The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry Tags: Companion Diagnostics,FDA,Genetic Testing,U.S. Food and Drug Administration (FDA)
Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry Tags: Genetic Tests,Personalized Medicine
Next generation sequencing[1] (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application of the information obtained from NGS is as a companion diagnostic for a therapeutic.[2] A significant reduction in the overall cost to sequence the … Continue reading this entry Tags: Companion Diagnostics,Genetic Testing,Personalized Medicine
On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document – “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary process for the qualification of medical device development tools (MDDT) used in device development and evaluation programs in the Center for Devices and … Continue reading this entry Tags: Biomarkers,Companion Diagnostics,Personalized Medicine
A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature Genetics, (“Meta-analysis of 74,046 individuals 11 new susceptibility loci for Alzheimer’s disease”, published online on October 27, 2013), is a significant step toward identifying genetic risk factors … Continue reading this entry Tags: Companion Diagnostics,Personalized Medicine
Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to … Continue reading this entry Tags: 35 U.S.C. 101,Companion Diagnostics,Diagnostic Method Claims,Diagnostic Test,Personalized Medicine,Prometheus
On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry Tags: Diagnostic Test,Genetic Test,Patents,Personalized Medicine
The California Institute for Regenerative Medicine (CIRM) announced on January 17, 2012 that its governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM was created by California’s Proposition 71, which authorized the state to issue $3 billion in grants over ten years to … Continue reading this entry Tags: Stem Cells; Genomics; Biomarkers
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 … Continue reading this entry Tags: Companion Diagnostics,FDA,Genetic Testing,Personalized Medicine Coalition
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 … Continue reading this entry Tags: Biomarkers,FDA
Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual. Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease. In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the … Continue reading this entry Tags: Dr. Andrew von Eschenbach,Personalized Medicine,U.S. Food and Drug Administration (FDA)
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