The NAVREF "In Case You Missed It (ICYMIT)" is where you can find updates and announcements from NAVREF and stakeholders alike. Refer to this page if you want more in depth information on topics found in your weekly email briefs.
The Prostate Cancer Foundation (PCF) & Pfizer, Inc. PCF-Pfizer Global Challenge Awards Request for Proposals (RFP) September 26, 2019
The Prostate Cancer Foundation (PCF) and Pfizer, Inc. are proud to announce the PCF-Pfizer Global Challenge Awards, a competitive, peer-reviewed Investigator Sponsored Research (ISR) grants program. Approximately $2 million USD is allocated to this research grants program focused on investigating talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in prostate cancer. Through this funding mechanism, PCF and Pfizer will support approximately three (3) innovative clinical investigations or clinical trial correlative research studies surrounding the use of talazoparib in prostate cancer. Applications will be peer-reviewed by an independent review panel led by PCF, composed of expert academic researchers in order to select the most impactful studies for funding. The amount of each award will be determined based on the external review panel’s evaluation of each project.
View and Download RFP
Geographic Scope: Investigators from institutions in all countries and geographic regions are eligible to apply. Team Eligibility Criteria: Teams must be composed of at least three (3) investigators from non-profit academic research centers, including one young investigator. Applicants (PI) must have a medical or postdoctoral degree (MD, PhD, or equivalent). The young investigator may hold the title of Postdoctoral Fellow, Instructor, Research Associate, Assistant Professor, or equivalent and should be within six-years following completion of a professional degree (MD, DO, PhD, MD-PhD, DSc, ScD, DDM, DDS, DMD, MBBS, or equivalent) or subsequent mentored academic or clinical training program. Both early career and experienced investigators are encouraged to apply, and consideration will be given to all proposals meeting the selection criteria. Area of Research Focus: The intent of this RFP is to invite investigators from around the world to submit innovative proposals for clinical investigations with correlative research for talazoparib in prostate cancer. Research proposals in the following topic areas are preferred:
General Guidance to All Proposals: Please include a plan for increasing diversity in clinical study enrollment. All studies should include comprehensive translational oncology analyses, including correlation of outcomes with DNA Damage Repair (DDR) gene mutation status. For combination with non-Pfizer assets, applicants may simultaneously apply for drug-only from other companies. Monetary Range of Grant Awards:
Key Dates:
How to Apply: Please go to www.cybergrants.com/pfizer/loi and sign in. The Letter of Intent (LOI) will be accepted via the online application. First-time users should click “REGISTER NOW.” Select the following Competitive Grant Program Name: 2019 Oncology G - PCF-Pfizer Global Challenge Awards. Complete all required sections of the online application. See Appendix A in the RFP for additional details. If you encounter any technical difficulties with the website, please click the ‘Technical Questions’ link at the bottom of the page. Applicant Notification: All applicants will be notified via email by the dates noted above. Applicants may be asked for additional clarification during the review period. For ‘Letter of Intent’ requirements, please refer to the RFP. Questions: If you have questions regarding this RFP, please direct them in writing to the Grant Officer, Jacqueline Waldrop (Jacqueline.Waldrop@pfizer.com), with the subject line “PCF-Pfizer Global Challenge Awards” To view ‘Frequently Asked Questions’ regarding the Competitive Grant Program, please click here.
We look forward to receiving your application.
Sincerely, Howard _____________________________________________________ Howard R. Soule, PhD Executive Vice President Chief Science Officer Prostate Cancer Foundation P: 310.570.4596 1250 Fourth Street, Santa Monica, CA 90401 hsoule@pcf.org | www.pcf.org _____________________________________________
Curing Together.
The FY19 Defense Appropriation provides $15 million (M) to the Department of Defense Combat Readiness – Medical Research Program (CRRP) to support military-relevant advanced technology and therapeutic research related to forward-deployable solutions that can promptly address life-threatening injuries, medical threats, and treatments for Service members in current and future battlefield settings. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Broad Agency Announcement/Funding Opportunity is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).
