By Turna Ray
The Coriell Personalized Medicine Collaborative has formed a new Pharmacogenomics Advisory Group headed by a top FDA official that will advise researchers about potentially actionable gene-drug combinations for inclusion in their projects.
The newly formed PGx advisory group's goal "is to provide information on potentially actionable gene-drug pairs to study participants and in some cases their physicians, along with information regarding published findings relating to gene status and drug efficacy or adverse events," Courtney Sill, director of communications for the Coriell Institute for Medical Research, told Pharmacogenomics Reporter this week.
Issam Zineh, associate director for genomics at the Office of Clinical Pharmacology in FDA's Center for Drug Evaluation and Research, will chair CPMC's PGx advisory body, which will also include experts in pharmacogenomics, physicians, and doctors of pharmacy. The advisory group will convene twice a year and vote on PGx-guided drugs for inclusion in the CPMC.
With Zineh as head of CPMC's PGx advisory group, the FDA can also learn more about the prevalence of specific drug response genes within the CPMC's diverse study cohort. Lawrence Lesko, director of the Office of Clinical Pharmacology at FDA's CDER, has previously indicated the agency's interest in collaborating with entities working in the consumer genomics space to track adverse drug reactions in the post-market setting [see PGx Reporter 11-19-2008].
FDA is working with Coriell strictly in a research capacity, but the information learned through this collaboration could be one of many data sources that inform the agency's drug labeling changes. "FDA's definitely interested in genetic variants associated with different drug metabolism groups," Sill said. "We have seen so many drug labels change … and we all agree that will continue to happen."
Other than Zineh, current members of the PGx advisory group include: Amalia Issa, director of the Personalized Medicine and Targeted Therapeutics program at the Abramson Center for the Future of Health; Andy Godwin, director of the Clinical Molecular Genetics Laboratory at the Fox Chase Cancer Center; Cal Knowlton, CEO of excelleRx and a member of the board of the American Pharmacists Association Foundation; Howard McLeod, Fred Eshelman Distinguished Professor of Pharmacogenomics and Individualized Therapy at UNC's School of Pharmacy and head of the Pharmacogenetics for Every Nation Initiative; Michael Ezekowitz, professor of cardiology at the Lankenau Institute for Medical Research; Michael Murray, director of the General Genetics Clinic at Brigham and Women's Hospital; Steve Murphy, founder of Helix Health; Teri Klein, senior research scientist in genetics at Stanford University; and Wolfgang Sadee, chair of the Department of Pharmacology at Ohio State University.
CPMC was launched in December 2007 with the aim of studying the impact of genome-informed treatment on medical care. The study, which has so far enrolled more than 4,000 participants, has research partnerships with Cooper University Hospital, Virtua Health, Fox Chase Cancer Center, Helix Health, and others, and plans to ultimately enroll 100,000 participants [see PGx Reporter 06-17-2009].
The PGx advisory group will work alongside CPMC’s informed cohort oversight board, which decides which genetic variants, including pharmacogenomic variants, will be included in the study. Several pharmacogenomic genes, including CYP2D6, CYP2C9, CYP2C19 and VKORC1, have been approved by the ICOB.
The CPMC's ICOB has recently deemed four additional conditions "potentially medically actionable" — colon cancer, inflammatory bowel disease, obesity, and type 1 diabetes — and participants will soon be able to view their genetic risk for these, as well.