Positron Emission Tomography Drugs: Product Quality, Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations

The workshop, held on November 13 and 14, is a recurring event and had the highest level of attendance to date. We were pleased to bring stakeholders together with the FDA in order to:

• Discuss regulatory compliance for the development and manufacturing of PET drugs and pathways for regulatory applications.

• Share perspectives from industry, academia, investigators and regulators on inspectional findings and trends.

• Provide information on the management of Part 212 inspections and maintenance of PET NDAs and ANDAs.

Immediately below are some photos from the workshop; further below is the meeting agenda. Further below — in the workshop agenda — you can find links to presentation PDF files and videos. The actual times of the sessions varied. We got behind at one point and an FDA presentation was added.

Program Schedule (with hyperlinks to speaker PDFs)

To view the VIDEOS, select the hyperlinks below:

Monday morning: https://bit.ly/PETDrugsWorkshopNov13AM (duration: 4h 38m 50s)
Monday afternoon: https://bit.ly/PETDrugsWorkshopNov13PM (duration: 3h 39m 08s)
Tuesday morning Q&A: https://bit.ly/PETDrugsWorkshopNov14QnA (duration: 3h 32m 09s)

Monday, November 13, 2023

8:00 - 8:25 AM Welcoming Remarks and Summary from the First Workshop - Louis Marzella, Sue Bunning, Cathy S. Cutler, Charles Metzger

Session I: Considerations and Trends in Facility Inspections and Compliance - Moderators: Krishna Ghosh, FDA, and Steve Zigler, PETNET Solutions

8:25 - 8:45 AM Manufacturing Process Assessment and Pre-/Post-approval Inspections - Speaker: Krishna Ghosh, FDA

8:45 - 9:05 AM FDA Inspections: Commercial Perspective - Speaker: Keith Bowen, Avid/Eli Lilly

9:05 - 9:25 AM FDA Inspections: Academic Perspective - Speaker: Robin Ippisch, UCSF

9:25 - 9:40 AM BREAK

9:40 - 10:00 AM PET Surveillance Inspections and Training Update - Speaker: Nicholas Violand, FDA

10:00 - 10:20 AM Community-based Training Efforts - Speaker: Sally Schwarz, Washington U. School of Medicine

10:20 - 10:45 AM Panel Discussion and Questions - Moderators: Steve Zigler and Krishna Ghosh
Panelists: Keith Bowen, Chris Ignace, Robin Ippisch, Ravi Kasliwal, Sally Schwarz, Tim Pohlhaus., Nick Violand, and Laura Wasil

Session II: Product Quality and Regulatory Submissions - Moderators: Danae Christodoulou, FDA and Ashley Mishoe, Pharmalogic

10:45 - 11:05 AM Product Quality Considerations for PET Regulatory Applications - Speaker: Danae Christodoulou, FDA

11:05 - 11:25 AM Microbiological Considerations for PET Regulatory Applications - Speaker: Laura Wasil, FDA

11:25 - 11:45 AM Chemistry, Manufacturing, and Control Issues - Speakers: Daniel Yokell, Telix Pharmaceuticals and Peter Scott, Univ of Michigan School of Medicine

11:45 AM - 12:05 PM Aseptic Controls in PET Manufacturing – PET Community Perspective - Speakers: Ashley Mishoe, Pharmalogic and Reiko Oyama, Washington U. School of Medicine

12:05 - 12:30 PM Panel Discussion and Questions - Moderators: Danae Christodoulou and Ashley Mishoe
Panelists: Ravi Kasliwal, Reiko Oyama, Chris Parr, Peter Scott, Laura Wasil, and Daniel Yokell

12:30 - 1:30 PM LUNCH BREAK

Session III: Product Safety and Risk Assessment - Moderators: Ravi Kasliwal, FDA, Henry VanBrocklin, UCSF

1:30 - 1:50 PM Safety and Benefit/Risk Considerations at Various Stages of Product Development - Speaker: Jonathan Cohen, FDA

1:50 - 2:10 PM Safety and Risk Management of PET Drugs - Speakers: Henry VanBrocklin, UCSF and Steve Zigler, PETNET Solutions

2:10 - 2:30 PM Postmarketing Safety and Risk Management - Speaker: Samantha Cotter, FDA

2:30 - 3:00 PM Panel Discussion and Questions - Moderators: Ravi Kasliwal and Henry VanBrocklin
Panelists: Jonathan Cohen, Samantha Cotter, Steve Zigler

3:00 - 3:15 PM BREAK

Session IV: Management of PET Drug Lifecycle - Moderators: Louis Marzella, FDA and Michael Nazerias, PETNET Solutions

3:15 - 3:35 PM Recalls and FARs: the PET Community Perspective - Speakers: David Dick, University of Iowa and Chris Ignace, Cardinal Health

3:35- 3:55 PM Introduction of New Manufacturing Sites in a Regulatory Submission - Speakers: Industry Julian Nwoko, SOFIE and Jill Wilson, Ionetix

3:55 - 4:15 PM Clarifying 21 CFR 212 and 211 – the Evolving Regulatory Landscape - Speakers: Serge Lyashchenko, MSKCC and Michael Nazerias, PETNET

4:15 - 4:35 PM Compliance Update – Microbiological Quality Deviations and Failures – Robust CAPAs and Real-Life Success Stories - Speaker: Tim Pohlhaus, FDA

4:35 - 4:55 PM PET Product Availability: Drug Shortage Mitigation and Prevention Efforts - Speaker: Leo Zadecky, FDA

4:55 - 5:15 PM PET Product Lifecycle - Speaker: Ramesh Raghavachari, FDA

5:15 - 5:30 PM Panel Discussion and Questions - Moderators: Louis Marzella and Michael Nazerias
Panelists: David Dick, Samantha Cotter, Cathy Cutler, Krishna Ghosh, Chris Ignace, Robin Ippisch, Jill Wilson, Julian Nwoko, Serge Lyashchenko, Ravi Kasliwal, Tim Pohlhaus, Ramesh Raghavachari, Leo Zadecky

5:30 - 5:40 PM Closing Remarks and Next Steps - Louis Marzella and Steve Zigler

5:30 PM Adjourn for the Day

Tuesday, November 14, 2023

08:00 AM - 12:00 PM Tuesday morning was devoted to an extended Q&A session.
Organizers gathered questions for FDA representatives through an online questionnaire and from remote viewers. These questions formed the basis for our extended Q&A session. Duration of each session was adjusted based on the number and/or relative importance of questions per category.

8:00 - 8:45 AM Q&A Related to Considerations and Trends in Facility Inspections and Compliance
Moderators: Steve Zigler and Krishna Ghosh

8:45 - 9:30 AM Q&A Related to Product Quality and Regulatory Submissions
Moderators: Danae Christodoulou and Ashley Mishoe

9:30 - 9:50 AM Break

9:50 - 10:35 AM Q&A Related to Product Safety and Risk Assessment
Moderators: Ravi Kasliwal and Henry VanBrocklin

10:35 - 11:20 AM Q&A Related to Management of PET Drug Lifecycle
Moderators: Louis Marzella and Michael Nazerias

11:20 AM - 12:00 PM Q&A Related to “Other” Questions (ones which don’t fit neatly in the other four categories above)
Moderators: Ravi Kasliwal and Cathy S. Cutler