Margaret A. Hamburg
Commissioner of the U.S. Food and Drug Administration
Presentation of the Working Group’s Key Recommendations
Former CGD Research Fellow and Working Group Chair Panel Discussion Featuring
AERAS Global TB Vaccine Foundation
Johns Hopkins Bloomberg School of Public Health
Bill & Melinda Gates Foundation
Director of Global Health Policy & Research Fellow
Center for Global Development
An estimated one billion people suffer from one or more neglected diseases like Tuberculosis, Malaria, Dengue Fever or others, and hundreds of millions of dollars have been spent to find effective treatments. Medicines, therapies and treatments have been discovered, but regulatory barriers in the late-stage clinical trials of developing countries have prevented these drugs from helping those in need.
The report of the Center for Global Development Clinical Trials and Regulatory Pathways Working Group —chaired by Tom Bollyky—offers practical and scalable policy recommendations to expedite the clinical trials process in developing countries. The report suggests a two pronged solution: (1) the development of regional pathways for the review of clinical trials in disease-endemic settings, and also (2) better, faster, and cheaper clinical trials by focusing on key parameters and objectives of trials, evidence-driven approaches, and early engagement among trial sponsors.
FDA Commissioner Margaret A. Hamburg’s opening remarks will be followed by presentation of the key findings and a discussion panel featuring members of the Clinical Trials and Regulatory Pathways Working Group.