Moving the Industry Towards Increased Patient Access

The Pre-approval Access Programs conference offers the chance to benchmark with key opinion leaders, connect with like-minded peers, and share different perspectives. This extensive program will highlight the most challenging regulatory requirements and best practices in creating a streamlined pre-approval access program.

Global access and regulatory compliance are the strongest drivers of pre-approval access programs from big pharma to small biotech. With the number of patients in need of new therapies to tackle their rare diseases growing, the public is clamoring for programs designed to offer drugs before they have been approved. Slow processes, cumbersome paperwork and the question of liability provide major roadblocks to the enactment of these programs. As awareness grows through social media and recent regulation, the industry must gain momentum in putting together the proper structure to get drugs to market. Join us this September to move the needle forward.

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Why You Can't Miss This

Engage in high level Industry discussion with legislative experts to illuminate recent developments in Right to Try, patient consent and more. 

Work towards building industry standards for a program structure best fit to deliver cures to those in need.

Hear Jennifer McNary speak to the importance of the often overlooked patient perspective.

Strengthening the relationship between key industry players to accelerate drug development.

Featured Speakers

Anne B. Cropp

Chief Scientific Officer
Early Access Care

Ramana Sonty

Director, Global Medical Organization
Johnson & Johnson

Jennifer McNary

Patient Advocate
Beauhawks Foundation

Brian Malkin

FDA Counsel
Arent Fox LLP

Alison Bateman-House

Assistant Professor – Division of Medical Ethics

Naomi Lopez Bauman

Director of Healthcare Policy
Goldwater Institute

Andrew McFadyen

Executive Director
The Isaac Foundation

Paul Aliu

Global Head Medical Governance, Chief Medical Office

Catherine Blansfield

Vice President of Patient Services
National Organization for Rare Disorders (NORD)

Pat Furlong

President & CEO
Parent Project Muscular Dystrophy

Jessica Imrie

Rare Diseases, Gene Therapy Head of Strategy and Operations

Paul Melmeyer

Director of Federal Policy
National Organization for Rare Disorders (NORD)

Karen Bartels

Director, Global Medical Affairs, Early Clinical Development and External Research

June Wasser

Executive Director and CEO
Reagan-Udall Foundation for the FDA

Jane Reese-Coulbourne

Senior Consultant

Richard Klein

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

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Advisory Board

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Sponsors & Exhibitors
Media Partners