Welcome and Introduction

Greg Warner
President
Health Care Compliance Association
Director for Compliance
Mayo Foundation
Rochester, MN

Leslie Platt, JD
Principal & Leader
Health Sciences Research Compliance Group
Ernst & Young, LLP
McLean, VA

The New National Human Research Protections Advisory Committee's Role in Protecting Human Subjects

Mary Faith Marshall, PhD
Chairperson
National Human Research Protections Advisory Committee
and Director of Programs in Bioethics
University of Kansas Medical Center
Kansas City, KS

Human Genome Project

Alan Guttmacher, MD
Senior Clinical Advisor
National Human Genome Research Institute
National Institutes of Health
Bethesda, MD

Managing Research in Changing World of Healthcare

Myron Genel, MD
Associate Dean for Governmental Affairs
Yale University
New Haven, CT

Susan Philp, Esq.
Powers, Pyles, Sutter & Verville
P.C., Washington, DC

Jeffrey M. Sconyers, Esq.
General Counsel
Children's Hospital & Regional Medical Center
Seattle, WA

Kenneth Dretchen
Dean of Research and Graduate Education
Georgetown University Medical Center
Washington, DC

Anthony M. Boccanfuso, PhD
PricewaterhouseCoopers LLP
(Moderator)
Presentation Material

Break

CONCURRENT SESSIONS 4

401. Enforcement & Response: Establishing Research Compliance Program

Kendra Dimond, Esq.
Partner
Arent Fox Kintner Plotkin & Kahn
Washington, DC

Bernie Ford
Partner
Ernst & Young LLP
McLean, VA
Presentation Material

402. IRB Operations: The Changing Roles of IRBs

Eugene DiMagno, MD
Chair IRB
Mayo Foundation
Rochester, MN
Presentation Material

403. Reimbursement and Finance: Using the National Coverage Decisionmaking Process for Investigational Products/Uses

Ron Milhorn
Ron Milhorn LLC
Finksburg, MD
Presentation Material A
Presentation Material B
Presentation Material C
Presentation Material D
Presentation Material E

404. Research Compliance A: Allocating Compliance Responsibilities among CROs, SMOs, Investigators and Institutions

Richard P. Anthony, PhD
President & CEO
AxisMed LLC
Pasadena, CA
Presentation Material

405. Research Compliance B: Managing Multi-Site Research Projects

William Alexander, PhD
Manager
Health Sciences Research Compliance Group
Ernst & Young LLP
McLean, VA

Philip Cyr
Manager
Health Sciences Research Compliance Group
Ernst & Young LLP
Boston, MA
Presentation Material

LUNCHEON AND PRESENTATIONS

Susan L. Rose
Health Scientist
Deptartment of Energy
Life Sciences Division
Germantown, MD
(Moderator)

When Things Go Wrong in the Conduct of Clinical Research: Lessons Learned

Stephen Hanlon, Esq.
Partner
Holland & Knight

Investigation and Prosecution of Medical Research Civil and Criminal Wrongs

David Hoffman, Esq.
Assistant United States Attorney for the Eastern District of Pennsylvania
Philadelphia, PA

Richard Stern, Esq.
Senior Counsel
Office of Inspector General
Department of Health & Human Services
Washington, DC

Diane Dean
Office of Policy on Extramural ResearchAdministration
National Institutes of Health
Bethesda, MD

Paul Kalb, MD, JD
Partner
Sidley & Austin
Washington, DC (Moderator)

TRANSITION BREAK

CONCURRENT SESSIONS 5

501. Academic Medical Center: Position on Human Subjects Research Protection

Stephen Heining
Division of Biomedical & Health Sciences Research Association of American Medical Colleges
Washington, DC

Viki Saito
Associate Vice Chancellor
Health Affairs and Communication
Duke University
Durham, NC

Soo Bang, MHSA
PricewaterhouseCoopers LLP
Washington, DC
(Moderator)

502. IRB Operations: Using Central and Commercial IRBs

Philip Cyr
Manager
Health Sciences Research Compliance Group
Ernst & Young LLP
Boston, MA

Josh Berlin
Senior Consultant
Ernst & Young LLP
McLean, VA
Presentation Material

503. Reimbursement and Finance: Costing Protocols Appropriately

Victor Lampafona, Pharm.D
Clinical Pharmaceutical Research Program
Emory University
Atlanta, GA
Presentation Material

504. Research Compliance A: Adverse Event Reporting

George Gasparis
Office for Human Research Protections
Department of Health and Human Services
Rockville, MD

ADJOURNMENT