Opportunity Information: Apply for RFA AI 10 012
Apply for RFA AI 10 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Next Generation PrEP (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 May 27, 2010 and posted on May 27, 2010.
- Applicants must submit their applications by Nov 2, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,800,000.00 to eligible and selected applicants.
- Eligible applicants include: Special district governments Small businesses County governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Independent school districts City or township governments.
- 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.
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Opportunity Summary:
The Next Generation PrEP (R01) funding opportunity (RFA-AI-10-012) is a National Institutes of Health initiative led by the National Institute of Allergy and Infectious Diseases (NIAID) focused on pushing HIV pre-exposure prophylaxis (PrEP) beyond first-generation approaches. The central aim is to build the basic and preclinical foundation needed to create second and later generations of PrEP agents, with an emphasis on making the early-stage development pathway more rigorous, more predictive, and more efficient. Rather than funding late-stage clinical trials, the opportunity is designed to strengthen the upstream science and decision-making that determines which candidates are truly promising enough to move forward into human testing.
A major component of the FOA is the expectation that applicants will help establish a rational discovery and selection pipeline for next-generation PrEP products. This includes two complementary tracks: (1) discovery and evaluation of New Molecular Entities (NMEs), meaning entirely new compounds or drug candidates that could function as preventive agents, and (2) systematic identification and repurposing assessment of existing antiretroviral drugs. Importantly, the FOA recognizes that useful PrEP candidates may include drugs already approved for HIV treatment as well as antiretrovirals that are not approved but have substantial clinical data, potentially allowing prevention development to benefit from prior investments in safety, dosing, and pharmacology.
Another core objective is to create preclinical algorithms with clear decision thresholds, including explicit go/no-go criteria. In practice, this means NIAID is looking for projects that do more than generate data; they should produce structured, reproducible frameworks for evaluating candidate PrEP agents and prioritizing them for advancement. The intent is to reduce uncertainty and inconsistency in how candidates are selected, and to improve the likelihood that agents entering clinical evaluation have strong, evidence-based justification. This also implies attention to comparative evaluation, standardization of endpoints where feasible, and the integration of multiple data types (for example, activity, exposure, safety signals, and durability).
The FOA also highlights pharmacokinetic and pharmacodynamic (PK/PD) modeling as a priority, specifically models that assess protective effects at mucosal sites relevant to HIV transmission. This reflects the reality that HIV acquisition often occurs at mucosal surfaces, and that systemic drug levels alone may not adequately predict prevention effectiveness. Applications responsive to this area would be expected to address how drug concentration, distribution, persistence, and biological activity at these key anatomical sites relate to protection, potentially producing models that can inform dose selection, formulation strategies (such as long-acting approaches), and interpretation of animal or ex vivo findings.
In addition, the opportunity calls for proof-of-concept safety and efficacy studies in animal models. The emphasis here is on preclinical demonstration that a candidate is both plausibly safe and capable of preventing infection under controlled experimental conditions, serving as a bridge between mechanistic or exploratory work and eventual clinical testing. While the FOA summary does not prescribe specific animal systems, the clear takeaway is that NIAID wants credible, well-justified in vivo evidence that helps validate candidates and refine the criteria for moving them into human studies.
Funding is provided through the NIH Research Project Grant (R01) mechanism. NIAID indicated an intention to commit approximately $1.8 million in fiscal year 2011 to support an anticipated 3 to 5 awards, contingent on fund availability and the receipt of sufficiently strong applications. The opportunity was posted May 27, 2010, with an original and current closing date of November 2, 2010, and an archive date of December 3, 2010. The program falls under CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research), and it does not require cost sharing or matching.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include state and local governments (such as county and city/township governments), special district governments, independent school districts, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, excluding higher education institutions in that category), for-profit organizations (including small businesses and other for-profits), public housing authorities/Indian housing authorities, and a range of tribal entities (including federally recognized tribal governments and other tribal organizations). The FOA also explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and foreign (non-U.S.) entities. This breadth signals an intent to draw on diverse scientific, translational, and organizational capabilities to accelerate the early pipeline for future PrEP options.
Overall, the Next Generation PrEP (R01) FOA is best understood as a targeted effort to improve the front end of PrEP innovation: discovering or selecting better candidates, applying disciplined preclinical decision rules, connecting drug exposure and biological effect at the most relevant transmission sites through PK/PD modeling, and validating safety and prevention potential in animal proof-of-concept studies. The desired end product is not just a set of individual candidate evaluations, but a more dependable and data-driven preclinical pathway that can feed stronger candidates into clinical development for HIV prevention.
Frequently Asked Questions (FAQs): Next Generation PrEP (R01) - RFA-AI-10-012
What is the Next Generation PrEP (R01) funding opportunity?
The Next Generation PrEP (R01) funding opportunity (RFA-AI-10-012) is a National Institutes of Health (NIH) initiative led by the National Institute of Allergy and Infectious Diseases (NIAID). It focuses on advancing HIV pre-exposure prophylaxis (PrEP) beyond first-generation approaches by strengthening the basic and preclinical foundation needed to create second and later generations of PrEP agents.
What is the main goal of this FOA?
The central goal is to make early-stage PrEP development more rigorous, more predictive, and more efficient. The FOA is designed to improve upstream science and the decision-making process used to determine which PrEP candidates are promising enough to advance toward human testing.
Does this opportunity fund late-stage clinical trials?
No. The opportunity is specifically aimed at strengthening early-stage and preclinical work and the frameworks used to evaluate and prioritize candidates. It is not intended to fund late-stage clinical trials.
What kind of pipeline does NIAID expect applicants to establish?
