The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics licensed applications (BLAs). Continue reading this entry
A multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to accelerate the drug approval process. Continue reading this entry
The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s full potential and benefits. This post summarizes the Coalition’s view of the state of the industry and the issues identified as critical to the ongoing development and adoption of personalized medicine.
Today, the FDA issued a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients (“Report”) which outlines proactive initiatives to promote science and innovation to meet today’s and the future’s health care challenges. The Report notes that because of its role as both a regulator and a public health agency facilitating the development of new and innovative products, the FDA has a unique perspective on the health of the biomedical industry. The Report acknowledges that while the quality of the submissions for new health care products has increased in the last few years, the number of new innovative products has decreased. Last year the FDA received the lowest number of applications for novel drugs in nearly two decades.
On August 10, 2011, the Food and Drug Administration (FDA) released a guidance document describing recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers. The guidance document was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is provided to facilitate a consistent format for the submission of data to the end of easy review and exchange of assessments.
On July 14, 2011, the FDA issued “Draft Guidance” relating to regulatory approval of in vitro companion diagnostic devices/tests, also called “IVD companion diagnostic devices.” The FDA intends the Guidance to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) who develop a companion diagnostic device intended for use with a corresponding therapeutic product. The FDA invites comments and suggestions regarding the Draft Guidance within 60 days.
On June 9, 2011, the Personalized Medicine Coalition (PMC) hosted its Seventh Annual State of Personalized Medicine Luncheon in Washington, D.C. As stated on its website, PMC’s mission “is to build the foundation that underpins the advancement of personalized medicine as a viable solution to the challenges of efficacy, safety and cost.” This year’s luncheon featured John J. Castellani, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) as its keynote speaker.