Coalition for PET Drugs Sponsors Three Sessions at SNMMI Annual Meeting

The Coalition for PET Drugs recently sponsored three sessions at the 2017 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Denver. The sessions focused on various topics relevant to PET drug manufacturers. Each session drew approximately 100 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others. The three sessions covered a broad range of topics ranging from analytical methods validation to USP standards to radiopharmaceutical compounding.

The first session was a day-long Categorical Session entitled, “Best Chemistry Practices to Support the Development of PET Drugs.” The session was held on the Saturday before the official start of the annual meeting and was co-sponsored with the SNMMI’s Radiopharmaceutical Sciences Council (RPSC). This is the third year in a row that the Coalition has jointly sponsored a session with the RPSC, which demonstrates the alignment of the Coalition’s mission with that of the RPSC. The Categorical was co-organized and co-moderated by Amy Vavere, Ph.D., and Steve Zigler, Ph.D.The presentations are available here:

  1. Introduction to Session – Steve Zigler, Ph.D.
  2. Overview of FDA Regulations and Guidance Documents related to PET Drug Chemistry – Steve Zigler, Ph.D.
  3. F-18 and C-11 Chemistry Challenges – Peter Scott, Ph.D.
  4. Special Considerations for Tracers based on Proteins or Protein Fragments – Serge Lyaschenko, Ph.D.
  5. Field Notes #1 – Challenges behind the scenes of clinical PET tracer production – Ashley Mishoe, Pharm.D.
  6. Stability Studies to Support PET Drug Applications – Danny Bingham, M.S.
  7. Common Deficiencies in PET Drug Applications – Ravi Kasliwal, Ph.D.
  8. Role of USP monographs and general chapters – Steve Zigler, Ph.D.
  9. Characterization of Active Ingredients, By-Products, Impurities, and Standards – Jeanne Link, Ph.D.
  10. Field Notes #2 – Validation of a Quality Control method in a clinical PET tracer – Amy Vavere, Ph.D.
  11. System suitability for Analytical Methods – Mike Haka, Ph.D.
  12. Transfer of Technology to Multiple Facilities – Pitfalls and Best Practices – Tyler Benedum, Ph.D.
  13. Field Notes #3 – Experience from Inspections (CFR 212 & USP <823>) – David Dick, Ph.D.

The second session was a Continuing Education Session entitled, “USP Standards for Radiopharmaceuticals.” The session was held on Monday morning. The session was co-organized by Jim Ponto, R.Ph., Steve Zigler, Ph.D., Ravi Ravichandran, Ph.D. Dr. Ravichandran moderated the session.

The presentations are available here:

  1. Historical Role of the USP in Radiopharmaceuticals – Steve Zigler, Ph.D.
  2. Overview of USP Activities and How to Get Involved – Ravi Ravichandran, Ph.D.
  3. Latest Developments in USP Monographs and the Compounding of Sterile Radiopharmaceuticals – Jim Ponto, R.Ph.

The third session was a Continuing Education Session entitled, “PET Drug Manufacturing: Current Topics Related to the FDA and USP.” The session was held on Tuesday afternoon. The session was co-organized by Sally Schwarz, R.Ph. and Steve Zigler, Ph.D. Dr. Zigler moderated the session.

The presentations are available here:

  1. Introduction and Year in Review – Steve Zigler, Ph.D.
  2. FDA’s eCTD Mandate for 2017: Latest Developments – Phillip DeNoble, Pharm.D.
  3. Harmonizing FDA Regulation and the Practice of Pharmacy: Challenges and Opportunities – Michael Nazerias, M.S.
  4. Latest USP Initiatives: Monographs, General Chapters, and Compounding – Jim Ponto, R.Ph.
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