Clinical and Regulatory Considerations for the Development of Therapeutic HIV Vaccines

Time

Tue, Jun 26 11:00AM
T 23

Title

Clinical and Regulatory Considerations for the Development of Therapeutic HIV Vaccines

Abstract Summary

Global regulatory guidances, advisory committee opinions, and regulatory intelligence databases were evaluated for product information, pivotal trial designs, endpoints, and regulatory precedence. Clinical and surrogate endpoints used in the pivotal trials, along with the regulatory guidances were compared. Competitive intelligence benchmarking and regulatory landscapes were developed for use in providing strategic regulatory development plans.

Poster Presenter

Kelly Denice Whitley De Padilla
PharmD, RPh,
Medical Information Scientist,
Glaxosmithkline
United States

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