The Congressional language for the CRRP encompasses research that would enable the Warfighter to better respond to serious injury, as well as solutions to mitigate the long-term effects of battlefield trauma. FY19 CRRP Broad Agency Announcement and General Submission Instructions for the following award mechanism are posted on the Grants.gov website.
FY19 CRRP will solicit research applications addressing at least one of the Focus Areas described below. The Focus Areas broadly describe current needs to ensure readiness for delivering front-line care in combat situations, and for delivering medical damage control capability, assets, and life-saving interventions to address the emerging needs of the Warfighter and Service medics during prolonged and en route care in austere and combat environments, including the acute and early management of combat-related trauma at the point of injury.
Applications submitted to the FY19 CRRP must address at least one of the following four Focus Areas:
o Hemorrhage and resuscitation (i.e., airway management, control of bleeding, sedation, etc.)
o Acute pain
o Multi-casualty events when delayed evacuation exceeds available capability and/or capacity, in order to extend provider capabilities
o Non-compressible torso hemorrhage
o Alternatives to optimize logistics and administration of blood products to the Warfighter
o Environmental exposures
o Onset of infection, including sepsis
o Physiological status (heart rate, blood pressure, respiration), stress monitoring tools
o Neurological injury
o Point-of-care imaging
Additional concurrent research approaches that address mitigation of long-term physical and psychological complications that occur from poor management of trauma pain and trauma care, as well as treatments for sepsis and new therapies for multidrug-resistant pathogens, including applications to sepsis, wound care, and injuries incurred outside the battlefield are encouraged, but not required.
https://cdmrp.army.mil/funding/crrp
Rapid Development and Translational Research Award – Letter of Intent due October 23, 2019
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.orgprior to the pre-application deadline. All applications must conform to the final Broad Agency Announcement and General Submission Instructions available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when Broad Agency Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the CRRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
Point of Contact:
CDMRP Help Desk
301-682-5507 help@eBrap.org
As you may recall, NAVREF has been in contact with NIH over the past several months discussing the NIH rules and regulations related to using NIH funds to pay salaries for VA-paid employees. In April 2019 the VA Office of Research and Development hosted a stakeholder meeting in Washington, DC to address the administration of extramural awards at VA Medical Centers. Key stakeholders included Associate Chiefs of Staff for Research at VA Medical Centers, Executive Directors at VA-affiliated Non-Profit Corporations (NPCs), representatives from academic affiliates, the Association of American Medical Colleges, NAVREF, and the National Institutes of Health Office of Policy for Extramural Research Administration (OPERA).
We are pleased to tell you that we have made a small but significant step forward. NIH OPERA has recently agreed that NPCs can reimburse the VA for certain categories of VA employees. There are other issues that still need to be addressed in the future, but for now we wanted to disseminate this good news to NAVREF members and provide understandable guidance and templates for necessary documentation. You should be advised that this is not a carte blanche for paying VA employees with NIH grant funds, but a set of exceptions that must be well documented to justify reimbursement of salaries under specific conditions.
Attached you will find the following documents related to Exception #1:
We are very pleased to share this favorable outcome of NAVREF’s advocacy efforts! We will have the opportunity to discuss this guidance as a group at the NAVREF Annual Meeting (don’t forget to register!).
NAVREF plans to continue our discussions with NIH and will address issues related to IPAs and the 40-hour work-week going forward. We will keep you posted as events unfold.
NAVREF welcomes input from members on this topic. If you have questions or need further information, please contact the NAVREF national office.
Included Documents/Handouts:
The FY19 Defense Appropriation provides $10 million (M) to the Department of Defense Chronic Pain Management Research Program (CPMRP) to support research of exceptional scientific merit with the potential to make a significant impact on improving the health and quality of life of Service members, Veterans, and all Americans living with chronic pain. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).
FY19 CPMRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.