NIAID expects applicants to help establish a rational discovery and selection pipeline for next-generation PrEP products. The pipeline should support disciplined, evidence-based evaluation and prioritization of candidate agents before they move forward into human testing.
What are the two complementary tracks emphasized in the FOA?
The FOA highlights two complementary tracks: (1) discovery and evaluation of New Molecular Entities (NMEs), meaning entirely new compounds or drug candidates that could function as preventive agents, and (2) systematic identification and repurposing assessment of existing antiretroviral drugs.
What are New Molecular Entities (NMEs) in the context of this FOA?
NMEs are entirely new compounds or drug candidates proposed as potential HIV preventive agents. The FOA encourages discovery and evaluation activities that can support identifying promising new PrEP candidates.
Can existing antiretroviral drugs be considered for PrEP under this FOA?
Yes. The FOA explicitly recognizes that useful PrEP candidates may include drugs already approved for HIV treatment, as well as antiretrovirals that are not approved but have substantial clinical data.
Why does the FOA emphasize repurposing of existing antiretroviral drugs?
The FOA notes that repurposing can allow prevention development to benefit from prior investments in safety, dosing, and pharmacology. This may help accelerate or strengthen early-stage decision-making for prevention candidates.
What does the FOA mean by "preclinical algorithms" and "decision thresholds"?
The FOA calls for structured, reproducible frameworks for evaluating candidate PrEP agents. These frameworks should include clear decision thresholds and explicit go/no-go criteria so that candidate selection is more consistent, evidence-based, and predictive of success in later stages.
What are "go/no-go criteria" in this program?
Go/no-go criteria are explicit, pre-defined standards used to decide whether a PrEP candidate should advance (go) or should not advance (no-go) to the next stage of development. The FOA emphasizes using these criteria to reduce uncertainty and inconsistency in selecting candidates.
Is generating data alone sufficient to be responsive to the FOA?
The FOA indicates that projects should do more than generate data. They should also produce structured, reproducible evaluation frameworks (including decision rules and thresholds) that help prioritize candidates for advancement.
Does the FOA encourage comparative evaluation and standardization?
Yes. The FOA implies attention to comparative evaluation and standardization of endpoints where feasible, along with integration of multiple data types to support disciplined candidate selection.
What types of data does the FOA expect to be integrated for decision-making?
The FOA references integration of multiple data types, including activity, exposure, safety signals, and durability. The intent is to support more evidence-based and reproducible prioritization of PrEP candidates.
Why is pharmacokinetic and pharmacodynamic (PK/PD) modeling a priority in this FOA?
PK/PD modeling is prioritized because HIV acquisition often occurs at mucosal surfaces, and systemic drug levels alone may not adequately predict prevention effectiveness. The FOA emphasizes models that assess protective effects at mucosal sites relevant to HIV transmission.
What does the FOA mean by "mucosal sites relevant to HIV transmission"?
The FOA refers to anatomical sites where HIV transmission commonly occurs at mucosal surfaces. It highlights the importance of understanding drug concentration, distribution, persistence, and biological activity at these sites when evaluating potential PrEP agents.
How can PK/PD modeling support PrEP candidate development under this FOA?
The FOA suggests PK/PD models can help link exposure and biological effect at relevant sites to protection. These models may inform dose selection, formulation strategies (including long-acting approaches), and interpretation of animal or ex vivo findings.
Does the FOA include animal studies?
Yes. The FOA calls for proof-of-concept safety and efficacy studies in animal models, emphasizing credible in vivo evidence that a candidate is plausibly safe and capable of preventing infection under controlled experimental conditions.
Are specific animal models required?
The summary does not prescribe specific animal systems. The key expectation is that proposed animal studies are credible, well-justified, and supportive of validating candidates and refining criteria for advancement to human studies.
What is meant by "proof-of-concept" safety and efficacy in this FOA?
In this FOA, proof-of-concept refers to preclinical demonstrations that a candidate shows plausible safety and prevention potential in animal studies, serving as a bridge between exploratory or mechanistic work and eventual clinical testing.
What funding mechanism is used for this opportunity?
Funding is provided through the NIH Research Project Grant (R01) mechanism.
How much funding did NIAID intend to commit, and how many awards were anticipated?
NIAID indicated an intention to commit approximately $1.8 million in fiscal year 2011 to support an anticipated 3 to 5 awards, contingent on fund availability and receipt of sufficiently strong applications.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
When was the opportunity posted, and what were the key dates?
The opportunity was posted on May 27, 2010. The original and current closing date was November 2, 2010, and the archive date was December 3, 2010.
What are the CFDA numbers associated with this program?
The program falls under CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Who is eligible to apply?
Eligibility is broad and includes many domestic and non-domestic organizations. Eligible applicants include state and local governments, special district governments, independent school districts, public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status, excluding higher education institutions in that category), and for-profit organizations (including small businesses and other for-profits).
Are tribal entities eligible to apply?
Yes. The FOA includes tribal entities such as federally recognized tribal governments and other tribal organizations, and also references Tribally Controlled Colleges and Universities (TCCUs).
Are organizations like HBCUs and Hispanic-serving institutions eligible?
Yes. The FOA explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based and community-based organizations eligible?
Yes. The FOA explicitly includes faith-based and community-based organizations among eligible applicants.
Are U.S. territories, possessions, and foreign entities eligible?
Yes. The FOA includes U.S. territories or possessions and foreign (non-U.S.) entities among eligible applicants, and also lists eligible federal agencies and regional organizations.
What is the overall focus of the FOA in one sentence?
The FOA is focused on improving the front end of PrEP innovation by discovering or selecting better candidates, applying disciplined preclinical decision rules, linking exposure and effect at transmission-relevant mucosal sites through PK/PD modeling, and validating safety and prevention potential through animal proof-of-concept studies.
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