P50FD007967

UCSF-STANFORD Pediatric Device Consortium - Project Summary

There is a critical clinical and commercial unmet need for novel pediatric devices that are designed specifically for the unique needs of children. The UCSF-STANFORD Pediatric Device Consortium (PDC) has been a key player in this space since its inception in 2009, with a successful history in supporting over 250 pediatric device innovations in many clinical specialties and in all device classes on their path to commercialization and patient access.

In the previous 5-year grant cycle, the UCSF-STANFORD PDC supported 128 projects in research, development, and engineering, 67 projects in bench and animal testing, 21 projects in intellectual property, 55 projects in regulation, 71 projects in business and commercialization, and 30 projects in payment and reimbursement. This has led to over $100M in collective follow-on funding, 9 commercially available products, and over 20,000 children positively impacted by these technologies.

The UCSF-STANFORD PDC is also proud to be the first PDC to effectively use real-world clinical data and real-world evidence for successful regulatory clearance of a device and label expansion for pediatric use.

UCSF-STANFORD PDC combines the outstanding resources and unique innovation ecosystems available in two world-class universities and two leading children's hospitals with the unsurpassed entrepreneurial network in the heart of the Bay Area, to equip pediatric innovators at all stages of development to translate their innovations into high-value, commercially viable, and equitable products that are accessible to all populations.

The PDC is now further expanding its scope and impact through 1) a partnership with world-class device incubator Fogarty Innovation, 2) the diversification of leadership with actionable plans to promote diversity, equity and inclusion (DEI) in device development, and 3) the expansion of real-world evidence (RWE) consulting and education through a collaborative PDC service center as well as a new partnership with a leading RWE firm, Aetion.

Two seasoned device innovators, Hanmin Lee, MD (pediatric surgeon and Surgeon in Chief at UCSF Benioff Children's Hospitals) and James Wall, MD (pediatric surgeon and Biodesign Lead, Stanford University) will lead the PDC team consisting of device experts with clinical, technical, regulatory, and other relevant expertise. They will be supported by senior medtech industry professionals, multidisciplinary advisory committees, and multiple institutional stakeholders (UCSF-STANFORD Center of Excellence in Regulatory Science and Innovation, Clinical Trials Offices, and DEI Council), to catalyze promising pediatric device innovations to viable commercial products.

Through committed leadership, collective efforts, great resources, and the unique expertise gained from previous grant cycles, the UCSF-STANFORD PDC will be able to achieve the objectives detailed in the proposal to accelerate many high-impact, value-based pediatric device solutions to commercialization and patient impact.

The UCSF-STANFORD PDC will continue to play a leadership role, along with other PDCs, in creating a national network and ecosystem to foster pediatric device innovations.

San Francisco Regents Of The University Of California

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of the Commissioner [HHS - FDA]

San Francisco, California 94143 United States

Single Zip Code

Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional (RFA-FD-23-024)

Amendment Since initial award the total obligations have increased 200% from $1,483,334 to $4,450,002.