Translating academic research into products and services that benefit patients is a time consuming and complex undertaking; however, YCCI and the Office of Cooperative Research (OCR) are collaborating to speed the translation of research discoveries in order to make them widely available to clinicians and patients around the world.
OCR works with Yale researchers to identify and facilitate the transition of inventions that may ultimately become commercial products. These efforts have been enhanced through the establishment of YCCI under the Clinical and Translational Science Award (CTSA) program. OCR is identifying translational projects that can benefit from modest amounts of YCCI funding, which are awarded on an ad hoc basis in order to move to the next step of initial commercial development.
“The questions that need to be answered for commercial viability tend to be somewhat prosaic from an academic point of view. From the commerce side, they’re very important because they’re the questions that are critical for assessing commercial viability,” said David Lewin, Ph.D., senior associate director of licensing for OCR. “These funding opportunities from YCCI allow us to get answers to the questions we will inevitably be asked, but don’t otherwise have the resources to get addressed.”
In some instances, these strategic investments—amounts vary but are typically less than $25,000—have had a tremendous impact on research discoveries that are currently being developed commercially or have led to other funding or research opportunities. Lewin, who is constantly looking for projects that could benefit from a small investment, noted that a little can go a long way in such cases. The resulting data are free of potential bias, making the information attractive to investors, as is the case for the following projects:
Kurt Roberts, M.D., associate professor of surgery (gastrointestinal), used an award of approximately $20,000 from YCCI to develop an internal organ retraction device that facilitates single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES). Roberts has used these techniques to perform pioneering appendectomies and gallbladder surgery using a minimum number of incisions, with lower risk of postoperative complications and much easier and faster recovery periods, including documented reductions in administration of opiate analgesia. OCR spun off a New Haven-based company, NovaTract Surgical, to commercialize the new device. NovaTract has leveraged YCCI’s investment over the intervening years with several funding rounds to raise $4.3 million to support product development. NovaTract expects to launch its first device on the market in 2013.
Barbara Ehrlich, Ph.D., professor of pharmacology and of cellular and molecular physiology, used a $25,000 grant to perform a critical study showing that lithium, a proposed therapy for preventing chemotherapy-induced peripheral neuropathy, does not interfere with the effects of chemotherapeutic agents. Promising results led to talks with a number of pharmaceutical companies that are interested in Ehrlich’s assay to test whether cancer drugs under development cause peripheral neuropathy. There is also a clinical trial in the planning stages to test the ability of lithium to prevent peripheral neuropathy.
Autotaxin (ATX) is an ecto-enzyme that activates LPA, a signaling molecule that enhances the vascularization of tumors, fosters tumor growth, and enhances cancer’s ability to metastasize. Demetrios Braddock, M.D., Ph.D., associate professor of pathology, and his colleagues at the Yale Center for Molecular Discovery at Yale’s West Campus screened more than 20,000 chemical compounds and found one that inhibits autotaxin’s activity in vitro. Using a $25,000 award from YCCI, Braddock subsequently demonstrated that bithionol, an anthelminthic drug withdrawn for safety reasons in 1992, shrinks tumors in mice. The YCCI-supported in vivo studies were subsequently leveraged by Braddock to receive a €50.000 award from Bayer HealthCare’s “Grants4Targets” program.
David A. Spiegel, M.D., Ph.D., associate professor of chemistry and pharmacology, was awarded less than $10,000 for a project which showed such promising results that he successfully applied for a Basic Science Pilot Award, which provides funding for new research initiatives that combine Yale investigators from different disciplines. Spiegel developed a new class of molecules with a novel bifunctional mechanism of action (antagonist and antibodyrecruiting molecules) targeting prostate cancer (ARM-P) and HIV (ARM-H). He had shown in vitro that ARM-P binds to a specific target protein on the surface of prostate cancer cells and then recruits antibodies, tagging them as a threat to be attacked by the body’s immune system. He and his laboratory demonstrated the robustness of this approach by showing that ARM-H will cause HIV-infected cells to be killed in a similar antibody-mediated manner. A Basic Science Collaboration pilot award from YCCI allowed him to evaluate the efficacy of this novel therapeutic strategy in mice, preparing the way for treatments that have fewer side effects, are inexpensive to produce, and could in theory be administered orally. OCR and the Office of Grant and Contract Administration recently concluded negotiations with Bristol-Myers Squibb for two sponsored research agreements supporting further development and exploration of the ARM technology.
These projects illustrate the innovative ways in which YCCI seeks to overcome obstacles that slow the development of therapeutics. “This approach has also allowed us to foster collaborations between investigators from different disciplines that are called upon to evaluate potential research projects and end up working together in unexpected ways.” said Robert Sherwin, M.D., director of YCCI. “I’m pleased that these efforts align so well with the broader vision of the NIH and its centers that support Yale’s research.”