Managing Legal Risks in Conducting & Promoting

Clinical Trials

Monday, September 19, 2005

About

How Effectively Are You Managing the Risks and Challenges Inherent in Clinical Trials?

Increasing public scrutiny and clamor over clinical trials have caused pharmaceutical, medical device and biotech manufacturers to reconsider how their clinical trials are conducted and what data is released to the public. Government oversight has increased globally, giving rise to regulatory actions as well as civil and criminal prosecutions. State attorneys general are claiming fraud with regard to the "concealment" of certain information in trials. The AMA, US Senators and medical journals are calling for the registration of all clinical trials. There are calls for broader disclosure of all clinical trial data from various public interest groups. Such public outcry makes it necessary for companies to reassess their clinical trial process and to structure a strategy to continue to effectively manage clinical trials and quell the outcry - while not jeopardizing company IP or increasing exposures to liability.

Further, the effective and ethical promotion of trials for off-label use or the use of data to support post-marketing claims is fraught with risk. Even the savviest of marketers, in-house counsel and regulatory affairs officers are challenged by the critical yet delicate balance of successful promotion of product and the fear of raising claims of impropriety or fraud in promotion. And, the daily management of clinical trials, from working with CROs to avoiding conflicts in industry-sponsored research, is a potential minefield of exposure.

With these challenges facing those in the clinical trial arena in mind, American Conference Institute has developed the Managing Legal Risks in Conducting & Promoting Clinical Trials publication that responds specifically to the most pressing concerns of those charged with managing their company's conduct of clinical trials. The experienced and successful faculty of senior food and drug lawyers; regulatory attorneys and in-house counsel will provide you with their expert insight on the most challenging regulatory, litigation and compliance issues, including:

  • Critical analysis of FDAMA 113 - what must you disclose?
  • Understanding the key provisions of PhRMA's code of conduct for clinical trials
  • Protecting your IP by knowing what clinical trial information shouldn't be disclosed
  • Using clinical data to promote off-label use
  • Industry - sponsored research: what you must know to avoid claims of fraud and conflict
  • Using clinical trial data to support post-marketing claims
  • Building successful and effective relationships with CROs
  • Compliant and successful conduct of international clinical trials

Contents & Contributors

About

How Effectively Are You Managing the Risks and Challenges Inherent in Clinical Trials?

Increasing public scrutiny and clamor over clinical trials have caused pharmaceutical, medical device and biotech manufacturers to reconsider how their clinical trials are conducted and what data is released to the public. Government oversight has increased globally, giving rise to regulatory actions as well as civil and criminal prosecutions. State attorneys general are claiming fraud with regard to the "concealment" of certain information in trials. The AMA, US Senators and medical journals are calling for the registration of all clinical trials. There are calls for broader disclosure of all clinical trial data from various public interest groups. Such public outcry makes it necessary for companies to reassess their clinical trial process and to structure a strategy to continue to effectively manage clinical trials and quell the outcry - while not jeopardizing company IP or increasing exposures to liability.

Further, the effective and ethical promotion of trials for off-label use or the use of data to support post-marketing claims is fraught with risk. Even the savviest of marketers, in-house counsel and regulatory affairs officers are challenged by the critical yet delicate balance of successful promotion of product and the fear of raising claims of impropriety or fraud in promotion. And, the daily management of clinical trials, from working with CROs to avoiding conflicts in industry-sponsored research, is a potential minefield of exposure.

With these challenges facing those in the clinical trial arena in mind, American Conference Institute has developed the Managing Legal Risks in Conducting & Promoting Clinical Trials publication that responds specifically to the most pressing concerns of those charged with managing their company's conduct of clinical trials. The experienced and successful faculty of senior food and drug lawyers; regulatory attorneys and in-house counsel will provide you with their expert insight on the most challenging regulatory, litigation and compliance issues, including:

  • Critical analysis of FDAMA 113 - what must you disclose?
  • Understanding the key provisions of PhRMA's code of conduct for clinical trials
  • Protecting your IP by knowing what clinical trial information shouldn't be disclosed
  • Using clinical data to promote off-label use
  • Industry - sponsored research: what you must know to avoid claims of fraud and conflict
  • Using clinical trial data to support post-marketing claims
  • Building successful and effective relationships with CROs
  • Compliant and successful conduct of international clinical trials

