As 2022 winds down in a blur of get-togethers and to-do lists a mile long, let’s take a moment (or 10!) to look back through all we’ve accomplished this year:
1. Submitting a Drug Master File for non-carrier-added lutetium-177 (Lu-177) to the FDA. This tiny radiopharmaceutical is at the forefront of developing precision cancer treatment. Two treatments using Lu-177 are currently approved by the FDA, with dozens of others in clinical trials. The treatments are designed to help slow, or even eliminate, tumors in late-stage cancer patients. Submitting a Drug Master File allows our pharmaceutical customers to reference our DMF when seeking approval for their medications. Once approved, this essentially puts us in a prioritized position as a supplier. So far, one customer has started this process with more expected to follow.
2. A visit to the White House by SHINE’s very own Greg Piefer. In March, the Biden-Harris administration hosted a summit, “Developing a Bold Decadal Vision for Commercial Fusion Energy.” Leaders in the industry shared their expertise as to the future of fusion energy. Fusion has the potential to offer abundant, reliable, carbon-free energy, getting the U.S. to net-zero emissions by 2050. Greg was invited to speak as one of the industry’s top experts in support of the use and strategy of fusion technologies.
3. SHINE supercell passes factory acceptance testing! The supercell will be housed in The Chrysalis, SHINE’s large-scale medical isotope facility in Janesville, Wisconsin. The supercell, which includes 10 hot cells, will be a major component in the production of medical isotopes, including “molybdenum-99.” This powerful isotope is relied upon for more than 40 million patient procedures each year for the detection of cancer, heart disease, and more.
4. Our Systems & Manufacturing facility in Fitchburg finally got its time to SHINE. Delayed by a pandemic, supply chain issues and a merger, our manufacturing facility celebrated its long-awaited ribbon-cutting celebration in September. Our team was joined by representatives of U.S. Senators Tammy Baldwin and Ron Johnson, as well as Fitchburg’s mayor and several city council members. Among other important projects, this manufacturing facility is critical in building the fusion systems that will be installed in The Chrysalis for medical isotope production.
5. Fusion takes centerstage. From December’s announcement from the Department of Energy about scientific breakeven to record amounts of funding in support of the advancement of fusion, you could argue 2022 was the biggest yet for nuclear fusion, to date. At SHINE, we’re already doing fusion today, and using it to greatly benefit society. We shared more about that: on the Titans of Nuclear podcast; in Popular Mechanics; on the podcast “Tycoons of Small Biz”; on CBS 58 in Milwaukee; in the Wisconsin State Journal; in Radiology Today; while featured on “Dealcast” podcast; on The Medical Marketing Executive podcast; on WCLO; and more!
6. New partnerships for our cancer-fighting medical isotope, lutetium-177. One way or another, everyone has been affected by cancer. That’s why every time we reach a new partnership deal to supply our Lu-177, we move one step closer to getting answers for patients, families and doctors. We announced clinical supply contracts with Telix Pharmaceuticals in February, ImaginAb in March and Radiopharm Theranostics in September. The latest was our ninth such supply agreement for Lu-177.
7. The Chrysalis is growing and ready to reach new regulatory milestones. The Chrysalis, SHINE’s fully dedicated medical isotope production facility, is currently under construction in Janesville, Wisconsin. Upon completion, we believe this will be the world’s highest-capacity medical isotope production facility. We anticipate being able to share more about achieving the next major regulatory milestone in a matter of days or weeks, as we work toward the approval of our operating license from the Nuclear Regulatory Commission.
8. We signed a 42-month contract with the Department of Homeland Security. SHINE was awarded a 42-month, $16.8 million contract with the U.S. Department of Homeland Security (DHS) to expand non-intrusive inspection and improve border security. What does that mean? It means SHINE will develop and provide the DHS with a safe new tool to detect and identify illegal bulk narcotics and other contraband material in commercial cargo ports of entry.
9. We welcomed (several!) new leaders to SHINE this year. Holli C. Ladhani and Janet S. Wong joined our Board of Directors, bringing in key perspectives from the financial and energy industries. And from GM of our Therapeutics Division (Chris Vessel) to Chief People Officer (Ben Pratt) to Phoenix CEO (Tom D’Orazio), SHINE is set to tackle the next year with fresh insight, expertise and creativity. Like our business itself, SHINE’s team is growing and expanding, and we can’t wait to see what that team can accomplish in 2023 and beyond!
10. SHINE Europe gets Dutch approval to look into terbium. In fall 2022, the Dutch government approved a substantial grant proposal, giving SHINE Europe the chance to develop terbium isotopes for use in nuclear medicine. These isotopes have shown potential in diagnosing and treating cancer and other diseases. Unfortunately, a lack of essential raw materials and complex processing technologies have created huge barriers to terbium production.
Editor’s note: This blog post was updated throughout the final days of 2022. Follow us on LinkedIn, Twitter and Facebook for more updates throughout 2023.