Third Annual Medical Research Summit: Agenda: Day One

  Pre-Conference

  Day One

  Day Two

Agenda: Day 1 Thursday, March 6, 2003
8:00 a.m.	Welcome and Introduction Robert M. "Skip" Nelson, MD, Ph.D. Associate Professor of Anesthesia and Pediatrics Chair, Committee for the Protection of Human Subjects The Children's Hospital of Philadelphia Philadelphia, PA (Co-chair) Michele Russell-Einhorn, Esq. Director, Clinical Research Consulting Team PricewaterhouseCoopers LLP Former Director of Regulatory Affairs Office for Human Research Protection Department of Health Human Services Washington, DC (Co-chair) Presentation Material (Acrobat) Presentation Material (Powerpoint)
8:15 a.m.	Medical Research in Times of Bioterrorism Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections, DHHS Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Jack Killen, MD, NIAID Assistant Director for Biodefense Research National Institute of Allergy and Infectious Diseases Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Kenneth Shine, MD Director, RAND Center for Domestic and International Health Security Former President, Institute of Medicine Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Dixie R. Snider, Jr., MD Associate Director of Science, Center for Disease Control Atlanta, GA Presentation Material (Acrobat) Presentation Material (Powerpoint) Michele Russell-Einhorn, Esq. Director, Clinical Research Consulting Team PricewaterhouseCoopers LLP Former Director of Regulatory Affairs Office for Human Research Protection Department of Health Human Services Washington, DC (Moderator)
9:30 a.m.	The Dryvax Vaccine Case: A Discussion of the OHRP 407 Dale E. Hammerschmidt, MD, FACP Director of Education, Human Subjects Protection University of Minnesota Editor in Chief, Journal of Laboratory and Clinical Medicine Minneapolis, MN Mary Faith Marshall, Ph.D. Former Chairperson National Human Research Protections Advisory Committee, and Director Program in Bioethics, University of Kansas Medical Center Kansas City, KS Robert M. "Skip" Nelson, MD, Ph.D. Associate Professor of Anesthesia and Pediatrics Chair, Committee for the Protection of Human Subjects The Children's Hospital of Philadelphia Philadelphia, PA Ernest Prentice, Ph.D. Associate Vice Chancellor for Academic Affairs University of Nebraska Medical Center Omaha, NE Thomas Puglisi, Ph.D. Clinical Research Consulting Team, PricewaterhouseCoopers Former Director of Human Subject Protections Office for Human Research Protections, DHHS Washington, DC (Moderator)
10:30 a.m.	Break
11:00 a.m.	CONCURRENT SESSIONS I
	1.01 Fraud and Abuse in Research: A Pharmaceutical Sponsor Perspective John Bentivoglio, Esq. Partner, Arnold and Porter Former Special Counsel for Healthcare Fraud Chief Privacy Officer, United States Department of Justice Washington, DC
	1.02 Adverse Event Reporting Dale E. Hammerschmidt, MD, FACP Director of Education, Human Subjects Protection University of Minnesota Editor in Chief, Journal of Laboratory and Clinical Medicine Minneapolis, MN Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.03 IRBs in the Community Hospital Setting with Particular Attention to HIPAA Compliance, State-Specific Consent Law, the Central IRB Project, Tissue Banking Initiatives, and Other Hot Topics Harry Shulman, Esq. Partner, Davis Wright Tremaine LLP San Francisco, CA Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.04 NCI Multi-site Trials and the Central IRB Project Jacquelyn L. Goldberg, J.D. Administrator, Central IRB Initiative National Cancer Institute, NIH Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.05 Social and Behavioral Research Ivor Pritchard, Ph.D. Senior Research Analyst Institute of Education Sciences U.S. Department of Education Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
Noon	Luncheon and Presentations Robert M. "Skip" Nelson, MD, Ph.D. Associate Professor of Anesthesia and Pediatrics Chair, Committee for the Protection of Human Subjects The Children's Hospital of Philadelphia Philadelphia, PA (Co-chair)
12:30 p.m.	Government Up-Date on Medical Research Funding and Regulation Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections, DHHS Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) John Mather, MD Chief Officer Office of Research Compliance and Assurance Department of Veterans Affairs Washington, DC Allan C. Shipp, MHA Director of Outreach, Office of Biotechnology Activities Office of Biotechnology Activities National Institutes of Health Bethesda, MD Mary McCabe Director, Office of Education and Special Initiatives National Cancer Institute Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Mary Faith Marshall, Ph.D. Former Chairperson, National Human Research Protections Advisory Committee Director, Program in Bioethics University of Kansas Medical Center Kansas City, KS (Moderator)
