| 2013 — 2017 |
Maltese, Matthew Rudolph |
P50Activity Code Description:
To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Philadelphia Regional Pediatric Medical Device Consortium @ Children's Hosp of Philadelphia
DESCRIPTION (provided by applicant): Pediatric device development has historically faced and presently faces major barriers. The Children's Hospital of Philadelphia (CHOP), together with Drexel University and the University of Pennsylvania, are proposing to develop the Philadelphia Regional Pediatric Medical Device Consortium(Philadelphia PDC). The mission of the Philadelphia PDC is to provide seed funding and business, legal, marketing, clinical, engineering, and scientific resources to inventors of promising pediatric medical devices that will benefit children and have a strong commercialization potential. The CHOP faculty researchers and research institute infrastructure will be the basis for the broad reaching pediatric device expertise in the Philadelphia PDC. A key partner in the Philadelphia PDC is the Coulter-Drexel Translational Research Partnership at Drexel University. The Coulter-Drexel Partnership promotes, develops, and supports innovations to improve patient care by providing sound business, regulatory, and intellectual property advice from pre-eminent experts, with funding and project oversight, to promising translational projects with commercialization potential. Partnering the Philadelphia PDC with Coulter-Drexel, forms a consortium of experts in all critical aspects of pediatric medical device development (business/finance, regulatory, IP, clinical, and science/engineering), reduces costs via shared management responsibilities and resources, and leverages funding from both the Philadelphia-PDC and Coulter-Drexel on projects that merit large investment.
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0.913 |
| 2018 |
Maltese, Matthew Rudolph
Nadkarni, Vinay M |
P50Activity Code Description:
To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Medical Device Consortium At the Children's Hospital of Philadelphia @ Children's Hosp of Philadelphia
Abstract/Summary Addressing unmet needs for treating childhood illnesses lead to the creation of the Philadelphia Pediatric Medical Device Consortium (PPDC) 4.5 years ago. Founded at the Children?s Hospital of Philadelphia (CHOP) with funding from the FDA Pediatric Device Consortia (PDC) program, the mission of the PPDC is to provide seed funding and business, legal, marketing, clinical, engineering and scientific resources to inventors of promising pediatric medical devices that will benefit children and have a strong commercialization potential. CHOP has national prominence in both clinical care and research, and combined with the vibrant medical device development ecosystem that is developing in our region, we have found success. Over the past 5 years, the PPDC has assisted more than 60 devices along the development pathway, and compared to our 7 peer PDCs, the PPDC has been responsible for responsible for half of the Investigational Device Exemption applications, 20% of 510Ks, and 71% of pre-submission meetings. The support offered by the PPDC network of preeminent experts in their field who volunteer their time to advise PPDC device innovators has allowed the PPDC to be a leader with parsimonious use of federal funds. From PPDC inception, NAMSA - the world?s largest contract research organization specializing in medical devices ? has assisted every device project that the PPDC has considered for support. Our Clinical and Scientific Advisory Committee ? clinicians and scientists who are thought-leaders in their fields ? evaluate the technical merit of every device project. Our Oversight Committee ? consisting of luminary CEOs, Investors, and other medical device business leaders ? evaluate the value proposition, reimbursement, regulatory, marketing and business strategy of each proposed device. All of these services are provided free of charge by the PPDC. Building on the aforementioned success, we propose new initiatives and enhanced partnerships that will increase our ability to assist innovators. First, we are partnering with the University of Pittsburgh?s McGowan Institute, a global Class III medical device development enterprise which has been at the forefront of investigating, testing and translating medical devices that have played a critical role in regenerative medicine for the past twenty-five years. McGowan?s partnership brings two strategic advantages to the PPDC: 1) McGowan?s Class III device development capabilities expands the capability of the PPDC. 2) McGowan has a pediatric device initiative in which their outstanding faculty are adapting adult devices for the pediatric population. The PPDC will continue our partnerships with Philadelphia-based academic, engineering, business and medical experts. We will enhance our ties with the University of Pennsylvania and Drexel University. The University of Pennsylvania has just launched ?Penn Health-Tech,? to catalyze medical device innovation, and the PPDC is partnering with this effort. Our productivity will also be enhanced by our real world data/results project building on CHOP expertise studying pediatric device endpoints concerning resuscitation outcomes.
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0.913 |