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Speakers

Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real World Evidence

March 28-29, 2018
  • Washington, DC

Paul Aliu, PharmD, MBA
Global Head, Medical Governance, Chief Medical Office
Novartis Pharma AG

Alison Bateman-House
Research Assistant Professor, Division of Medical Ethics
NYU

Anne B. Cropp
Chief Scientific Officer
Early Access Care

Mariangela Demarcus, PhD
Associate Director, Managed Access Programs, Ph IV & Medical Strategy
Vertex Pharmaceuticals (Europe) Limited

Cartier Esham
Executive Vice President, Emerging Companies,
Vice President, Science and Regulatory Affairs
Biotechnology Innovation Organization (BIO)

Elena Gerasimov, MA, MPH
Director of Programs
Kids v Cancer

Brenda Gleason
President, M2 Health Care Consulting;
Professorial Lecturer, GWU School of Public Health

Beverly Harrison
Head of Patient Support,
Office of the Chief Medical Officer
Johnson & Johnson

Myra R. Herrle, PhD, RPh, RAC
Senior Director, Global Regulatory Strategy (GRS)
AbbVie Inc.

Emma James, PhD
Senior Director, Medical Affairs & Health Outcomes
Audentes Therapeutics, Inc.

Erika Segear Johnson, PhD, RAC
Associate Director, Regulatory Affairs,
Office of Regulatory Affairs and Quality
Duke University School of Medicine

Richard Klein
Former Director, Patient Liaison
FDA

Christine MacCracken
Director, Patient Support,
Office of the Chief Medical Officer
Johnson & Johnson

Hank Mansbach
Vice President, Clinical Development
Ultragenyx Pharmaceutical Inc.

Jennifer McNary
Board Member, Beauhawks Foundation; and Manager
JMcNary Consulting

Paul Melmeyer
Director, Federal Policy
National Organization of Rare Disorders

Jess Rabourn
Co-founder and Managing Director
WideTrial

Gretchen M. Randlett
Consultant – Clinical Trial Commercial Product Strategy and Process
Eli Lilly and Company

Ramana Sonty
Director, Global Medical Organization
Johnson & Johnson

Kristin Van Goor
Senior Director, Global Regulatory Policy, US Lead
Biogen

June Wasser
Executive Director/CEO
Reagan-Udall Foundation

Weatherwax
Director IND/IDE Assistance Program
University of Michigan Health System

Paul Aliu, PharmD, MBA
Global Head, Medical Governance, Chief Medical Office
Novartis Pharma AG

Alison Bateman-House
Research Assistant Professor, Division of Medical Ethics
NYU

Anne B. Cropp
Chief Scientific Officer
Early Access Care

Mariangela Demarcus, PhD
Associate Director, Managed Access Programs, Ph IV & Medical Strategy
Vertex Pharmaceuticals (Europe) Limited

Cartier Esham
Executive Vice President, Emerging Companies,
Vice President, Science and Regulatory Affairs
Biotechnology Innovation Organization (BIO)

Elena Gerasimov, MA, MPH
Director of Programs
Kids v Cancer

Brenda Gleason
President, M2 Health Care Consulting;
Professorial Lecturer, GWU School of Public Health

Beverly Harrison
Head of Patient Support,
Office of the Chief Medical Officer
Johnson & Johnson

Myra R. Herrle, PhD, RPh, RAC
Senior Director, Global Regulatory Strategy (GRS)
AbbVie Inc.

Emma James, PhD
Senior Director, Medical Affairs & Health Outcomes
Audentes Therapeutics, Inc.

Erika Segear Johnson, PhD, RAC
Associate Director, Regulatory Affairs,
Office of Regulatory Affairs and Quality
Duke University School of Medicine

Richard Klein
Former Director, Patient Liaison
FDA

Christine MacCracken
Director, Patient Support,
Office of the Chief Medical Officer
Johnson & Johnson

Hank Mansbach
Vice President, Clinical Development
Ultragenyx Pharmaceutical Inc.

Jennifer McNary
Board Member, Beauhawks Foundation; and Manager
JMcNary Consulting

Paul Melmeyer
Director, Federal Policy
National Organization of Rare Disorders

Jess Rabourn
Co-founder and Managing Director
WideTrial

Gretchen M. Randlett
Consultant – Clinical Trial Commercial Product Strategy and Process
Eli Lilly and Company

Ramana Sonty
Director, Global Medical Organization
Johnson & Johnson

Kristin Van Goor
Senior Director, Global Regulatory Policy, US Lead
Biogen

June Wasser
Executive Director/CEO
Reagan-Udall Foundation

Weatherwax
Director IND/IDE Assistance Program
University of Michigan Health System