Regulatory Beat: Critical Path Initiative Tops FDA Priority List for 2006 - Manufacturers are collaborating with FDA and research organizations to spur biomedical innovation and streamline


Regulatory Beat: Critical Path Initiative Tops FDA Priority List for 2006
Manufacturers are collaborating with FDA and research organizations to spur biomedical innovation and streamline production

BioPharm International
Volume 19, Issue 1

For example, the Critical Path Institute (Tucson, AZ), a non-profit organization supported by FDA, SRI International, and the University of Arizona, is launching a Toxocogenomic Cross Validation Consortium that will bring manufacturers together to validate each other's safety test methods. Separately, FDA's National Center for Toxicological Research (NCTR) and Massachusetts-based BG Medicine have signed a CRADA for a Liver Toxicology Biomarker Study to identify standard tests for early-stage product development.

Internally, FDA is surveying its medical officers on what biomarkers have been submitted in applications and accepted as surrogate endpoints. FDA plans to form a group to develop guidance on biomarkers and to support Critical Path collaborations.

FDA's pharmacogenomics (PG) initiative also provides important information on how industry is using genomic data to identify drug targets and devise development programs. In March 2005, FDA established a voluntary genomic data submissions process that encourages pharma and biotech companies to share PG data with the agency outside the normal application review process. FDA has received 30 submissions for discussion by its PG review group. The European Medicines Evaluation Agency is participating in some meetings to encourage a common approach to assessing genomic submissions, which may become a topic for review by the International Conference on Harmonization.

In the near future, FDA hopes to issue a draft guidance on drug-diagnostic co-development that describes how to link a targeted drug with a test to identify individuals likely to respond to treatment. Diagnostics are crucial to the development of personalized medicines, but appropriate product development timing is a big concern, along with fear that FDA may require co-development with certain new therapies.


Although FDA's campaign to update good manufacturing practices has launched a number of projects in this area over the past two years, the Critical Path initiative aims to spur further collaboration on innovative manufacturing practices. CDER's Office of Pharmaceutical Science is establishing a CRADA with Con-formia Software of California to survey the industry on what issues most affect the selection of drug candidates for commercial manufacturing. In addition, Purdue leads a group of 11 universities in forming the National Institute for Pharmaceutical Technology & Education to address manufacturing and scientific issues that affect variability in product quality.

Although industry and academia have to take the lead in addressing these issues, FDA recognizes the need for a better toolkit to reduce the amount of uncertainty in the drug approval process. "What we need to do is fundamentally change the dynamic and to focus therapy on the people who benefit," Woodcock explains.

One sign of progress is finalization of the long-awaited Critical Path Opportunities List of research projects and collaborative efforts that FDA believes can streamline pre-clinical testing, clinical trial operations, and quality production. CBER's "wish list" includes a number of investment opportunities to improve biotech R&D:

  • Develop well characterized cell banks and assays for adventitious agents
  • Develop methods of pathogen inactivation for blood, plasma, and tissues
  • Develop multipathogen and rapid detection methodologies
  • Improve storage methods for blood and tissues
  • Establish assays, standards, and reagents for the flu vaccine.

Woodcock considers the list a "call to action" for industry and academia to work together to reduce the high cost of new drug development and spur innovation.

Jill Wechsler is BioPharm International's Washington editor,7715 Rocton Avenue, Chevy Chase,MD 20815,301.656.4634,

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