Skip navigation
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

7:45

Registration and Continental Breakfast
Hosted By:

8:30

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

8:45

OPENING KEYNOTE ADDRESS

Amy P. Abernethy, MD, PhD
Principal Deputy Commissioner
U.S. Food and Drug Administration (FDA)

9:15

CDER KEYNOTE ADDRESS 2019 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

FIRESIDE CHAT Updates on the Innovation and Investment Summit

Nielsen Hobbs
Editor
Pink Sheet

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 UPDATE 2019 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 Afternoon Remarks

Nielsen Hobbs
Editor
Pink Sheet

1:00

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

INTERVIEWER:

Sue Sutter
Senior Editor
Pink Sheet and Scrip

PARTICIPANT:

Celia M. Witten, PhD, MD
Deputy Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)

1:45

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

INTERVIEWER:

Michael Cipriano
Senior Writer
Pink Sheet and Scrip

PARTICIPANT:

Peter Stein, MD
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

3:00

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A-B)

Track A Trends in Aligning
Data Requirements
and Advancing Biosimilars Adoption

3:00

PANEL Evolving the Rare Disease Drug Review Process

MODERATOR:

Derrick Gingery
Senior Writer
The Pink Sheet and Scrip

PANELISTS:

Emil D. Kakkis, MD, PhD
CEO, President and Founder
Ultragenyx Pharmaceutical Inc.

Ron Cooper
President & CEO
Albireo Pharma

Adora Ndu, PharmD, JD
Vice President, Regulatory Affairs;
PRE & International
BioMarin Pharmaceutical Inc.

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

 
Track B Med Device and Technology Powered by: MedTech Insight logo

3:00

INTERACTIVE Q&A SESSION Addressing the Evolution of Cybersecurity Issues in Medical Devices

INTERVIEWER:

Jithesh Veetil, PhD
Program Director, Data Science & Technology
Medical Device Innovation Consortium (MDIC)

PARTICIPANTS:

Paul Westfall
Washington Counsel
American Medical Association

Linda Ricci
Acting Director, Division of All Hazard Response, Science and Strategic Partnerships
Office of Strategic Partnerships and Technology Innovation (OST), CDRH, FDA

3:45

PANEL Understand the Shifting Regulatory Policy Landscape for Cell and Gene Therapies

MODERATOR:

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

PANELISTS:

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

Dan Takefman, PhD
Head, Regulatory Affairs
Spark Therapeutics

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

Janet Maynard, MD, MHS
Director,
Office of Orphan Products Development
U.S. Food and Drug Administration (FDA)

 

3:45

Examine the Current Regulatory Landscape for Diagnostics

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

4:30

PANEL Expanding the Role of RWE and PROs in Regulatory Decision-Making

MODERATOR:

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

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

Robbert Zusterzeel, MD, PhD, MPH
Data Network Director
NEST Coordinating Center (NESTcc)

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 TWO Wednesday, December 4, 2019

8:00

Registration and Continental Breakfast
Hosted By:

8:30

Chairman’s Welcome

Nielsen Hobbs
Editor
Pink Sheet

8:45

PANEL Advancing Value-Based Payment Models

MODERATOR:

Jay Jackson
Associate Principal, Commercialization and Regulatory Strategy
Avalere Health

PANELISTS:

Tamar Thompson
Health Policy Strategist
Consultant
Former Head, Federal Executive Branch Strategy & State Government Affairs
Bristol-Myers Squibb Company

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

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

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

9:45

FIRESIDE CHAT Examine the Impact of the Drug Pricing Debate on Pharma from Lab to Life

MODERATOR:

David Thompson, PhD
Senior Vice President, Real World and Late Phase
Syneos Health

PANELISTS:

Ron Cohen, MD
Founder, President and CEO
Acorda Therapeutics

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

10:30

Networking and Refreshment Break

Track A Trends in Aligning
Data Requirements
and Advancing Biosimilars Adoption

11:00

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

MODERATOR:

David Thompson, PhD
Senior Vice President,
Real World and Late Phase
Syneos Health

PANELISTS:

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Chris Garabedian
Chairman and CEO
Xontogeny

 
Track B Med Device and Technology Powered by: MedTech Insight logo

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, MD
Senior Medical Advisor for Innovation,
Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

11:45

Current and Future Trends in Advancing Adoption of Biosimilars

MODERATOR:

Christine M. Simmon
Senior Vice President Policy & Strategic Alliances, Executive Director
Pfizer Inc.

PANELISTS:

Dara Corrigan
Vice President, Government Affairs and Policy
Fresenius Kabi

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, MD, FACP
Associate Executive Director
The Permanente Medical Group

Leah Christl
Executive Director, Global Regulatory and R&D Policy
Amgen

 

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

Jon Speer
Founder & VP of QA/RA
Greenlight Guru

12:30

Networking Luncheon

1:30

Transformative Reimbursement for Transformative Therapies

MODERATOR:

Miriam Kalnicki
Senior Strategist, Reputation and Risk Management Practice
Syneos Health

PANELISTS:

Richard Elkind
Chief PA, Oncology
Montefiore Medical Center

Erin Frey
Senior Director of Advocacy
CureDuchenne

Peter Pitts
President and co-founder of the Center for Medicine in the
Public Interest and Former FDA Associate Commissioner
Center for Medicine in the Public Interest

2:15

PANEL Driving Patient Focused Product Development

PANELISTS:

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

Maura Dickler, MD
Late Stage Development, Lilly Oncology
Eli Lilly & Company

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

Nielsen Hobbs
Editor
Pink Sheet

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

7:45

Registration and Continental Breakfast
Hosted By:

