Pictured left to right: P. Fontes, C. Hughes

We are delighted to announce that PLRC members Dr. Chris Hughes and Dr. Paulo Fontes have been selected as recipients of the PLRC–Coulter Joint Translational Grant in the Liver category! The award period is July 1, 2017 – June 30, 2018. In addition to $50,000, the awardees will work closely with Coulter staff as they continue to develop their project and prepare it for clinical use. Congratulations, Dr. Hughes and Dr. Fontes!

“Whole-organ sonothrombolysis for prevention of ischemic cholangiopathy in DCD liver transplantation” 

Clinical PI – Paulo Fontes, MD
Scientific PI – Christopher Hughes, MD
Congratulations to Dr. Fontes and Dr. Hughes!

 

Pittsburgh Liver Research Center/Coulter Translational Research Program
Joint Translational Grant Program
University of Pittsburgh
The University of Pittsburgh & UPMC Pittsburgh Liver Research Center (PLRC) is pleased to announce a new translational grant program in collaboration with the Coulter TPII Program (Coulter) at the University of Pittsburgh. In June of 2017, the PLRC/Coulter will award up to one $50,000 grant, aimed at developing the commercial potential of healthcare solutions that are based on innovative technologies related to liver health, including disease diagnosis, surgery, treatment, and public health.
Projects may be medical devices, diagnostics, healthcare IT/software or drug delivery systems.  While not an exhaustive list, the following examples may provide guidance:
  • Medical devices – engineered surgical instruments, implants, other hardware products
  • Diagnostics – biological and chemical assays, genetic screens, electronic analytical instruments
  • Healthcare IT/Software – Software applications, data capture systems, smart phone apps, data-analytics
  • Drug delivery systems – extended release agents for drugs and biologics, implantable delivery devices
Drug projects may be considered, however, only if Coulter funding has the potential to advance the technology enough to generate commercial interest.
Ultimately, our mission is to provide awardees with the means to develop a viable path to commercialization via a license to an existing commercial entity or the initiation of a startup company through Pitt’s Innovation Institute.  The Coulter team will provide guidance, project management support and personnel resources to assist this process.  Grant awards will be based upon consideration for potential patient benefit, impact on the healthcare system, likelihood of technical success, economic viability, timeline to commercialization, and product scalability, all of which may significantly influence future adoption potential when the technology is commercialized.  More detailed information on the Coulter philosophy is available at http://www.engineering.pitt.edu/coulter/.
As with other Coulter projects, each proposal must include a scientific co-principal investigator (Co-PI) and at least one clinical practitioner (Co-PI) from the Schools of the Health Sciences or UPMC, whose job responsibilities include direct contact with patients or patient data. University of Pittsburgh faculty members at the levels of assistant or research assistant professor, associate or research associate professor, and professor or research professor are eligible to apply as Co-PI’s.  Instructors, fellows, research associates, predoctoral and postdoctoral researchers may also apply, providing there is a qualified faculty member who participates as a Co-PI.

The application process for this program begins with the submission of a letter of intent (LOI), which is due by 5:00 pm on Tuesday, November 15, 2016.

Submission Guidelines & Selection Process:

Proposal submission and selection is a four-stage process.
The Coulter Oversight Committee (OC) will select the funded Coulter projects based on presentation of the full proposal for the period July 1, 2017 through June 30, 2018. A budget of direct costs will be further prepared during the development of the full proposal.
One-Page LOI Submission: Deadline – 5:00 p.m. Tuesday, November 15, 2016
In one page, the LOI should convey the unmet clinical need, market potential, uniqueness, and protectable nature of your solution and business proposition, including path to market/clinical use.

The body of the LOI narrative must include:

1. A description of the unmet or poorly met clinical need
        a. The LOI should include metrics, such as:
               i. Number of patients affected annually
               ii. Health care expenditures for treatment and/or diagnosis
               iii. Likely future trend of the problem
               iv. Defined market and estimated market size
2. The proposed solution, including status
       a. The proposal must be as focused as possible on the development of an innovative technology solution for the identified problem, i.e. “translational” as opposed to “academic” (which is defined as adding to the general body of knowledge, but not product specific)
       b. Comparison to the current standard of care and other competitive considerations
       c. Successful applications would have already progressed through an initial in vivo proof of concept for their technology
3. Concise summary of preliminary data
       a. Include published articles, if any, which support the efficacy of the proposed technology; i.e., evidence that the approach would actually “work” (proof of concept) and that there would be a future clinical demand for it
4. A realistic R&D / product development timeline
       a. Include estimated time from “bench to bedside,” taking into consideration technology feasibility, proof of in vivo feasibility, product development, verification and validation, manufacturing, and regulatory/reimbursement considerations.  Is this a 1-2 year project or 8-10 years to clinical use/market?
5. The proposed one-year scope of work and budget allocation for non-PI personnel, minor equipment and supplies
      a. Do not include the university overhead, at this point
      b. Please summarize previous work and grants received for this solution
      c. Include if and for how long your investigative team has worked together on this solution and other successful translational research activities
6. The Intellectual Property Status
      a. Include invention disclosures, patent applications filed, shared IP ownership with others, patents awarded and/or technologies licensed, related to the proposed technology, including third party IP
      b. Innovation Institute disclosure docket numbers for the proposed technology must be provided. Include any assessments of the strength of the Intellectual Property (such as patent searches and applications)

Written Format:

1 inch page margins, Times New Roman Font – at least 11 point size, line breaks between paragraphs. Only proposals meeting these format guidelines will be evaluated.  Please include PI names and titles.

Evaluation:

The Coulter Leadership Team will review and evaluate the LOI proposals.  Investigators will be notified regarding the result of the LOI on or before Friday, January 20, 2017, along with specific and relevant feedback. Selected LOI finalists will be invited to prepare a Full Proposal during participation in a commercialization strategy development process.  It is expected that finalists who are working toward a Full Proposal submission will work closely with the Coulter TPII Program Director (CPD) and the Office of the CPD, and use other provided translational resources, in the formulation and submission of the Full Proposal.  Full Proposals are due in May 2017, and they will be presented to the Coulter Oversight Committee in June 2017. The OC will then select the winning project based on a presentation of the Full Proposal for the funding period July 1, 2017 through June 30, 2018.