Description:
A. Innovations to accelerate the utilization of personalized medicine:
1. Biomedical materials and medical devices;
2. Medical drug, biologics and product development;
3. Therapeutics;
4. Drug/product delivery;
5. Drug-device combination products;
6. Integrated bio-engineering and pharmacogenomic/genetic research.
B. Innovative Health Informatics for Clinical and Translational Researchers including:
1. Data Repositories for Research: Innovations in the creation and maintenance of large scale data repositories, designed specifically to support translational research use cases; including patient-centered outcomes research.
2. Participant Recruitment Tools and Strategies: Innovations in Informatics to enhance and accelerate participant recruitment for clinical studies.
3. Clinical Information Systems and Research Study Management Systems: New means to identify, link and export research-relevant data from electronic health records.
4. Research Portal Innovations: innovations in the creation and maintenance of research portals that facilitate investigator-initiated identification of research resources and potential collaborators. Support and document concierge-based navigation and access to institutional core resources; track investigator use of services; and provide dashboards to monitor project-specific financial information and progress of regulatory reviews.
C. Innovative technologies that enable use of electronic medical records (EHR) and personal health records (PHR) for clinical and translational research purposes. Elements could include:
1. Interoperability and mapping among technologies;
2. Development of software to process data from multiple clinical and translational research sites;
3. Security systems development to protect storage and transmission of confidential medical data;
4. Development of standardizing agreements for patient privacy and protection.
D. Innovative biomedical technologies to enhance the feasibility or improve the quality of clinical research, conducted in the neonatal intensive care unit.
E. Innovations in the development of vectors for gene therapy, with improved:
1. Targeting of specific cells and/or tissues;
2. Transduction and expression;
3. Delivery to patients; and/or
4. Production and purification.
F. Innovative vehicles for drug delivery.
G. Innovations in tools used by patients or for patients in Mobile Health (mHealth) and TeleHealth technologies for communication, diagnosis, monitoring, evaluation, medical management, tracking, training, and treatment.
H. Innovations in specialized medical devices and robotics for clinical use as implantable sensors, surgical instruments, and imaging devices for medical diagnostics and treatment improvements.
Dr. Jody Sachs
Division of Clinical Research, NCRR
301-435-0802, Fax: 301-480-3661
Email: HYPERLINK "mailto:SachsJG@mail.nih.gov"SachsJG@mail.nih.gov
Human Stem Cell Technologies, Methods, and Tools
Dr. Tony L. Beck
Division of Clinical Research, NCRR
301-435-0805, Fax: 301-480-3661
Email: HYPERLINK "mailto:BeckL@mail.nih.gov" BeckL@mail.nih.gov