Post-Approval Commercialization

Find presenter-approved materials from the Post-Approval Commercialization ASGCT Pre-Meeting Workshop

The Post-Approval Commercialization Workshop includes sessions on patient focused drug development; post-approval change management and overall impact on commercialization; and pricing, reimbursement, and payment models for gene therapies.

2019 Workshop Materials

Role of the Patient

Ron Bartek—Friedreich’s Ataxia Research Alliance (FARA)

Achieving Sustainable Patient and Market Access

Philip Reilly M.D., J.D.—Third Rock Ventures

Achieving Sustainable Market and Patient Access: Medicare and Medicaid Coverage, Reimbursement, and Coding Issues for CAR-T

Jugna Shah, MPH—Nimitt Consulting

Limitations of QALYs in Cost-Effectiveness Reviews

William Smith, Ph.D.—Visiting Fellow in Life Sciences Pioneer Institute

Managing Post-Approval Changes In Gene Therapy Products

Ramjay S. Vatsan, Ph.D., CQA—FDA CBER

The Role of The Patient

Celia M. Witten, Ph.D., M.D.—FDA CBER