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Jennifer’s clients are innovators of disruptive technologies that are fundamentally changing the way research is done, the way medicine is practiced, and the way health care is delivered. She helps clients navigate the evolving regulatory and reimbursement landscape for targeted therapeutics, laboratory-based diagnostics, and mobile and digital health technologies. Jennifer also specializes in assisting young companies and associations with building a brand presence in Washington through relationship building with advocates and policymakers. Prior to launching Innovation Policy Solutions, Jennifer co-founded another consulting firm, HealthFutures, which was acquired by CRD Associates in 2009. Board certified in genetic counseling, she previously worked at the National Institutes of Health, the Senate Committee on Health, Education, Labor and Pensions, and in the biotechnology industry. Jennifer holds a master's degree in genetic counseling from The Johns Hopkins University and a bachelor's degree with honors and high distinction in sociology from the University of Michigan.
Aided by new practice guidelines and recommendations by the Clinical Pharmacogenetics Implementation Consortium (CPIC), the field of pharmacogenomics (PGx) has grown both in those offering testing services and in providers utilizing this technology. At the same time, the FDA is actively creating policy and standards for PGx services by setting special controls associated with over-the-counter PGx testing, issuing a safety alert, and sending warning letters and other communications to laboratories. This session will review recent FDA activity and explore its significance for more substantial changes to diagnostic regulatory policy and implications for patients, providers, and diagnostic developers.