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Development of Novel Clinical and Translational Methodologies (NCTM) This section focuses on the impact of the Delaware Valley Institute for Clinical and Translational Science (DVICTS) on development of transformative methodologies and enabling processes that overcome traditional obstacles from bench to bedside translation to positively impact patient care and human health. Objectives: We will develop new, cross-institutional Delaware Valley Resources for Novel Clinical and Translational Methods (DVR-NCTM) with 4 specific objectives:
Overview: Although many products of biomedical research are moving rapidly "from bench to bedside," significant barriers exist that limit the effective and efficient translation of technological advancements into clinical practice. There are institutional barriers to pooling research and clinical and technological resources that restrict innovation. Also, there is a conceptual gap between basic and clinical investigators and those who disseminate and deploy novel methodologies into practice. Silos across communities of practice have limited cross-fertilization and interdisciplinary/transdisciplinary innovation. Solutions include establishing platforms and processes that exploit resources across consortium members to create research synergies. Similarly, there is an educational mandate to train basic scientists to consider clinical applications, and correspondingly for clinicians to consider the scientific underpinnings that support clinical innovation. Interdisciplinary teams that bridge traditional silos should focus on methodological development and application, critical to technological development with broad and innovative application. Additional constraints include the paucity of funding for development of new methodologies for clinical translation and the difficulty in negotiating regulatory and intellectual property issues associated with delivering novel applications. In that context, the objective of the DVR-NCTM is to develop new methodologic and process innovations to ensure that biomedical research and resultant technological products are translated rapidly into clinical practice. Innovations in the discovery-translation paradigm will be complemented by evolution of mechanisms to disseminate advanced clinical tools into practice. Moreover, discovery and translation platforms will serve as a focus for innovations in training the next generation of translational investigators. DVICTS will provide critical infrastructure components, processes, and platform technologies directed at supporting th research enterprise, creating new insights into fundamental clinicopathologic processes, translating those insights into validated diagnostic and therapeutic methodologies, and their dissemination into communities of practice. These infrastructure components are complemented by collaborative research opportunities, at the interface of discovery and practice, which will significantly impact a large and diverse healthcare community. Innovation: Aims here describe the processes that will transform the pursuit of new clinical/translational methodologies within the DVICTS, with the goal of bringing innovative translational research to the community for improved healthcare. To achieve this, we will develop the DVR-NCTM, bringing together basic and clinical investigators from member institutions to develop innovative methodologies with quantifiable clinical impact. Participants will have a wealth of opportunities for developing novel clinical and translational methodologies. These interinstitutional areas of excellence provide a base that will need to be developed and maintained to realize the current opportunities and develop new applications to enhance clinical care in our community. The DVR-NCTM will serve as the intellectual nidus for advances in medical imaging, biomarkers, and therapeutics with an innovative focus to stimulate the translation of methodological developments to clinical practice at the academic health center and across the community. To achieve these goals, the DVR-NCTM will have discrete functions that involve the development and validation of new methodologies and programs to facilitate the translation of these advances to clinical practice. Leadership: The DVR-NCTM will operate as a collaborative entity outside of the normal bounds of departmental and institutional structures involved in biomedical research within DVICTS. For this center to be successful, it needs to be led by individuals who have substantial expertise in basic, translational, and clinical research. The leadership team will contribute to bridging the diverse disciplines represented within the center. Additionally, these individuals are well acquainted with the research and clinical infrastructures at the participating institutions. The director will be S. A. Waldman, MD, PhD, chair of the Department of Pharmacology and Experimental Therapeutics and director of the Division of Clinical Pharmacology in the Department of Medicine at Thomas Jefferson University (TJU). Dr. Waldman has been an institutional, regional, and international leader in the discovery, development, and clinical translation of novel, targeted diagnostics and therapeutics in gastrointestinal malignancies. He will be complemented by the associate director, V. Funanage, PhD, director of Biomedical Research for Nemours, including the A. I. duPont Hospital for Children (AlDHC), Nemours Pediatrics at TJU, and Nemours Children's Clinics in Wilmington, DE, as well as Jacksonville, Orlando, and Pensacola, Florida. In addition, she is director of the CLIA-certified Molecular Diagnostic Laboratory and Head of the Musculoskeletal Inherited Disease Laboratory at Nemours/AIDHC. The director and associate director complement each other in areas of expertise and in institutional and geographical location. They are each leaders at their home institutions. This leadership team will interface with the overall leadership of the DVICTS to define priorities and objectives and evaluative metrics for the DVR-NCTM. They will contribute to interdisciplinary working groups that will define the elements of the Center and promote the goal of developing novel methodologies and their dissemination to the community. |