2nd Annual Forum on
Managing Legal Risks in Conducting & Promoting

Clinical Trials

Thursday, February 10, 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 designed the 2nd National Forum on Managing Legal Risks in Conducting & Promoting Clinical Trials. This forum will respond 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, in-house counsel and government representatives will provide insight on the most challenging regulatory, litigation and compliance issues, including:

Front-line analysis of FDAMA 113 from the FDA - 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
The SSRI efficacy study - how it will impact pharma, biotech and device R&D
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

Don't miss this opportunity to hear from those on the front lines of research and from those who are designing and conducting clinical trials while managing the considerable legal risks involved and reducing the exposures faced by their clients. You'll also have a chance to exchange ideas and concerns with your peers and colleagues across the country who are facing similar issues. Register now by calling 1-888-ACI-2480; by faxing your registration form to 1-877-927-1563; or by using our online registration service. We look forward to seeing you there.

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 designed the 2nd National Forum on Managing Legal Risks in Conducting & Promoting Clinical Trials. This forum will respond 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, in-house counsel and government representatives will provide insight on the most challenging regulatory, litigation and compliance issues, including:

Front-line analysis of FDAMA 113 from the FDA - 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
The SSRI efficacy study - how it will impact pharma, biotech and device R&D
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

Don't miss this opportunity to hear from those on the front lines of research and from those who are designing and conducting clinical trials while managing the considerable legal risks involved and reducing the exposures faced by their clients. You'll also have a chance to exchange ideas and concerns with your peers and colleagues across the country who are facing similar issues. Register now by calling 1-888-ACI-2480; by faxing your registration form to 1-877-927-1563; or by using our online registration service. We look forward to seeing you there.

Contents & Contributors


FDAMA 113 AND CLINICAL TRIALS.GOV UPDATE ON IMPLEMENTATION
Theresa Toigo, Food and Drug Administration

CLINICAL TRIAL DISCLOSURE: CURRENT LAW AND PROPISED REFORMS
Paul T. Kim, Foley Hoag

THE PHRMA PRINCIPLES OF CONDUCT OF CLINICAL TRIALS AND COMMUNICATION OF CLINICAL TRIAL RESULTS: WHAT YOU NEED TO KNOW
Scott Lassman, PhRMA

THE ELI LILLY CLINICAL TRIAL REGISTRY INITIATIVE
Mark R. Lange, Eli Lilly and Company

WHAT EVERY IN-HOUSE COUNSEL AND RISK MANAGER NEEDS TO KNOW ABOUT CLINICAL TRIAL AGREEMENTS
Dan O'Connor, ImClone Systems Incorporated
Amor Esteban, Drinker Biddle & Reath LLP
Lee Farrow, ACE Medical Risk

POINTS TO CONSIDER: IRB REVIEWS
Melissa Abraham, PhD, MS, Massachusetts General Hospital

MINIMIZING LIABILITY IN CLINICAL TRIALS
Harvey L. Kaplan, 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

MINIMIZING RISK WHEN CONTRACTING WITH CRO'S: TIPS AND CURRENT ISSUES
Blaine Templeman, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo

USE OF SSRIS IN DEPRESSED YOUTH: EFFICACY AND RISKS
J. John Mann, MD, Columbia University

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

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

SPONSOR OBLIGATIONS IN CLINICAL TRIALS AND MINIMIZING RISK
Susan J. Thompson, Guidant Corporation

INDUSTRY SPONSORED RESEARCH AND THE ACADEMIC MEDICAL CENTER
J. Mark Waxman, Caregroup, Inc.

PRACTICAL STRATEGIES FOR MINIMIZING OFF-LABEL PROMOTION LIABILITY RISKS
Jerrie Chiu, Bayer Pharmaceuticals Corporation

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

USE OF CLINICAL TRIAL DATA TO COUNTER POTENTIAL POST-MARKETING CLAIMS
Ken Baum, MD, JD, Wiggin and Dana LLP
Joseph Hetrick, Dechert LLP

PRIVACY ISSUES IN INTERNATIONAL CLINICAL TRIALS
Daniel Garen, Bayer Healthcare

MASTERING THE MAZE: CONDUCTING INTERNATIONAL CLINICAL TRIALS
James Lovett, Covance, Inc.

GENERATING ACCEPTABLE FOREIGN CLINICAL STUDY DATA
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

SECONDARY USES OF BIOLOGIC MATERIALS AND MEDICAL DATA BY RESEARCHERS AND COMMERCIAL RESEARCH SPONSORS
Kate Gallin-Heffernan, Ropes & Gray

MANAGING ELECTRONIC DATA SUBMISSION
Cecelia Gassner, Lifetech Law Group
Peter Adler, Foley & Lardner

MINIMIZING CLINICAL TRIAL LIABILITY THROUGH COMPLIANCE WITH FDA REGULATIONS
Robert Nicholas, McDermott, Will & Emery



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0