10:45 am Break
11:00 am Session 6: Regulatory Issues
Moderator: Richard L. Schilsky, American Society of Clinical Oncology (ASCO)

Optimizing Safety Data Collection in Cancer Clinical Trials
  • Richard L. Schilsky, ASCO

FDA Perspective on Data Quality Issues
  • Rachel Sherman, FDA Office of Medical Policy

The Role of the Cancer Therapy Evaluation Program/NCI in Registration Trials
  • Jeffrey Abrams, NCI Division of Cancer Treatment and Diagnosis

FDA/NCI Collaboration—Independent Radiologic Review
  • Lori Dodd, NCI Biostatistics Research Branch

Pharmaceutical Industry
  • Sandra Horning, Genentech

EMA-FDA Harmonization
  • Francesco Pignatti, EMA

Panel Discussion
Speakers plus:
  • Robert Iannone, Merck Research Laboratories
  • Debasish Roychowdhury, Sanofi Oncology
1:45 pm Workshop Wrap-Up
  • Monica Bertagnolli, Alliance for Clinical Trials in Oncology and DFCI
2:00 pm Adjourn

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