Personalized Medicine: A View from the Top (1)
Last week, a star-studded panel gathered at the Achieving ROI in Personalized Medicine: Barriers, Incentives, and Pathways to Successful Commercialization conference hosted by the Personalized Medicine Coalition to review the results of the newly completed Deloitte study on ROI in personalized medicine and to offer their perspectives. It was the week after the inauguration. The excitement about personalized medicine was amplified by the optimism around the new administration, and justifiably so. After all, our new president happens to have been the sponsor of the Genomics and Personalized Medicine Act of 2007. At the same time, the economy, rising healthcare costs and the state of the pharmaceutical industry weighed heavily on everyone’s mind. And what resulted was a day of dialogue that was both expansive and sanguine, and a balance of vision, analysis and introspection that I found refreshing.
The fact that the consumer came out as an undisputed winner in the ROI study, led by Paul Keckley, Deloitte Center for Health Solutions, reaffirmed the role of personalized medicine in the future of healthcare. But a host of scientific, business, regulatory, reimbursement and societal barriers challenge the realization of its potential. It is quite clear that better integration between therapeutics (Rx) and diagnostics (Dx) from the start would be desirable in streamlining the development process, but a winning business model for Rx/Dx collaboration remains to be crafted. It was telling when Aidan C. Power of Pfizer pointedly stated that the drug developer would want to keep its options open to work with different diagnostic partners to develop the second-generation biomarker test after launch. Not surprisingly, Randy Scott of Genomic Health commented that the current cost-based reimbursement system for diagnostics is outdated, and he foresees a rebalancing of healthcare spending between therapeutics and diagnostics. This view was supported by a comment later in the day by Janet Woodcock of the FDA, in the context of discussing the need for more data to support science-based medicine, that current reimbursement for diagnostic tests generally is not sufficient to justify adequate study.
Woodcock’s comprehensive review touched not only on the regulatory gaps such as the In Vitro Diagnostic Multivariate Index Assays (IVDMIA) guidance that remains to be taken beyond the draft, and the yet-to-be-published draft of Rx/Dx co-development guidance, but also complex issues around valuation of specific therapies, government incentives for the development of personalized medicine, and the role of academia and federal research funding. Both Woodcock and Francis Collins, former director of the National Human Genome Research Institute, advocated a strong partnership between academia and the private sector. But Woodcock wondered if the reward system within academia, and the scientific community’s innate respect for pure science, would penalize those who engage in translational research.
Next week: The discussion around science, reimbursement and the future of healthcare.