Second Annual Medical Research Summit: Agenda: Day 2

  Pre-Conference

  Day One

  Day Two

Agenda: Day 2 Tuesday, March 26, 2002
8:00 a.m.	Welcome and Introduction to Day Two
8:15 a.m.	An Update - When Things Go Wrong in the Conduct of Clinical Research: Lessons Learned Stephen F. Hanlon, Esq. Member Holland & Knight Tallahassee, FL Alan C. Milstein, Esq. Partner Sherman, Silverstein, Kohl, Rose & Podolsky Pennsauken, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:15 a.m.	The Future of Pharmaceutical Research and Development J.D. Kleinke President Health Strategies Network Author Bleeding Edge: The Business of Health Care in the New Century and Oxymorons: The Myth of a U. S. Health Care System Denver, CO Presentation Material (Acrobat) Presentation Material (Powerpoint)
10:15 a.m.	Responding to the Threat of Bioterrorism: A Status Report on Vaccine Research in the United States Dixie E. Snider, Jr., M.D. Associate Director of Science Center for Disease Control and Prevention Atlanta, GA Presentation Material (Acrobat) Presentation Material (Powerpoint)
11:15 a.m.	TRANSITION BREAK
11:30 a.m.	CONCURRENT SESSIONS IV
	4.01 Academic Medical Centers and Pharmaceutical Companies: Improving Relationships in the Medical Research Context Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University of California, Los Angeles Los Angeles, CA Presentation Material (Acrobat) Presentation Material (Microsoft Word) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	4.02 Billing and Research: A Practical Approach Towards Compliance Kim St. Amant, CPA Senior Manager National Clinical Research Consulting Team Deloitte & Touche LLP Boston, MA Sandy Piersel Senior Manager National Clinical Research Consulting Team Deloitte & Touche LLP Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint)
	4.03 Managing Institution-Investigator Relationships Sandra A. Davis Director Risk and Compliance Services Huntington Memorial Hospital Pasadena, CA
	4.04 Negotiating Clinical Trials Agreements William A. Knowlton, Esq. Partner, Ropes & Gray Boston, MA Jeff Kahn, Esq. Associate General Counsel Children's Hospital of Philadelphia Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint)
	4.05 Overview of Financial and Administrative Commitments of Clinical Research Timothy J. Fournier Senior Manager Higher Education and Healthcare Consulting Arthur Andersen LLP Chicago, IL Presentation Material (Acrobat) Presentation Material (Powerpoint)
12:30 p.m.	Luncheon and Presentations
1:00 p.m.	Adverse Event Reporting: Trials and Tribulations Michael Carome, MD Director, Compliance Oversight Office for Human Research Protections Department of Health and Human Services Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Joanne R. Less, Ph.D. Director, IDE/HDE Programs Center for Devices and Radiological Health Food and Drug Administration Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University of California, Los Angeles Los Angeles, CA
2:00 p.m.	Annual Roundtable on Medical Research Compliance, Legal Counsel, Ethics and Privacy John Bentivoglio, Esq. Partner Arnold and Porter Former Special Counsel for Healthcare Fraud Chief Privacy Officer United States Department of Justice Washington, DC Thomas E. Merchant, Esq. Vice President R & D Legal Operations U.S. GlaxoSmithKline King of Prussia, PA John H. Mather, MD Chief Officer Office of Research Compliance and Assurance Department of Veterans Affairs Washington, DC Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University of California, Los Angeles Los Angeles, CA John E. Steiner, Jr., Esq. Chief Compliance Officer Cleveland Clinic Health System Cleveland, OH Jay H. Tureen, MD Director Research Education and Compliance Program Clinical Professor of Pediatrics University of California, San Francisco San Francisco, CA Paul E. Kalb, JD, MD Partner Sidley Austin Brown & Wood Washington, DC (Moderator)
3:15 p.m.	TRANSITION BREAK
3:30 p.m.	CONCURRENT SESSIONS V
	5.01 Clinical Research from the Independent IRB's View Paul W. Goebel, Jr. Vice President Chesapeake Research Review, Inc. Columbia, MD Matthew D. Whalen, Ph.D. President Chesapeake Research Review, Inc. Columbia, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	5.02 Advanced Issues In Research Compliance Edward B. Goldman, Esq. Health System Attorney Office of General Counsel University of Michigan Health System Ann Arbor, MI Presentation Material (Acrobat) Presentation Material (Powerpoint) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	5.03 Epidemiological Studies: to Research or not to Research, That is the Question? Thomas Puglisi, Ph.D. Clinical Research Consulting Team PricewaterhouseCoopers LLP Former Director Human Subject Protections Office for Human Subjects Research Protections Department of Health and Human Services Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	5.04 Benchmarking Clinical Research Compliance Efforts: Identifying and Avoiding Key Areas of Risk H.Guy Collier Partner Health Law Department ShawPittman LLP Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
4:30 p.m.	Adjournment

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