Contents & Contributors


ASSESSMENT OF FDAMA 113: UPDATE ON IMPLEMENTATION, REGISTRATION AND ENFORCEMENT
Marc J. Scheineson, Alston & Bird LLP

CLINICAL TRIAL DISCLOSURE: CURRENT LAW AND PROPOSALS FOR REFORM
Paul Kim, Foley Hoag

CLINICAL TRIAL DISCLOSURE: PhRMA'S PERSPECTIVE
Scott M. Lassman, PhRMA

DISSEMINATION OF CLINICAL TRIAL RESULTS: SCIENTIFIC EXCHANGE VS. PRODUCT PROMOTION
Thomas M. Goutman, White and Williams LLP
Charlene A. Gallagher, Wyeth Pharmaceuticals

DISSEMINATION OF CLINICAL TRIAL RESULTS: SCIENTIFIC EXCHANGE VS. PRODUCT PROMOTION
Lori G. Cohen, Greenberg Traurig, LLP
Darcy E. Coty, Greenberg Traurig, LLP

WHAT EVERY IN-HOUSE COUNSEL AND RISK MANAGER NEEDS TO KNOW ABOUT CLINICAL TRIAL AGREEMENTS
Charles Yon, Coley Pharmaceuticals
Lee Farrow, ACE Medical Risk
Amor Esteban, Drinker Biddle & Reath LLP

MINIMIZING THE RISK OF LIABILITY IN THE U.S. ARISING FROM CLINICAL TRIALS
Harvey L. Kaplan, Shook, Hardy & Bacon LLP
John F. Kuckelman, Shook, Hardy & Bacon LLP

MINIMIZING RISKS IN PARTNERSHIPS WITH CRO'S
Charlene A. Gallagher, Wyeth Pharmaceuticals

MINIMIZING RISKS IN PARTNERSHIPS WITH CRO'S
Susan M. Flint, M.S., R.A.C., C.C.R.A., Cato Research Boston

MANAGING RISK WHEN CONTRACTING WITH SERVICE PROVIDERS: TIPS AND CURRENT ISSUES
Blaine Templeman, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

THE ACNP AND FDA STUDY OF EFFICACY OF SSRIs FOR THE TREATMENT OF DEPRESSION IN ADOLESCENTS?
Graham Emslie, M.D., University of Texas Medical Center

PUBLIC DEBATE ON NEED FOR DRUG SAFETY REFORM
Nicole A. Liffrig, Arent Fox

STEERING CLEAR OF LEGAL PITFALLS IN INDUSTRY-SPONSORED RESEARCH
Ashok David Marin, Sanofi-Synthelabo Inc.

STEERING CLEAR OF LEFAL PITFALLS IN INDUSTRY-SPONSORED RESEARCH: THE ACADEMIC MEDICAL CENTER
Mary Ellen Allen, Foley & Lardner LLP

OFF-LABEL PROMOTION: PHARMA RULES AND RISKS
Hope S. Freiwald, Dechert LLP
Joseph D. Piorkowski, Jr., Law Offices of Joseph D. Piorkowski, Jr.

USE OF CLINICAL TRIAL DATA TO COUNTER POTENTIAL POST-MARKETING CLAIMS
Ken Baum, M.D., J.D., Wiggin and Dana LLP
Joseph K. Hetrick, Dechert LLP

MASTERING THE MAZE: CONDUCTING INTERNATIONAL CLINICAL TRIALS
Marc Ginsky, Covance, Inc.

THE TRENDS DEFINING THE GLOBAL FRONTIER OF CLINICAL TRIALS
Amy Fortenberry, Womble Carlyle Sandridge & Rice, PLLC

BEST PRACTICES FOR SECONDARY USES OF BIOLOGIC MATERIALS AND MEDICAL DATA BY RESEARCHERS AND SPONSORS
Angela R.C. Wishon, University of Texas Medical Branch

MAKING SENSE OF SECONDARY RESEARCH USES OF HUMAN BIOLOGIC MATERIALS
Mark Barnes, Ropes & Gray



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