Personalized medicine is still more a potential than a reality
Just after she was accepted as secretary of HHS by Congress, Kathleen Sebelius was sent a letter from two groups representing a wide swath of diagnostics technology developers and patient advocates (108 in all). The letter petitions Sebelius to move ahead on developing a regulatory framework that would in effect validate genetic and other “advanced diagnostic testing” methods for healthcare providers.
According to the two groups, the Genetics and Public Policy Center and the Coalition for 21st Century Medicine, there are already more than 1,500 genetic and other tests in use by healthcare providers to analyze the interaction of patients and drugs. In 2007, then-secretary Mike Leavitt charged an advisory committee to make recommendations on a framework, but there has been no further action on its recommendations.
Industry sources indicate that there is little consensus on the value of the tests, and that quality of testing performed, and the relevance of the results obtained, vary significantly. The potential of personalized medicine rides on using these tests, and getting the testing in turns rides on the willingness of CMS and private payers to support them.
Among other things, the groups seek an oversight and rulemaking process from FDA, setting up a registry for laboratories, and validating their practices through the existing HHS Clinical Laboratory Improvement Amendments (CLIA) program.
Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste
March 24th 2025Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals. The packaging industry is meeting the moment with advances of its own, including high-performance, environmentally-friendly materials that allow life science companies meet stringent thermal requirements and ambitious CO2e reduction goals. In this episode, TemperPack’s CEO Peter Wells shares insights from working with life sciences to move to certified biobased, home compostable, and curbside recyclable shipping solutions.