Transcript Slide 1

2-Topic Imaging Workshop:
(1)Standards for Imaging Endpoints in Clinical Trials
(2) Manufacturing of PET Radiopharmaceutical Products
Wendy R. Sanhai, Ph.D., M.B.A
Senior Scientific Advisor
Office of the Commissioner, FDA
Society of Nuclear Medicine
Albuquerque, Feb 1, 2009
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Catalyst and Next Steps
• The Prescription Drug User Fee Act (PDUFA)
IV signed in 2007 called for the development
of a guidance to address “Imaging Standards
for Use as an End Point in Clinical Trials”
• Two-day scientific workshop, co-sponsored
with SNM, RSNA, with key input from
NCI/CIP
PET cGMP Regulations
• FDA issued final rule for cGMP for PET drugs (21
CFR part 212) in the Federal Register of December
10, 2009 (74 FR 65409).
• Concurrently, FDA also announced the availability of
a guidance entitled ‘‘PET Drugs—Current Good
Manufacturing Practice (cGMP)” to help PET drug
producers better understand FDA’s thinking
regarding compliance with the new PET cGMP
requirements.
Workshop Objectives
• Bring together pharmaceutical/device industries, CROs,
imaging core laboratories, academia, government agencies,
and other professional organizations toward:
– Identify and develop standards for the use of imaging to determine
endpoints in clinical trials
– Inform regulatory guidance development
– Share regulatory perspectives on cGMP for PET imaging: review on
the 21 CFR Part 212 cGMP regulation and the associated guidance
– Share lessons learned and expectations for Chemistry, Manufacturing
and Controls (CMC) in regulatory submissions
– Share regulatory perspectives on PET radiopharmaceuticals registration
and use in multicenter clinical trials
Day 1: General Issues of Imaging Standards in
Clinical Trials
• Image Acquisition & Analysis: quality control
concepts, equipment and software, phantoms
• Image Interpretation: Local vs central read
design, sources and solutions to read variability
• Data Management: display, storage, transmission
Day 2: Manufacturing of PET Radiopharmaceutical Products
•
Regulatory framework for PET drugs: 21 CFR Part 212 regulations establishing
the Current Good Manufacturing Practice (cGMP) for PET drugs
•
Considerations for Chemistry Manufacturing and Controls (CMC) for:
– Investigational New Drug Application (IND)
– New Drug Application (NDA)
– Radioactive Drug Research Committee (RDRC)
•
FDA Perspective on PET Radiopharmaceuticals Registration & Manufacturing
•
Industry Perspective on PET Drug Manufacturing
•
Lessons learned in multi-center trials:
– National Cancer Institute: FLT F-18 IND and F-18 NaF NDA
– American College of Radiology Imaging Network
– Society of Nuclear Medicine
– Academy of Molecular Imaging
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Next Steps
• Outreach to stakeholders
• Complete concept paper to stimulate
discussion for future guidance:
– “Essential Imaging Standards for Successful
Development of Imaging End Points in Clinical
Trials”
Thank You!
[email protected]
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