Chemistry of Life Processes Institute (CLP) recently introduced a new resource for Northwestern University academic drug developers who wish to explore the necessary steps in developing and eventual marketing of promising drug therapies discovered in their labs. The Beginner’s Guide to Academic Drug Development was developed by Dr. Bill Sargent, CLP’s Entrepreneur in Residence, drawing upon his 30-year career in the pharmaceutical industry and a decade in academic research and translation.
Hosted on the Center for Developmental Therapeutics home page, the Guide provides a detailed overview of the drug development process from discovery to filing an IND (Investigational New Drug Application) as well as links to Northwestern-specific experts.
“Drug development in an academic setting is very different from the pharmaceutical sector due to the lack of drug development experience and supporting infrastructure,” says Sargent. “In the pharmaceutical industry, once we had identified a treatable target, we created a project team with people who had all the different drug development skills sitting around the table. Having gone through that process, I thought I could bring the most important parts of it back to academia to show how we move the product from an idea to a commercially viable product that can help the patient.”
The Guide provides drug developers with information about:
- Northwestern policies and guidance
- FDA’s structure and selected guidance documents for drug development
- Scientific steps leading to identification of a patentable compound
- Northwestern fee-for-service Scientific Cores and Centers of Excellence that can assist at each step
- The patenting process, licensing and/or partnering process and Northwestern proprietary funding sources
In developing the Guide, Sargent incorporated feedback from the Institute’s transdisciplinary faculty and staff, managers of the University’s Core facilities, the Office of Research, the Innovation and New Ventures Office (INVO), NUCATS, Chicago Biomedical Consortium and other internal organizations involved in bringing innovations from the lab to society. These stakeholders form what Sargent considers “a ‘virtual’ project team” for University drug developers.
“We’ve got some really creative ideas at Northwestern. Our scientists conduct years of research to understand a biological pathway and its role in a disease process. Without this basic science, one would not know where to find a treatable target in the pathway,” says Sargent. “However, progressing from understanding basic pathways to identifying treatable targets takes a very long time, on average, about 10-15 years.”
As Entrepreneur-in-Residence, Sargent helps scientists determine whether a new discovery can address an unmet medical need in treating a specific disease process, and what other types of characteristics the drug will need in order to demonstrate efficacy in patients and to compete in the marketplace. He also helps to co-ordinate the research translation process. He hopes the Guide will stimulate researchers to press on in the development of promising treatments for clinical use.
“Many of Northwestern’s outstanding faculty in life scientists, chemistry, medicine, and engineering have phenomenal ideas about how to deliver drugs in novel ways, overcome toxicities, and target very specifically the disease tissue, or the tumor,” says Thomas O’Halloran, Founding Director of the Institute. “However, most of us do not have very much knowledge about how to develop our idea from theory to practice. This effort is an important first step.”
Sargent is available for consultation by appointment at email@example.com.
by Lisa La Vallee