The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers; clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. FDA's outreach efforts uncovered a consensus that the two most important areas for improving medical product development are biomarker development (Topic 1 ) and streamlining clinical trials (Topic 2).

Biomarkers are measurable characteristics in animals or humans that can help predict the performance of a product during development, reducing uncertainties about safety or effectiveness.


"Most researchers agree that a new generation of predictive biomarkers would dramatically improve the efficiency of product development, help identify safety problems before a product is on the market (and even before it is tested in humans), and facilitate the development of new types of clinical trials that will produce better data faster," said Janet Woodcock, MD, Deputy Commissioner for Operations and head of FDA's Critical Path Initiative. "Similarly, researchers stressed that reforming the clinical trial process -- both trial design and trial conduct -- would dramatically improve the efficiency of product development, which means getting products to patients faster at less cost."

Accomplishment of the research priorities will require unprecedented collaboration among public and private sector partners. To facilitate completion of these projects in a timely manner, the FDA will bring together partnerships and consortia to accomplish a majority of the projects. FDA's regulatory experience and knowledge of the hurdles in scientific research will enable the agency to play a consultative role in many of the projects. In addition, the initiative will require a new, cooperative partnership among the primary research, evaluation, approval and medical treatment delivery and reimbursement divisions of HHS, including the FDA, National Institutes of Health, (NIH), Centers for Medicare and Medicaid Services (CMS), and Agency for Healthcare Research and Quality (AHRQ).

"Coordinated leadership is essential to illuminate and align this pathway to personalized medicine to an era when doctors will eliminate -- or even prevent -- dozens of today's most-devastating diseases," said von Eschenbach. "Instead of taking a pill and hoping it works effectively and safely, patients will receive treatments designed just for them. Results will be more certain and more affordable."

More Industry Headlines