Shrinking the Manufacturing Footprint with PET Point-of-Care
Jared Driskill, Sr. Medical Advisor at MedTrace
“Today, most PET radiopharmaceuticals are produced at centralized locations and distributed. However, there are logistical limitations to this model and that is why it becomes increasingly interesting, and perhaps important, to consider point-of-care manufacturing.”
The Value Initiative is SNMMI’s (Society of Nuclear Medicine and Molecular Imaging’s) strategic vision and roadmap for working with the industry and other partners to advance the crucial role of nuclear medicine, molecular imaging, and radiopharmaceutical therapy to the medical community, regulators, patients, and the public.
In the article “The Future of PET Point-of-Care Manufacturing – Interview with Jared Driskill, Sr. Medical Advisor at MedTrace”, Driskill shares his insights on where the field is headed and what challenges manufacturers and regulators must overcome before PET point-of-care manufacturing can be made available in clinical practice.
“The industry stakeholders in this space, including MedTrace, are now investigating how we might shrink the entire PET radiopharmaceutical manufacturing footprint and put it in a ‘box’ placed right at the point of patient care. The challenge here is that the drug manufacturer will, of course, be held accountable for everything that goes on within this box, and to the same caliber of standards as those expected from a more traditional PET manufacturing facility. It is a regulatory challenge, but it will be fun to figure all of that out!” Jared Driskill says.
Driskill has spent more than 25 years working in the nuclear medicine and imaging arena. As Sr. Medical Advisor at MedTrace, he is currently occupied with the company’s Phase III Clinical Trial which seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
Continue to read the full article published in the January 2024 SNMMI Value Initiative Newsletter below or find it here (p. 5).
Article in the January 2024 edition of the SNMMI Value Initiative Newsletter:
The Future of PET Point-of-Care Manufacturing
Interview withJared Driskill, Sr. Medical Advisor at MedTrace
You’ve worked in the nuclear medicine and imaging arena for more than 25 years. What do you see as the biggest challenges for making PET point-of-care manufacturing available in clinical practice?
Today, most PET radiopharmaceuticals are produced at centralized locations and distributed. However, there are logistical limitations to this model and that is why it becomes increasingly interesting, and perhaps important, to consider point-of-care manufacturing.The industry stakeholders in this space, including MedTrace, are now investigating how we might shrink the entire PET radiopharmaceutical manufacturing footprint and put it in a “box” placed right at the point of patient care. The challenge here is that the drug manufacturer will, of course, be held accountable for everything that goes on within this box, and to the same caliber of standards as those expected from a more traditional PET manufacturing facility. It is a regulatory challenge, but it will be fun to figure all of that out! Based on ongoing conversations with both regulatory authorities and other manufacturers of ultra-short half-life PET radiopharmaceuticals, the interest in pursuing solutions to these challenges appears to be gaining momentum. Some of these concepts, as outlined in a recently posted FDA discussion paper (Distributed Manufacturing and Point-of-Care Manufacturing of Drugs), were also entertained at the November 2023 FDA PET Drugs Workshop (co-organized by the FDA, SNMMI, MITA, and the Coalition of PET Drug Manufacturers).
Tell us more about that. How do you see PET point-of-care manufacturing influencing the future of imaging?
Things are becoming really interesting as more institutions are beginning to offer whole-body PET/CT imaging. I think by combining the ability to produce ultra-short half-life PET radiopharmaceuticals at the point-of-care with the capacity to perform whole-body PET/CT imaging, we will begin to see correlatives that have never been seen before. What if we had the ability to perfuse multiple organs, look at blood flow throughout the body, and quantify it all in one imaging session? And by using ultra-short half-life PET isotopes, perhaps we may even be able to get multiple serial infusions and images under different conditions back-to-back while the patient remains in the scanner.
From a practical point of view, I think we can certainly see some advantages regarding patient throughput and department flow as there are no drug distribution and delivery constraints with an on-site manufacturing point-of-care model. To say the least, it can be challenging to keep an imaging department on schedule when having to rely on just-in-time delivery of radiopharmaceuticals from a centralized manufacturer, but for a facility who has the ability to manufacture PET radiopharmaceuticals on-site, perhaps your schedule becomes a little more robust, a little more flexible. So, I think that’s the essence of point-of-care practicality. We have the opportunity to re-think the radiopharmaceutical distribution model and its limitations, including the need for longer half-life isotopes, while enjoying some of the advantages point-of-care manufacturing affords, such as flexibility in novel imaging protocols and departmental flows.
What kind of timeline are we looking at in terms of having PET point-of-care manufacturing available in clinical practice?
Iwon’t speculate on the timing, but I can say that we at MedTrace are tirelessly working to make point-of-care manufacturing for ultra-short half-life radioisotopes practically available and a real possibility! We are certainly hoping to see favorable results from our ongoing Phase 3 trial and welcome the additional work it would create as we seek regulatory approval for 15O-water along with the P3 point-of-care manufacturing system.
MedTrace has an automated manufacturing system, P3 MT-100, which is in use at several hospitals around the world as part of the company’s Phase 3 Clinical Trial, which seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
