Opportunity Information: Apply for RFA AI 11 023
Apply for RFA AI 11 023
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Next Generation PrEP II (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Mar 30, 2011 and posted on Mar 30, 2011.
- Applicants must submit their applications by Sep 8, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- Eligible applicants include: Small businesses Special district governments State governments Native American tribal governments (Federally recognized) County governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
Next Generation PrEP II (R01) (Funding Opportunity Number RFA-AI-11-023) was a National Institutes of Health grant opportunity focused on building the early-stage scientific and preclinical foundation for the next wave of HIV pre-exposure prophylaxis (PrEP) products. Rather than funding late-stage clinical trials, this announcement emphasized the upstream work needed to expand PrEP beyond first-generation approaches by creating a disciplined, evidence-driven process for selecting, testing, and advancing the most promising drug candidates. The overall intent was to strengthen the pipeline so that future PrEP options could be identified more efficiently, evaluated more rigorously before human testing, and better tailored to preventing HIV at the actual biological sites where transmission occurs.
A major goal of the opportunity was to develop a rational discovery and development pipeline for PrEP candidates. This included two complementary paths: (1) discovery and early development of new molecular entities (NMEs), meaning novel compounds not previously used clinically, and (2) systematic identification and repurposing of existing antiretroviral drugs that might be suitable for prevention, including drugs already approved for HIV treatment as well as investigational antiretrovirals that were not approved but might have human clinical data. The rationale here is practical: some existing agents may have known safety profiles, manufacturing pathways, or partial clinical datasets that could shorten timelines, while novel agents might offer improved potency, durability, resistance profiles, or tissue penetration needed for prevention.
The announcement placed strong emphasis on creating clear, preclinical decision frameworks that move the field away from ad hoc candidate selection. Applicants were expected to develop preclinical algorithms with explicit go/no-go criteria for prioritizing which PrEP candidates should advance toward clinical evaluation. In practice, this means defining measurable benchmarks and thresholds (for example, potency, toxicity margins, resistance barriers, tissue distribution, dosing feasibility, or formulation suitability) and using them consistently to rank candidates. The intent was to reduce wasted effort on compounds that look promising on paper but fail predictable hurdles later, and to encourage standardized, transparent criteria that other groups can replicate and refine.
Another central feature was pharmacokinetic/pharmacodynamic (PK/PD) modeling aimed specifically at mucosal sites of HIV transmission. Because most HIV acquisition occurs across mucosal tissues (such as the genital or rectal mucosa), the opportunity highlighted the need to understand how candidate PrEP agents distribute into these tissues, how long protective concentrations persist, and what exposure levels correlate with meaningful protection. By supporting PK/PD models that connect drug levels to antiviral effect at these key anatomical sites, the program sought to improve the ability to predict real-world prevention performance and to inform dosing strategies, routes of administration, and formulation choices before entering costly human studies.
The opportunity also supported proof-of-concept safety and efficacy work in relevant animal models. These studies were intended to provide early evidence that a candidate can be delivered safely and can reduce or prevent infection in controlled preclinical challenge settings. This focus on animal model testing served as a bridge between laboratory measurements (like in vitro potency and tissue concentration data) and the decision to move a candidate into early human testing. The overall expectation was that applicants would integrate these animal data with PK/PD modeling and the go/no-go algorithm so that advancement decisions were backed by multiple converging lines of evidence rather than a single positive result.
From an administrative standpoint, this was an NIH discretionary funding opportunity using the R01 grant mechanism, categorized under health research, and associated with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). The program did not require cost sharing or matching. The opportunity was posted and created on March 30, 2011, with an original and current closing date of September 8, 2011, and an archive date of October 9, 2011. NIH estimated total funding at $3.2 million, with an award ceiling of $300,000.
Eligibility was broad and included many types of organizations: small businesses; for-profit entities (other than small businesses); nonprofits with or without 501(c)(3) status; private and public institutions of higher education; state, county, city/township, and special district governments; public housing authorities/Indian housing authorities; independent school districts; and tribal governments and tribal organizations. The announcement explicitly included additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, foreign organizations, and regional organizations. It also allowed foreign components of U.S. organizations, signaling that NIH was open to international expertise and resources when relevant to the preclinical development goals.
In practical terms, a strong application under this announcement would have proposed an integrated, end-to-end preclinical plan: a structured process to discover or select candidate PrEP agents; a transparent, metrics-driven screening and prioritization scheme with defined stop/go thresholds; rigorous PK/PD work focused on mucosal protection; and animal studies that test both safety and prevention efficacy in ways that meaningfully inform whether the candidate is ready for clinical evaluation. The unifying theme across all aims was to professionalize and standardize preclinical PrEP development so that the field could produce better candidates faster and with fewer late-stage failures.
Frequently Asked Questions (FAQs)
What is the Next Generation PrEP II (R01) funding opportunity?
Next Generation PrEP II (R01) (Funding Opportunity Number RFA-AI-11-023) was a National Institutes of Health (NIH) grant opportunity focused on building the early-stage scientific and preclinical foundation for the next wave of HIV pre-exposure prophylaxis (PrEP) products.
