FDA's Environmental Monitoring (EM) Enforcement

Discussion moderators: Marianna Dakanali (University of Michigan) and Richard Jahn (GE HealthCare)

Using prior Coalition Member EM survey data, combined with the results of real-time (in-the-meeting) Google QR code survey responses and live discussion, this session will raise awareness of the approaches PET drug manufacturers are currently using for environmental monitoring, and provide direction for potential future Coalition position development and advocacy on this topic.

Incoming Materials Testing

Discussion moderators: Robin Cumming (University of California, San Francisco) and Chris Parr (Pharmalogic)

The FDA has asserted that more complex precursors — such as those with multiple chiral centers — present an issue where existing HPLC methods for radiochemical identity and purity of finished drug products cannot resolve the stereoisomers, potentially requiring new finished-product or precursor identity testing. This session will discuss developing a path forward for Coalition advocacy given that drug developers and their CDMOs may need to comply with the Agency's direction while academic producers/RDRCs may not face the same scrutiny, what compliance with the Agency's expectations would look like in practice, and potential alternative compliance pathways for the community.

Addressing FDA Inconsistency and the Training Level of FDA Reviewers and Inspectors

Discussion moderators: David Dick (University of Iowa) and Eric Webster (Telix Pharmaceuticals)

This session aims to gain attendee input on (1) instances where FDA inspectors have stated they were not trained on relevant requirements, (2) instances of inconsistency across FDA audits, including cases where auditors applied different interpretations from one audit to another, and (3) what the Coalition can do to help close these gaps, including potential training options such as courses already available through SNMMI or offering to hold training sessions with FDA, potentially even at a member's facility.

Communicating Risk Assessment and Justification with the FDA

Subcommittee members: Cathy Cutler (Brookhaven National Labs), Richard Jahn (GE Healthcare), Henry VanBrocklin (University of California, San Francisco) and Steve Zigler (PETNET)

This session will examine how to anticipate FDA expectations by adopting a higher-level, systems-based perspective rather than focusing only on individual product issues. Attendees will explore and propose recommendations regarding the potential benefits, risks, and strategic considerations of aligning internal processes, risk assessments, and regulatory justifications with the broader FDA framework that guides both application review and inspection activities.

External Relationships: Effective Cultivation & Communication

Discussion moderators: Adam Rosenberg (Vanderbilt University) and Steve Zigler (PETNET)

This session will explore and refine the Coalition's goals and desired outcomes for external relationships with the FDA, USP, and other regulatory bodies. Discussion will cover the value of workshops, conference presentations, peer-reviewed publications and editorials, and potential technical reports (similar to those from the Parenteral Drug Association); the role of policy-level discussions with the FDA; and how to engage USP on the development and maintenance of public standards for PET drugs.

Theragnostics

Discussion moderators: Cathy Cutler (Brookhaven National Labs) and Keith Bowen (Eli Lilly & Co)

This session examines whether the PET Drug Manufacturing Coalition should formally expand its role to include theranostic agents. It will discuss the potential benefits of addressing shared manufacturing, quality, and regulatory needs, as well as the risks of overextension, overlap with existing organizations, and shifting regulatory expectations — with the goal of determining whether theranostics represent a natural and necessary evolution of the Coalition's mission.