1:15 p.m.	Update on DHHS Advisory Committee on Human Research Protection Ernest Prentice, Ph.D. Associate Vice Chancellor for Academic Affairs University of Nebraska Medical Center Chair, DHHS Advisory Committee on Human Research Protection Omaha, NE
1:45 p.m.	Transition Break
2:00 p.m.	CONCURRENT SESSIONS II
	2.01 Conducting a Compliance Assessment and Building Internal Controls in a Pharmaceutical R & D Operation Allen G. Ditch Director, GCP/GLP Sales & Marketing Corporate Quality Bristol-Myers Squibb Company Syracuse, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) Michael Swiatocha Director, PricewaterhouseCoopers Florham Park, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.02 What FDA Looks for When Inspecting IRBs and Sponsors Marian S. Serge, RN Nurse Consultant, Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Heath Food and Drug Administration Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.03 R & D Privacy Issues for a Pharmaceutical Manufacturer Carol Pratt, JD, Ph.D. Associate, Davis Wright Tremaine Portland, OR Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.04 Research Involving Children Robert M. "Skip" Nelson, MD, Ph.D. Associate Professor of Anesthesia and Pediatrics Chair, Committee for the Protection of Human Subjects The Children's Hospital of Philadelphia Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat)
	2.05 Education and Training in Human Subject Protections Jeffrey M. Cohen, Ph.D. Associate Dean for Research Weill Medical College of Cornell University Former Associate Director of Education Office for Human Research Protections, DHHS New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint)
3:00 p.m.	Transition Break
3:15 p.m.	CONCURRENT SESSIONS III
	3.01 NIH Enhancement Grants Belinda Seto, Ph.D. Acting Deputy Director, Office of Extramural Research National Institutes of Health Bethesda, MD Presentation Material (Acrobat) Presentation Material (Microsoft Word)
	3.02 Independent IRBs Gary L. Yingling, Esq. Partner, Kilpatrick & Lockhart Former President, Food and Drug Law Institute Washington, DC Presentation Material (Acrobat) Presentation Material (Microsoft Word)
	3.03 The Impact of HIPAA on Research Operations Thomas Puglisi, Ph.D. Clinical Research Consulting Team, PricewaterhouseCoopers Former Director of Human Subject Protections Office for Human Research Protections, DHHS Washington, DC Presentation Material (Acrobat) Presentation Material (Microsoft Word) Michele Russell-Einhorn, Esq. Director, Clinical Research Consulting Team PricewaterhouseCoopers LLP Former Director of Regulatory Affairs Office for Human Research Protection Department of Health Human Services Washington, DC Presentation Material (Acrobat) Presentation Material (Microsoft Word)
	3.04 IRB and QI - An Uneasy Marriage Janet Brown, JD, MSW Assistant Attorney General State of Maryland Department of Health and Mental Hygiene Baltimore, MD Robert Schwartz, MD Medical Director Friends Research Institute, Inc. Baltimore, MD Adil Shamoo, Ph.D. Professor, Department of Biochemistry and Molecular Biology University of Maryland School of Medicine Baltimore, MD Ned Rubin, MS,RN,APRN Director of Quality Improvement Friends Research Institute, Inc. Jacksonville, FL (Moderator)
	3.05 Investigating Allegations of Scientific Misconduct and the False Claims Act Edwin Rauzi, Esq. Partner, Davis Wright Tremaine Seattle, WA Presentation Material (Acrobat)
4:15 p.m.	Transition Break
4:30 p.m.	The Duke Center for BioEthics Program Jeremy Sugarman, MD, MPH, MA Director, Center for the Study of Medical Ethics and Humanities Duke University Medical Center Durham, NC Presentation Material (Acrobat) Presentation Material (Powerpoint)
5:15 p.m.	A Panel Discussion: The Medical Research Enterprise from a National and International Perspective Oppel Greeff, MD President, Global Product Development Quintiles Transnational Corporation Research Triangle Park, NC John Kelly, MD, Ph.D. Senior Vice President, Science and Regulatory Affairs, PhRMA Washington, DC Mary McCabe Director, Office of Education and Special Initiatives National Cancer Institute Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Roger E. Meyer, MD Senior Consultant on Clinical Research Association of American Medical Colleges Washington, DC Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University of California, Los Angeles Los Angeles, CA (Moderator)
6:30 p.m.	Adjournment and Networking Reception

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