Despite promise, hurdles to personalized med’s potential remain

Print 11 March 2016
Michael Fitzhugh / BioWorld

SAN FRANCISCO – Despite growing appreciation for many benefits of personalized medicine, earning it new attention in health care institutions and Washington, progress in the field continues to be decidedly mixed, according to speakers at the Molecular Medicine Tri-Con meeting this week.

While overly optimistic views of the field were common in the early 2000s, since then, much has changed, Edward Abrahams, president of the Personalized Medicine Coalition (PMC), told attendees on Tuesday. One of the most interesting recent dynamics, he noted, has been the pharmaceutical industry’s embrace of the field. During 2015, the FDA approved 13 new drugs that included biomarker strategies in their labels, a group that accounted for 28 percent of the total number of new drugs the agency approved and one that was up 20 percent over 2014.

Therapies such as Genentech Inc.’s Alecensa (alectinib) and Cotellic (cobimetinib) as well as Astrazeneca plc’s Tagrisso (osimertinib) and Glaxosmithkline plc’s Nucala (mepolizumab) all brought tailored approaches to patients and helped generate some of what data compiled by L.E.K. Consulting tallied to be $25 billion in worldwide revenue from all personalized therapies. (See BioWorld Today, Nov. 6, 2015, Nov. 16, 2015, and Dec. 14, 2015.)

Personalized therapies are also increasingly well represented in the biopharma industry’s pipeline, said Abrahams, accounting for nearly 43 percent of all medicines in development and 73 percent of all cancer drugs in development, according to a PMC-sponsored survey conducted by the Tufts Center for the Study of Drug Development. (See BioWorld Today, Aug. 21, 2015.)

Despite that progress, there remains a long ways to go, noted Eric Lai, senior vice president and head of pharmacogenomics and companion diagnostics at Takeda Development Centers of America. Both financial and educational issues are to blame, he said during a talk on roadblocks to the effective rollout of personalized medicine beyond oncology.

On the financial side of the equations, he said he’d seen way too many instances of companies formed around 100-sample experiments, while on the commercial and marketing side of existing companies, concerns about disqualifying potential customers still abound.

Furthermore, patients have been generally much more concerned about co-pays than quality of health care.

Education of doctors about personalized medicine approaches has also fallen short, with only about one quarter of medical schools including more that four hours of training around pharmacogenomics and companion diagnostics.

Only 13 percent of physicians are even familiar with the concept and use of pharmacogenomic tests, he said.

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