Monika S. Markowitz, Ph.D. Director, Office of Research Integrity and Ethics Virginia Commonwealth University

Transcription

1 2013 Forum on Conflict of Interest in Academe Meeting March 21-23, 2013 Agenda Thursday, March 21 10:30 am - 6:00 pm Registration and Information Key South Foyer 11:45 am - 1:15 pm COI Chairs Luncheon (Additional Fee Required) Ruth 1:30 pm - 1:45 pm Welcome Key 5-6 Guy M. Chisolm, Ph.D., M.S. Vice Chairman, Lerner Research Institute Cleveland Clinic Foundation Barbara E. Barnes, MD, MS Associate Dean for CME, Associate Vice Chancellor for Continuing Ed & Industry Support University of Pittsburgh School of Medicine Monika S. Markowitz, Ph.D. Director, Office of Research Integrity and Ethics Virginia Commonwealth University Welcome message from the FOCI Steering Committee chair and the Program Committee co-chairs. 1:45 pm - 2:15 pm Keynote Address: Maintaining Public Trust: Ethics, Professionalism, and the Commercial Realities of Medicine Key 5-6 Alexander Capron University Professor, Vice Dean, Faculty and Academic Affairs, Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Professor of Law and Medicine Keck School of Medicine of the University of Southern California 2:15 pm - 3:00 pm Keynote Reactions and Responses Key 5-6 Panelist(s): Curt Civin, M.D. Associate Dean for Research Director for Stem Cell Biology & Regen Med University of Maryland School of Medicine Page 1 of 11

2 Thursday, March 21 Julie Ann Freischlag, M.D. The William Stewart Halsted Professor, Chair Department of SurgerySurgeon-in-Chief Johns Hopkins Hospital 3:00 pm - 3:30 pm Break Key South Foyer 3:30 pm - 5:00 pm Implementing the Final Rule on COI in Federally Funded Research Moderator: Key 5-6 Joy Bryde Conflict of Interest Officer University of North Carolina at Chapel Hill Elizabeth Herbert Executive Director, Compliance & Internal Audit Memorial Sloan-Kettering Cancer Center Kara Manning Drolet, Ph.D. Associate Director, Research Integrity Office Chair, COIR Committee Oregon Health & Science University School of Medicine Julie D. Gottlieb, M.A. Associate Dean, Policy Coordination Johns Hopkins University School of Medicine Several institutions share their challenges and solutions and we hear from you. Page 2 of 11

3 Thursday, March 21 5:00 pm - 5:45 pm AAMC Update and COI Metrics Project Key 5-6 Heather Pierce, JD, MPH Senior Director, Science Policy & Regulatory Counsel AAMC David Shepherd Raiford, M.D. Senior Associate Dean for Faculty Affairs; Vice Chancellor for Health Affairs Vanderbilt University School of Medicine An update from the AAMC on major priorities and initiatives across the organization and a discussion of the COI Metrics Project 6:00 pm - 8:00 pm Welcome Reception Key South Foyer & Key 3-4 All attendees are invited to join their colleagues to wine, dine, socialize, and continue the day's discussions Forum on Conflict of Interest in Academe Meeting March 21-23, :00 am - 6:00 pm Registration and Information Key South Foyer 7:15 am - 8:30 am Discussion Breakfast - Topic Tables Key 7-8 8:30 am - 8:35 am Welcome Key 5-6 Guy M. Chisolm, Ph.D., M.S. Vice Chairman, Lerner Research Institute Cleveland Clinic Foundation 8:35 am - 9:45 am A Word from NIH Key 5-6 Sally Rockey, Ph.D. Deputy Director for Extramural Research National Institutes of Health Page 3 of 11

4 9:45 am - 10:00 am Break Key South Foyer 10:00 am - 10:50 am s (Block 1) Multiple Rooms 10:00 am - 10:50 am Clinical Conflicts: How a Diligent COI Committee Could Leave an Institution at Risk Key 4 Tammy Capretta, M.P.H., R.N. Chief Administrative Integration and Risk Officer Keck School of Medicine of the University of Southern California Daniel K. Shapiro, JD Director, Research Compliance University of Southern California Presented in collaboration with the AAMC Compliance Officers Forum (repeated at 11:00 a.m.) 10:00 am - 10:50 am COI 101 (Part I) Key 1 Facilitator(s): Teresa K Anderson Director, COI Office Wake Forest Baptist Health Jeneane Braden Manager, Research Ethics and Compliance Office Washington University in St. Louis School of Medicine Page 4 of 11

5 Marianne Hockema Administrator Office, COI Review Board Mayo Medical School 1. A brief overview of the history of Research COI and the revised federal regulations 2. Examples of disclosure processes (e.g. paper, electronic, annual, transactional, travel) 3. Disclosure Review Processes Staff/Committee structure and responsibilities Thresholds for reviewing financial interests Identifying COIs (assessing relatedness, definitions, etc.) 10:00 am - 10:50 am Managing Large Scale Clinical Trial Networks Key 3 Facilitator(s): Susan H. Ehringhaus, JD Office for Interactions with Industry Partners HealthCare System, Inc. (Not repeated) Page 5 of 11

