Opportunity Information: Apply for W81XWH 11 WBPR IIA
Apply for W81XWH 11 WBPR IIA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Whole Blood Pathogen Reduction (WBPR) Investigator Initiated Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Oct 4, 2011 and posted on Oct 4, 2011.
- Applicants must submit their applications by Jan 5, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $3,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The Whole Blood Pathogen Reduction (WBPR) Investigator Initiated Award is a U.S. Department of Defense funding opportunity under the Combat Casualty Care Research Program (CCCRP), sponsored by the Assistant Secretary of Defense for Health Affairs through the Defense Health Program. The program is focused on advancing biotechnology solutions that improve medical protection and treatment, with clear relevance to combat casualty care while also aiming for spillover benefits in civilian healthcare. The application process is administered by the Telemedicine and Advanced Technology Research Center (TATRC) at Fort Detrick, Maryland, while the U.S. Army Medical Research Acquisition Activity (USAMRAA) is the issuing and awarding office and is responsible for negotiating any resulting awards.
At its core, this opportunity targets the development of a pathogen reduction approach for whole blood that can realistically move toward FDA licensure. The DoD’s longer-term objective is an FDA-licensable device or methodology that treats whole blood and still allows that blood to be further processed into pathogen-reduced components, including red blood cells, platelets, and plasma, as well as maintaining the option to transfuse treated whole blood. In the nearer term, the emphasis of this specific announcement is on creating a workable whole-blood treatment methodology and demonstrating the ability to produce FDA-licensable red blood cells derived from that treated whole blood. A major expectation is that the work is not just exploratory science, but development-oriented research that could qualify as advanced development activity within the DoD and lead to a practical, deployable capability.
The technical requirements are defined around making emergency fresh whole blood safer for transfusion using a method that is safe and non-toxic in humans. Applicants are expected to propose a pathogen reduction process that can inactivate a wide spectrum of threats and contaminants relevant to transfusion risk, especially in operational or austere settings where rapid transfusion decisions may be needed. The required performance areas include: inactivation of parasites (examples provided include Babesia, malaria, and Trypanosoma cruzi), inactivation of donor white blood cells (important for reducing complications such as transfusion-associated graft-versus-host disease and other immunologic risks), reduction or inactivation of viral load (examples include hepatitis C, hepatitis B, and HIV), and inactivation of clinically significant bacteria. Beyond killing or reducing pathogens, the program also expects evidence that the resulting blood product remains functional: applicants must demonstrate the viability and suitability of derived red blood cells after treatment and show credible potential that the same general approach could later support development for platelets, plasma, and treated whole blood as transfusion products.
A key feature of this award is the translation milestone built into the end of the project period. By completion, the product is expected to have finished FDA Phase I and Phase II clinical trials, or an equivalent package acceptable under FDA requirements. That signals that proposals should include a regulatory strategy and a development plan that bridges preclinical validation, manufacturing/quality considerations, and clinical evaluation, rather than stopping at laboratory proof-of-concept. The program also emphasizes building sustained collaborations and enduring initiatives, leveraging the capabilities of U.S.-based businesses and academic research institutions to create solutions that can be carried forward beyond the award.
From a funding and administrative standpoint, the opportunity is listed as discretionary research and development support, using cooperative agreement and grant mechanisms. The total estimated funding is $3.5 million, with an award ceiling of $3.5 million and an expected number of awards of one, indicating a single, relatively large project is anticipated. There is no cost-sharing or matching requirement, and eligibility is described as unrestricted (open to any entity type, subject to any additional eligibility clarifications in the full text). The funding opportunity number is W81XWH-11-WBPR-IIA, and it falls under CFDA 12.420 (Military Medical Research and Development). The announcement was posted October 4, 2011, with a closing date of January 5, 2012, and was archived February 4, 2012. Contact for access issues is listed as Mary Rico, Grants Officer.
Frequently Asked Questions (FAQs) - Whole Blood Pathogen Reduction (WBPR) Investigator Initiated Award
What is the Whole Blood Pathogen Reduction (WBPR) Investigator Initiated Award?
The WBPR Investigator Initiated Award is a U.S. Department of Defense (DoD) funding opportunity under the Combat Casualty Care Research Program (CCCRP). It supports development-oriented research aimed at creating a pathogen reduction approach for whole blood that can realistically progress toward FDA licensure, with direct relevance to combat casualty care and potential spillover benefits for civilian healthcare.
Which DoD organizations are involved in this funding opportunity?
The program is sponsored by the Assistant Secretary of Defense for Health Affairs through the Defense Health Program. The application process is administered by the Telemedicine and Advanced Technology Research Center (TATRC) at Fort Detrick, Maryland. The U.S. Army Medical Research Acquisition Activity (USAMRAA) is the issuing and awarding office and is responsible for negotiating any resulting awards.
