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Pre-Approval Access: Can Compassion, Business, and Medicine Coexist?

  
  October 01, 2015
Medical Research (others)
  
     
 
New York Academy of Sciences, The New York Academy of Sciences 7 World Trade Center 250 Greenwich Street, 40th floor New York, NY 10007-2157
10/28/2015 - 10/29/2015

Day 1: Wednesday, October 28, 2015

7:00 AM

Registration and Breakfast

8:00 AM

Welcome Remarks
Ellis Rubinstein, The New York Academy of Sciences
Paul Stoffels, MD, Janssen Pharmaceutical Companies; Johnson & Johnson

8:30 AM

Setting the Stage: Current Challenges and Complexities of Compassionate Use
Arthur Caplan, PhD, NYU School of Medicine

Session I. Patients' Perspectives: Compassionate Use and Expanded Access

9:00 AM

Panel Discussion

Moderator:

 

Arthur Caplan, PhD, NYU School of Medicine

Panelists:

 

Danielle Leach, MPA, St. Baldrick's Foundation
Musa Mayer, MS, MFA, AdvancedBC.org; National Breast Cancer Coalition
Steve Walker, Abigail Alliance
Marc Boutin, JD, National Health Council
Pat Furlong, Parent Project Muscular Dystrophy

10:30 AM

Networking Coffee Break

Session II. Case Study: Josh Hardy and the Impact of Social Media

11:00 AM

Panel Discussion

Moderator:

 

Brooke Gladstone, National Public Radio, On the Media

Panelists:

 

Richard Plotkin, JD, The Max Cure Foundation
Kenneth I. Moch, BA, MBA, Chimerix (2009-2014); Euclidean Life Science Advisors
Debra Birnkrant, MD, U.S. Food and Drug Administration
Nancy Goodman, Kids v Cancer
Additional Panelist to Be Announced

12:30 PM

Networking Lunch

Session III. Compassionate Use during a Public Health Crisis: Lessons Learned from the Ebola Epidemic

1:45 PM

Panel Discussion

Moderator:

 

Arthur Caplan, PhD, NYU School of Medicine

Panelists:

 

Marion Danis, MD, U.S. National Institutes of Health
Piero Olliaro, MD, PhD, World Health Organization
Linda M. Mobula, MD, MPH, Johns Hopkins University
Annette Rid, MD, PhD, King's College, London

2:15 PM

Networking Coffee Break

3:45 PM

Keynote Lecture

Can Evidence-based Medicine and Compassionate Use Coexist?
Speaker to Be Announced

Session IV. Stakeholder Perspectives: Key Issues When Considering a Compassionate Use Request

4:15 PM

Panel Discussion

Moderator:

 

Nancy Neveloff Dubler, LLB, New York City Health and Hospitals Corporation; NYU School of Medicine

Panelists:

 

Michael Rosenblatt, MD, Merck & Co., Inc.
Steve Usdin, BioCentury
Jane Reese Coulbourne, MS, ChE, Reagan-Udall Foundation for the U.S. FDA
Ronald Krall, MD, University of Pittsburgh
Richard Klein, U.S. Food and Drug Administration

5:15 PM

Closing Remarks

5:45 PM

Networking Reception

7:00 PM

Day 1 Adjourns

Day 2: Thursday, October 29, 2015

7:00 AM

Continental Breakfast

8:00 AM

Welcome Remarks
Future Vision and New Directions
Joanne Waldstreicher, MD, Johnson & Johnson

Session V. Can Legislative or Regulatory Changes Ameliorate the Challenges of Compassionate Use and Expanded Access?

8:30 AM

Panel Discussion

Moderator:

 

Alison Bateman-House, MA, MPH, PhD, NYU School of Medicine

Panelists:

 

The Honorable Linda Rosenthal, New York State Assembly
Christina Sandefur, JD, The Goldwater Institute
Fritz Bittenbender, Biotechnology Industry Organization
Peter C. Adamson, MD, The Children's Hospital of Philadelphia

10:00 AM

Networking Coffee Break

Session VI. International Perspectives: How do Compassionate Use and Expanded Access Policies Differ Globally?

