2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC23
Submitter : Mr. Daniel Raymond Date & Time: 08/02/2004 07:08:16
Organization : AIDS Treatment Activist Coalition
Consumer Group
Category :
Issue Areas/Comments
As a member of the Drug Development Committee (DDC) of the AIDS Treatment Activist Coalition (ATAC), I am writing to express my support for the FDA's Critical Path Initiative.

ATAC is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS and broadening access to treatment.

The DDC meets routinely with pharmaceutical companies and researchers to discuss challenges in drug discovery and development for HIV and associated infections, including hepatitis C. Through our work, we have come to recognize a range of obstacles facing current efforts at HIV therapeutics and vaccines.

We particularly welcome the Critical Path Initiative?s attention to improving models and technology for enhancing the clinical relevance and predictive value of preclinical assays, especially those related to pharmacology and toxicology. These areas represent important concerns in the development path of novel therapeutics.

We also share the FDA's interest in promoting innovative approaches to drug delivery systems and manufacturing techniques. We have seen the value of concerted and coordinated investments in these areas in the HIV vaccine field, where the efforts of entities including the International AIDS Vaccine Initiative, the Gates Foundation-sponsored Global Enterprise, and the NIH's Vaccine Research Center have paved the way for more efficient product development, testing, and validation.

In summary, we are excited by this initiative and look forward to collaborating with the FDA, industry, and academia on identifying priorities and opportunities for innovation in HIV research.