Funding Wizard

The OCRP Investigator-Initiated Research Award is intended to support high-impact research that addresses a critical need and has the potential to make an important contribution to ovarian cancer or patient/survivor care. Research projects may focus on any phase of research, from basic laboratory research through translational research, excluding clinical trials. The application must demonstrate logical reasoning and a sound scientific rationale established through a critical review and analysis of the literature for the application to be competitive. Applications must include preliminary data that are relevant to ovarian cancer and support the proposed research project. These data may be unpublished or from the published literature.

Initially created in FY09, the OCRP Ovarian Cancer Academy Award mechanism is a unique, interactive virtual academy providing intensive mentoring, national networking, collaborations, and a peer group for junior faculty. The overarching goal of the Ovarian Cancer Academy (OCA) is to develop successful, highly productive ovarian cancer researchers in a collaborative research and career development environment.The OCA is a virtual career development and research training platform that consists of Early-Career Investigators (ECIs), their Designated Mentors from different institutions, and an Academy Dean and Assistant Dean. The OCRP Ovarian Cancer Academy – Early-Career Investigator Award is not a traditional career development award; the ECI is expected to participate in monthly webinars and annual workshops and to communicate and collaborate with other members of the Academy (other ECIs, Mentors, Dean, Assistant Dean) as well as with the advocacy community. Since its inception, the Academy’s ECIs have presented at and chaired sessions for ovarian cancer-specific symposia and served on symposia review committees. They have also served as peer reviewers for the Department of Defense (DOD) OCRP and other funding agencies.

The OCRP Pilot Award supports the exploration of innovative concepts or theories in ovarian cancer that could ultimately lead to critical discoveries or major advancements that will drive the field forward. The proposed research must demonstrate a clear focus on ovarian cancer (e.g., using tissues, cell lines, datasets, or appropriate animal models), and serve as a catalyst to expand or modify current thinking about and/or approaches in ovarian cancer.

The FY23 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Potential impact is not whether a therapy is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients.Applicants not investigating a therapeutic but proposing a clinical trial to optimize established ALS clinical care must submit under a lower total direct cost Clinical Care Tier. Examples of efforts that will be supported under this tier include but are not limited to optimization of respiratory care strategies, improvements to approved devices and assistive technologies, specific symptom management strategies, and/or telemedicine strategies. The capacity for near-term impact on patient care is an important component of the Clinical Care Tier.

The intent of the FY23 ALSRP Clinical Biomarker Development Award is to support the development of biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Biomarker development projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. A description of the biomarker category and intended context of use (COU) in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.Examples of studies appropriate for submission to the FY23 ALSRP Clinical Biomarker Development Award include, but are not limited to:Using patient-based resources to link biosamples to rigorous molecular data.Collecting and analyzing biospecimens as a companion to an anticipated/ongoing clinical trial.Correlation of clinical trial-related data (e.g., biosample analysis, imaging, or epidemiological data) with clinical outcomes or responses to therapies.Strategies to better measure disease progression, including the development or use of digital biomarkers.

The FY23 ALSRP Therapeutic Idea Award supports the initial exploration of innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or treatment discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. All research projects should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality. Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.Projects that focus primarily on investigating the pathophysiology of ALS, without consideration of therapeutic development, are not within the scope of this funding opportunity.Innovation and impact are important aspects of the Therapeutic Idea Award. Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS. Research with high impact should pioneer transformative research that could lay the foundation for a new direction in the field of ALS therapeutic development. Projects should strive to produce the type and amount of data needed to apply for the next stage, i.e., ALSRP Therapeutic Development Award or other mechanisms for ALS therapeutic advancement.The Therapeutic Idea Award encourages applications submitted by early-career investigators as well as applications that include meaningful and productive collaborations between/among investigators. Applicants from outside the ALS research field are encouraged to include collaborators with the necessary relevant expertise, such as experience with ALS model systems, endpoints, and pathogenic findings.Biomarker Option: The FY23 ALSRP Therapeutic Idea Award Biomarker Option encourages applicants to include the development of biomarker(s) in parallel with the main proposed Therapeutic Idea Award research effort. Additional funding, as described in Section II.D.5, Funding Restrictions, is being offered for the co-development of biomarkers that will enhance the drug development process. Efforts may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression apart from consideration of the therapeutic development process will not be supported.To apply for this option, applicants must clearly describe the marker and its potential to improve the effectiveness of the therapeutic development process. For further description, see Section II.D.2.b.ii, Full Application Submission Components, Attachment 9, Biomarker Statement.

