Thursday, June 26, 2003
The National Academies, 500 Fifth Street, NW Room 100

9:00 am            Introduction—Goals for the day and new members
                        Queta Bond, Ph.D.
                        Chair, Clinical Research Roundtable
                        President, Burroughs Wellcome Fund

9:30                 Problems and proposed solutions for research oversight  
                       Anne Wood, MA
                       National Human Genome Research Institute
                       View Slides  

10:00               Break

10:30                Central Review Mechanisms (15 minutes each)
                        Eileen Hilton, M.D.
                        Chief Executive Officer 
                        Biomedical Research Alliance of New York, LLC (BRANY)
                        View Slides

                        Daniel Schuster, M.D. 
                        Director, Center for Clinical Studies
                        Washington University School of Medicine
                        Multicenter Academic Clinical Research Organization (MACRO)
                        View Slides

                        Jaci Goldberg, JD
                        Administrator, Central Review Board
                        Cancer Therapy Evaluation Program (CTEP)
                        National Cancer Institute
                        View Slides

                        Duane T. Smoot, M.D., FACP, FACG
                        Professor and Chief, Gastroenterology Section
                        Department of Medicine
                        Howard University College of Medicine
                        View Slides

11:30                ROUNDTABLE DISCUSSION

12:00                Lunch

1:00                 Central review perspectives – implementation of CIRB
                        Cara Laubach
                        Regulatory Coordinator, Washington Cancer Institute
                        MedStar Research Institute
                        View Slides           

1:15                 Central review perspectives – survey results      
                       Eva Loh, Ph.D.
                       Staff Associate
                       Association of American Medical Colleges    
                       View Slides

1:45                 Steps to improve the risk environment associated with human protections a
                       CRO perspective
                       Doug Peddicord, Ph.D.
                       Legislative Director
                       Association of Clinical Research Organizations
                       View Slides

2:10                 Steps to improve the risk environment associated with human protections an 
                       industry perspective
                       Janet Keyser
                       Senior Director of Worldwide Clinical Quality Assurance and Research
                       Merck & Co., Inc.
                       View Slides

2:35                 Steps to improve the risk environment associated with human protections an 
                       academic perspective
                       Robert Bishop, J.D.
                       Associate General Counsel 
                       University of Arkansas
                       College of Medicine
                       View Slides

3:00                 Break

3:15                 IOM recommendations to reform the system – key action needed
                        Fran Visco, J.D.
                        President, National Breast Cancer Coalition
                        Member, Committee on Assessing the System for Protecting Human
                        Research Participants

                        Robert M. Nelson, M.D., Ph.D.
                        Associate Professor, Department of Anesthesia and Critical Care Medicine
                        Children's Hospital of Philadelphia
                        Member, Committee on Clinical Research Involving Children

3:45                 Discuss approaches for OHRP to promote use of streamlined mechanisms
                        Bernard Schwetz, D.V.M., Ph.D. (Moderator)
                        Acting Director
                        Office for Human Research Protections
                        Senior Advisor for Science
                        U.S. Food and Drug Administration

4:15                 Discuss approaches for FDA to promote use of streamlined mechanisms
                       Joanne Rhoads, M.D., M.P.H. (Moderator)
                       Director, Division of Scientific Investigations
                       Center for Drug Evaluation and Research
                       U.S. Food and Drug Administration

5:45                 Adjourn to reception

June 27, 2003

8:30 am     Basic versus Applied Research:  Five easy questions
                 Jessie Gruman, Ph.D.
                 President, Center for the Advancement of Health

                 Sharon Begley
                 Science Editor, Wall Street Journal

9:15          Funding of Evaluative Research
                 Joel Kupersmith, MD
                 Scholar in Residence
                 Board on Health Sciences Policy
                 Institute of Medicine

10:30        Break

10:45        Identifying Roundtable and Member action:  public engagement 
                 Fran Visco, J.D.                                      Susan Weiner, Ph.D.
                 President                                                President
                 National Breast Cancer Coalition               The Children’s Cause, Inc.

12:00        Lunch

1:00          Identifying Roundtable and Member action:  workforce and career development
                 Harold Slavkin, D.D.S.                            Nancy Sung, Ph.D.
                 Dean                                                     Program Officer
                 University of Southern California               Burroughs Wellcome Fund
                 School of Dentistry

2:00          Adjourn