Collaboration Key To Overcoming Obstacles To Drug Development
Washington, D.C. - Industry, academic medicine, and government researchers are calling for new and increased collaborations among pharmaceutical companies, academic researchers, and regulatory agencies to strengthen the processes that move scientific breakthroughs to novel diagnostics and therapeutics that benefit the public. A January conference, sponsored by the AAMC (Association of American Medical Colleges) and the U.S. Food and Drug Administration (FDA), and part of the FDA's Critical Path Initiative, was the basis for a new report that describes an array of immediate opportunities for stakeholders to work together toward breakthroughs in the drug development sciences.
"This report identifies many ways that industry, academic and government researchers can and must work together to remove scientific hurdles in drug development," according to FDA Commissioner Dr. Lester M. Crawford. "FDA is looking forward to seeing these plans translated into action, to achieve our shared goal - breakthroughs in getting more treatments to patients."
The joint report, "Drug Development Science Obstacles and Opportunities for Collaborations," points out that despite significant growth in public and private sector funding for scientific research in recent decades, the number of new medical products, especially innovative drugs, submitted to the FDA has declined steadily since 1996. In January of this year, the AAMC and FDA brought together leading researchers and research executives from the drug industry, academic medicine, and the National Institutes of Health for a two-day conference to try to pinpoint the major obstacles that contributed to this decline and identify opportunities for solutions.
According to the conference report, partnerships among stakeholders need to focus on four major areas in order to effectively improve the drug development process: a much greater sharing of knowledge, regulatory and legislative relief, earlier evaluation of drugs in humans, and improved education and training for physicians and other health professionals in whole animal and human systems biology.
"The AAMC was very pleased to work with FDA in mounting what we both regarded as an extraordinarily successful meeting," said David Korn, M.D., senior vice president of AAMC's Division of Biomedical and Health Sciences Research. "By seizing the opportunities identified in the conference report, with their repeated emphasis on the need to facilitate more collaborative research among FDA, NIH, industry and academic medicine, we can accelerate the rate at which scientific discoveries give rise to novel products that improve the health of the public."
The report identified several immediate opportunities for enhanced collaborations between industry, academia and government, such as:
- Develop mechanisms that facilitate learning from failed drug targets
- Create collaborative systems to enable the sharing of toxicology data across the industry and FDA
- Establish joint models for biomarker validation
- Set up a consortium to analyze and learn from failed clinical trails
- Identify and propose to Congress new regulatory incentive policies for small market drugs
- Develop model agreements for sharing information now restricted as intellectual property or proprietary, which would greatly increase the pool of shared knowledge, stimulate collaborative research and development across the sectors, and enable learning from failures at every stage of drug development.
To view the full report go to: www.aamc.org/publications
SOURCE: FDA