Per the FY19 CPMRP Congressional appropriation, chronic pain is defined as a pain that occurs on at least half the days for six months or more, and which can be caused by issues including, but not limited to: combat- and training-related physical or mental stress and trauma, migraines and chronic headaches, traumatic brain injury, arthritis, muscular-skeletal conditions, neurological disease, tick and vector-borne disease, other insect-transmitted or tropical disease, and cancer. The CPMRP seeks to support and promote innovative, high-impact research to prevent the development and improve the management of chronic pain, with specific emphasis on the utilization and implementation of non-opioid therapies or non-addictive complementary methods. Applications from investigators within the military Services and applications involving multidisciplinary collaborations among academia, industry, the military Services, the U.S. Department of Veterans Affairs (VA), and other Federal Government agencies are highly encouraged.
https://cdmrp.army.mil/funding/cpmrp
Investigator-Initiated Research Award – Preproposal due September 13, 2019
Independent investigators at all academic levels (or equivalent)
· Supports research that will make an original and important contribution to the field of research or patient care in the Focus Area of Chronification of Pain.
· Multidisciplinary collaborations and innovative approaches are encouraged.
· Clinical trials are not allowed.
· Pre-application submission is required; application submission is by invitation only.
· The maximum allowable funding for the entire period of performance is $900,000 for direct costs.
· Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
· The maximum period of performance is 4 years.
Translational Research Award – Preproposal due September 13, 2019
· Supports translational research that will accelerate the movement of efficacious, evidence-based ideas into clinical applications.
· Research must address one or both of the Focus Areas of Implementation Science and Comparative Effectiveness.
· Studies to develop novel pharmacological therapies or non-pharmacological approaches that consist entirely of a clinical trial will not be funded.
· Effectiveness-implementation hybrid studies that incorporate biopsychosocial models of assessment are encouraged.
· The maximum allowable funding for the entire period of performance is $1,400,000 for direct costs.
· The maximum period of performance is 4 years
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the CPMRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
The FY19 Defense Appropriation provides $12 million (M) to the Department of Defense Reconstructive Transplant Research Program (RTRP) to support research projects that specifically address needs in the field of vascularized composite allotransplantation (VCA). As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).
The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY19 RTRP Program Announcement and General Application Instructions for the Qualitative Research Award mechanism are anticipated to be posted on the Grants.gov website in August 2019. Pre-application and application deadlines will be available when the Program Announcement is released. This pre-announcement should not be construed as an obligation by the government.
Focus Area: To meet the intent of the FY19 RTRP Qualitative Research Award mechanism, applicants must address at least one of the FY19 RTRP Qualitative Research Award Focus Areas listed below:
https://cdmrp.army.mil/pubs/press/2019/19rtrppreann_qra
Qualitative Research Award
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcement and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural Funding Opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
Submission deadlines are not available until the Program Announcement is released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the RTRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
The FY19 Defense Appropriation provides $125 million (M) to the Department of Defense Psychology Health/Traumatic Brain Injury Research Program (PH/TBIRP) to support critical psychological health (PH) - and traumatic brain injury (TBI)-related research and development efforts to benefit Service members, Veterans, and other beneficiaries of the military health system. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The U.S. Army Medical Research and Materiel Command (USAMRMC) Congressionally Directed Medical Research Programs (CDMRP) provides execution management support for DHA research program areas, including the Joint Program Committee-8/Clinical and Rehabilitative Medicine Research Program (JPC-8/CRMRP). The managing agent for this Program Announcement is the CDMRP with strategic oversight from the JPC-8/CRMRP.
The JPC-8/CRMRP seeks to implement long-term strategies to develop knowledge and materiel products to reconstruct, rehabilitate, and provide definitive care for injured Service members. The ultimate goal is to return Service members to duty and improve their quality of life. FY19 PH/TBIRP Complex TBI Rehabilitation Research (CTRR) Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on Grants.gov.
https://cdmrp.army.mil/funding/phtbi
CTRR – Clinical Research Award (CTRR-CRA) – Preproposal due September 10, 2019
CTRR – Clinical Trial Award (CTRR-CTA) – Preproposal due September 10, 2019
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcement and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
Subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the PH/TBIRP, or other CDMRP-administered programs, please visit the CDMRP (https://cdmrp.army.mil).
