Illuminating the Way for Ethical, Cooperative and Efficient Pre-Approval Access in Unchartered Territory
Join us at the second annual Pre-approval Access Programs Summit to reconvene with major topic influencers and be a part of the plan the future of Pre-Approval. Pharmaceutical and biotech executives, patient advocates, regulators and academia combine forces to create an all-encompassing program spotlighting each perspectives’ most challenging road blocks yielding standards and procedures you can look to for guidance.
We dive back into the most polarizing topics such as patient consent, right-to-try and what these programs mean for your adverse event data and continue to trail blaze program structures for newcomers looking to provide these potentially life-saving solutions. Faster processes, less paperwork and more defined roles provide more reliable guidelines than ever, but there is much more to do. With the number of patients in need of new therapies to tackle their rare diseases growing, we have an obligations to ensure the right therapies and responsibly given to those who need it most. Join us this July as we continue the conversation and clarify this uncertain landscape.
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.
Executive Board Chair
Quorum Review IRB
Director, Global Medical Organization
Johnson & Johnson
Anne B. Cropp
Chief Scientific Officer
Early Access Care
Director, Global Medical Affairs, Early Clinical Development and External Research
Timothy M Miller
VP & Head, North America Medical Affairs, Rare Diseases
Assistant Professor – Division of Medical Ethics
Executive Director and CEO
Reagan-Udall Foundation for the FDA
Beth E. Roxland
Senior Consultant on Law, Policy, and Ethics; Associate Division of Medical Ethics
NYU Langone School of Medicine
Pre-approval Access Consultant
TW Consulting Group
The Social Medwork
Co-Founder and Executive Director
Global Bioethics Initiative Inc.