Corporate Partnerships

Pioneering Progress in Cancer Treatments [MURR Joint Publication]

This article is a collaboration with the University of Missouri Research Reactor (MURR) team and was originally published on the MURR website. Co-authors on this article are Jared Hager, Associate Director, Feasibility, PSI, and Uriah Orland, Associate Director, MU News Bureau.

From its research reactor to revolutionary therapies, Mizzou’s innovations are shaping the future of precision medicine.

Bringing a new medicine to market can be a long journey, but the potential to save lives makes it worthwhile.

Twenty years ago, the University of Missouri helped research and develop a little-known radioisotope called lutetium-177 (Lu-177). That innovation laid the foundation for clinical trials and Food and Drug Administration (FDA) approvals for a new class of drugs known as radiopharmaceuticals, resulting in thousands of successful cancer treatments.

More than 2,000 clinical trials for cancer treatments using radioisotopes like Lu-177 are now underway. In this burgeoning field, Mizzou is the essential first stop — because the University of Missouri Research Reactor (MURR) is the only supplier in the United States creating the part of these drugs that destroys cancer cells while sparing healthy ones.

“Our research reactor has been at the forefront of the development and production of radioisotopes that are saving lives every day,” said Matt Sanford, MURR’s executive director. “MURR’s innovative design and year-round operating cycle allow us to reliably produce the active pharmaceutical ingredients in multiple FDA-approved drugs. What we produce today has a direct impact on the lives and well-being of patients around the world.”

Even though only two approved radiotherapies for cancer are on the market today, these treatment possibilities represent one of the fastest-growing fields in oncology research and testing.

What is a radiopharmaceutical?

Radiopharmaceuticals use highly targeted radiation to treat or diagnose a disease. To develop these therapies, a radioactive isotope, such as those produced at MURR, is linked to a targeting molecule that seeks out certain cellular features on a tumor. The isotope, linker and targeting molecule will form a radiopharmaceutical.

“The advancement of radiopharmaceuticals has created one of the most effective forms of precision medicine to date,” said Dylan Stoy, director of Therapeutic Strategy at PSI, a CRO with over a decade of experience working with these therapies. “With applications in diagnostics, therapeutics, or ideal theranostic pairings, radiopharmaceuticals give patients and providers a great option in an ever-growing list of cellular targets and indications — and I think we are just starting to see the tip of the iceberg.”

Leading-edge science and medicine meet when the radiopharmaceutical is administered to the body and sticks to cancer cells. The radioisotopes release energy that acts as a wrecking ball to cancer cells, eventually destroying them while leaving healthy cells unaffected, unlike the radiation therapies traditionally used in cancer treatment. As a result of this advanced treatment, used either on its own or in combination with existing therapies, patients typically face fewer side effects and have greater opportunities to resume a vibrant and healthy life.

Making radioisotopes

The singular design, power and operating schedule of MURR allow the irradiation of stable isotopes to create the desired active pharmaceutical ingredient for treatments.

The center of the reactor has the highest concentration of neutrons, and these neutrons change less than one percent of a sample of ytterbium-176 to ytterbium-177 (Yb-177). Through radioactive decay, Yb-177 becomes Lu-177 in a matter of hours. A chemical process is then carried out under the FDA’s good manufacturing practices (GMP) to separate the lutetium from the ytterbium.

After the GMP process is complete, the active pharmaceutical ingredient — Lu-177 — is shipped to a pharmaceutical company for inclusion in its drug. With a half-life of 6.6 days, the entire process is designed to ensure radioisotopes produced this week will be administered to patients next week.

The long road of clinical research

Researchers join a radioisotope such as Lu-177 with two other components: a targeting molecule, which will guide the radioisotope to a specific cancer cell, and a linker, which connects the two. Each combination is tested to determine its viability. Once proven in the lab, the treatment is ready for clinical trials.

Although the timeline is lengthy and the results are not guaranteed, research and clinical trials to identify new radiopharmaceuticals are ongoing. These studies require highly specialized expertise and face many challenges — something Stoy and PSI know well. Today, PSI manages 50% of the industry’s pivotal radiopharmaceutical studies, which generate the data for drug approvals by regulatory authorities around the world.

“As the space continues to grow, it will be important to work closely with regulators across the globe to ensure reasonable access and availability,” Stoy said. “Although mapping for these products has improved significantly throughout the course of development, there are still challenges. In addition, many regulatory authorities, including the European Medicines Agency and FDA, are now working with groups dedicated to ensuring the safety of these treatments, meaning that an in-depth understanding of each specific country’s requirements is essential.”

This can be a challenge for large global studies like those PSI runs, as can the complexities of transporting radioactive materials such as Lu-177 with very short half-lives across borders in time to reach patients. Only a few nuclear pharmacies can provide the needed expertise and support for such trials.

In such cases, it’s often passionate individuals who drive this important research forward. PSI has built strong relationships around the world with more than 1,000 clinical research sites with experienced nuclear medicine teams. It has even created specialized roles to help overcome common delays during the clinical trial process. Reliable sources of manufacturing, such as MURR, will be the keystone to scalability as the field continues to progress.

