Featured Conference

Maximizing the Value of Investigator-initiated Post-marketing Clinical Trials
June 23-25, 2004 • The Inn at Union League, Philadelphia, PA

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Investigator-initiated Trials are on the rise and sponsor spending on post-marketing clinical grants is higher than ever before. While most companies are doing these types of trials, not all of them are doing them in the most efficient or cost-effective manner. However, while budgets are being continually trimmed, itÂ’s important for companies to wisely invest resources in these trials. Moreover, some companies still fail to get the most value from these trials, even after repeated attempts to do them successfully.

The legal and regulatory hurdles are another major pitfall to investigator-initiated trials. Recent legislation and newly revised guidance documents for the pharmaceutical industry are being introduced regularly in light of the latest anti-kickback statutes. Pharmaceutical companies must carefully navigate the guidelines to ensure a successful outcome in these investigator-initiated studies.

WeÂ’ve created this leading-edge event based on comprehensive research into the most pressing issues facing pharmaceutical companies today in their investigator-initiated studies. Hear from industry experts on how to:

  • Bypass regulatory pitfalls that might initiate an investigation of your organization
  • Choose the best trial design that fits your intended outcomes
  • Collect the best and most relevant data in your trials
  • Ensure a rewarding relationship with clinical investigators
  • Expand product visibility through case studies of oncology IITs

Plus – Get the Most Out of Your Learning Experience and
Register for the Half-Day Interactive Pre-Conference Workshops

Managing Interactions between Pharmaceutical Manufacturers and Healthcare Professionals highlights the best ways in which pharmaceutical companies and investigators can communicate, without fear of violating regulatory constraints.

And

Benefit from the Expertise of Our Top-Notch Faculty

Susan Brousseau (invited)
Oncology National Director of Scientific Affairs
ASTRAZENECA PHARMACEUTICALS

Jane Chin, PhD
Independent Consultant, Founder
MSL QUARTERLY

W. David Dawson, PhD
Dir. of Medical Information and Science Liaisons
Global Head of Field Medical Affairs
EMD PHARMACEUTICALS

John P. Fruehauf, MD, PhD
Associate Professor of Clinical Medicine
Chao Family Comprehensive Cancer Center
UNIVERSITY OF CALIFORNIA IRVINE

Stanley B. Garbus, MD, MPH
Co-Founder and Chief Medical Officer
SENTRX

Richard Gliklich, MD
President and CEO
OUTCOME
John T. Kelly, MD, PhD
formerly Sr. VP, Scientific & Regulatory Affairs
PhRMA

Charles Laudadio, MD, MBA
Director, Medical & Regulatory Affairs
J & J / MCNEIL SPECIALTY PHARMACEUTICALS

Alan Minsk
Partner & Leader, Food and Drug Law
ARNALL GOLDEN GREGORY LLP

Charles Pierce, MD, PhD, CPI
Adj. Professor, Pharmaceutical Sciences
UNIVERSITY OF CINCINNATI

James Sheehan
US Attorney
DEPARTMENT OF JUSTICE

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