NIH-FDA Collaboration Aids Mesothelioma Treatment
Mesothelioma patients can now benefit from a new partnership formed between the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH). The two agencies joined forces in early 2010 in an effort to speed the release of medical innovations to physicians and their patients.
Research is currently underway to develop biomarkers for any cancer, including mesothelioma, potentially opening the door to highly personalized cancer treatments. Mesothelioma is a serious cancer that occurs in individuals exposed to airborne asbestos fibers. Even small amounts of asbestos and infrequent exposure can create a risk for contracting mesothelioma or other asbestos-related diseases. Mesothelioma is highly aggressive and is resistant to many cancer treatments. Currently there is no known cure for the disease.
Scientific Disciplines Come Together
The NIH and FDA will be developing initiatives to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. To support these initiatives, the agencies will bring together translational science and regulatory science.
Translational science is often referred to as the bench-to-bedside aspect of scientific discovery. This is where the discoveries are translated into practical applications. The scientists begin the process at “the bench” with basic research, such as studying disease at the molecular level. They then provide the tools to clinicians to take the innovation to the clinical level or to the patient’s bedside. This aspect of the scientific partnership is led by the NIH.
The FDA must then take the information from the translational research and develop policies and regulations that take the medical devices and products to market.
The agencies will be establishing a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The new council will ensure that regulatory considerations become an integral part of biomedical research planning, and that the latest science is integrated into the regulatory review process.
Enhancing Regulatory Science and Encouraging Research
According to an FDA report, the development of new therapies has been in decline, and the costs of bringing them to market have soared. This trend has had a negative impact on the U.S. biotechnology industry, and some scientists say the FDA’s evaluation methods are not keeping pace with the changes in the drug discovery methodologies.
The NIH-FDA collaboration recognizes that breakthroughs in regulatory science are critical to ensure medical innovations reach the patients in a timely manner. The joint team will make $6.75 million available over three years for work in regulatory science. The goal is to provide new methods for the scientific and regulatory communities to better evaluate medical product development.