While the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America declined to submit nominations for the Patient Centered Outcomes Research Institute's methodology committee, the Personalized Medicine Coalition has submitted a list of industry experts to the Government Accountability Office for consideration.

The methodology committee will set key parameters around the comparative effectiveness research directed by PCORI, which was established by the Affordable Care Act. Under the law, the methodology committee has 18 months from the date PCORI was established to develop scientifically based methodological standards for research conducted through the institute.

PMC nominated the following industry experts for the methodology committee: Eli Lilly and Co. VP of Global Health Outcomes Marc Berger; Johnson & Johnson Pharmaceutical Research & Development VP of Epidemiology Jesse Berlin; Pfizer Global Research & Development Senior Director Joseph Cappelleri; Pfizer Head of Health Technology Assessment Kimberly McGuigan; Amgen VP of Global Coverage & Reimbursement, Global Government Affairs and VP of Global Health Economics Joshua Ofman; Abbott Molecular Director of Global Scientific Affairs and Infectious Disease Mark Sanborn; and Genomic Health Chief Medical Officer Steven Shak.

PMC also submitted three individuals from academia: Amy Abernathy, program director, Duke Cancer Care Research Program; Susan Fisher, professor in the University of California San Francisco's Department of Obstetrics, Gynecology and Reproductive Sciences and director of the university's Human Embryonic Stem Cell Program; and Ronald Weiss, professor in the University of Utah School of Medicine's Department of Pathology.

BIO and PhRMA submitted nominees for the overall PCORI board of governors. One of the nominees - Pfizer Chief Medical Officer and Medical Division Senior VP Freda Lewis-Hall - was appointed to the board (Also see "Pfizer's Lewis-Hall To Represent Pharma Interests On PCORI Board" - Pink Sheet, 23 September, 2010.). But neither association submitted nominees for the methodology committee.

In a Nov. 5 letter to GAO, which is handling the appointments to the committee, PhRMA Senior VP of Policy, Research and Strategic Planning Richard Smith recommended that GAO "consider experts nominated by biopharmaceutical research companies and other research-intensive medical sectors. ...Including experts from private-sector research companies as well as academia and public health agencies will ensure the broadest possible range of expertise on the Methodology Committee."

BIO told the "The Pink Sheet" DAILY that it encouraged its members to submit nominations.

The National Pharmaceutical Council made one nomination, recommending one of its own, Chief Science Officer Robert Dubois. He joined NPC in October and has experience as a researcher, most recently from serving as chief medical officer at Cerner LifeSciences, where Dubois focused on comparative effectiveness and the use of electronic health records to implement clinical change.

GAO Names Imparato Replacement

GAO announced that it has appointed Gail Gibson Hunt, president and CEO of the National Alliance for Caregiving to the PCORI board of governors.

She is replacing Andrew Imparato, who stepped down from the board after announcing he was leaving his role as president and CEO of the American Association of People with Disabilities to take over as senior counsel and disability policy director for the Senate Health, Education, Labor and Pensions Committee (Also see "PCORI Board Will Add New Consumer/Patient Rep After One Member Joins Senate HELP Committee Staff" - Pink Sheet, 29 October, 2010.).

-Gregory Twachtman (g.twachtman@elsevier.com)

Personalized Medicine Coalition Submits List Of Drug Firm Nominees For PCORI Methodology Committee

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