What is the main goal of this award?
The core goal is to develop a pathogen reduction method for whole blood that can realistically move toward FDA licensure. The longer-term DoD objective is an FDA-licensable device or methodology that treats whole blood and still allows that blood to be further processed into pathogen-reduced components (red blood cells, platelets, and plasma), while also preserving the option to transfuse treated whole blood.
What does the announcement emphasize in the near term?
The near-term emphasis is on creating a workable whole-blood treatment methodology and demonstrating the ability to produce FDA-licensable red blood cells derived from that treated whole blood.
Is this opportunity focused on basic research or development?
It is development-oriented. The award expects work that goes beyond exploratory science and could qualify as advanced development activity within the DoD, leading toward a practical and deployable capability.
What type of blood product is the program trying to make safer?
The technical requirements focus on making emergency fresh whole blood safer for transfusion, particularly for operational or austere settings where rapid transfusion decisions may be needed.
What safety expectations apply to the pathogen reduction method?
The approach is expected to be safe and non-toxic in humans while reducing transfusion risks by inactivating a broad spectrum of threats and contaminants relevant to whole-blood transfusion.
What kinds of pathogens or threats must the proposed technology address?
Applicants are expected to propose a process capable of inactivating a wide spectrum of threats relevant to transfusion risk. The required performance areas include parasites (examples provided: Babesia, malaria, Trypanosoma cruzi), donor white blood cells, viral load (examples provided: hepatitis C, hepatitis B, HIV), and clinically significant bacteria.
Does the program require inactivation of parasites?
Yes. Inactivation of parasites is a required performance area, with examples including Babesia, malaria, and Trypanosoma cruzi.
Does the program require inactivation of donor white blood cells?
Yes. Inactivation of donor white blood cells is explicitly required and is tied to reducing complications such as transfusion-associated graft-versus-host disease and other immunologic risks.
Does the program require viral reduction or inactivation?
Yes. Reduction or inactivation of viral load is required, with examples including hepatitis C, hepatitis B, and HIV.
Does the program require inactivation of bacteria?
Yes. Inactivation of clinically significant bacteria is a required performance area.
Is pathogen inactivation alone enough to meet the program expectations?
No. In addition to reducing or inactivating pathogens, applicants are expected to provide evidence that the resulting blood product remains functional, including demonstrating the viability and suitability of derived red blood cells after treatment.
What blood components must be considered in the overall vision of the program?
While the near-term emphasis is on treated whole blood and FDA-licensable red blood cells derived from that treated whole blood, the broader program objective includes maintaining the ability to produce pathogen-reduced components such as red blood cells, platelets, and plasma, and also keeping open the option to transfuse treated whole blood.
What evidence is expected regarding red blood cells (RBCs) after treatment?
The opportunity expects applicants to demonstrate the viability and suitability of derived red blood cells after treatment and to show the ability to produce FDA-licensable red blood cells derived from treated whole blood.
Does the award expect potential applicability to platelets and plasma?
Yes. Applicants must show credible potential that the same general approach could later support development for platelets, plasma, and treated whole blood as transfusion products.
Are clinical trial milestones required by the end of the project?
Yes. A translation milestone is built into the end of the project period. By completion, the product is expected to have finished FDA Phase I and Phase II clinical trials, or an equivalent package acceptable under FDA requirements.
What does the FDA milestone imply about what the proposal should include?
It implies proposals should include a regulatory strategy and a development plan that bridges preclinical validation, manufacturing and quality considerations, and clinical evaluation, rather than stopping at laboratory proof-of-concept.
Is collaboration encouraged under this program?
Yes. The program emphasizes building sustained collaborations and enduring initiatives, leveraging the capabilities of U.S.-based businesses and academic research institutions to create solutions that can be carried forward beyond the award.
What is the total estimated funding and the maximum award amount?
The total estimated funding is $3.5 million, and the award ceiling is also $3.5 million.
How many awards are expected to be made?
The expected number of awards is one, indicating a single, relatively large project is anticipated.
What funding mechanisms are used for this opportunity?
The opportunity is listed as discretionary research and development support and uses cooperative agreement and grant mechanisms.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility clarifications in the full text of the announcement.
What is the funding opportunity number and CFDA number?
The funding opportunity number is W81XWH-11-WBPR-IIA. It falls under CFDA 12.420 (Military Medical Research and Development).
When was the announcement posted and when did it close?
The announcement was posted on October 4, 2011, and the closing date was January 5, 2012.
Is this opportunity still active?
No. The opportunity was archived on February 4, 2012.
Who should be contacted for access issues related to the opportunity?
The contact listed for access issues is Mary Rico, Grants Officer.
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