Join us in the Coalition of PET Drug Manufacturers

We invite you to help us advocate for the advancement of scientific and regulatory standards in PET drug manufacturing. Together, we provide a dynamic forum where industry, academia, and regulatory bodies come together to establish rational practices, offer education and training, and ensure the safety and efficacy of PET drugs. Let's unite to shape the future of PET drug manufacturing!  Our fiscal/membership year runs from July 1 - June 30.

The Benefits of Coalition Membership

Membership in the Coalition is more than just a subscription. Member organizations play critical roles as the Coalition advances scientific and regulatory principles associated with the manufacturing of PET drugs. Working together through the Coalition, members ensure the reliable supply of safe and effective PET drugs throughout the United States.

Here is a summary of membership benefits:

1. Stay Informed

The Coalition is the leading clearinghouse of regulatory information on PET drug manufacturing, including regulatory standards established by FDA, USP, ICH, and other authorities. Through stakeholder meetings, social media, and teleconferences, member organizations stay up to date on critical regulatory issues associated with PET drug manufacturing. In addition to the latest developments, the Coalition also maintains a deep history of PET drug regulations. As a Coalition member, your organization has access to stays abreast of regulatory issues pertinent to PET drug manufacturing.

2. Get Involved

The Coalition is nothing without its members. Member organizations actively participate in the identification of issues and priorities. Through surveys, social media, teleconferences, stakeholder meetings and a soon-to-be developed online forum, Coalition members are involved in all aspects of Coalition activities, including strategy development, strategy execution, legislative initiatives, comments on proposed regulations and guidance documents, white paper development, and others. As a Coalition member, your organization will have the opportunity to be an active participant in these activities and more.

3. FDA Workshops

Since its inception, the Coalition has organized several FDA workshops, most recently the FDA-hosted, November 13-14, 2023 PET Drugs Workshop. To view videos and slides from this workshop, browse HERE.

4. Symposia

The Coalition has organized numerous symposia to increase awareness of compliance and regulatory issues that threaten the availability of safe, effective, and cost-effective PET drugs. These symposia, which typically take place during meetings of the Society of Nuclear Medicine and Molecular Imaging, often attract audiences with more than 100 attendees. The primary goals of these symposia are to ensure proper recognition of the unique manufacturing and quality characteristics of PET drugs, and to discuss any current regulatory issues facing coalition members.

5. Stakeholder Meetings

Stakeholder meetings provide a forum for Coalition members to collaborate with other stakeholders on key topical issues associated with PET drug manufacturing. Through these meetings, members seek common ground and find practical solutions. These meetings also provide a voice for members to the Coalition leadership on strategic topics and initiatives. An annual meeting will be established for the election of Board Members and Coalition leadership.

6. Publications

The Coalition published a peer-reviewed manuscript describing the February 2020 FDA workshop on inspectional and regulatory issues for PET drug manufacturers. The paper provides a summary of the workshop as well as recommendations for future policy and regulatory directions for the FDA. The paper, which appeared in the Journal of Nuclear Medicine, illustrates how Coalition members can be involved in scientific and regulatory issues associated with PET drug manufacturing. Future publications will include technical reports on specific topical issues, press releases, and additional submissions to peer-reviewed journals, including a 2023 PET Drugs Workshop proceedings article.

7. Web-based Resources

The Coalition upgraded its website to provide access to a wealth of regulatory and quality material, cross-references to important records from meetings, and links to other resources for PET drug manufacturers. This ensures access to information and a historical record of events as the field evolves. The Coalition recently created an online member-only forum to (a) strengthen our sense of community as we pursue a common objective to provide safe and effective PET drugs to U.S. patients and (b) enable members to gain practical input toward resolving regulatory, facility and production issues.

8. Education

The Coalition has been active in the development of educational materials related to PET drug manufacturing. Recent efforts include the development of content for the SNMMI’s Qualified Systems Personnel Training Program (QSPTP) and the FDA’s internal training program for field investigators. Future educational programs will include training for audits, risk management, best practices, and other compliance needs.

List of Current Member Facilities

Avid Radiopharmaceuticals, Inc.
BAMF Health, Inc.
Cardinal Health
Center for Molecular Imaging & Therapy (CMIT Louisiana, LLC)
Evergreen Theragnostics, Inc.
Facet Life Sciences
GE HealthCare
Huntsman Cancer Institute - University of Utah
Ionetix Corporation
JLVMI Consulting LLC
Kettering Health Main Campus
Life Molecular Imaging
Mayo Clinic PET Radiochemistry Facility
Medical Imaging & Technology Alliance (MITA)
MedTrace Pharma Inc.
PETNET Solutions
Pharmalogic Holdings Corp
Society of Nuclear Medicine and Molecular Imaging
Soffing Consulting Incorporated
SOFIE Co.
Synthra GmbH
UCLA Biomedical Cyclotron Facility
University of Alabama at Birmingham
University of California San Francisco
University of Iowa Hospitals & Clinics PET Imaging Center
University of Michigan
University of Pennsylvania Cyclotron Facility
University of Texas Southwestern Medical Center
University of Wisconsin Hospital
UT MD Anderson Cancer Center
Vanderbilt University Medical Center
Washington University School of Medicine Cyclotron Facility & Nuclear Pharmacy
World Molecular Imaging Society