Medical Research Summit: Agenda: Day 1

  Pre-Conference

  Day One

  Day Two

Agenda: Day 1
Monday, March 19, 2001

8:00 a.m.	Welcome and Introduction Odell Guyton, Esq. Corporate Compliance Officer University of Pennsylvania Philadelphia, PA Michele Russell-Einhorn Director Clinical Research Consulting Team PricewaterhouseCoopers Former Director of Regulatory Affairs for the Office for Human Research Protection Department of Health Human Services Washington, DC Conference Co-chairs
8:15 a.m.	Human Subject Protections: The View from Congress Annette Dula, EdD Senior Research Associate Women's Studies University of Colorado at Boulder Seattle, WA
8:45 a.m.	Human Subject Protections: Food and Drug Administration Policies David Le Pay, MD Acting Senior Advisor for Clinical Science, Food and Drug Administration Office of the Commissioner Rockville, MD
9:30 a.m.	Office for Human Research Protections Initiatives Greg Koski, MD Director Office for Human Research Protections Department of Health and Human Services Rockville, MD
10:15 a.m.	Break
10:45 a.m.	CONCURRENT SESSIONS 1
	101. Enforcement & Response: Investigator Misconduct in Your Organization Sheila Zimmet, JD Georgetown University Washington, DC Kathleen McDermott Blank Rome Comisky & McCauly Baltimore, MD
	102. IRB Operations: ABC's of Establishing an IRB Stephanie J. Taylor Manager Research Compliance Greenville Hospital System Greenville, SC Adam Kohn, Esq. Shaw Pittman Washington, DC Presentation Material A Presentation Material B
	103. Reimbursement and Finance: Medicare Billing and Reimbursement Essentials for Research Soo Bang, Senior Associate Clinical Research Consulting Team PricewaterhouseCoopers Washington, DC Jorge Lopez, Esq. Akin Gump Strauss Hauer & Feld Washington, DC Presentation Material
	104. Research Compliance A: The Effect of HIPAA on Research, Part I Richard Marks, Esq. Partner Davis Wright Tremaine LLP Washington, DC Carol Pratt, JD, PhD Davis Wright Tremaine Portland, OR Presentation Material
	105. Research Compliance B: Fraud and Abuse, Stark and Business Issues in Contracting With Research Sites and Investigators Ron Wisor, Esq. Arent Fox Kintner Plotkin & Kahn Washington, DC Elizabeth A. Lewis, Esq. Epstein Becker & Green Washington, DC Presentation Material A Presentation Material B Presentation Material C
11:45 a.m.	LUNCHEON AND PRESENTATIONS
12:15 p.m.	The Impact of Information Technology on Clinical Research John Cline CEO ETRIALS Morrisville, NC Presentation Material
1:00 p.m.	Emerging Governmental Initiatives in Medical Research Chris Pascal Director Office of Research Integrity Department of Health & Human Services Washington, DC Melanie Lynn, PhD Deputy Director Human Subject Protections Office for Human Research Protections Rockville, MD Belinda Seto, PhD Director Office of Reports & Analysis Office of Extramural Research National Institutes of Health Bethesda, MD Peter Harrington Michele Russell-Einhorn Director Clinical Research Consulting Team PricewaterhouseCoopers LLP Washington, DC (Moderator) Presentation Material A Presentation Material B Presentation Material C
2:15 p.m.	TRANSITION BREAK
2:30 p.m.	CONCURRENT SESSIONS 2
	201. Enforcement and Response: Whistleblowers in Research: The Role of the False Claims Act Christopher A. Myers, Esq. Partner Holland & Knight Washington, DC Edwin Rauzi, Esq. Partner Davis Wright Tremaine LLP Seattle, WA Presentation Material A Presentation Material B Presentation Material C Presentation Material D
	202. Financing Research Compliance Operations David Hudson, PhD Associate Vice President for Research & Public Service University of Virginia Charlottesville, VA Anthony M. Boccanfuso, PhD Manager Clinical Research Consulting Team PricewaterhouseCoopers LLP Charlotte, NC
	203. Enforcement & Response: Assuring Scientific Integrity Kim Gunter, LLM, JD Senior Associate PricewaterhouseCoopers Philadelphia, PA Karen Santoro, JD Deputy Ethics Council NIAID NIH Bethesda, MD Caroline Elmendorf Department of Health & Human Services Washington, DC Presentation Material A Presentation Material B
	204. Research Compliance A: The Effect of HIPAA on Research, Part II Richard Marks, Esq. Partner Davis Wright Tremaine LLP Washington, DC Carol Pratt, JD, PhD Davis Wright Tremaine LLP Portland, OR Presentation Material
	205. Research Compliance B: Old and New Issues in Recruiting Subjects for Clinical Trials Karen McDonnell Suddath, Esq. Pepper Hamilton LLP Philadelphia, PA
3:30 p.m.	TRANSITION BREAK
3:45 p.m.	CONCURRENT SESSIONS 3
	301. Enforcement & Response: Responding to Government Investigation Harvey Yampolsky, Esq. Partner Arent Fox Kintner Plotkin & Kahn Former Chief Counsel to the Inspector General Department of Health & Human Services Washington, DC
	302. Maintaining Compliance in a Growing Research Environment Leslie Platt, JD Principal & Leader Health Sciences Research Compliance Group Ernst & Young LLP McLean, VA
	303. Reimbursement and Finance: Implementing the National Coverage Decision for Clinical Trials Diane Lee, Esq. Partner Davis Wright Tremaine LLP San Francisco, CA Karen Dunlop, Esq. Sidley & Austin Chicago, IL
	304. Research Compliance A: Special Issues in International Research Shirley Hicks National Institutes of Health Bethesda, MD
	305. Research Compliance B: Investigator and Institutional Conflicts of Interest Guy Collier, Esq. Shaw Pittman Washington, DC Susan K. Burgess, Esq. CCO MCV Physicians Richmond, VA
4:45 p.m.	TRANSITION BREAK
5:00 p.m.	The Government's Role in Supporting Biomedical Research Representative Susan Myrick United States House of Representatives Washingon, DC
6:00 p.m.	ADJOURNMENT
6:30 p.m.	NETWORKING RECEPTION

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