The Institute for Global Pharmaceutical Development expects to be operational in early 2005 with University of Arizona VP-Health Sciences Raymond Woosley, MD/PhD, as its head.

The Tuscon, Ariz.-based institute is a collaboration between FDA, SRI International (formerly Stanford Research Institute) and the University of Arizona. IGPD will conduct educational and research programs to help speed drug development.

IGPD is expected to perform research and offer drug development training related to FDA's "Critical Path" initiative (¹ Also see "FDA Will Fund Research On “Critical Path” Of Drug Development" - Pink Sheet, 22 March, 2004., p. 30).

The consortium will be created via a memorandum of understanding between FDA and the other partners. The goal will be to obtain funding via a legislative appropriation tied to the "Critical Path" initiative.

IGPD is envisioned as "neutral ground," similar to the Illinois Institute of Technology's Moffett Center, a consortium of representatives from FDA, industry and academia that investigates food processing and packaging issues.

"The University of Arizona will serve as home for the Institute's educational and research programs and provide an environment of innovation and inquiry," an IGPD backgrounder states.

"The participating FDA scientists will provide first-hand knowledge of the regulatory process and a wealth of experience in the evaluation of new pharmaceutical agents. SRI will bring practical experience in modern pharmaceutical development, scientific expertise and a track record of commercializing innovations," the backgrounder says.

To establish operations, the three partners will provide in-kind support. It is expected FDA will eventually contribute personnel to work on-site at the University of Arizona.

A three-month planning process is underway to develop IGPD's business plan, management structure and research and educational agenda.

Projects could include validation of biomarkers and work in predictive toxicology.

Educational programs through the institute will provide advanced training in drug development and cover global drug development issues and FDA regulatory education.

"The results of the research conducted in the Institute and in other institutions will be rapidly incorporated into the curriculum of the Institute," the backgrounder states.

The University of Arizona plans to expand its research faculty addressing drug development issues. The university currently has a research contract from FDA Office of Women's Health for testing drugs during pregnancy and is a Centers for Education & Research on Therapeutics site.

IGPD appears to expand on the CERTs mission. Established through the FDA Modernization Act in 1997, the CERTs program uses academic centers to study drugs, biologics and device issues.

Woosley was principal investigator of the Georgetown University CERT; he was considered for the FDA commissioner position prior to moving to Arizona (² Also see "FDA commissioner in a McCain Administration?" - Pink Sheet, 25 June, 2001., p. 36). The University of Arizona is now a CERTs site with programs focusing on reducing adverse events from drug interactions.

IGPD will be governed by an oversight board including representatives from the three founding partners, the city of Tuscon, Pima County and the community. A scientific advisory board will include "experts in drug development representing the University of Arizona, SRI, FDA and leading international institutions."

IGPD has raised $7.5 mil. in public and private funds to fund its operation for the first five years.

"Once established, the Institute is expected to become self-sustaining within the first five years and operate on funding from government agencies, unrestricted endowment from pharmaceutical foundations, grants and donors," the backgrounder states.

FDA will not immediately contribute funding, but IGPD expects it may receive funding as part of a proposed fiscal year 2006 appropriation to support "Critical Path" partnerships.

FDA “Critical Path” Leads To Arizona; Rx Development Institute Being Formed

More from Archive

More from Pink Sheet