The Baylor Licensing Group: An Interview with Director Michael Dilling
The translation of medical discoveries to viable treatments for patients is a painstaking process, requiring collaboration between investigators and commercial companies. The Baylor College of Medicine Licensing Group (BLG) helps facilitate such collaborations by securing license agreements that allow commercial development of promising new technologies. VIICTR.org spoke with BLG Director Michael Dilling about the steps needed to bring new medical discoveries to the marketplace.
What is the role of the Baylor Licensing Group (BLG), and how does it benefit Baylor and its investigators?
We exist primarily to facilitate technology transfer – the process of converting scientific and technological advances into marketable goods or services. In that regard, we help Baylor principal investigators (PIs) maximize the impact of their research through commercial partnerships that lead to the development of new medical products that potentially can benefit patients. We also coordinate patent filing and prosecution activities for the therapeutic products, medical devices, and diagnostic tests that the PI’s have developed, thereby building the college’s pool of proprietary intellectual property. We make the decision to file a patent when a patent is necessary to induce a company to license an invention and develop it. The goal is always to land a licensee.
How do Baylor scientists engage the BLG, and what services do you provide?
Engagement begins when a Baylor PI submits an invention disclosure to us. They can do so by clicking on this link: https://ota.vpdr.bcm.tmc.edu/disclosuredefault.asp. The disclosure names the developer(s) of the technology, the funding sources used to financially support the development, and a description of the technology. When a disclosure is received, it is assigned to one of the BLG project managers, who will work closely with the PI to evaluate the invention in relation to existing technologies and to determine whether it is necessary to file a patent application in order to successfully commercialize the invention. Once we complete our evaluation and investigate prospects for commercializing the technology, we make a recommendation to the PI via an Invention Disclosure Analysis (IDA). The IDA provides a description of the prior art that is relevant to the invention, as well as a description of the commercial market associated with it. Our goal behind the IDA is to provide the PI with high-quality, consistent feedback regarding their disclosure.
With regard to our services, we execute various agreements with commercial partners, including license agreements that convey intellectual or property development rights to a commercial third party (e.g., a pharmaceutical company). These agreements include exclusive licenses to a single company in which we confer rights to allow them to develop a Baylor-patented technology, typically a therapeutic or a device. They also include non-exclusive licenses, which often involve non-patented research tools that can be used by as many companies as are interested. For example, if the license concerns a cell line or a knock-out mouse, we are not interested in granting exclusive rights; we would rather disseminate the cell line or knock-out mouse to any company interested in paying for access to our research tool. Companies will readily do this because it saves them the time and resources that they would have to commit if they were to independently develop the tool.
What types of submissions do you receive?
Baylor is a comprehensive biomedical research institution, so we receive a wide variety of disclosures for new therapeutics, medical devices, vaccines, diagnostics (e.g., biomarkers for cancer or neurological disorders), computer software (e.g., a novel algorithm for predicting outcomes), and iPhone® app technologies. We also receive disclosures for a variety of research tools – knockout mice, antibodies, engineered cell lines, vectors, etc. Basically, the submissions we receive cover anything and everything that might emerge from the research at Baylor and that may have applications in the commercial market.
At what stage should a PI approach you to discuss his or her work?
Well in advance of any public disclosure of the invention is always better. The reasoning is that we may want to file a patent if the technology is proprietary and may have therapeutic, device, or diagnostic (in some cases) applications in human disease. For a therapeutic technology to be developed and launched into the commercial marketplace, the company that procures a license for that technology will have to shepherd it through the regulatory approval process of the U.S. Food and Drug Administration, which will take years. For a drug, it could literally represent an investment of hundreds of millions of dollars. So, patent protection is necessary for a company to undertake that process. Without some assurance of exclusivity, there is no incentive for a company to undertake the costs associated with developing a therapeutic or device.
To be patented, a technology must satisfy three parameters: 1) it must be novel; 2) it must be nonobvious to a skilled practitioner; and 3) it must have practical utility. Additionally, the applicant must provide evidence that the invention is enabled – i.e. that it can be used by a skilled practitioner in the art. It also is important to avoid public disclosure of the technology. Presentation at a scientific meeting or at another academic institution, a publication either online or in print, or publication in a meeting abstract or poster all constitute public disclosure and can create barriers to patentability. So, we recommend that a PI discuss his or her technology with us before any public disclosure.
