Trends in Personalized Medicine

An article published in the current edition of Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS), and authored by Hyman, Phelps & McNamara, P.C.’s Alexander J. Varond discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and new challenges facing industry.  Despite the promising potential of personalized medicine, the field is still in its infancy and there is much uncertainty.  The article surveys key issues for sponsors, including the potential effect of next-generation sequencing technology on companion diagnostics, the importance of payers in the development of personalized therapies, and new regulatory pathways being proposed to ensure companion diagnostic reviews keep pace with breakthrough therapies.