McDonald Merrill Ketcham Lecture
"Challenges for Drug Safety"
Symposium Overview:
The Annual McDonald-Merrill-Ketcham Lecture and Indiana Health Law Review Symposium features Professor Alta Charo of the University of Wisconsin speaking on the Challenges for Drug Safety. The keynote address will be followed by a panel discussion of experts. March 24, 2011.
Agenda:
| 10:00 am - 12:00 pm | Registration (Conour Atrium) |
| 11:00 am - 12:00 pm | Informal Buffet Lunch (Conour Atrium) |
| 12:00 pm - 1:00 pm | McDonald Merrill Ketcham Lecture (Wynne Courtroom) Topic: Challenges for Drug Safety Keynote Speaker: R. Alta Charo, University of Wisconsin |
| 1:00 pm - 1:15 pm | Break |
| 1:15 pm - 2:45 pm | Panel Discussion (Wynne Courtroom) Moderator: Professor David Orentlicher, MD, JD Samuel R. Rosen Professor of Law Co-director, Hall Center for Law and Health, Indiana University School of Law – Indianapolis |
| 2:45 pm - 4:00 pm | Reception in the Atrium |
About the Keynote Speaker:
R. Alta Charo is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison, where she is on the faculty of the Law School and the Department of Medical History and Bioethics at the medical school. She also serves on the faculty of the UW Masters in Biotechnology Studies program and lectures in the MPH program of the Dept. of Population Health Sciences.
Alta Charo (B.A. biology, Harvard 1979; J.D. Columbia, 1982) is an elected member (2004) of the World Technology Network and (2005) the Wisconsin Academy of Sciences, Arts and Letters. And in 2006 she was elected to membership in the National Academies' Institute of Medicine.
Professor Charo served on President Obama's transition team, where she was a member of the HHS review team, focusing her attention particularly on transition issues related to NIH, FDA, bioethics, stem cell policy, and women's reproductive health. She is on leave 2009-2011 to serve as a senior policy advisor on emerging technology issues in the Office of the Commissioner at the US Food & Drug Administration.
Professor Charo is the author of nearly 100 articles, book chapters and government reports on law and policy related to environmental protection, reproductive health, new reproductive technologies, medical genetics, stem cell research, science funding, and research ethics. She has served as a member of the boards of the Alan Guttmacher Institute and the Foundation for Genetic Medicine, the National Medical Advisory Committee of the Planned Parenthood Federation of America, and the program board of amfAR, the Foundation for AIDS Research. She has also been on the boards of the Society for the Advancement of Women's Health and the former American Association of Bioethics, as well as the ethics advisory board of the Howard Hughes Medical Institute. In addition, she has served as a consultant to the National Academy of Science's Institute of Medicine and the former NIH Office of Protection from Research Risks.
Charo has also served on several expert advisory boards of organizations with an interest in stem cell research, including CuresNow, the Juvenile Diabetes Research Foundation, the International Society for Stem Cell Research and WiCell, as well as on the advisory board to the Wisconsin Stem Cell Research Program. From 2005-2009 she was a member of the ethics standards working group of the California Institute for Regenerative Medicine. Also in 2005, she helped to draft the National Academies' Guidelines for Embryonic Stem Cell Research, and in 2006 she was appointed to co-chair the National Academies' Human Embryonic Stem Cell Research Advisory Committee.
Charo's advisory committee service for the federal government includes the 1994 NIH Human Embryo Research Panel, and (1996-2001) President Clinton's National Bioethics Advisory Commission where she participated in drafting its reports on "Cloning Human Beings"(1997); "Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity"(1998); "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance"(1999); "Ethical Issues in Human Stem Cell Research"(1999); "Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries" (2001); and "Ethical and Policy Issues in Research Involving Human Participants" (2001).
At the National Academies, from 2001-2008 she was a member of the Board on Life Sciences. She served as its liaison to the Committee on Research Standards and Practices to Prevent Destructive Applications of Biotechnology as well as its committee to develop national voluntary guidelines for stem cell research. She also served as a member of the Institute of Medicine's Committee on Smallpox Vaccination Program Implementation and since 2006 she has served on its Board on Population Health and Public Health Practice. In 2005-2006, she was a member of the committee to review the FDA and the U.S. national system for the assurance of drug safety.
About the Panelists:
Dean D. Craig Brater, M.D.
Dr. Brater is the dean at the IU School of Medicine, which is located on nine campuses. The school's regional centers for medical education include more than 1,000 faculty and more than 2,200 physicians who serve as volunteer faculty.
Dr. Brater joined the faculty at the Indiana University School of Medicine in 1986, where he began the Division of Clinical Pharmacology in the Department of Medicine. Four years later he was selected to chair the Department of Medicine, the largest department in the School. In 2000, Dr. Brater was selected to be the ninth dean of the IU School of Medicine. As dean, Dr. Brater is responsible for 26 academic departments, a full-time faculty of more than 1,000 members, and nearly 2,500 medical students, residents and doctoral candidates on nine campuses throughout the state of Indiana.
