Molecular Imaging Participation in Clinical Trials

張貼者:2009年7月1日 下午6:02林昆儒   [ 已更新 2009年7月1日 下午6:22 ]

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Molecular Imaging Participation in Clinical Trials:
Nuts & Bolts of the SNM Clinical Trials Network
Saturday, June 13th, 2009
Toronto, Canada


Recorded Live! presentations are now available for viewing online.

Hear specific feedback direct from therapeutic pharmaceutical developers on
what works (and doesn't work) today when it comes to the use of 
imaging in multicenter clinical trials.
Hear candid talk from FDA representatives on the need for
improved standardization and harmonization in imaging.
Learn more about the FLT demonstration projects being planned by the
SNM Clinical Trials Network.

For more information on the SNM Clinical Trials Network, please contact us at

SNM Clinical Trials Network Community Workshop

Presented Feb. 8–9, 2009, at the SNM Mid-Winter Educational Symposium, Clearwater Florida
Chairs: Alexander Sandy McEwan, MD, and Michael M. Graham, PhD, MD

Program Book and Faculty Listing

Note: Click the session titles below to view the flash presentation. Click the  to view the PDF version (no audio).
Due to their large size, some presentations may take a few minutes to download.

February 8, 2009

Keynote Address: Imaging in Clinical Trials: Choosing the Right Imaging Application for Therapy Response Assessment 
    Gustav K. von Schulthess, University Hospital, Zurich, Switzerland

Session I: The Role of Imaging Biomarkers in Drug Development and Multicenter Trials

Moderator: Peter Conti, SNM
  1. Untapped Potential for Imaging Biomarkers in Multicenter Clinical Trials    Diane Jorkasky, Pfizer
  2. Drug Development: Current Methods and Short-Comings    Jeff Evelhoch, Merck
  3. Current Limitations and Common Pitfalls of Multi-site Imaging in Clinical Trials: A CRO Perspective Matt Barish, Perceptive Informatics
  4. Challenges of Standardization and Harmonization in Multicenter Imaging Clinical Trials    Wendy Sanhai, FDA-Office of the Commissioner

Session II: Areas of Need for Imaging Biomarkers in Drug Development

    Moderator: Sandy McEwan, SNM
  1. Imaging Biomarkers–An Overview    Dan Sullivan, RSNA
  2. Oncology: Needs for Imaging Biomarker Development   Jim Tatum, NCI
  3. Neurology: Needs for Imaging Biomarker Development   Dan Skovronsky, Avid
  4. Cell Therapeutics: Needs for Imaging Biomarker Development   Sudha Kadiyala, Advanced Technologies & Regenerative Medicine
  5. FDA Initiatives and the Regulatory Perspective: Bridging Gaps    Wendy Sanhai, FDA-Office of the Commissioner
February 9, 2009

Session III: SNM Clinical Trials Network Introduction

Moderator: Michael Graham, SNM

  1. SNM Clinical Trials Network    Robert Atcher, SNM
  2. The Role of the Network in Drug Development    Susan Galbraith, BMS
  3. Regulatory Considerations: Mechanisms of Centralized INDs and CMC for Distributed Biomarker Manufacturing    George Mills, Perceptive Informatics

Session IV: 2009 FLT Demonstration Project: Participation, Qualification and Responsibilities

Moderator: Dominique Delbeke, SNM

  1. FLT Clinical Overview    Michael Graham, SNM
  2. FLT Metabolic Pathways and Pharmacokinetics    David Mankoff, University of Washington
  3. Trial Design for Imaging Biomarkers and Diagnostic Agents    Chaitanya Divgi, University of Pennsylvania
  4. FLT Demonstration Project Overview    George Mills, Perceptive Informatics
  5. FLT Centralized IND: Standardized Imaging Protocols    John Hoffman, University of Utah
  6. SNM Clinical Trials Network Phantom Program Update    Paul Christian, University of Utah
  7. PET Quantitative Measurements    Paul Kinahan, University of Washington

Session V: Fundamentals of Clinical Trials Participation: Workshops

  1. Group A: Multicenter Standardization and Harmonization: Phantoms, Quantification, Statistics, Outcomes and Data Collection Part 1Part 2Part 3  Larry Clarke, NCI; Paul Kinahan, University of Washington; Paul Christian, University of Utah; Lisa Karam, NIST; Chekesha Clingman, FDA Office of the Commissioner
  2. Group B: Operational Nuts and Bolts   Lindsey Pendleton, Perceptive Informatics; Denise Harbora, Cross Cancer Institute
  3. Group C: Centralized IND Manufacturing Practices: CGMP & CMC Regulatory Considerations Part 1Part 2,Part 3  Ravi Harapanhalli, Parexel and FDA, Immediate Past CMC Division Director; Paula Jacobs, NCI; Sally Schwarz,  Washington University; Joseph Hung, Mayo Clinic Wrap Up and Summary: Next Steps for the Clinical Trials Network Sandy McEwan, SNM, and Michael Graham, SNM