead —
Strategic Plans and Priorities

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

10:00

INTERACTIVE Q&A SESSIONUpdates on the Innovation and Investment Summit

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

10:30

Networking and Refreshment Break

11:00

CDER OFFICE OF NEW DRUGS UPDATE2019 Update, 2020 Strategic Plans and Priorities

Khushboo Sharma, MBA, RAC
Deputy Office Director of Operations, Office of New Drugs,
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

11:45

Networking Luncheon

12:45

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

1:00

INTERACTIVE Q&A SESSION Advanced Therapeutics and Cell and Gene Therapies

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

1:45

INTERACTIVE Q&A SESSIONRare Diseases — Common Issues in Drug Development Guidance for Industry

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

2:30

Networking and Refreshment Break

Track A Updates on Regulatory Polices for Gene Therapies and the Expanding Role of RWE

3:00

PANELEvolving the Rare Disease Drug Review Process

PANELISTS:

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

Ron Cooper
President & CEO
Albiero Pharma

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

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

3:45

PANELUnderstand the Shifting Regulatory Policy Landscape for Cell and Gene Therapies

PANELISTS:

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

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

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

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

Track B Med Device and Technology

Powered by:

3:00

Addressing the Evolution of Cybersecurity Issues in Medical Devices

Paul Westfall
Washington Counsel
American Medical Association

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

3:45

Examine the Current Regulatory Landscape for Diagnostics

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

4:30

PANELExpanding the Role of RWE and PROs in Regulatory Decision-Making

PANELISTS

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

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

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

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

James Reimann
Vice President, Global Head Oncology, Biostatistics
Genentech

5:30

Closing Remarks and Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWOWednesday, December 4, 2019

8:00

Conference Registration & Continental Breakfast

8:30

Chairman’s Welcome

Nielsen Hobbs
Editor
Pink Sheet

8:45

PANELAdvancing Value-Based Payment Models

PANELISTS

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

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

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

9:45

Review Medicare Coverage and Access

10:30

Networking and Refreshment Break

Track A Updates on Regulatory Polices for Gene Therapies and the Expanding Role of RWE

11:00

Manufacturer, Payer and Regulator
Perspectives on Aligning Data Requirements for Global Drug Development

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Chris Garabedian
Chairman and CEO
Xontogeny

11:45

Current and Future Trends in Advancing Adoption of Biosimilars

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

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

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

Track B Med Device and Technology

Powered by:

11:00

Value-Based Arrangements and Coordinated Care — Impact on Medical Technology

Matt Wetzel
Senior Counsel
Akin Gump Strauss Hauer & Feld LLP

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

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

11:45

Software as a Medical Device — Review Current Findings for the FDA Pre-Certification Pilot Project

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

12:30

Networking Luncheon

1:30

PANELDriving Patient Focused Product Development

PANELISTS

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

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

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

2:15

FIRESIDE CHATExamine the Impact of the Drug Pricing Debate on Pharma from Bench to Bedside

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

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

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Tuesday, December 3, 2019

7:30

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

8:45

OPENING KEYNOTE ADDRESS

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

9:15

CDER KEYNOTE ADDRESS2019 and the Year Ahead —
Strategic Plans and Priorities

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

10:00

INTERACTIVE Q&A SESSIONUpdates on the Innovation and Investment Summit

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

10:30

Networking and Refreshment Break

11:00

CDER OFFICE OF NEW DRUGS UPDATE2019 Update, 2020 Strategic Plans and Priorities

Khushboo Sharma, MBA, RAC
Deputy Office Director of Operations, Office of New Drugs,
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

11:45

Networking Luncheon

12:45

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

1:00

INTERACTIVE Q&A SESSION Advanced Therapeutics and Cell and Gene Therapies

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

1:45

INTERACTIVE Q&A SESSIONRare Diseases — Common Issues in Drug Development Guidance for Industry

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

2:30

Networking and Refreshment Break

Track A Updates on Regulatory Polices for Gene Therapies and the Expanding Role of RWE

3:00

PANELEvolving the Rare Disease Drug Review Process

PANELISTS:

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

Ron Cooper
President & CEO
Albiero Pharma

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

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

3:45

PANELUnderstand the Shifting Regulatory Policy Landscape for Cell and Gene Therapies

PANELISTS:

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

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

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

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

Track B Med Device and Technology

Powered by:

3:00

Addressing the Evolution of Cybersecurity Issues in Medical Devices

Paul Westfall
Washington Counsel
American Medical Association

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

3:45

Examine the Current Regulatory Landscape for Diagnostics

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

4:30

PANELExpanding the Role of RWE and PROs in Regulatory Decision-Making

PANELISTS

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

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

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

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

James Reimann
Vice President, Global Head Oncology, Biostatistics
Genentech

5:30

Closing Remarks and Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWOWednesday, December 4, 2019

8:00

Conference Registration & Continental Breakfast

8:30

Chairman’s Welcome

Nielsen Hobbs
Editor
Pink Sheet

8:45

PANELAdvancing Value-Based Payment Models

PANELISTS

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

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

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

9:45

Review Medicare Coverage and Access

10:30

Networking and Refreshment Break

Track A Updates on Regulatory Polices for Gene Therapies and the Expanding Role of RWE

11:00

Manufacturer, Payer and Regulator
Perspectives on Aligning Data Requirements for Global Drug Development

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Chris Garabedian
Chairman and CEO
Xontogeny

11:45

Current and Future Trends in Advancing Adoption of Biosimilars

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

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

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

Track B Med Device and Technology

Powered by:

11:00

Value-Based Arrangements and Coordinated Care — Impact on Medical Technology

Matt Wetzel
Senior Counsel
Akin Gump Strauss Hauer & Feld LLP

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

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

11:45

Software as a Medical Device — Review Current Findings for the FDA Pre-Certification Pilot Project

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

12:30

Networking Luncheon

1:30

PANELDriving Patient Focused Product Development

PANELISTS

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

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

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

2:15

FIRESIDE CHATExamine the Impact of the Drug Pricing Debate on Pharma from Bench to Bedside

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

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

3:00

Close of Conference