Harnessing Ohio State's Innovative Engine
The OSUCCC – James and the University are preparing an initiative to methodically develop cancer therapeutics
By TIMOTHY WRIGHT, director Drug Development Institute
After a long career in the pharmaceutical industry, I recently joined Ohio State and the OSUCCC – James to help advance a drug-development initiative at the University and cancer center. After careful consideration, I concluded that the endeavor holds great potential to benefit cancer patients in Ohio and beyond. My role is to facilitate the work of the OSUCCC – James research community and to work with Ohio State's Technology Commercialization Office (TCO) to optimize the value from our research inventions.
It takes many people and diverse expertise to develop anticancer agents. Scientists and clinicians are essential, of course, but the needed know-how goes beyond that. It can include engineers to help solve solubility problems and experts who can navigate intellectual property laws, assess market opportunities and negotiate agreements. For chemopreventive agents, experts are needed in agriculture, food technology and nutrition. Systems are needed to manage product portfolios and to match developmental milestones with funding support.
As a broad-based, land-grant university, Ohio State possesses much of this expertise:
- The OSUCCC – James has nearly 300 investigators from 11 of Ohio State's 14 colleges. They include some 50 members in the Experimental Therapeutics Program from the colleges of Medicine, Pharmacy, Engineering, Veterinary Medicine and Business.
- The OSUCCC – James Molecular Carcinogenesis and Chemoprevention Program and the University's Crops to Clinic program include members from the colleges of Food, Agricultural and Environmental Sciences; Arts and Sciences; Education and Human Ecology; Public Health; and Veterinary Medicine, as well as Medicine and Pharmacy.
- Ohio State is one of only seven centers funded by the National Cancer Institute (NCI) to conduct both phase I and phase II clinical trials on new anticancer agents sponsored by the NCI.
A nascent drug-development pipeline already exists, much of it in the discovery phase. There is huge potential for an early-stage pipeline to create value.
Two targeted agents invented by OSUCCC – James investigators are already in early-phase clinical trials: AR-12, for solid tumors, and AR-42, a histone deacetylase inhibitor for relapsed or treatment-resistant multiple myeloma, chronic lymphocytic leukemia or lymphoma. More agents – synthetic and natural-product based, therapeutic and chemopreventive – are in the pipeline.
At Ohio State, our goal is to develop a model of collaboration that encourages pharmaceutical and biotech companies to partner with
the OSUCCC – James to develop novel anticancer agents.
Furthermore, the timing is good to establish a drug-development initiative at Ohio State. Currently, the pharmaceutical and biotechnology industries are reducing their in-house research budgets and establishing external research and development partnerships. This is a long-term trend.
Our goal at Ohio State is to develop a model of collaboration that encourages pharmaceutical and biotech companies to partner with the OSUCCC – James to develop novel anticancer agents. These partnerships will help fund drug-development research at the OSUCCC – James, and products that are commercialized will produce royalties that can be invested in University research programs.
We are developing a methodology to advance a drug-development program systematically. The installation of project and portfolio management tools is under way. We are leveraging the capabilities of the University to advance these agents along a predetermined project plan that includes important milestones and "go/no-go" decision points.
Drug development is about science, but it's also about economics. To ensure a robust drug-development initiative, we will create a project plan for select drugs. This includes timing of experiments and determining who is accountable for what and when. A sound understanding of the time, costs and probability of technical success to develop a compound is essential in determining if investment should be pursued, as this forms the basis for key assumptions that ultimately drive financial valuation.
I am working with our researchers to generate data and with the TCO to facilitate appropriate patent filings to ensure that we can capture value down the road. The structure we are creating will mimic certain core processes of a pharmaceutical company while remaining academically sensitive. We must promote smart academic freedom to publish, and we must avoid conflicts of interest while also creating value for the inventions that are discovered and that mature here.
Few universities can match Ohio State's competitive scale and diverse capabilities, but bringing together the many colleges, departments and investigators into a single functioning system is a sensitive undertaking. We must be inclusive and good communicators as we build this initiative. Everyone involved must understand the many benefits it holds for the University, for cancer patients and their families, and for the efforts of the OSUCCC – James to achieve a cancer-free world.