Coordinating Center for the NHLBI Catalyze Program

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The gap in funding and support for the transition of products from bench research to clinical application often results in the loss of potentially important discoveries. This translational gap, also called the “Valley of Death,” has been an area of increased biomedical spending by the National Institutes of Health (NIH) during the past two decades. The National Heart, Lung, and Blood Institute (NHLBI) recognized the need for programs to foster translational research nearly 20 years ago, starting with the Production Assistance for Cellular Therapies program, followed by the Gene Therapy Resource Program, Science Moving Towards Research Translation and Therapy (SMARTT), and the National Institutes of Health Centers for Accelerated Innovations (NCAI) These programs were designed to provide a diverse array of services to accelerate the development of novel products into clinical application and commercialization. The Catalyze Program continues NHLBI’s support of translational science through funding, technical support, and skills development to ensure that investigators can successfully advance novel therapies and platform technologies for heart, lung, blood, and sleep diseases and disorders. This program will merge the best practices from two decades of translational programs to become a model for mentoring investigators and advancing translational research. Catalyze will provide technical guidance from discovery through Investigational New Drug (IND)–enabling studies, as well as assist investigators in the development of milestones, identify the optimal regulatory pathway, and build a commercial strategy for their product. Each investigator in the Catalyze Program will be mentored by an experienced technical team with the expectation that they will use their knowledge not only to develop a novel technology or therapeutic, but also to train the next generation of translational scientists. As the Catalyze Coordinating Center (CC), RTI International will draw on 20 years of experience in translational research to provide exceptional operational and technical leadership. Through our experience as the CC for SMARTT and the independent evaluator of NCAI and REACH, we have a unique insight into best practices and challenges in translational programs and will apply that knowledge to ensure that Catalyze provides a comprehensive development support system for investigators and an efficient, strategic, and flexible program for NHLBI. We recognize that the success of Catalyze will depend on the success of the investigators in the program. As the CC for SMARTT, we were able to work with investigators from across the country effectively by having frequent communication and providing an atmosphere of collaboration. The key to the success of the SMARTT program was to customize our team and our approach to meet the needs of each investigator. Through comprehensive discussions with each investigator and their team, we were able determine their level of knowledge/experience in product development, the gaps/needs in the program, and the communication style that worked best with each investigator. The success of this approach for SMARTT is evident in the number of products that advanced along the development path, including 25 manufacturing campaigns, 18 pharmacology/toxicology packages completed, 7 INDs cleared, 11 pre-IND meetings, 2 IND amendments, 4 Orphan Drug Designation applications approved, and 4 pharmaceutical partnerships or licensing deals. As the CC for Catalyze, we will take a similar approach to ensure that each investigator receives the support and services tailored to him/her. We will approach our role in providing investigators with project management and technical guidance with sensitivity, responsiveness, and collaboration. We will work as a partner with NHLBI to rapidly establish the CC using our established infrastructure, programming, and processes, which we will customize for the needs of the Catalyze Program. Because program flexibility is critical for NHLBI, we will be able to provide state-of-the-art tracking tools to ensure that NHLBI is apprised of the status of each project and informed when we anticipate delays or technical challenges that may impede product development.