The FY23 ALSRP Therapeutic Development Award supports research ranging from preclinical validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology. Examples of activities that will be supported by this award include:Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds.Validation of pilot efficacy studies (such as from an ALSRP Therapeutic Idea Award), including the use of additional ALS model systems and/or replicating preliminary data with more time points or additional doses.IND-enabling studies to include: compound characterization; absorption, distribution, metabolism, and excretion (ADME) studies; studies on formulation and stability leading to Good Manufacturing Practice production methods; dose/response and toxicology studies in relevant model systems.Applications supported by this award must begin with lead compounds in hand and must include preliminary data relevant to the phase of development, such as:Proof of identity and puritySelectivity for the intended target over closely related targetsAvailability of primary and secondary in vitro bioactivity assays for optimization or structure–activity relationship studiesAvailability of clear efficacy data in at least one relevant preclinical Amyotrophic Lateral Sclerosis (ALS) model, with adequate power and methods.Applicants seeking support for basic research focused on ALS drug discovery are encouraged to apply for the FY23 ALSRP Therapeutic Idea Award (Funding Opportunity Number HT9425-23-ALSRP-TIA), which does not require preliminary data (https://cdmrp.health.mil/funding/alsrp).

The Era of Hope Scholar Award supports individuals early in their careers who have demonstrated significant potential to effect meaningful change in breast cancer. These individuals should be exceptionally talented scientists who have shown that they are the “best and brightest” in their field(s) through extraordinary creativity, vision, innovation, and productivity. They should have demonstrated experience in forming effective partnerships and collaborations and must exhibit strong potential for future leadership in breast cancer research.As the intent of the Era of Hope Scholar Award is to recognize creative and innovative individuals rather than projects, the central features of the award are the demonstrated ability of the individual named as the Principal Investigator (PI) in the application to go beyond conventional thinking in their field and the innovative contribution that the PI can make toward ending breast cancer. The application should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention.Experience in breast cancer research is not required; however, the application must focus on breast cancer, and the PI must commit a minimum of 25% level of time and effort during the period of performance to conduct breast cancer research under this award. Individuals from other disciplines who apply novel concepts to breast cancer are encouraged to submit.The PI is encouraged to assemble a research team that will provide the necessary expertise and collaborative efforts toward accomplishing the research goals. The PI’s research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they may not be employees of any organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.

The Innovator Award supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field including, but not limited to, breast cancer. The Innovator Award will provide these individuals with the funding and freedom to pursue their most novel, visionary, high-risk ideas that could accelerate progress to ending breast cancer.Because the intent of the Innovator Award mechanism is to recognize these remarkably creative and innovative visionary individuals, rather than projects, the central feature of the award is the innovative contribution that the Principal Investigator (PI) can make toward ending breast cancer. The PI should have a record of challenging the status quo, shifting paradigms by changing a field of research or approach to patient care, exhibiting high levels of creativity, and demonstrating promise for continued innovation in future work. These rare individuals will be able to articulate a vision for ending breast cancer that challenges current dogma and demonstrates an ability to look beyond tradition and convention. The PI is also expected to be established in their field and have demonstrated success at forming and leading effective partnerships and collaborations. To further the development of innovative individuals and spark the generation of novel ideas, applications are required to incorporate the mentoring of promising junior investigators. Experience in breast cancer research is not required; however, the application must focus on breast cancer, and the PI must commit a minimum of 15% level of time and effort during the period of performance to conduct breast cancer research under this award. Individuals from other disciplines who will apply novel concepts to breast cancer are encouraged to submit. The PI is expected to assemble a research team that will provide the necessary expertise and collaborative efforts toward accomplishing the research goals. The PI’s research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at a risk for, breast cancer.

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a fundamentally new approach that is significantly more effective than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget. The current program announcement discusses the Breakthrough Award Level 3. Funding Levels 1, 2, and 4 are available under other program announcements (HT9425-23-BCRP-BTA12 for Levels 1 and 2 and HT9425-23-BCRP-BTA4 for Level 4). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcements before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level. The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s) and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human, phase 1/1b) may be appropriate. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Level 3 applications unless they are clearly addressing distinct research questions. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most or all of the experiments and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project. Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project.