Invited Speaker

Translational Research in Cancer: Programs of Multi-Institutional University and Industry Collaboration in Drug Discovery and Development
Jonathan Lewis, Robert F. Struck, Larry Norton
USA

Translational research is a way of thinking about and conducting life science research to try and accelerate healthcare outcomes. The NIH and other key institutions have funded major infrastructure and support for translational research in the United States. The same is now occurring in several countries throughout the world.

The focus is to encourage multi-disciplinary and often multi-institutional collaboration. By enabling physicians, basic scientists, pharmacologists and others to leverage biologic techniques and technologies, translational research may enable more facile research, increased efficiency in drug discovery and development, and ultimately improved drug efficacy. At the same time, patients now expect better treatment outcomes and in particular want therapies that have fewer side effects. Furthermore, there is global pressure to reduce healthcare costs.

We have 3 separate programs in development for cancer drugs. Each is derived from academia, studied in both academia and industry and developed in industry. All are small molecules, in both IV and oral forms and envisioned to be low-cost and in particular in oral form, ultimately globally distributed. We have used novel techniques in molecular and cell biology applied to validated targets and pathways to discover and develop these innovative drugs. We are also using novel mathematical modeling for dosing, and have found that with some molecules the major effect of therapy occurs within a few days of exposure. In other words, “on-off-on-off etc. ” dosing may be more efficacious.

We have translated some of these findings into the clinic. Data from Phase I and Phase II studies will be presented, in particular emphasizing the translational components. There are many challenges to translational research. Universities are traditionally associated with basic research while technology institutes and biotech are typically associated with applied research. This separation is both cultural and physical as the separation across different institutions makes it difficult to establish the multidisciplinary and multi-skilled teams that are often necessary to be successful in translational research. Other challenges arise in the traditional incentives which reward individual principal investigators over the types of multi-disciplinary teams that are necessary for translational research. Also, journal publication norms, and regulatory authorities often require tight control of experimental conditions, and these may be difficult to achieve in real-world contexts. These issues will be addressed in the context of current and future drug discovery and development.