Washington, D.C. (August 19, 2010) — Personalized medicine is about to get a much-needed kick start: The FDA has agreed to produce draft guidance documents that clarify and revise the standards by which companion diagnostics and biomarker qualifications are tested and approved. In a speech to the Personalized Medicine Coalition, FDA Commissioner Margaret Hamburg identified personalized medicine as one of the key themes to the future of healthcare and said that regulatory science must evolve to keep pace with it. “It is clear to me that we need to develop a consistent, comprehensive, and integrated approach to the evaluation and regulation of medical products which separately, and in combination, comprise the practice of personalized medicine,” Hamburg said.
When Craig Venter mapped the human genome in 2003, medical experts believed the healthcare industry stood on the precipice of a new era in medicine. At last doctors, using new biomarkers and diagnostic tools, would be able to determine the safest and most efficacious medicines for individual patients. Seven years later we’re still on that precipice. It has taken some time to overcome the information analysis challenges.
Euan Ashley and colleagues published a study in The Lancet recently assessing the potential of a patient’s genome in a clinical setting to find out what a physician could do for a patient with a specific genetic profile. This was only the fifth human genome ever sequenced, and the first time that this type of study was done. The field of genomics and genetics has generated a vast amount of information to date, and the researchers tested the integration of these results with the genome and medical history of a specific patient. They were able to test disease risk and link it to the patient’s medical history. They also tested pharmacogenomics, the genetic predisposition of an individual to react to a drug treatment, information that can tell a physician if a patient will benefit from a particular drug and if the patient is likely to experience adverse effects.
The pharmaceutical industry has always been on the forefront of this trend but drug development processes are slow and only a handful of drug diagnostic tools have passed clinical trials. With no real clarification on what needs to happen to integrate personalized medicine into the healthcare system, it is a challenging and uncertain process. Also, the industry has done a poor job of making stakeholders aware of the value of diagnostic tools in the pipeline. Support from the FDA will help. Hamburg said the agency will produce the draft guidance documents—which will clarify what evidence the FDA needs to deem a companion diagnostic or biomarker qualification clinically effective—before the end of the year. She also said the FDA will to try to serve as a general catalyst for the innovation and advancement of personalized medicine by reaching out and collaborating with industry, academia, and government research colleagues. The rising regulatory scrutiny for drug safety and treatment options, the passage of healthcare reform with mandates for comparative effectiveness, and the global recession all should create positive movement in personalized medicine’s direction. The question is, beyond the FDA, who’s going to harness that momentum?
These important topics will be discussed at the Personalized and Translational Medicine Summit 2010, held in Boston, Massachusetts, September 20th and 21st. More than 22 senior level speakers from the pharmaceutical and diagnostics industry will offer insights into their biggest challenges and develop ways to overcome them. This platform will foster the collaboration between drug and diagnostics development and generate practical solutions for all stakeholders.
Media Contact Dr. Johannes Stanta VP, eyeforpharma +44 (0) 207 375 7225 jstanta@eyeforpharma.com
