Funding Opportunities

Department of Defense Fiscal Year 2010 Prostate Cancer Research Program

DoD Fiscal Year 2010 Prostate Cancer Research Program:

The Fiscal Year (FY) Department of Defense 2010 Appropriation included $80 million for the Prostate Cancer Research Program (PCRP). The PCRP has released its final four program announcements for the following awards:

1. Laboratory-Clinical Transition Awards
2. Physician Research Training Awards
3. Population-Based Research Awards
4. Prostate Cancer Training Awards

Full Program Announcements, Application Instructions and deadlines are available on the CDMRP website:
http://cdmrp.army.mil/funding/pcrp.htm

The Synopsis Table with deadlines is also on the website:
http://cdmrp.army.mil/funding/pdf/10pcrpreftable.pdf

Please forward to bio-life, oncology, basic, bio-markers, genetics, epigenetics, imaging, behavioral, rehabilitation therapies, epidemiology, and pharmacology scientists considering prostate cancer research funding at the University of Michigan. You may disseminate this information to the widest possible audience using links, list serves, funding websites, newsletters, and forwarding this e-mail.

The overall goal of the FY10 PCRP is to find and fund innovative, high-impact research that will eliminate death and suffering from prostate cancer. Specifically, the PCRP seeks to:
- Support innovative high-risk, high-gain research with potential near-term impact;
- Sponsor multidisciplinary synergistic research;
- Fund translational studies to promote the fluid transition of knowledge between bedside and bench;
- Invest in research on patient survivorship (quality of life);
- Foster the next generation of prostate cancer investigators through mentored research; and
- Promote research into prostate cancer health disparities.

Applications must address at least one of the following FY10 PCRP focus areas (revised for FY2010):
1. Biomarkers: Discovery and validation of biomarkers for the detection, prognosis, and progression of prostate cancer.
2. Genetics: Understanding the genetics and epigenetics responsible for susceptibility, disease progression, and treatment outcomes for clinically significant prostate cancer.
3. Imaging: Development of new imaging technology for the detection and prognosis of prostate cancer, including progression to systemic disease.
4. Survivorship: Studies on the impact of treatment, nutrition, metabolism, and exercise on the well being of prostate cancer patients and their families.
5. Therapy: Identification of new targets, pathways, and therapeutic modalities or molecules for the treatment of prostate cancer.
6. Tumor Biology: Understanding the heterogeneity and microenvironment for the prognosis and progression of prostate cancer.

New for FY10: PCRP Overarching Challenges
The overarching goals of the FY10 program are aimed towards eliminating death and suffering from prostate cancer:
- Develop effective treatments for advanced prostate cancer
- Distinguish lethal from indolent disease

Award Mechanism Summaries:

1) The PCRP Laboratory-Clinical Transition Award supports goal- and product-driven preclinical studies of promising lead agents that have the potential to revolutionize prostate cancer clinical care. This award is intended to fund PIs who lack support to conduct the preclinical studies needed to advance lead agents to human testing. The goal of this award is the generation of pharmacology and toxicology data for inclusion in a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application prior to current Good Manufacturing Practice (cGMP) production of the lead agent(s). Agents supported by this award mechanism are expected to have high potential for commercial licensing for continued development and clinical use.

All applications for the PCRP Laboratory Clinical Transition Award must address at least one of the aforementioned PCRP overarching challenges.

Applicants are expected to have a validated target, and to have identified either one lead agent or a limited number of lead agents for optimization before applying for this award. In addition, the PI should present data establishing the mechanism of action of the lead agent(s) on the target. Lead agents are defined as novel biological, molecular, or chemical therapeutics or imaging agents, that have potential clinical application to prostate cancer. Examples of lead agents include, but are not limited to: novel chemotherapeutics, antibodies, nanoparticles, and imaging contrast agents.

Interesting features of the PCRP Laboratory-Clinical Transition Award also include: open to independent investigators at or above the level of Assistant Professor (or equivalent); focus of the award is to support the development of the lead agent(s) up to but not including cGMP production of the agent; proposals must include preliminary data relevant to the lead agent(s) under development. Maximum funding is $750,000 for direct costs plus appropriate indirect costs, for a period of performance of up to three (3) years.

2) The PCRP Physician Research Training Award supports a mentored training experience to prepare physicians with clinical duties and/or responsibilities for productive careers in prostate cancer research. Applications must include a robust description of an individualized training program appropriate to the area of study, which may include coursework and seminars, that will provide the Principal Investigator (PI) with experience in key areas such as statistics, bioethics, and/or relevant basic science disciplines. This award requires the involvement of a designated mentor with an established research program in prostate cancer.

Applications for the PCRP Physician Research Training Award are encouraged but not required to address at least one of the aforementioned PCRP overarching challenges.

This award is intended to provide aggressive protection of at least 40% of the PI's time for research. The PI must demonstrate a commitment to a career in prostate cancer research and clinical practice. In addition, salary for up to a 50% combined level of effort from one to two key support personnel may be provided by this award. Up to $10,000 in funds per year from this award may be used for research supplies and equipment. These funds may be used for research with laboratory animals and human biological substances, as well as research with human subjects, provided that the funds are not used to support clinical trials. PIs may participate in clinical trials as part of their training for this award, but funding for the clinical trials must come from a source other than this award.

