FDA’s Center for Drug Evaluation and Research and Genentech have disclosed the witnesses they intend to present at the June 28-29 hearing before the Oncologic Drugs Advisory Committee on CDER’s proposal to withdraw Avastin’s accelerated approval for first-line metastatic breast cancer. CDER plans to present testimony from five staffers, the highest level being Office of New Drugs Director John Jenkins. Genentech plans to introduce six witnesses: three company employees, its outside legal counsel, and two clinicians with extensive research experience in breast cancer and solid tumors. Despite their diametrically opposed viewpoints on whether the MBC claim should be maintained, the CDER witnesses and Genentech experts have previously collaborated in cancer research endeavors. For example, Division of Biologic Oncology Products Director Patricia Keegan and clinical reviewer Lee Pai-Scherf are both listed as co-authors with Joyce O’Shaughnessy, a Baylor-Sammons Cancer Center breast cancer specialist and Genentech witness, on publications about treatments for advanced breast cancer, according to the CDER employees’ curricula vitae. Similarly, Office of Oncology Drug Products Director Richard Pazdur co-authored a 1999 journal article with Howard Burris, a Genentech witness and chief medical officer at the Sarah Cannon Research Institute, about use of docetaxel for cholangiocarcinoma. Below is a listing of each party’s respective witnesses, their current positions, experience and the issues they are expected to address at the June hearing.
Witness and Title	Experience	Hearing Issues
CDER
Abby Brandel Associate Chief Counsel, Office of Chief Counsel	Agency legal counsel on drug-related issues; spent a decade in private practice advising companies on regulatory matters; former subcommittee staff director for the Senate Health, Education, Labor & Pensions Committee	Regulatory and legal
John Jenkins Director, Office of New Drugs	OND director since January 2002; previously director of the Office of Drug Evaluation II and the Division of Pulmonary Drug Products; joined FDA as medical officer in 1992	Regulatory and policy
Patricia Keegan Director, Division of Biologic Oncology Products	DBOP director since 2005; previously director of the Division of Therapeutic Biological Oncology Products, and deputy director and oncology branch chief of the Division of Clinical Trials Design and Analysis in CBER’s Office of Therapeutics Research and Review (OTRR); joined CBER as a medical officer in 1990 from the faculty of the University of North Carolina	Clinical data
Lee Pai-Scherf Medical Officer, Division of Biologic Oncology Products	Clinical reviewer on Avastin BLAs for MBC; joined OTRR’s Division of Clinical Trials Design and Analysis in 2000; previously worked at the National Cancer Institute as a principal investigator	Clinical data
Richard Pazdur Director, Office of Oncology Drug Products	Signatory on the 2008 approval letter for Avastin in MBC; OODP director since its creation in 2005; joined FDA in 1999 as Division of Oncology Drug Products director; previously held various positions at University of Texas M.D. Anderson Cancer Center, including assistant VP for academic affairs and associate director of Clinical Trials Administration	Overview
Genentech
Hal Barron Executive Vice President of Global Product Development, Chief Medical Officer, Genentech	Exec VP since 2009; previous roles include senior VP of development, VP medical affairs and senior director of Cardiopulmonary and Clinical Immunology Research; joined Genentech in 1996 from the faculty of the University of California-San Francisco	Overview
Howard Burris III Chief Medical Officer, Executive Director of Drug Development, Sarah Cannon Research Institute	Served as director of the drug development program at Brooke Army Medical Center (Oncology Service) before joining Cannon in 1997; previously held various research and teaching posts at the University of Texas Health Science Center and the Cancer Therapy and Research Center for South Texas; has published extensively on taxanes and solid tumors, particularly lung cancer; appeared as an expert for AstraZeneca at ODAC’s March 2005 review of Iressa	Clinical perspectives on treatment of HER2-negative MBC
Sandra Horning Senior VP, Global Head of Clinical Development for Hematology/Oncology, Genentech	Joined Genentech in 2009 from Stanford University, where she held various academic posts in oncology and blood/marrow transplantation; ODAC member 1988-1992	Clinical data and proposed confirmatory study
Michael Labson Partner, Covington & Burling	Joined the law firm in 2002; advises pharma, biotech and medical device clients on FDA, regulatory and compliance issues	Regulatory and legal
Joyce O’Shaughnessy Celebrating Women Endowed Chair in Breast Cancer Research, Baylor-Charles A. Sammons Cancer Center; Co-Chair of Breast Cancer Research, U.S. Oncology; Medical Oncologist, Texas Oncology	Served as director of the cancer prevention program at Baylor-Sammons Cancer Center from 2000-2009; previously held a variety of roles at NCI, including senior investigator of the medical breast cancer section and special assistant to the director; has been a lead investigator on a number of breast cancer trials	Clinical perspectives on treatment of HER2-negative MBC
James Reimann Global Head of Oncology Biostatistics, Genentech	Held various positions in biostatistics at Genentech since 1994, including director of oncology biostatistics leading the Avastin Biostatistics Group; served as member of the oversight committee to prepare for ODAC reviews of Avastin in glioblastoma (March 2009) and first-line MBC (July 2010)	Biostatistics

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