Molecular Imaging Participation in Clinical Trials

Post date: 2009/7/2 上午 01:02:52

Did you miss it?!

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, PfizerDrug Development: Current Methods and Short-Comings Jeff Evelhoch, MerckCurrent Limitations and Common Pitfalls of Multi-site Imaging in Clinical Trials: A CRO Perspective Matt Barish, Perceptive Informatics

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

Moderator: Sandy McEwan, SNM

  1. Imaging Biomarkers–An Overview Dan Sullivan, RSNAOncology: Needs for Imaging Biomarker Development Jim Tatum, NCI
  2. Neurology: Needs for Imaging Biomarker Development Dan Skovronsky, Avid
  3. Cell Therapeutics: Needs for Imaging Biomarker Development Sudha Kadiyala, Advanced Technologies & Regenerative Medicine

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

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

Moderator: Dominique Delbeke, SNM

FLT Clinical Overview Michael Graham, SNMFLT Metabolic Pathways and Pharmacokinetics David Mankoff, University of WashingtonTrial Design for Imaging Biomarkers and Diagnostic Agents Chaitanya Divgi, University of PennsylvaniaFLT Demonstration Project Overview George Mills, Perceptive InformaticsFLT Centralized IND: Standardized Imaging Protocols John Hoffman, University of UtahSNM Clinical Trials Network Phantom Program Update Paul Christian, University of UtahPET 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 1, Part 2, Part 3 Larry Clarke, NCI; Paul Kinahan, University of Washington; Paul Christian, University of Utah; Lisa Karam, NIST; Chekesha Clingman, FDA Office of the Commissioner
  1. Group B: Operational Nuts and Bolts Lindsey Pendleton, Perceptive Informatics; Denise Harbora, Cross Cancer InstituteGroup C: Centralized IND Manufacturing Practices: CGMP & CMC Regulatory Considerations Part 1, Part 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