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.
Why You Can't Miss This
- High level Industry discussion and networking
- Working towards industry standards
- Interactive workshops – Deep dive into industry challenges
- Strengthening the relationship between key industry players to accelerate drug development
Meet the Advisory Board and Speakers
Advisory Board
- Anne B. Cropp, Chief Scientific Officer, Early Access Care, LLC
- Ramana Sonty, Director, Global Medical Organization, Johnson & Johnson
- Naomi Lopez Bauman, Director of Healthcare Policy, Goldwater Institute
- Brian J. Malkin, FDA Counsel, Arent Fox LLP
- Beth E. Roxland, Senior Consultant on Law, Policy, and Ethics; Associate Division of Medical Ethics, NYU Langone School of Medicine
- Jennifer McNary, Patient Advocate, Beauhawks Foundation
- Andrew McFadyen, Executive Director, The Isaac Foundation
- Frank Burroughs, CEO, Abigail Alliance for Better Access to Developmental Drugs
- Tom Watson, Pre-approval Access Consultant, TW Consulting Group
- Mark Corbett, Executive Vice President, Inceptua Medicines Access
- Sjaak Vink, CEO, The Social Medwork
- Kevin J. Weatherwax, Administrative Program Director; Co-Chair - Expanded Access Oversight Committee, University of Michigan Health System
- Ana Lita, Co-Founder and Executive Director, Global Bioethics Initiative Inc.
- John Lagus, Head of Managed Access, Clinigen Group
Speakers
- Anne B. Cropp, Chief Scientific Officer, Early Access Care
- Pat Furlong, President & CEO, Parent Project Muscular Dystrophy
- Ramana Sonty, Director, Global Medical Organization, Johnson & Johnson
- Beverly Harrison, Head, Patient Support, Johnson and Johnson
- Christine MacCracken, Director, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
- Paul Aliu, Global Head Medical Governance, Chief Medical Office, Novartis
- Jessica Imrie, Rare Diseases, Gene Therapy Head of Strategy and Operations, GSK
- Romina Oxborough, Director Clinigen Consulting, Clinigen Group
- Dane Hartung, Director Marketing and Access, Fougera / PharmaDerm Pharmaceuticals a Division of Novartis
- Dr. Kiran Bhirangi, Head of Medical Affairs, Cardiome Pharma Corp
- Shellie Unell, Operational Lead, Global Medical Affairs, Astrazeneca
- Alison Bateman-House, Assistant Professor – Division of Medical Ethics, NYU
- Naomi Lopez Bauman, Director of Healthcare Policy, Goldwater Institute
- Catherine Blansfield, Vice President of Patient Services, National Organization for Rare Disorders (NORD)
- Paul Melmeyer, Director of Federal Policy, National Organization for Rare Disorders (NORD)
- Brian Malkin, FDA Counsel, Arent Fox LLP
- Andrew McFadyen, Executive Director, The Isaac Foundation
- Frank Burroughs, Founder & CEO, Abigail Alliance for Better Access to Developmental Drugs
- Jennifer McNary, Patient Advocate, Beauhawks Foundation
- Kevin J. Weatherwax, Administrative Program Director; Co-Chair - Expanded Access Oversight Committee, University of Michigan Health System
- Blair Holbein, Director, Assistant Professor, UT Southwestern Medical Center
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference Workshop Day - Monday, September 25th, 2017
Main Conference Day One - Tuesday September 26, 2017
Main Conference Day Two - Wednesday September 27th, 2017
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
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Venue
Venue to be confirmedPhiladelphia, PA
AccommodationMore information to follow...
Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the HotelMap link provided; this shows live availability and rates for all hotels in the area and allows you to book directly with the hotel of your choice within your budget.