Looking to the future

The success of drugs like Lutathera® and Pluvicto® has opened the door for new treatments, and researchers and pharmaceutical companies are looking at different radioisotopes and radiopharmaceuticals that can be used to treat and diagnose other types of cancer as well as diseases such as neurodegenerative disorders. Potential isotopes include terbium-161, actinium-225, lead-212, among others.

The demand for radioisotopes is rapidly increasing, and the University of Missouri is meeting the challenge. The university plans to build a new, larger, state-of-the-art reactor — NextGen MURR — which will expand the university’s capacity to produce medical isotopes that will be used in advanced cancer medicines for decades to come.


For more information, visit murr.missouri.edu or contact:

Uriah Orland
uriah.orland@missouri.edu
573-884-5139

Pioneering Progress in Cancer Treatments [MURR Joint Publication] Read More »

PSI Partners With Medidata to Expand Data-Driven Feasibility Capabilities

PSI CRO, 30 April 2024PSI CRO, a leading full-service, global contract research organization (CRO), today announced a partnership with Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, to expand PSI’s data-driven feasibility solutions for pivotal Phase 2 and 3 trials. PSI’s use of the Medidata AI Intelligent Trials solution builds on a long-standing collaboration between the two companies and will add another data source to VISIONAL™, PSI’s proprietary machine-learning-powered study modeling platform.  

VISIONAL™ helps PSI accurately predict study enrollment timelines, beyond human ability, by using historical clinical trial performance data from both internal and external data sources. The collaboration with Medidata will provide PSI with access to the industry’s largest performance dataset for unmatched site-level granularity.  

“PSI is using Intelligent Trials to gain access to aggregated and anonymized global enrollment data,” says Kasia Moscicka, Head of Feasibility, PSI. “A critical process in powering a successful clinical trial is site selection. With a clearer understanding of previous enrollment performance, spanning the industry, a more comprehensive understanding of a site’s capabilities can be developed. PSI is now able to understand a site’s performance outside of trials powered by our organization, which will aid in more concise profiling and selection.”  

About PSI CRO 

PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors. 

Global headquarters are based Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com 

For Media Inquiries: 

Ashley Collins, Marketing Specialist 919-972-9572 |ashley.stufanocollins@psi-cro.com 

 

PSI Partners With Medidata to Expand Data-Driven Feasibility Capabilities Read More »

“One Huge Night” for Patients and PSI: The Gift of Life Gala

Last week, we were honored to receive the 2022 Corporate Partner Award from the Gift of Life Marrow Registry at its annual One Huge Night Los Angeles Gala at the SLS Hotel in Beverly Hills. In addition to raising funds for the organization, the Gift of Life Gala offers a chance for transplant recipients and their donors to meet in person for the first time.

At PSI CRO, we are guided by a simple, straightforward calling: every patient counts. We’re proud of our longstanding partnership with Gift of Life, a national, public, not-for-profit registry facilitating peripheral blood stem cell and bone marrow transplants for patients in the United States and abroad.

Rhonda Critchlow, PSI CRO’s Senior Director, Operations, and Jeremie Braun, Senior Director, Business Development, were in attendance to accept the award, and more importantly, to meet with the people who make the Gift of Life’s mission possible.

Jeremie was instrumental in connecting PSI to the Gift of Life organization through his involvement in the Hope4Adam campaign in 2016.

The award was presented to Jeremie and Rhonda by Jay Feinberg, Gift of Life’s founder and Chief Executive Officer as well as a 26-year transplant survivor. “It is an honor to play a small part as a corporate partner when we know we are saving lives,” said Rhonda. “PSI will remain committed to Gift of Life and the important work you are doing.  I challenge all of my friends to take up the battle – by doing something so simple as joining the registry with a cheek swab, which ultimately can turn into saving a life.”

Rhonda and Jeremie at One Huge NightAbout Gift of Life

Gift of Life is accredited by the World Marrow Donor Association and is a member of the global registry, Bone Marrow Donors Worldwide. Joining the registry is simple: it requires a mouth swab, making it simple for anyone to help save lives.

The Gift of Life headquarters in Boca Raton, Florida, has been servicing donors and patients alike since 1991. The state-of-the-art apheresis center, which opened in 2019, has made it  convenient for donors to donate stem cells in a relaxing and spa-like facility, and PSI is grateful to be able to sponsor a collection chair at the center to make donors comfortable during the process.

PSI CRO: A Proud Partner for Patients

From the beginning, PSI has worked alongside Gift of Life to gather cheek swabs at conferences like ASH and ASCO, and inspire global employees to get involved during World Marrow Donor Day, held annually on the third Saturday of each September.

But the partnership isn’t exclusive. To meet the needs of patients around the globe, raising more awareness is imperative. Corporate partners aren’t just appreciated at Gift of Life, they’re celebrated.

If your company is dedicated to patients and passionate about saving lives, you, too, can partner with Gift of Life, and help find matches for patients like Aiden, who is fighting a rare blood disorder right now.

“One Huge Night” for Patients and PSI: The Gift of Life Gala Read More »