2-Topic Imaging Workshop: (1)Standards for Imaging Endpoints in Clinical Trials (2) Manufacturing of PET Radiopharmaceutical Products

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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 MedicineAlbuquerque, 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

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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 DrugsCurrent Good
  Manufacturing Practice (cGMP) to help PET drug
  producers better understand FDAs thinking
  regarding compliance with the new PET cGMP
  requirements.

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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

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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

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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

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Thank You!

• Wendy.Sanhai_at_fda.hhs.gov