Critical Markers of Disease
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May 1, 2009 Manufacturing PET Radiopharmaceuticals
Natcher Auditorium, National Institutes of Health, Bethesda, MD
Presentations

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    May 1, 2009  
    6:10 PM ‐ 6:20 PM Introduction and Overview
    Peter Libby, Brigham and Women’s Hospital; Donald M. Black, GEHC Diagnostics; Michael M. Graham, U of Iowa
    6:20 PM ‐ 6:40 PM PET Drug Regulation: A Brief History
    Dennis Swanson, University of Pittsburgh
    6:40 PM ‐ 7:00 PM Review of Current USP Chapter 823 for IND and RDRC Regulated PET Compounding
    Sally Schwarz, Washington University
    7:00 PM – 7:20 PM Current Regulatory Draft Guidelines for PET Drug Products
    Eldon Leutzinger, Chemistry Team Leader, Medical Imaging, FDA
    7:20 PM ‐ 7:40 PM Applying Current Guidelines: Challenges and Successes
    Luke Augustine, PharmD, Cardinal Health
    7:40 PM ‐ 8:00 PM CGMP Compliance with a Centralized IND – Comparison of FDA PET CGMP and USP <823> Requirements
    Joseph Hung, Mayo Clinic
    8:00 PM – 8:20 PM The Development and Commercialization of New PET Tracers
    Donald Black, Head R&D GEHC Diagnostics
    8:20 PM – 8:40 PM Introduction to the SNM Clinical Trials Network: CMC Compliance with a Multicenter IND
    George Q. Mills, Perceptive Informatics
    8:40 PM ‐ 9:45 PM Q & A and Guided Panel Discussion

     

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About CMOD

CMOD is a 501(c)3 non-profit organization established in 2006 to advance the science of biomarkers used to identify, monitor and treat cardiovascular and related diseases.

 
 
"Building partnerships that lead to innovation and better patient outcomes."
International Partnership for Critical Markers of Disease
PO Box 132200 • Ann Arbor, MI 48113
Phone: 734.929.2095
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