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. 

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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

Stephen Rosenfeld

Executive Board Chair

Quorum Review IRB

Ramana Sonty

Director, Global Medical Organization

Johnson & Johnson

Anne B. Cropp

Chief Scientific Officer

Early Access Care

Karen Bartels

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


Timothy M Miller

VP & Head, North America Medical Affairs, Rare Diseases

Sanofi Genzyme

Alison Bateman-House

Assistant Professor – Division of Medical Ethics


June Wasser

Executive Director and CEO

Reagan-Udall Foundation for the FDA

Marjorie Speers

Executive Director

WCG Foundation

Jennifer McNary

Patient Advocate

Beauhawks Foundation

Advisory Board

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