Since the completion of the Human Genome Project, the explosive growth in molecular diagnostics and specialty pharmaceuticals is outpacing the growth seen in any prior era, raising serious concerns about clinical quality and cost. According to an industry survey conducted earlier this year by the Pharmaceutical Research and Manufacturers of America (PhRMA), more than 900 medicines and vaccines have been identified in various stages of development. To keep pace, the strategies that were adequate for the “empty pipeline” scenarios of a few years ago-to code each agent, communicate clinical evidence and clinical guideline developments, and update reimbursement methodologies-must now be enhanced.
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