Infrastructure and expertise for accelerating the development of new therapeutics
Program Director: Cheryl London, DVM, PhD
The Translational Therapeutics (TT) program provides infrastructure and expertise for the accelerated development of new therapeutics to advance human health. OSU and NCH support more than 25 resources, cores and centers that support translational science and bridge basic services (e.g. nucleic acid, microarray,and proteomics resources) with more clinically-oriented resources (Clinical Research Centers, GMP and biobanking facilities).
Its secondary mission is to advance integration of translational research efforts across colleges, centers and shared resources. To accomplish this, the CCTS directly supports two cores critical for moving therapeutics through the preclinical process (Drug Development and Discovery and the Comparative Animal Core) and guides project design and implementation through a newly formed Translational Therapeutics Think Tank and Drug Development Institute.
TT supports efforts of investigators to traverse the traditional T1/preclinical space and seamlessly progress to human clinical trials by:
- coordinating work in focused areas to reduce duplication of effort and maximize progress through method innovation;
- real-time communication to adjust drug design, dose and delivery that quickly facilitates lead candidate and regimen identification; and
- pooling efforts to promote novel and rapid approaches to problem-solving.
The pre-IND matrix shown below promotes open communication not only among the pods of activities, but also among the various resources to generate an environment that emphasizes innovative approaches to problem-solving and the development and application of new technologies.
Translational Therapeutics: Changing Paradigms Pre-IND
While TT focuses primarily in the pre-IND setting, a similar model is used to facilitate therapeutic success in the post-IND arena in which spontaneous disease in large animal models (primarily dogs) is integrated into the human clinical trial process. The diagram to the right depicts how this occurs during cancer drug development, but a similar scheme applies to other disease processes such as osteoarthritis, chronic renal failure, and cardiomyopathy, among others. This novel approach utilizes the concept of co-clinical trials whereby information is generated contemporaneously in dog and human studies to better guide the development pathway. In this manner, data generated in the large animal model guides both ongoing and subsequent human trials with the ultimate goal of avoiding therapeutic failure late in the process of drug development.
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