The Congressional language for the CRRP encompasses research that would enable the Warfighter to better respond to serious injury, as well as solutions to mitigate the long-term effects of battlefield trauma. The CRRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY19 CRRP Broad Agency Announcement and General Submission Instructions for the following award mechanism are anticipated to be posted on the Grants.gov website in August 2019. Pre-application and application deadlines will be available when the Broad Agency Announcement is released. This pre-announcement should not be construed as an obligation by the Government.
https://cdmrp.army.mil/pubs/press/2019/19crrppreann
Rapid Development and Translational Research Award
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.orgprior to the pre-application deadline. All applications must conform to the final Broad Agency Announcement and General Submission Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
Submission deadlines are not available until the Broad Agency Announcement is released. For email notification when Broad Agency Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the CRRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
The FY19 Defense Appropriation provides $125 million (M) to the Department of Defense Psychological Health and Traumatic Brain Injury Research Program (PHTBIRP) to support specific Defense Health Agency (DHA) J9 Research and Development Directorate program areas, including Joint Program Committee-5/Military Operational Medicine Research Program (JPC-5/MOMRP). As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the DHA J9 Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcement/Funding Opportunity is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).
The FY19 PHTBIRP Program Announcement and General Application Instructions for the following award mechanism are posted on the Grants.gov website.
Prevention Research to Reduce Sexual Assault and/or Understand Adjustment Disorders (PSAAD) – Letter of Intent Due September 19, 2019
Investigators at all academic levels are eligible to be names as a Principal Investigator on the application.
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the PHTBIRP or other CDMRP-administered and supported programs, please visit the CDMRP website (https://cdmrp.army.mil).
The FY19 Defense Appropriation provides $10 million (M) to the Department of Defense Chronic Pain Management Research Program (CPMRP) to support research of exceptional scientific merit with the potential to make a significant impact on improving the health and quality of life of Service members, Veterans, and all Americans living with chronic pain. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).The CPMRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY19 CPMRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in July 2019. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the government.
For FY19, the CPMRP Focus Areas will be required. Each award mechanism (listed below) will require at least one of the FY19 CPMRP Focus Areas as indicated in the table.
Award Mechanism
FY19 Focus Area
Investigator-Initiated Research Award
“Chronification” of Pain (i.e., the acute-to-chronic pain transition)
Translational Research Award
Comparative Effectiveness
Implementation Science (evidence-based, efficacious interventions to manage chronic pain)
https://cdmrp.army.mil/pubs/press/2019/19cpmrppreann
Investigators at or above the level of Assistant Professor (or equivalent)
· Emphasis on innovative and impactful research
· Applications must include preliminary and/or published data or clinical observations that originated from the research team that support the rationale for the proposed study.
· Should be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.
· Multidisciplinary collaborations are encouraged.
· Maximum funding of $900,000 for direct costs (plus indirect costs)
· Maximum period of performance is 4 years
· Supports acceleration of evidence-based ideas and research into clinical applications (e.g., healthcare products, technologies, practice guidelines).
· Applications must include preliminary and/or published data collected by the research team that support the rationale for the proposed study.
· Effectiveness-implementation hybrid type 2 and type 3 studies are encouraged.
· Projects may include studies using prospective human subject enrollment or retrospective data analysis; limited clinical studies are allowed.
· Animal studies are not allowed.
· Maximum funding of $1,400,000 for direct costs (plus indirect costs)
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the CPMRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
The FY19 Defense Appropriation provides $10 million (M) to the Department of Defense (DoD) Melanoma Research Program (MRP)to support innovative, high-impact melanoma research. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).
FY19 MRP Program Announcements and General Application Instructions for the following award mechanism is posted on the Grants.gov website.
The FY19 MRP Focus Areas are listed below:
The MRP challenges the research community to redefine the concept of prevention and has issued a FY19 MRP Challenge Statement that should be considered when responding to the FY19 MRP Focus Areas and funding opportunities.
https://cdmrp.army.mil/funding/mrp
Concept Award – Letter of Intent due October 2, 2019
Investigators at or above postdoctoral fellow (or equivalent)
· Supports the exploration of highly innovative, untested, potentially groundbreaking concepts in melanoma.
· Emphasis is on Innovation.
· Preliminary data is strongly discouraged.
· Blinded review.
· The maximum allowable funding for the entire period of performance is $75,000 in direct costs.
· The maximum period of performance is 1 year.
A pre-application (letter of intent or pre-proposal) is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the MRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
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