Our goal is to provide a means by which new therapeutic discoveries can be delivered effectively and safely to the market. Each potential therapy discovered will face the same series of problems to be overcome --- including safety and stability testing, formulation, clinical trials, and a New Drug Application (NDA). This Pivotal Point team can shepherd molecule development from discovery through NDA, to field-ready in oral solid or any other required dosage form.
Our solution? Tiger Teams – Any research-based institution needs to know when a candidate molecule is in hand, and to analyze what expertise is needed to carry it forward to in-the-field success. To do this, we propose a management team that is small, flexible, multi-talented, and multidisciplinary. This group has a mission whose job it is to do these three things - (1) to know intimately the entire R&D process from lab to field – business, regulatory, testing, manufacturing, distribution, administering, the sociological factors for therapy X in location Y; (2) to follow developments within the institutions’ research efforts; and, (3) to solve (or better yet, avoid) the problems of going from lab to field. Given a lab-successful therapy candidate, the management team will analyze the pathway and the expertise needed to get it to the field. As indicated by the analysis, the management team will then assemble a Tiger Team to handle that therapy. Each Team must be ad-hoc, despite across-therapy pattern similarities – any misstep along the way, any lack of proper planning and execution, can delay or frustrate a promising therapy. Each Tiger Team will have all the needed talents and be exclusively focused on driving its particular therapy through the entire transition from lab to market distribution. Obviously the management team must have widespread contacts with all the necessary fields, and must have an extensive list of experts who can be called upon to be part of a Team. We have the needed expertise and contacts to design, assemble, and manage such Tiger Teams.