A cyclotron is a complicated device that makes very short-lived radioisotopes. These radioisotopes can be used to manufacture radiopharmaceuticals for positron emission tomography (PET) imaging. PET imaging, also called a PET scan, is a type of radiology imaging. Doctors use radiology imaging tests to look inside the body and see where cancer is located. Huntsman Cancer Institute (HCI) director of cyclotron operations, , explains how use of the cyclotron has changed at HCI over the years and how it helps patients and HCI and across the Mountain West.
How have you seen the use of HCI's cyclotron expand since you have been involved?
I started in 2005 when the cyclotron lab was only producing one clinical radiopharmaceutical (FDG) for positron emission tomography (PET) imaging and mostly serving patients here at Huntsman Cancer Institute. We were supplying FDG doses for only a few patients’ PET scans each day. It rapidly expanded at the beginning with steady growth throughout the years as PET imaging became essential to clinical care. The regulatory landscape with the FDA also changed PET drug manufacturing, requiring our team to implement current Good Manufacturing Practices (cGMP) standards. We received our first FDA approvals for our own PET radiopharmaceuticals in 2014 for [18F]fludeoxyglucose (FDG) and [18F]sodium fluoride. In more recent years, we have become a contract manufacturing organization for several commercial pharmaceutical companies to manufacture and supply their drug products. Axumin®, the first PET imaging agent for prostate cancer, is one example of these commercial partnerships that have added to clinicians’ tools to improve cancer care.
We have also assisted in providing radiopharmaceuticals for other diseases, including Vizamyl™, an Alzheimer’s imaging agent. We are continuing to make arrangements to manufacture other exciting commercially approved agents for our community. While maintaining reliable manufacturing and delivery of approved drugs, we have also developed and manufactured PET research drugs for many of HCI’s clinical trials. Our site has received approval for more than eight different radiopharmaceuticals for investigational studies for multiple clinical trials being conducted at Huntsman Cancer Institute. Recently, we received approval to manufacture [18F]fluoroestradiol (FES) for breast cancer related clinical trials. Over these past 16 years, we have expanded our operation, maintaining the vision of improving diagnosis and monitoring therapy.
How is this resource an asset to the region?
We are the sole medical cyclotron and PET radiopharmaceutical laboratory in our area. We provide a critical supply of PET drugs for Utah and neighboring states that enable PET/CT scans to be performed on patients. Due to the short shelf-life of the radiopharmaceuticals, they must be manufactured on the same day the PET/CT scans are performed. Through a robust maintenance program and critical upgrades to our cyclotron, our team has been able to maintain a 99% uptime.
What are some new innovations that are now manufactured by our cyclotron and what are they used for?
Our field is experiencing unprecedented growth in the development of new PET drugs that are becoming increasingly more specific for certain cancer types. Our first success in this regard was with Axumin®, which is a PET drug that was developed for imaging prostate cancer. We worked with the company developing this compound to validate the manufacturing process, and investigators at HCI also participated in the clinical trial that led to the FDA approval. We are now routinely manufacturing Axumin® and distributing it for PET/CT scans throughout the state. Most recently, we established manufacturing and received subsequent FDA approval for investigational use of [18F]FES for estrogen receptor imaging of breast cancer. This PET drug enables imaging of tumors based on whether they are estrogen receptor positive. This can improve the detection of breast cancer as well as help guide the use of hormonal therapy. We are also developing novel PET compounds to support scientists throughout the Ï㽶ÊÓƵ of Utah, and there are several NIH grants utilizing these compounds in preclinical research.
How has your position grown or changed?
I started as a radiochemist in the lab with a BS degree in chemistry from the Ï㽶ÊÓƵ of Utah and after many years of training, hard work, and lack of sleep obtained a PhD in pharmaceutics and pharmaceutical sciences. I have grown in my skills in radiochemistry and appreciation for the radiopharmaceutical industry as a whole. I have had opportunities to interact with many others in our field from various locations all around the globe. Since the early days of my career starting at 1 am in the morning producing FDG as a basic radiochemist, I’ve gone on to manage the team and program as the director of cyclotron operations.
I have learned and experienced much. I never imaged when I started how much I would grow to love this part of science. We get a glimpse of the whole process. We are truly at the bench-to-bedside interface of drug development and not many have had that opportunity in their career to be involved in all of it. It has become a very complicated role that I now play in managing all the aspects of day-to-day operations, product development, regulatory affairs, and personnel management. However, I have been part of some amazing growth and have an amazing team including support from our administration.
What is your favorite part about working at HCI?
The favorite thing about working at HCI is the people. We have amazing people as part of this work. We learn a lot from each other. I have had some great leaders and mentors that have guided me along the way. I am proud to be part of a mission to understand cancer from its beginnings, to use that knowledge in the creation and improvement of cancer treatments, to relieve the suffering of patients with cancer, and to provide education about cancer risk, prevention, and care.
Something I have always felt is important is be involved in changing people’s lives for the better. That is something I see every day here. Hopefully, we can keep accomplishing that through continued support for our team, our program, and our resources.
The average lifespan of a cyclotron is 10 to 14 years. HCI's only cyclotron is 17 years old and rapidly approaching the end of its life. The replacement cost is estimated at $25 million. Learn how you can .