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
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 firstname.lastname@example.org.
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
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
- 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
- Imaging Biomarkers–An Overview Dan Sullivan, RSNAOncology: Needs for Imaging Biomarker Development Jim Tatum, NCI
- Neurology: Needs for Imaging Biomarker Development Dan Skovronsky, Avid
- Cell Therapeutics: Needs for Imaging Biomarker Development Sudha Kadiyala, Advanced Technologies & Regenerative Medicine
February 9, 2009
Session III: SNM Clinical Trials Network Introduction
Moderator: Michael Graham, SNM
SNM Clinical Trials Network Robert Atcher, SNMThe Role of the Network in Drug Development Susan Galbraith, BMSRegulatory 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
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
- 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
- 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