Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.
A changing R&D paradigm fueled by the growing demand for personalized medicine is "one of the reasons that the pharmaceutical industry is facing rising taxes," a PricewaterhouseCoopers expert said. As a result, a PwC report released earlier this month advised pharma, biotech, and device firms to invest in tax planning early in their business strategic decisions.
At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.
The FDA cleared an update to the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.
In a draft paper, entitled "The NCCN Comparative Therapeutic Index as a Paradigm for Near-Term Comparative Effectiveness Analyses of Existing Data in Oncology," the NCCN said its methodologies for comparing the risk/benefit value of treatments "will not be in conflict with 'personalized medicine' as it pertains to the care of cancer patients."
Studies on genomically defined subpopulations that would advance personalized medicine are "going to get lost in the wash by considering everybody equivalent, which we know they are not," Collins said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science.
Comparative effectiveness research that analyzes the efficacy and safety of a particular treatment in a genomic subgroup "should address strengths and limitations of this evidence, how specific it is for patient subgroups, and evidence gaps that are priorities for further CER," the report states.
"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins said at a colloquium on personalized medicine hosted by AAAS.