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

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

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  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 MedicineAlbuquerque, Feb 1, 2009

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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”

  8. Thank You! Wendy.Sanhai@fda.hhs.gov

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