Main Day 2

9:00 AM - 9:45 AM Get an Insider’s Look into J&J’s Compassionate Use Advisory Committee (CompAC): 17 Months of Data Provides Groundbreaking Insight into the Patient Perspective

Beverly Harrison, Head, Patient Support , Johnson and Johnson

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Beverly Harrison

Head, Patient Support
Johnson and Johnson

10:00 AM - 10:45 AM Explore Manufacturers’ Challenges to Facilitate Understanding and Potential Approaches Within Gene Therapy

Jessica Imrie, Rare Diseases, Gene Therapy Head of Strategy and Operations, GSK

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Jessica Imrie

Rare Diseases, Gene Therapy Head of Strategy and Operations
GSK

11:30 AM - 12:15 PM Strategies for Interpreting Regulations within your Access Programs Globally

Paul Aliu, Global Head Medical Governance, Chief Medical Office, Novartis

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Paul Aliu

Global Head Medical Governance, Chief Medical Office
Novartis

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Paul Aliu

Global Head Medical Governance, Chief Medical Office
Novartis
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Ramana Sonty

Director, Global Medical Organization
Johnson & Johnson

Tom Watson

Pre-approval Access Consultant
TW Consulting Group

1:45 PM - 2:30 PM Adapting Big Pharma Logistics Strategies to Ensure Success within Biotech Organizations

Arun Kumar , President & CEO, Neuracon Biotech Inc

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Arun Kumar

President & CEO
Neuracon Biotech Inc

2:30 PM - 3:15 PM Converting PAP data into Real World Insights to Advance the Cure

Romina Oxborough, Director Clinigen Consulting, Clinigen Group

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Romina Oxborough

Director Clinigen Consulting
Clinigen Group

3:45 PM - 4:30 PM Understanding Recent Legislative and Regulatory Developments, including 21st Century Cures and the Final Rule

Jane Reese-Coulbourne, Senior Consultant, MK&A

Jane Reese-Coulbourne

Senior Consultant
MK&A

4:30 PM - 5:15 PM Collecting Adverse Event Data and their Impact on Drug Development

Richard Klein, Former Director, FDA Patient Liaison Program at Food and Drug Administration, FDA

Richard Klein

Former Director, FDA Patient Liaison Program at Food and Drug Administration
FDA