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NIH-FDA Collaboration Could Speed Innovations for Mesothelioma Treatment

Friday, March 12, 2010

by Nancy Meredith
In an effort to speed medical innovations to physicians and their patients, the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have joined forces. The partnership has identified several key areas that could benefit including stem cells for Parkinson’s disease, safer pain medications, and personalized treatment for cancer through the use of markers.

Research is currently underway that could develop biomarkers for any cancer including mesothelioma making way for personalized treatment. Mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers. There is no known cure for mesothelioma, however, many clinical trials and studies are in progress that could offer hope to mesothelioma patients.

Scientific Disciplines Come Together
Through collaboration the NIH and FDA will be developing initiatves to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. To support this 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 is the NIH’s discipline.

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. Regulatory science is the science and tools used by the FDA and other government agencies to evaluate product safety, efficacy, potency, quality and performance to protect and benefit American citizens.

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.

The Health and Human Services Secretary Kathleen Sebelius said that “collaboration between NIH and FDA will go a long way towards fostering access to the safest and most effective therapies for the American people.”

Enhancing Regulatory Science and Encouraging Research
According to the FDA report “Speeding Progress to Patients” 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 economic health of the U.S. biotechnology industry. The report further states that “American lives are at risk” because 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. In addition, incentives in the translational field are important.

Currently the FDA offers millions of dollars in grants each year per the U.S. Orphan Drug Act providing financial incentives to bring biological products for rare diseases, such as mesothelioma, to market. Only one drug, Alimta, has been approved as an orphan drug in the treatment of malignant pleural mesothelioma.

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.

Saving Lives
“I am confident that our strengthened coordination and collaboration with NIH will enhance our efforts and add important momentum toward achieving our common goals of improving health, reducing disease and saving lives,” said Dr. Margaret A. Hamburg, M.D., Commissioner of Food and Drugs.

The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.

Sources:
NIH-FDA Collaboration
Speeding Progress
Hamburg Remarks

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posted by Nancy Meredith at 8:00 AM
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