Dr. Brater has published more than 100 research articles and 50 books or book chapters. These publications, for the most part, concern diuretics or the effects of non-steroidal inflammatory drugs (NSAIDs) on renal function.
He has been awarded memberships in the American Society for Clinical Investigation and the Association of American Physicians. He has been or is currently president of the American Society for Clinical Pharmacology and Therapeutics, the Association of Professors of Medicine, the Central Society for Clinical Research, and the United States Pharmacopoeia. He is a member of the board and the executive committee of BioCrossroads, an Indiana consortium of business, industry, and academic organizations dedicated to economic development through advancements in the life sciences. He also serves on the boards of directors of Clarian Health Partners and the Riley Children's Foundation. In 2000, his alma mater awarded him the Duke Medical Alumni Award in recognition of his contributions to academic medicine.
Professor Emily Morris, J.D.
Emily Michiko Morris came to IU during the summer of 2008. She teaches patent law, copyright law, and intellectual property survey courses. Before joining the Indiana University faculty, Professor Morris was a visiting associate professor at Chicago-Kent College of Law, where she taught both Patent Law and Patent Litigation. She earned her A.B. (magna cum laude) from Harvard University and her J.D. from the University of Michigan Law School (magna cum laude), where she was an articles editor on the Michigan Law Review . After law school, Professor Morris clerked for the Honorable Bruce M. Selya on the U.S. Court of Appeals for the First Circuit, and then worked for three years as an associate in the Issues & Appeals section of the Washington, DC office of Jones Day. She also served as an adjunct assistant professor and Humphrey Fellow in Law and Economic Policy at the John M. Olin Center for Law and Economics, University of Michigan Law School.
Professor Morris’s research and teaching interests include patent law, health law and bioethics, Japanese law, and law and economic analysis. Her current work focuses on economic analysis of various patent law issues, including the effects of patent claim construction and scope on incentives and innovation. She is the co-author with Mark D. West of “ The Tragedy of the Condominiums: Legal Responses to Collective Action Problems after the Kobe Earthquake,” 51 Am. J. Comp. L . 903 (2003), which received the Hessel Yntema Prize from the American Society of Comparative Law.
Professor Ralph Hall, J.D.
Professor Ralph Hall is Counsel to the Indianapolis, Indiana law firm of Baker & Daniels where he counsels clients in the area of drug and medical device regulation. He also serves as CEO of MR3 Medical LLC, a start-up medical device company.
Prior to his association with the University of Minnesota Law School, Professor Hall served in various capacities with Guidant Corporation including Senior Vice President and Deputy General Counsel—Litigation and Compliance and General Counsel of the Cardiac Rhythm Management group. During this time, Professor Hall also served as Special Counsel to the Guidant Board of Directors Compliance Committee and as Counsel to the Guidant Chief Compliance Officer. Prior to joining Guidant, he was with Eli Lilly, including serving as the head of Lilly’s worldwide environmental law group.
Dr. Paul Helft, M.D.
Dr. Paul Helft is the current Director of the Fairbanks Center for Medical Ethics. His Clinical interests include, medical oncology, gastrointestinal malignancies, and esophageal cancer. Dr. Helft received his M.D. from the University of Chicago in 1995.
Dr. Helft was appointed Director of the Charles Warren Fairbanks Center for Medical Ethics in November, 2004. A native of Indianapolis, he completed his undergraduate degree in humanities, medical degree, his internship and residency in internal medicine, and fellowships in hematology/oncology and clinical medical ethics at the University of Chicago. There, he was a Fellow and Senior Fellow and Doctor-Patient Relationship Scholar at the MacLean Center for Clinical Medical Ethics. Dr. Helft joined the faculty of the Indiana University School of Medicine in 2001, where he is currently an Associate Professor of Medicine. His clinical work is based in the Gastrointestinal Oncology Program at the Indiana University Melvin and Bren Simon Cancer Center. At Indiana University Health, he is a member of the Ethics Committee and co-chairs the Ethics Consultation Subcommittee.
Dr. Helft oversees all aspects of Fairbanks Center operations and is responsible for the creation of its major programs, including the Fairbanks Fellowship in Clinical Ethics and the Fairbanks Program in Nursing Ethics. Dr. Helft's own research interests have focused on the ethical aspects of doctor-patient communication. He is the author of more than thirty publications and dozens of abstracts. He has lectured widely on ethics and gastrointestinal malignancies, and has been the principal investigator on seven grants. In 2007, because of his work in creating connections in ethics between doctors and nurses, he was awarded the Victoria L. Champion Boundary Spanning Award from the Indiana University School of Nursing. He has taught ethics to scores of multidisciplinary professionals and created the core curriculum taught to ethics fellows at the Fairbanks Center.
For More Information:
Please contact Carsandra Knight at (317)274-1912. .