The PCRP seeks Physician Research Training Award applications from the wide spectrum of basic to clinical research, that are responsive to at least one of the PCRP focus areas. It is strongly encouraged, although not required, that applications also be responsive to at least one of the PCRP overarching challenges.

Interesting features of the PCRP Physician Research Training Award also include: open to physicians with clinical duties and/or responsibilities who, at the application submission deadline, are either in the last year of an accredited medical residency or medical fellowship program, or are within three years of having initiated an appointment as an Instructor, Assistant Professor, or equivalent. Maximum funding is $130,000 per year for direct costs plus appropriate indirect costs, for a minimum period of performance
of three years and a maximum period of performance of five years.

3) The PCRP Population-Based Research Award supports high-impact, population-based approaches to prostate cancer research. These studies, if successful, should contribute significantly to the elimination of death and suffering from prostate cancer. Proposed research must be responsive to at least one of the FY10 PCRP overarching challenges and at least one of the focus areas. The overall goal of this award is to generate unique information and/or tools that can only be achieved from the perspective of statistical analysis of a defined patient population. Note: This award mechanism, first offered in 2009 as the Population-Based Idea Development Award, has been modified for FY2010.

All applications for the PCRP Population-Based Research Award must address at least one of the aforementioned PCRP overarching challenges.

Applications may propose retrospective, prospective, case control, cohort, or other population-based study designs, provided the population sample is of sufficient size to demonstrate statistical significance. The study should address a well developed hypothesis that is conceptually sound and specific for prostate cancer. The statistical expertise of the study team should be clearly described and evident in the study plan. It is expected that investigators will demonstrate appropriate access to the population(s) needed for the study.

Research proposed under the Population-Based Research Award may include the following areas:
- Biomarkers
- Predictors of response to therapy
- Disease aggressiveness
- Epidemiology
- Genomics (germline or somatic)
- Health disparity
- Molecular genetics
- Risk prediction

Interesting features of the PCRP Population-Based Research Award include: open to investigators at or above the level of Assistant Professor (or equivalent); research involving human subject use is permitted under this funding opportunity, but is restricted to studies without clinical studies. Maximum funding is $600,000 in direct costs plus appropriate indirect costs, for a period of performance of up to four (4) years.

4) The PCRP Prostate Cancer Training Award supports predoctoral or postdoctoral training opportunities focused on prostate cancer research or patient care for individuals in the early stages of their careers. The trainee will be considered the Principal Investigator (PI) and author of the proposal. These awards primarily provide salary support for the PI and require the active involvement of a mentor who is an established prostate cancer researcher, as evidenced by a demonstrated record of funding and publications in prostate cancer research. The focus of these awards is on the PI, the mentor, and the training program and environment.

Applications for the PCRP Prostate Cancer Training Award are encouraged but not required to address at least one of the aforementioned PCRP overarching challenges.

Interesting features of the PCRP Prostate Cancer Training Award also include:

Eligibility:

Applicants must meet the eligibility requirements for one of the following categories:

1. Predoctoral Ph.D. and M.D./Ph.D. PIs
- Must be graduate students enrolled full-time in an accredited doctoral program; and
- Must have successfully completed comprehensive examinations or otherwise met predissertation requirements by October 1, 2010.

2. Postdoctoral Ph.D. PIs
- Must have successfully defended a doctoral thesis by October 1, 2010; and
- Must have 3 years or less of postdoctoral fellowship experience by October 1, 2010.

3. Postdoctoral M.D. PIs
- Must hold an M.D. degree;
- Must be able to participate at a minimum of
- 40% level of effort for the performance period of the award; and
- By August 1, 2010:  Must be enrolled in an accredited intern training program; or
- Must be enrolled in an accredited residency or fellowship training program with at least 2 years of training remaining; or
- If not enrolled in an accredited intern, residency, or fellowship training program, must be within 3 years of the last formal training.

Funding:
1. Predoctoral Ph.D. and M.D./Ph.D. PIs
- The maximum period of performance is 3 years.
- The maximum allowable funding for the entire period of performance is $92,500 in direct costs.
2. Postdoctoral Ph.D. and M.D. PIs
- The maximum period of performance is 2 years.
- The maximum allowable funding for the entire period of performance is $115,000 in direct costs.

Award Mechanism Deadlines:

- Pre-Application (Letter of Intent) through http://cdmrp.org required and due: May 5, 2010; 5:00 p.m. Eastern Time.
- Application through http://www.grants.gov due May 26, 2010, 11:59 p.m. Eastern Time.
- The Prostate Cancer Training Award and the Physician Research Training Award applications only also require, in addition to the completed Grants.gov application, the submission of three (3) Confidential Letters of Interest submitted by the individuals designated during the pre-application process, due by 11:59 p.m. Eastern Time on May 26, 2010. Please refer to the respective Program Announcements for additional details.

For more information, please visit the Congressionally Directed Medical Research Programs website: http://cdmrp.army.mil.