Virtualizing Long-Term Follow-Up Studies for Gene Therapy Products

March 27, 2019
1:00PM EDT | 5:00PM GMT | 6:00PM CET - 1 hour in duration
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Speaker: Jennifer Urwongse, MBA

In recent years, there has been a tremendous surge in gene therapy research, with several recent approvals and a large pipeline of candidates currently in trials. In 2018, the FDA published its updated draft recommendations for long-term follow-up (LTFU) observational studies after administration of gene therapy products. This presentation provides an overview of the FDA’s recommendations on how to design LTFU studies, including specific considerations on observation and data collection, and monitoring for clinical events of interest. This presentation will also offer suggested approaches to “virtualize” LTFU studies, that could strengthen patient engagement and retention, and facilitate the collection of information over extended periods of time.

Learning Objectives:

  • Discover the FDA’s updated recommendations for long-term follow-up after administration of gene therapy products.
  • Describe how to design LTFU studies using these recommendations.
  • Discover approaches that could strengthen patient engagement and retention over extended periods of time.

This is a Members ONLY webinar.
Members will receive an official member invitation via Email.
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Jennifer Urwongse, BA Economics, MBA
Associate Director
Covance Inc

Please note: On the day of the scheduled webinar, the first 500 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 weeks after the scheduled Webinar.

Reservations are on a first-come, first-served basis for all ISPOR members.

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