8:30

Chairperson’s Welcome and Opening Remarks

Nielsen Hobbs
Editor
Pink Sheet

8:45

OPENING KEYNOTE ADDRESS

Amy P. Abernethy, MD, PhD
Principal Deputy Commissioner
U.S. Food and Drug Administration (FDA)

9:15

CDER KEYNOTE ADDRESS 2019 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

FIRESIDE CHAT Updates on the Innovation and Investment Summit

Nielsen Hobbs
Editor
Pink Sheet

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 UPDATE 2019 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 Afternoon Remarks

Nielsen Hobbs
Editor
Pink Sheet

1:00

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

INTERVIEWER:

Sue Sutter
Senior Editor
Pink Sheet and Scrip

PARTICIPANT:

Celia M. Witten, PhD, MD
Deputy Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)

1:45

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

INTERVIEWER:

Michael Cipriano
Senior Writer
Pink Sheet and Scrip

PARTICIPANT:

Peter Stein, MD
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

3:00

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A-B)

Track A Trends in Aligning
Data Requirements
and Advancing Biosimilars Adoption

3:00

PANEL Evolving the Rare Disease Drug Review Process

MODERATOR:

Derrick Gingery
Senior Writer
The Pink Sheet and Scrip

PANELISTS:

Emil D. Kakkis, MD, PhD
CEO, President and Founder
Ultragenyx Pharmaceutical Inc.

Ron Cooper
President & CEO
Albireo Pharma

Adora Ndu, PharmD, JD
Vice President, Regulatory Affairs;
PRE & International
BioMarin Pharmaceutical Inc.

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

 
Track B Med Device and Technology Powered by: MedTech Insight logo

3:00

INTERACTIVE Q&A SESSION Addressing the Evolution of Cybersecurity Issues in Medical Devices

INTERVIEWER:

Jithesh Veetil, PhD
Program Director, Data Science & Technology
Medical Device Innovation Consortium (MDIC)

PARTICIPANTS:

Paul Westfall
Washington Counsel
American Medical Association

Linda Ricci
Acting Director, Division of All Hazard Response, Science and Strategic Partnerships
Office of Strategic Partnerships and Technology Innovation (OST), CDRH, FDA

3:45

PANEL Understand the Shifting Regulatory Policy Landscape for Cell and Gene Therapies

MODERATOR:

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

PANELISTS:

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

Dan Takefman, PhD
Head, Regulatory Affairs
Spark Therapeutics

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

Janet Maynard, MD, MHS
Director,
Office of Orphan Products Development
U.S. Food and Drug Administration (FDA)

 

3:45

Examine the Current Regulatory Landscape for Diagnostics

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

4:30

PANEL Expanding the Role of RWE and PROs in Regulatory Decision-Making

MODERATOR:

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

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

Robbert Zusterzeel, MD, PhD, MPH
Data Network Director
NEST Coordinating Center (NESTcc)

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 TWO Wednesday, December 4, 2019

8:00

Registration and Continental Breakfast
Hosted By:

8:30

Chairman’s Welcome

Nielsen Hobbs
Editor
Pink Sheet

8:45

PANEL Advancing Value-Based Payment Models

MODERATOR:

Jay Jackson
Associate Principal, Commercialization and Regulatory Strategy
Avalere Health

PANELISTS:

Tamar Thompson
Health Policy Strategist
Consultant
Former Head, Federal Executive Branch Strategy & State Government Affairs
Bristol-Myers Squibb Company

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

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

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

9:45

FIRESIDE CHAT Examine the Impact of the Drug Pricing Debate on Pharma from Lab to Life

MODERATOR:

David Thompson, PhD
Senior Vice President, Real World and Late Phase
Syneos Health

PANELISTS:

Ron Cohen, MD
Founder, President and CEO
Acorda Therapeutics

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

10:30

Networking and Refreshment Break

Track A Trends in Aligning
Data Requirements
and Advancing Biosimilars Adoption

11:00

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

MODERATOR:

David Thompson, PhD
Senior Vice President,
Real World and Late Phase
Syneos Health

PANELISTS:

Susan Cantrell
CEO
Academy of Managed Care Pharmacy

Chris Garabedian
Chairman and CEO
Xontogeny

 
Track B Med Device and Technology Powered by: MedTech Insight logo

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, MD
Senior Medical Advisor for Innovation,
Office of the Administrator
Centers for Medicare and Medicaid Services (CMS)

11:45

Current and Future Trends in Advancing Adoption of Biosimilars

MODERATOR:

Christine M. Simmon
Senior Vice President Policy & Strategic Alliances, Executive Director
Pfizer Inc.

PANELISTS:

Dara Corrigan
Vice President, Government Affairs and Policy
Fresenius Kabi

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, MD, FACP
Associate Executive Director
The Permanente Medical Group

Leah Christl
Executive Director, Global Regulatory and R&D Policy
Amgen

 

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

Jon Speer
Founder & VP of QA/RA
Greenlight Guru

12:30

Networking Luncheon

1:30

Transformative Reimbursement for Transformative Therapies

MODERATOR:

Miriam Kalnicki
Senior Strategist, Reputation and Risk Management Practice
Syneos Health

PANELISTS:

Richard Elkind
Chief PA, Oncology
Montefiore Medical Center

Erin Frey
Senior Director of Advocacy
CureDuchenne

Peter Pitts
President and co-founder of the Center for Medicine in the
Public Interest and Former FDA Associate Commissioner
Center for Medicine in the Public Interest

2:15

PANEL Driving Patient Focused Product Development

PANELISTS:

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

Maura Dickler, MD
Late Stage Development, Lilly Oncology
Eli Lilly & Company

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

Nielsen Hobbs
Editor
Pink Sheet

3:00

Close of Conference