About one in eight American men will be diagnosed with prostate cancer during their lifetime. It is the second-deadliest cancer for American men, claiming tens of thousands of lives every year.
Today, however, physicians have a powerful tool that allows them to detect prostate cancer accurately and determine how far it has spread before treatment begins. Since receiving FDA approval in 2021, the PET radiotracer that my former Johns Hopkins University colleague, Dr. Martin Pomper, and I helped develop has been used in more than 760,000 patients and will help many more.
Yet bringing the test to patients was far from simple. Its journey from university laboratory to hospital imaging suite was made possible by one of the most successful, and least appreciated, pieces of innovation policy in American history: the Bayh-Dole Act of 1980. This act allows universities, federal laboratories and small businesses to patent federally funded discoveries and license them to private companies for commercialization.
As policymakers debate the future of federally funded research, they must remember what Bayh-Dole has accomplished. Without it, countless discoveries would never leave university laboratories, patients would lose access to lifesaving innovations and taxpayers would see far less return on their investment in scientific research.
Before Bayh-Dole, university discoveries were topics of academic publications. Few actually reached the clinic. When they did, it was often due to special circumstances rather than a systematic pipeline. But now, there are many important medicines stemming from federally funded university research benefiting millions of patients.
I have spent much of my career translating laboratory discoveries into diagnostic and therapeutic tools that physicians can use to improve patient care. So, when Dr. Pomper’s team created a promising molecule that selectively targeted and lit up prostate cancer cells in PET scans, my team wanted to help develop it into a practical tool for diagnostic nuclear medicine.
The original radioactive compound showed enormous promise, but producing it reliably and efficiently was challenging. My laboratory developed a faster, more robust synthesis that generated larger quantities of the radiotracer, transforming an intriguing scientific discovery into something that could realistically become a clinical diagnostic used to detect and locate prostate cancer cells without invasive procedures.
But there was still a long way to go before the breakthrough could benefit patients. The technology required years of costly clinical trials, regulatory review and FDA approval. No academic laboratory could handle that burden alone. It required a private-sector partner willing to invest substantial time, expertise and capital in the face of significant financial risk.
That was where the technology transfer system established by Bayh-Dole made all the difference.
Bayh-Dole allowed Johns Hopkins to patent our compound and its synthesis and license it to Progenics Pharmaceuticals. Progenics saw our discovery’s potential and invested its resources and expertise to conduct clinical testing and develop the compound into an FDA-approved product.
The impact of Bayh-Dole became deeply personal during a recent visit to Capitol Hill with the Bayh-Dole Coalition, a nonprofit organization dedicated to preserving the Bayh-Dole system. As I was describing our invention to congressional staff, one coalition member suddenly realized that our test helped save his father’s life. After his father was diagnosed with terminal prostate cancer, his family sought a second opinion from a doctor who used the test to identify the extent of his disease and develop a treatment strategy that gave him a chance he otherwise might never have had.
Countless patients have similar stories because of the many breakthroughs made possible by Bayh-Dole. More than 200 different drugs and vaccines have been developed through public-private partnerships since 1980.
This is why policymakers must protect Bayh-Dole, the broader technology transfer system it anchors and the federal research funding that allows institutions such as Johns Hopkins to pursue early-stage discoveries in the first place.
Recently, critics have questioned whether this system delivers enough return on public investment. Some have proposed reducing research funding or reinterpreting Bayh-Dole to give the government greater control over university inventions. While perhaps well-intentioned, they risk undermining the very system that has enabled many scientific breakthroughs to become real-world medical advances.
Discovery alone does not save lives. Translation does.
America’s universities excel at generating new knowledge. America’s private sector excels at transforming that knowledge into products that physicians prescribe and patients rely on. Bayh-Dole provides the bridge between those two worlds.
The next breakthrough in cancer diagnosis, Alzheimer’s disease, heart disease and countless other conditions is likely sitting today in a university laboratory or is an idea in some imaginative scientist’s head. Maintaining federal research funding, the Bayh-Dole system and the public-private partnerships that it encourages is crucial.
If we want federally funded research to continue delivering lifesaving discoveries, and not just scientific publications, we should strengthen, not weaken, the Bayh-Dole Act.
Dr. Robert Dannals is a professor in the Johns Hopkins Medicine Department of Radiology and Radiological Science.
