(726c) Rationally Designed Controlled Release Therapeutics

Controlled release technology can resolve the half-life and delivery issues that prevent regenerative medicines, vaccines and many other therapeutics from achieving their full potential. However, current methods for developing custom release formulations require costly trial-and-error experiments that rarely achieve optimal delivery kinetics. For this reason, our research group has recently developed the very first rational, non-iterative design methodology where practically any dosing schedule can be ?pre-programmed? into resorbable polymer matrices of any shape, size, and form. These matrices can also be made entirely from ?FDA approved? materials poly(lactic) acid and poly(lactic-co-glycolic) acid without compromising their delivery kinetics. Further, because design is done in silico this approach is incredibly cost effective. The result is unparalleled speed, precision, and savings in the development of custom timed release formulations.

Using our new designed methodology, we have developed a variety of controlled release therapeutics and tested them successfully in preclinical models. For example, our neonatal vaccination platform has successfully delayed the onset of immunization for seven days following injection in the Ovalbumin mouse model. Another rationally designed vehicle has successfully extended the dosing interval for the antiviral peptide, enfuvirtide, from twice daily to once every 30 days. A third controlled release formulation provides local delivery of cytokines and chemokines in a regenerative treatment for periodontal disease. Each case of these rationally designed formulations automate dosing, extend delivery or localize application, helping to enable long-awaited treatments.