FDAnews Drug Daily Bulletin


March 21, 2006

The pharmaceutical industry and federal agencies are developing legal agreements to ensure greater cooperation and information-sharing in the interest of accelerating the development of personalized medicines to treat cancer and other ailments, sources say.

PhRMA and several of its member companies are nearing agreement on a broad consortium to share research data on biomarkers, said Alan Goldhammer, the group's associate vice president for scientific and regulatory affairs, in an interview with FDAnews. Biomarkers are indicators of normal biological processes that show how well a particular treatment will work.

Industry wants to discover why certain drugs work better in some patients than in others, and biomarkers are seen as the way to answer that question. "Biomarkers will play an important role in looking at drug safety and drug efficacy," Goldhammer said. "The goal is for scientists from government and industry to work together to identify and validate new biomarkers from the body for use in [prevention] and earlier detection of diseases," said PhRMA spokesman Jeff Trewhitt.

The PhRMA consortium would establish a means for different companies to share their early research on biomarkers, Goldhammer added. This data would be "precompetitive," Goldhammer said, which means laboratory studies would be conducted prior to animal or human studies. Industry has undertaken similar efforts before, such as a multicompany consortium to address HIV/AIDS.

Cooperation will help firms avoid the time and cost of following the same path their competitors have already taken. "Instead of reinventing the wheel, it is probably better to have collaboration between industry scientists and government," Trewhitt added.

This cooperative effort will also help companies select the right patients for clinical trials, said Goldhammer. The companies will be able to better identify which populations receive more benefits from a certain drug and which groups should not be given that drug because of safety concerns. The overall effect will be accelerated drug development and treatments more likely to benefit certain patients, he said.

Industry efforts come as the federal government begins to implement two high-profile agreements meant to accelerate the development of new drugs. The FDA, National Cancer Institute (NCI) and Centers for Medicare & Medicaid Services published an agreement in the Federal Register to work together to develop biomarkers for cancer treatment. In their "Memorandum of Understanding," the agencies will work together under a new initiative to develop biomarkers and will reach out to the private sector to secure funding for it.

Under the Oncology Biomarker Qualification Initiative, the three agencies will prepare white papers on various topics including scientific rationales, availability technologies and general concepts in experimental design. The agencies will also prepare protocols to evaluate biomarkers in clinical trials and outline approaches for assessing research progress.

The memorandum is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/ora065-m000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/ora065-m000001.pdf).