The Health Law, Ethics & Policy Seminar Series
presents
Barbara Evans
Yale University
Clinical Translation of Pharmacogenomics under the U.S. Food & Drug Administration Amendments Act of 2007
Thursday, November 24, 2011
12:30 – 2:00 p.m.
Faculty of Law, University of Toronto
84 Queen's Park, Falconer Hall, Solarium (FA2)
Toronto, Ontario, M5S 2C5
Everyone is welcome to attend, no registration is required.
(Co-sponsored by the Centre for Innovation Law & Policy)
ABSTRACT
The Food and Drug Administration Amendments Act of 2007 (FDAAA) is the most profound reworking of U.S. drug regulation in half a century. This seminar explores major contours of the post-FDAAA regulatory paradigm, with emphasis on how these changes help address problems that have hindered the clinical translation of pharmacogenomics. Because FDAAA envisions heavy use of evidence from large-scale observational studies of postmarket drug safety and effectiveness, access to data is a critical issue. The seminar also will give a brief update on recent initiatives to modernize privacy and human-subject protection regulations that govern access to data for use in public health studies and research.
Recommended reading: Evans, Barbara J., Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era (March 17, 2009). Notre Dame Law Review, Vol. 85, 2009; U of Houston Law Center No. 2009-A-11. Available at SSRN:
http://ssrn.com/abstract=1359314.
BIOGRAPHY
Barbara Evans is a law professor, co-director of the Health Law & Policy Institute, and director of the Center on Biotechnology & Law at the University of Houston Law Center, which is one of the 49 member institutions of the famed Texas Medical Center. Prof. Evans has been named a Greenwall Foundation Faculty Scholar in Bioethics for the period 2010-2013. This award provides funding for a three-year study of legal and ethical issues surrounding the nonconsensual use of health data in research and public health studies. She recently served on the (U.S.) Institute of Medicine’s Committee for the Public Health Effectiveness of the F.D.A. 510(k) Clearance Process which, in October 2011, published recommendations on F.D.A.’s medical device regulatory framework. Her research interests include governance, privacy, and financing issues with large health information networks and tissue repositories; regulatory and judicial uses of evidence from large-scale observational studies; and legal barriers to the clinical translation of genetic testing and pharmacogenomics. Earlier in her career, she was a partner in the international regulatory practice of a large New York law firm and subsequently advised clients on U.S. privacy and research regulatory matters. She holds an electrical engineering degree from the University of Texas at Austin; M.S. and Ph.D. degrees from Stanford University; a J.D. from Yale Law School, an LL.M. in Health Law from the University of Houston, and she completed a Post-doctoral Fellowship in Clinical Ethics at the M.D. Anderson Cancer Center.
For other upcoming seminars, see the schedule online. To subscribe to our mailing list please contact: m.casco@utoronto.ca.
The Health Law Ethics and Policy Workshop series brings local, national, international scholars and policy makers as guest speakers to the Faculty of Law, University of Toronto to stimulate discussion of issues related to the intersection of law with health care and related ethical and social issues. The series is organized by the Faculty’s Health Law group and is sponsored by the CIHR Training Program in Health Law, Ethics and Policy. The training program addresses the global shortage of experts in the multidisciplinary field of health law, ethics and policy by providing key learning opportunities and competitive scholarships to outstanding Canadian and international graduate students. For more information about the seminar series and/or the training program, please visit our website at: www.healthlawtraining.ca.