10:30 AM

Panel Discussion

Moderator:

 

Arthur Caplan, PhD, NYU School of Medicine

 

Panelists:

 

Additional Panelists to Be Announced

Session VII. New Directions for "Pre-Approval" Access

11:30 PM

Panel Discussion

Moderator:

 

Fred Guterl, Scientific American

Panelists:

 

Amrit Ray, MD, Johnson & Johnson
David Scheer, MS, Scheer and Company, Inc.
Tanya Scharton-Kersten, PhD, International AIDS Vaccine Initiative (IAVI)
Alicia Jackson, PhD, GEVentures

12:30 PM

Networking Lunch

Session VIII. Future Vision: Ethics and Policy Lens

1:30 PM

Panel Discussion

Moderator:

 

Alison Bateman-House, MA, MPH, PhD, NYU School of Medicine

Panelists:

 

Nancy Neveloff Dubler, LLB, New York City Health and Hospitals Corporation; NYU School of Medicine
Beth Roxland, JD, MBioethics, Johnsohn & Johnson; NYU School of Medicine
Luann Van Campen, MA, MS, PhD, Eli Lilly and Company
Franklin Miller, PhD, Weill Cornell Medical College
Jerry Menikoff, MD, JD, U.S. Department of Health and Human Services
Daniel McIntyre, Biogen

3:00 PM

Closing Remarks

3:15 PM

Colloquium Concludes

  
 
Organized by: New York Academy of Sciences
Invited Speakers:

Scientific Organizing Committee

Alison Bateman-House, PhD, MPH, MA

NYU School of Medicine

Melanie Brickman Stynes, MSc, PhD

The New York Academy of Sciences

Art Caplan, PhD

NYU School of Medicine
website

Brooke Grindlinger, PhD

The New York Academy of Sciences

Erick T. Tatro, PhD

The New York Academy of Sciences

Speakers

Peter C. Adamson, MD

The Children's Hospital of Philadelphia
website

Debra Birnkrant, MD

U.S. Food and Drug Administration
website

Fritz Bittenbender

Biotechnology Industry Organization

Marc Boutin, JD

National Health Council
website

Rob Camp

European Organization for Rare Diseases

Marion Danis, MD

U.S. National Institutes of Health

Nancy Neveloff Dubler, LLB

New York City Health and Hospitals Corporation; NYU School of Medicine

Pat Furlong

Parent Project Muscular Dystrophy
website

Nancy Goodman

Kids v Cancer

Fred Guterl

Scientific American
website

Alicia Jackson, PhD

GEVentures

Richard Klein

U.S. Food and Drug Administration

Ronald Krall, MD

University of Pittsburgh

Danielle Leach, MPA

St. Baldrick's Foundation
website

Musa Mayer, MS, MFA

AdvancedBC.org; National Breast Cancer Coalition
website

Daniel McIntyre

Biogen
website

Jerry Menikoff, MD, JD

U.S. Department of Health and Human Services

Franklin Miller, PhD

Weill Cornell Medical College 

Linda M. Mobula, MD, MPH

Johns Hopkins University

Kenneth I. Moch, BA, MBA

Chimerix (2009-2014); Euclidean Life Science Advisors

Piero Olliaro, MD, PhD

World Health Organization

Richard Plotkin, JD

The Max Cure Foundation, Inc.
website

Amrit Ray, MD

Janssen Research & Development, LLC
website

Jane Reese Coulbourne, MS, ChE

Reagan-Udall Foundation for the U.S. FDA

Annette Rid, MD

King's College, London
website

Michael Rosenblatt, MD

Merck & Co., Inc.
website

The Honorable Linda Rosenthal

New York State Assembly

Beth Roxland, JD, MBioethics

Johnsohn & Johnson; NYU School of Medicine

Christina Sandefur, JD

The Goldwater Institute
website

David Scheer, MS

Scheer and Company, Inc.

Tanya Scharton-Kersten, PhD

International AIDS Vaccine Initiative (IAVI)
website

Steve Usdin

BioCentury
website

Luann Van Campen, MA, MS, PhD

Eli Lilly and Company
website

Joanne Waldstreicher, MD

Johnson & Johnson

Steve Walker, MS

Abigail Alliance
website
 
Deadline for Abstracts: 2015-10-28
 
Registration:

This event is free, but registration is required. To attend, please click on the “Register Now” button in the grey box at the top of this page. Your registration will be complete upon receipt of a confirmation email. If you do not receive a confirmation, please contact customerservice@nyas.org for assistance. Although on-site registration may be possible on the day of the event, pre-registration is highly encouraged due to space limitations.

The New York Academy of Sciences

7 World Trade Center
250 Greenwich Street, 40th floor
New York, NY 10007-2157
212.298.8600

 http://www.nyas.org/Events/Detail.aspx?cid=e98dad27-f8db-4af3-88bc-a1e2fa11e066
E-mail: nyas@gomeeting.com
 
   
 
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