6 10:00 am - 10:50 am Methods for COI Education and Training Key 2 Bridget B. Chamberlain, M.B.A. Director, Compliance Northwestern University The Feinberg School of Medicine Robert Rosa Vice Dean for Regulatory Affairs and Chief Compliance and Privacy Officer Northwestern University The Feinberg School of Medicine (Repeated at 1:40 p.m.) 11:00 am - 11:50 am s (Block 2) Multiple Rooms 11:00 am - 11:50 am Clinical Conflicts: How a Diligent COI Committee Could Leave an Institution at Risk Presented with the AAMC Compliance Officers Forum Key 4 11:00 am - 11:50 am COI 101 (Part I continued) Key 1 Facilitator(s): Jeneane Braden Manager, Research Ethics and Compliance Office Washington University in St. Louis School of Medicine 11:00 am - 11:50 am COI Case Scenariors: SBIR and STTR Issues Key 2 (repeated at 2:40 p.m.) 11:00 am - 11:50 am Here Comes the Sun - What are you doing to prepare for the Sunshine Rule implementation? (not repeated) Key 3 Page 6 of 11

7 12:00 pm - 1:30 pm Lunch: Research about Conflicts of Interest Key 7-8 Eric Campbell, Ph.D. Associate Professor, Medicine Institute of Health Policy Massachusetts General Hospital 1:40 pm - 2:30 pm s (Block 3) Multiple Rooms 1:40 pm - 2:30 pm COI 101 (Part II) Key 1 1. Management Plans How to Primary Components Templates 2. Examples of FCOI reports via the era Commons" 3. Compliance Monitoring 4. PHS Retrospective Reviews 1:40 pm - 2:30 pm Internal Coordination with the IRB, Tech Transfer, Sponsored Programs, and Others Key 3 Elizabeth Boyd, Ph.D. Associate Vice Chancellor, Ethics and Compliance University of California - San Francisco Monika S. Markowitz, Ph.D. Director, Office of Research Integrity and Ethics Virginia Commonwealth University (Not Repeated) 1:40 pm - 2:30 pm Methods for COI Education and Training Key 2 Page 7 of 11

8 1:40 pm - 2:30 pm Research About COI Key 4 Aaron Seth Kesselheim, M.D., J.D., M.P.H. Susannah L Rose, PhD Assistant Professor, Lerner College of Medicine Case Western Reserve University Associate Professional Staff, Bioethics Department Cleveland Clinic Foundation 2:40 pm - 3:30 pm s (Block 4) Multiple Rooms 2:40 pm - 3:30 pm COI Case Scenariors: SBIR and STTR Issues Key 2 2:40 pm - 3:30 pm Mentor Versus Marketer: What Can and Should Industry Teach Us About the Use of Devices? Moderator: Key 4 Barbara E. Barnes, MD, MS Associate Dean for CME, Associate Vice Chancellor for Continuing Ed & Industry Support University of Pittsburgh School of Medicine Julie D. Gottlieb, M.A. Associate Dean, Policy Coordination Johns Hopkins University School of Medicine Ziya Gokaslan, MD, FACS Donlin M. Long Prof., Prof. of Neurosurgery, Oncology and Orthopedic Surgery, Dir. Neurosurgical Spine Program, Vice Chairman, Dept. of Neurosurgery Johns Hopkins University School of Medicine Page 8 of 11

9 2:40 pm - 3:30 pm Using Doctors to Market Products: How does the FDA affect physician / industry interactions? Key 3 Joy J Liu, JD Ms. Ropes & Gray LLP 2:40 pm - 3:40 pm COI 101 (Part II) continued Key 1 3:30 pm - 4:15 pm Refreshment Break Key South Foyer 4:15 pm - 5:00 pm How Do Other Countries Do It? Conflict of Interest Regulation Abroad Key 5-6 Alexander Dreier, J. D. Partner Hogan Lovells Challenges and Approaches in Management 5:00 pm - 6:00 pm Expert Advice Worth $276 Million??? Insider Trading and Expert Networks Moderator: Key 5-6 Raymond Joseph Hutchinson, M.D., M.S. Associate Dean, Regulatory Affairs University of Michigan Medical School Ross Erwin McKinney, M.D. Chair, School of Medicine COI Committee and Institutional COI Committee Duke University School of Medicine Helen C. McLaughlin, M.B.A. Asst. Dean for Administration Emory University School of Medicine Page 9 of 11

10 6:15 pm - 7:15 pm Cocktail Reception Key South Foyer All attendees invited. 7:15 pm Adjourn for the Day - Dinner on your Own Saturday, March Forum on Conflict of Interest in Academe Meeting March 21-23, :15 am - 10:00 am Registration and Information 7:30 am - 8:30 am Breakfast Key 7-8 8:30 am - 8:45 am Welcome and FOCI Business Meeting Key 5-6 All attendees invited. 8:45 am - 10:00 am Institutional Conflicts of Interest Key 5-6 Marjorie Ann Speers, Ph.D. President and CEO Panelist(s): Ross Erwin McKinney, M.D. Chair, School of Medicine COI Committee and Institutional COI Committee Duke University School of Medicine Lynn A. Zentner Director, Office of Institutional Compliance University of Minnesota-Twin Cities Page 10 of 11

11 Saturday, March 23 10:15 am - 11:45 am Working with Industry - Advancing our Missions Through Principled Partnerships Moderator: Key 5-6 Heather Pierce, JD, MPH Senior Director, Science Policy & Regulatory Counsel AAMC Panelist(s): Guy M. Chisolm, Ph.D., M.S. Vice Chairman, Lerner Research Institute Cleveland Clinic Foundation David Shepherd Raiford, M.D. Senior Associate Dean for Faculty Affairs; Vice Chancellor for Health Affairs Vanderbilt University School of Medicine Tara R Shewchuk, LL.B., LL.M. Vice President, Ethics and Compliance Medtronic Spinal Catherine Stehman-Breen, MD Vice President, Clinical Development Amgen Inc. 11:45 am - 12:00 pm Closing Remarks, Meeting Adjournment Key Forum on Conflict of Interest in Academe Meeting March 21-23, 2013 Page 11 of 11