What are the overall benefits—outside of the potential financial aspect—for Baylor entering into a commercial partnership?
Partnerships are not just financial but also logistical. For example, a phase I or phase II clinical trial can be conducted at an academic institution. However, a pivotal phase III clinical trial—which seeks to establish the efficacy of a particular drug—is enormously costly and would require a commercial partner. Without a partnership, it is highly unlikely that a new drug will ever broadly impact the patient population for which it is intended.
Although we have executed numerous license agreements, the number of these that lead to any large financial gains or significant market impact is very small. This is true not only at Baylor, but across academia. We are trying to improve the odds of success at BCM by adding value to a subset of our best technologies to make them more attractive commercialization candidates. The goal of technology transfer is not to make money per se (although it is great when a deal results in financial/market success), but to catalyze the commercial development of Baylor’s most exciting technologies. We are trying to make Baylor technologies known to as many potential partners as possible and hopefully penetrate the marketplace. While the financial benefits of a partnership are always helpful, the real benefit is having a technology move into the commercial sector so that it can be developed and eventually help people. Baylor investigators are gratified when their research is validated through a commercial relationship.
Do pharmaceutical companies typically approach Baylor, or is it the other way around?
An interesting shift has occurred over the past several years. Pharmaceutical companies have cut back on their own research and development efforts and are looking elsewhere for earlier stage technologies to fill their pipelines. They have greater interest in talking with academic PIs than they did 5 years ago.
But, it definitely is a two-way street. We actively approach pharmaceutical companies and have effectively marketed Baylor technologies to them. In fact, Andrew Wooten, executive director of research and development in Baylor’s Institute for Clinical and Translational Research, has successfully facilitated visits between company representatives and Baylor PIs. In addition, Baylor PIs, who present their research at scientific conferences often are approached by pharmaceutical company representatives. These impromptu introductions have eventually led to licensing agreements. It is important for PIs to keep their BLG project manager in the loop if they talk with a company representative.
In building commercial relationships, do Baylor PIs risk public disclosure of their research?
Yes. It is important that PIs not share confidential, unpublished data or information with third parties in the absence of a confidential disclosure agreement (CDA). That is why we encourage PIs to talk with us first to determine whether or not a discovery requires patent protection. Building a successful commercial partnership requires a coordinated effort among the Baylor PI, the licensing manager, and the company.
What happens if a faculty member waits too long before approaching the BLG with their discovery?
There is a 1-year grace period in the United States, meaning that we have a year to file a patent application after an initial public disclosure of a discovery or invention. However, other countries require absolute novelty. So, once an invention has been disclosed in a meeting presentation or publication, the ability to patent that intervention is lost in most countries, which diminishes its commercial prospects. Although commercialization potential is lost, scientific credit is not. The PI can still formally publish his or her research findings.
Are there any new projects in the pipeline that have commercialization potential?
Yes. We’re very excited about the prospects associated with a license and research collaboration relationship between a team of PIs at the Center for Cell & Gene Therapy and a major pharmaceutical company. The goal of the collaboration is to develop novel T-cell based therapies against cancer that rely on the use of chimeric antigen receptors (CARs) to direct the antitumor specificity of these immune system cells. Immunotherapeutic approaches against cancer have come a long way, and while there is much work remaining to be done, I think day is coming when these technologies will significantly impact patient care.
Another long-term development project is underway at a Baylor start-up company founded in 2001. The start-up, which has partnered with a pharmaceutical company, is developing a promising autologous T-cell–based vaccine against multiple sclerosis. The vaccine is currently being tested in a phase II trial that likely will progress to a phase III trial. The fact that it has taken this company over 10 years to get to a phase III clinical trial perfectly illustrates the point that commercial development of new biomedical therapies is a marathon.
For more information about the Baylor Licensing Group, visit: https://www.bcm.edu/research/office-of-research/baylor-licensing-group.