What was the main purpose of this grant program?
The main purpose was to strengthen the PrEP development pipeline by supporting a disciplined, evidence-driven process to identify, test, and advance the most promising PrEP drug candidates before human testing.
Did this opportunity fund late-stage clinical trials in humans?
No. The announcement emphasized upstream, preclinical work rather than late-stage clinical trials. The goal was to improve selection and evaluation of candidates prior to entering costly human studies.
What kinds of PrEP candidates were supported under this opportunity?
The opportunity supported two complementary paths: (1) discovery and early development of new molecular entities (NMEs), and (2) systematic identification and repurposing of existing antiretroviral drugs that might be suitable for prevention, including approved HIV treatment drugs and investigational antiretrovirals that may have human clinical data.
What is meant by "new molecular entities (NMEs)" in this context?
NMEs were described as novel compounds not previously used clinically. The program supported early discovery and development efforts for these new candidates as potential next-generation PrEP options.
Why did the program include repurposing existing antiretrovirals?
The rationale was practical: existing agents may have known safety profiles, manufacturing pathways, or partial clinical datasets that could shorten timelines. At the same time, novel agents might offer improvements such as potency, durability, resistance profiles, or tissue penetration needed for prevention.
What does "rational discovery and development pipeline" mean for applicants?
Applicants were expected to propose a structured, systematic pipeline for PrEP candidate discovery/selection and early development, rather than relying on ad hoc or informal selection practices.
What were "go/no-go" criteria and why were they emphasized?
The announcement strongly emphasized preclinical decision frameworks with explicit go/no-go criteria. This meant defining measurable benchmarks and thresholds (for example, potency, toxicity margins, resistance barriers, tissue distribution, dosing feasibility, or formulation suitability) and using them consistently to prioritize which candidates should advance toward clinical evaluation.
What was the intended benefit of using explicit preclinical decision algorithms?
The intent was to reduce wasted effort on candidates that fail predictable hurdles later and to encourage standardized, transparent criteria that can be replicated and refined by other groups.
What role did pharmacokinetic/pharmacodynamic (PK/PD) modeling play in this opportunity?
PK/PD modeling was a central feature, aimed specifically at mucosal sites of HIV transmission. The program emphasized understanding how candidates distribute into mucosal tissues, how long protective concentrations persist, and what exposure levels correlate with meaningful protection.
Why did the opportunity focus on mucosal sites?
Because most HIV acquisition occurs across mucosal tissues (such as genital or rectal mucosa), the opportunity highlighted the need to link drug exposure and antiviral effect at these biological sites where transmission occurs.
How were applicants expected to use PK/PD information?
Applicants were expected to use PK/PD models to better predict prevention performance and to inform dosing strategies, routes of administration, and formulation choices before moving into expensive human studies.
Were animal studies supported under this funding opportunity?
Yes. The opportunity supported proof-of-concept safety and efficacy work in relevant animal models to provide early evidence that a candidate can be delivered safely and can reduce or prevent infection in controlled preclinical challenge settings.
How were animal model results supposed to fit into the overall approach?
Animal data were expected to be integrated with PK/PD modeling and the go/no-go decision algorithm, so that advancement decisions were backed by multiple converging lines of evidence rather than a single positive result.
What grant mechanism was used for this program?
This was an NIH discretionary funding opportunity using the R01 grant mechanism and categorized under health research.
What CFDA numbers were associated with this opportunity?
The opportunity was associated with CFDA 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Was cost sharing or matching required?
No. The program did not require cost sharing or matching.
When was the opportunity posted and when did it close?
The opportunity was posted and created on March 30, 2011. The original and current closing date was September 8, 2011. The archive date was October 9, 2011.
What was the estimated total funding and the award ceiling?
NIH estimated total funding at $3.2 million, and the award ceiling was $300,000.
Who was eligible to apply?
Eligibility was broad and included: small businesses; for-profit entities (other than small businesses); nonprofits with or without 501(c)(3) status; private and public institutions of higher education; state, county, city/township, and special district governments; public housing authorities/Indian housing authorities; independent school districts; and tribal governments and tribal organizations.
Were specific institution types explicitly included?
Yes. The announcement explicitly included Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, foreign organizations, and regional organizations.
Were foreign organizations or international participation allowed?
Yes. Foreign organizations and regional organizations were eligible, and foreign components of U.S. organizations were also allowed, indicating openness to international expertise and resources relevant to preclinical development goals.
What would a strong application have looked like under this announcement?
A strong application would have proposed an integrated end-to-end preclinical plan that included: (1) a structured process to discover or select candidate PrEP agents, (2) a transparent, metrics-driven screening and prioritization scheme with defined stop/go thresholds, (3) rigorous PK/PD work focused on mucosal protection, and (4) animal studies evaluating safety and prevention efficacy in ways that inform readiness for clinical evaluation.
What was the unifying theme across the supported activities?
The unifying theme was to professionalize and standardize preclinical PrEP development so the field could produce better candidates faster and with fewer late-stage failures.
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