Robert Dannals, PhD, and Martin Pomper, MD, PhD, named 2026 Faces of American Innovation, discuss the scientific and radiochemistry work behind the prostate cancer imaging agent PYLARIFY.
By Alyx Arnett
Robert Dannals, PhD, and Martin Pomper, MD, PhD, have been named among the Bayh-Dole Coalition’s 2026 Faces of American Innovation for work that helped bring PSMA-targeted prostate cancer imaging into clinical practice. Their research at Johns Hopkins contributed to DCFPyL, the compound that later became PYLARIFY, a PET imaging agent used to detect prostate cancer.
For Pomper, now professor and chair of radiology at UT Southwestern Medical Center, the clinical need was apparent early on: Physicians needed a better way to determine where prostate cancer had spread. Dannals, professor in the Johns Hopkins Medicine Department of Radiology and Radiological Science, says the goal was to create “clear, quantitative imaging of prostate cancer, unanswerable by existing agents and methods.”
Joe Allen, executive director of the Bayh-Dole Coalition, says the work reflects the purpose of the Bayh-Dole Act, which allows universities and other institutions to retain patent rights to federally funded inventions and license them for commercialization.
“These discoveries could easily have remained confined to academic journals,” Allen says, “but through the technology transfer and commercialization ecosystem enabled by Bayh-Dole, they reached patients and physicians in the real world.”
Why PSMA Became the Target
Pomper says researchers had already shown prostate-specific membrane antigen, or PSMA, could serve as an imaging target in prostate cancer, including with radiolabeled monoclonal antibodies. The difference, he says, was the move toward small molecules.
“The innovation was focusing on small molecules, which have superior pharmacokinetic properties for imaging that can be further manipulated using medicinal chemistry and a variety of imaging isotopes, and are more readily and inexpensively scaled up than antibodies and other biological agents,” Pomper says.
According to Pomper, antibody-based agents can circulate in the blood for days, obscuring smaller lesions. Small-molecule agents offered a workflow more compatible with routine PET imaging: Inject the radiopharmaceutical, wait a short period, scan the patient, and send the patient home.
Pomper’s interest in PSMA grew out of earlier brain imaging research. He had been studying glutamatergic neurotransmission with PET in the mid-1990s when he came across papers linking an enzyme target to PSMA, which is overexpressed in prostate cancer. The finding pushed his research toward prostate cancer imaging.
Dannals says the medical community did not fully appreciate the limits of existing prostate cancer imaging tools at the time. When physicians later began seeing PSMA-targeted images, he says one reaction stood out: “Their surprise at how many more lesions could be uncovered by this tech versus bone scan, CT, and earlier molecular imaging attempts.”
The Problem of Seeing Cancer Near the Bladder
The science was not straightforward. Dannals says one early obstacle was proving that prostate cancer could be imaged with an agent cleared by the kidneys into the bladder.
That issue is familiar to nuclear medicine physicians and radiologists who interpret pelvic studies. Urinary excretion can complicate lesion detection near the prostate bed, lymph nodes, and other pelvic structures. For a PSMA PET agent to be useful, it needed sufficient tumor uptake and contrast despite activity passing through the urinary tract.
According to the Bayh-Dole Coalition report, Pomper’s early compounds showed promise but did not yet provide the image quality needed to change clinical practice. One compound, DCFPyL, eventually stood out. The report describes the compound as lighting up cancer cells “clearly, precisely, and in real time.”
Dannals says PSMA-targeted imaging provides “more accurate staging and re-staging information than is possible with legacy imaging modalities,” supporting more individualized treatment decisions, including metastasis-directed therapy in selected patients. He adds that PSMA imaging also helps identify patients who may be candidates for targeted radioligand therapy.
Why Radiochemistry Determined Clinical Reach
Even after DCFPyL showed promise, it still had to be manufactured reliably. For PET imaging agents labeled with fluorine-18, Dannals says the isotope’s 109.8-minute half-life creates constant production pressure. Every delay reduces the amount of usable radiotracer available for patients.
“When working with isotopes for diagnostic PET studies, the biggest challenges are the isotope half-life and the regulatory landscape,” Dannals says.
The original synthesis was not practical for widespread clinical use. Dannals says the initial process produced a radiochemical yield of about 3%. His team worked with Pomper’s group to simplify production using what Dannals described as a “unified” precursor for a more efficient synthesis. According to Dannals, the revised process increased the yield to nearly 31% and reduced total synthesis time to about 66 minutes.
“In the business of radiotracer production, one is always battling the isotope half-life,” Dannals says. “Even though the half-life for F-18 is 109.8 minutes, a synthesis might take one half-life or more to complete, meaning that half of the starting radioactivity has decayed.”
Dannals says the simplified reaction scheme was more familiar to commercial radiopharmacies and made it more feasible to produce multiple patient doses from a single synthesis. He credits a team effort, including work by Hayden Ravert, PhD; Hong Fan, PhD; and Daniel Holt, in helping move the agent toward broader clinical adoption.
“The simpler the synthesis, the less expensive and easier it is to scale up, including across multiple sites,” Dannals says.
From Academic Discovery to Clinical Product
According to the report, Johns Hopkins patented the underlying PSMA imaging technology and licensed it to Progenics Pharmaceuticals, which supported the clinical trials and regulatory work that eventually led to US Food and Drug Administration approval of PYLARIFY in 2021.
Allen says that type of commercialization process is often necessary in biomedical imaging research.
“Breakthroughs like these require years of scientific research, sustained investment, entrepreneurial leadership, and strong partnerships between our public and private sectors,” he says.
The report says more than 760,000 people with prostate cancer have undergone imaging with the technology since approval.
For radiologists and nuclear medicine teams, PSMA PET is now part of staging, restaging, treatment planning, and identifying patients for PSMA-targeted radioligand therapy.
What Comes Next for Radiopharmaceutical Imaging
Dannals says he has been surprised by how quickly PSMA imaging and theranostics have expanded. He emphasizes that PYLARIFY is part of a broader field that includes both PSMA-targeted imaging agents and therapeutic analogs.
He says radiopharmaceutical imaging offers highly sensitive, quantitative imaging tied directly to disease biology. CT and MRI will continue advancing, he says, but radiopharmaceuticals can provide molecular information that other imaging modalities cannot.
“We are merely scratching the surface in leveraging precision medicine and nearly infinite chemical space for generating new radiopharmaceuticals against new targets—for subtyping and managing a wide variety of diseases,” Dannals says.
He also expects theranostics to continue expanding, with related compounds used for either imaging or therapy depending on the isotope. Dannals says artificial intelligence may also play a role in prognosis, patient selection, and dosing for molecular radiotherapy.
For imaging professionals, Dannals says radiopharmaceutical imaging represents “the most viable way to image disease in a precise, quantitative, and highly sensitive manner.”
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Alyx Arnett is chief editor of Axis Imaging News. Questions or comments? Email [email protected].
