Pilot Funding

ITHS Ignition Awards

The "Institute of Translational Health Sciences" (ITHS)funded through the NIH Clinical and Translational Science Award (CTSA), brings together scientists at the University of Washington, Fred Hutchinson Cancer Research Center (FHCRC), Children’s Hospital and Regional Medical Center (CHRMC) and other institutions within the WWAMI region to advance and transform clinical and translational research. The ITHS sponsors or co-sponsors the Ignition Award to help develop new models, assays, tools, and directions in translational research that may ultimately benefit human health.

The ITHS and the University of Washington School of Pharmacy are pleased to co-sponsor a new Ignition Award, focused on Preclinical Pharmaceutical Studies. The purpose of this Ignition Award is to explore innovative areas of drug delivery, transport, metabolism, pharmacokinetics, or pharmacogenetics. All applications must be sponsored by a faculty member of the School of Pharmacy (Departments of Pharmacy, Pharmaceutics or Medicinal Chemistry) and describe how the proposed studies will support new research grant applications (e.g. R01-type grant to NIH or other funding agency) and/or subsequent clinical studies. See Application Process below for information on identifying a School of Pharmacy sponsor. Applications may be submitted by investigators from the UW, FHCRC, CHRMC, and other institutions within the WWAMI region. Applications for awards of $20,000 - $40,000 (inclusive of direct and indirect costs) will be considered during this review cycle.

Purpose:

This Ignition Award is designed to support innovative, translational studies utilizing the resources within the UW School of Pharmacy. In particular, the School of Pharmacy maintains the DNA Sequencing and Gene Analysis Center, Mass Spectrometry Center, and Drug Interactions Database and provides expertise in the delivery, disposition and effectiveness of drugs in the human body. It encompasses a molecular evaluation of drug metabolism and transport processes and the study of genetic, environmental and disease-related factors that control or affect those processes, as well as the fundamental mathematical relations between enzyme/transporter function, blood concentration-time profiles and the spectrum of pharmacological effects. The Department of Medicinal Chemistry is exceptionally well equipped with modern research instrumentation, notably in the areas of mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy. This award will facilitate use of these and other resources as well as research expertise within the School of Pharmacy in translation of basic molecular processes into clinical practice. The program is intended to help investigators generate preliminary data to serve as the basis for submission of a subsequent grant and/or clinical studies. Particular emphasis and priority will be given to applications directed at the development of novel therapeutics (small molecules or biologics).

Eligibility and Review Criteria:

All applicants must be sponsored by a faculty member in the School of Pharmacy (see process below for identification of Pharmacy School partners)
Faculty from the UW, FHCRC, CHRMC, and other institutions within the WWAMI region are eligible to apply.
The proposed research MUST be readily identifiable as addressing issues in either translational or clinical research.
It will be the responsibility of the PI to clearly demonstrate how the proposed research has the potential to positively impact the quality or the conduct of clinical and translational research. The investigator should clearly describe how the proposed evaluation methodology provides an innovative approach to conducting the proposed evaluation research.

Review Committee and Standards:

The combined UW School of Pharmacy Research Review Committee and ITHS Drug, Device and Biologics Development Advisory Committee (DDB) constitute the Research Review Committee (RRC) for this Ignition Award. The RRC will conduct reviews of all applications proposing potential translational research programs. The RRC is currently composed of a total of four members from the School of Pharmacy (including the Associate Dean of Research) and four members from the ITHS Drug, Device, and Biologics Development Advisory Committee. If necessary, or where potential conflict of interest may exist, ad hoc reviewers may augment the RRC membership. Members of the committee are reappointed on an annual basis and membership is designed to provide a diverse cross-section of research interests with representation from both core and affiliate researchers.

Application Process:

One round of review will be performed with each project scored against the criteria listed above. It is anticipated that the projects with the lowest scores/highest priorities will be funded. The current plan is to fund two applications at $20,000 and one at $40,000.

Step 1

If you have not already done so, you must join the ITHS prior to submitting the application. Please go to http://www.iths.org/AboutITHS/Membership/to join. Applications from non-members will not be reviewed.
Applicants must submit the full ITHS Ignition Award Application by October 15, 2008
The applications are solicited from the local and regional (WWAMI) biomedical research communities via an electronically distributed official announcement.
The applications should be submitted as a signed PDF file to Kathy Long at ithsapps@u.washington.edu
Applications must be signed by the applicant and the School of Pharmacy sponsor. For more information regarding School of Pharmacy resources and faculty sponsors contact Flip Wood at flipwood@u.washington.edu or consult the School of Pharmacy website at http://depts.washington.edu/pha/.
Applicants are offered assistance in preparing and submitting appropriate applications and budgets (contact flipwood@u.washington.edu).

Step2

The combined RRC will review the submitted abstracts relative to the evaluation criteria, and score them according to:

Applicability to the School of Pharmacy and ITHS missions
Scientific merit
Innovation
Translational Impact
Probability of future grant funding and/or clinical studies

Step 3

Applications will be reviewed and applicants notified by December 1, 2008. Unsuccessful applicants may resubmit their applications for the next round up to a total of 3 times, unless the reviewers determine that the application does not meet the intent of the program.

Download ITHS Ignition Award Application

After downloading the Word document application, fill it out electronically. Convert to a pdf file and then e-mail the completed application to Kathy Long at ithsapps@u.washington.edu

For more information regarding the application process contact Kathy Long at ithsapps@u.washington.edu

Appendix: NIH's Definitions of Clinical and Translational Research

Clinical Research:

NIH defines human clinical research as:

Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:

mechanisms of human disease
therapeutic interventions
clinical trials
development of new technologies
epidemiologic and behavioral studies.
outcomes research and health services research.

Source: NIH PHS 398 Instructions on Human Subjects Research

Translational Research:

the process of making discoveries in the research laboratory or in preclinical studies that will have an impact on human health and may lead to the development of studies in humans
the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans
research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.

Source: Institutional Clinical and Translational Science Award (U54) RFA-RM-07-0072007 CTSA RFA