Amyotrophic Lateral Sclerosis Research Program

Transcription

1 Amyotrophic Lateral Sclerosis Research Program The mission of the ALSRP is to fund innovative pre-clinical research to develop new treatments for ALS for the benefit of Service members, Veterans, and the general public. The following mechanisms are planned for release: Award Eligibility Key Elements Funding ($) Therapeutic Development Award Independent investigators at all academic levels Supports post-discovery, preclinical development of therapeutics for ALS Preliminary data, including identify and purity of an identified bioactive compound(s), are required Types of efforts that will be supported include: Standard award maximum funding of $1,000,000 for direct costs (plus indirect costs) o o o o Confirmation of candidate therapeutics obtained from screening or by other means Validation of early pilot studies in multiple model systems and/or replicating preliminary data with more time points or additional doses Optimization of potency and pharmacology, studies of formulation, stability and production methods based on Good Manufacturing Practices Investigational New Drug (IND)-enabling studies Clinical trials are not allowed Does not support screening or development of screens or models Standard award with Option: If applying for the Therapeutic Relevance Option, maximum funding of up to $1,250,000 for direct costs (plus indirect costs) Maximum period of performance is 2 years The following option, with additional funding for qualified applications, is being offered: Therapeutic Relevance Option supports development of markers that will improve the drug development process in parallel with the main therapeutic advancement effort Therapeutic Idea Award Independent investigators at all academic levels Supports new ideas aimed at drug or treatment discovery that are still in the early stages of development Preliminary data are not required Types of efforts that will be supported include: Maximum funding of $500,000 for direct costs (plus indirect costs)

2 o o o Exploitation of pathways known to be relevant to ALS for the purpose of improving treatment and/or advancing a novel treatment modality Development, modification, and use of high-throughput screens and novel model systems to define or assess lead compounds Projects that focus primarily on investigating the pathophysiology of ALS are outside of the scope of this announcement Maximum period of performance is 2 years Bone Marrow Failure Research Program Award Eligibility Key Elements Funding ($) Idea Development Award Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent) and 10 years or more from a terminal degree or Early-Career Investigators: Investigators at the level of Assistant Professor, Instructor, or Assistant Research Professor (or equivalent) and less than 10 years from a terminal degree (excluding time spent in medical residency or on family medical leave) at the time of application submission deadline are eligible Preproposal is required; full application submission is by invitation only. Supports innovative ideas and high-impact approaches based on scientifically sound evidence to move toward the vision to understand and cure bone marrow failure (BMF). Strong BMF research team. May include relevant preliminary data Clinical trials will not be supported. Maximum funding of $325,000 in direct costs (plus indirect costs) Period of performance not to exceed 2 years

3 Multiple Sclerosis Research Program Award Eligibility Focus Area Key Elements Funding ($) Exploration - Hypothesis Development Award Investigator-Initiated Research Award Independent investigators at or above the level of Assistant Professor (or equivalent) Independent investigators at or above the level of Assistant Professor (or equivalent) All applications submitted in this funding opportunity must address at least one of the following Focus Areas: (1) Obstacles to Remyelination and/or Obstacles to Axonal Protection in MS (2) Correlates of Disease Activity and Progression in MS (3) Biology and Measurements of MS Symptoms All applications submitted in this funding opportunity must address at least one of the following Focus Areas: (1) Obstacles to Remyelination and/or Obstacles to Axonal Protection in MS (2) Correlates of Disease Activity and Progression in MS Pre-application submission is required; application submission is by invitation only. Supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the MS research field. Preliminary data not required. Clinical trials not allowed. Pre-application submission is required; application submission is by invitation only. Supports highly rigorous, high-impact research with the potential to make an important contribution to MS research and/or patient care. Preliminary data required. Clinical trials not allowed. Maximum funding of $150,000 for direct costs (plus indirect costs) Maximum period of performance is 2 years Maximum funding of $600,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years

4 Ovarian Cancer Research program The mission of the OCRP is to support patient-centered research to prevent, detect, treat, and cure ovarian cancer to enhance the health and well-being of Service members, Veterans, retirees, their family members, and all women impacted by this disease. Award Eligibility Key Elements Funding ($) Clinical Development Award Omics Consortium Development Award Must be an independent investigator at or above the level of Assistant Professor (or equivalent). Must be an independent investigator at the Associate Professor level or above (or equivalent). Supports the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life. Near-term impact is expected. Preclinical studies in animals are not allowed. Small-scale clinical trials (Phase 0, Phase 1, Pilot), studies enriching a clinical trial, and projects related to or associated with ongoing or completed clinical trials are allowed. Preliminary data are required. Optional Nested Early-Career Investigator (ECI): Applications proposing clinical trials and having an ECI that meets the criteria outlined in the Program Announcement/Funding Opportunity will qualify for a higher level of funding. Submission of a Letter of Intent is required prior to full application submission. Supports a multi-institutional research effort conducted by leading cancer researchers and advocates that Maximum funding of $600,000 for direct costs (plus indirect costs) With ECI option the maximum funding is $800,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years Maximum funding of $400,000 for direct costs (plus indirect costs)

5 focuses on the origin of ovarian cancer, with an emphasis on risk stratification, screening and early detection. Funds support assembling consortium members and laying the groundwork for the research project, including proof of concept. Ovarian cancer advocate(s) are required on the research team. Funded applicants will be eligible to compete for the consortium award, which will support the execution of the full research project and is anticipated to be offered in FY20, pending availability of funds. Submission of a Letter of Intent is required prior to full application submission. Period of performance not to exceed 2 years Investigator-Initiated Research Award Must be an independent investigator at or above the level of Assistant Professor (or equivalent). Supports meritorious basic and clinically oriented research in ovarian cancer. Impact is an important review criterion. Preliminary data are required. Clinical trials are not allowed. Pre-application is required; application is by invitation only. Maximum funding of $450,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years Ovarian Cancer Academy Award - Early-Career Investigator Must be within 3 years of his/her last postdoctoral research position (Ph.D.) or clinical fellowship (M.D.), or equivalent as of the full application submission Supports the addition of new ECIs to the unique, interactive virtual academy that provides intensive mentoring, Maximum funding of $725,000 for direct costs (plus indirect costs)

6 deadline. A letter attesting to eligibility is required. national networking, and a peer group for junior faculty. ECIs whose ability to commit to conducting ovarian cancer research is limited by lack of resources or other overwhelming obstacles are encouraged to apply. A Designated Mentor who is an experienced ovarian cancer researcher with ovarian cancer funding is required. A Designated Mentor may only mentor one ECI candidate. The Designated Mentor is not required to be at the same institution as the ECI. Preliminary data are required. Clinical trials are allowed. Submission of a Letter of Intent is required prior to full application submission. Maximum period of performance is 4 years Pilot Award Investigators at or above the postdoctoral level (or equivalent). Supports innovative, high-risk/highreward research that could ultimately lead to critical discoveries or major advancements that will drive the field of ovarian cancer research forward. Innovation and Impact are important review criteria. Goal is to develop preliminary data; thus, preliminary data are not required, but are allowed. Clinical trials are not allowed. Maximum funding of $250,000 for direct costs (plus indirect costs) Maximum period of performance is 2 years

7 Pre-application is required and blinded; application submission is by invitation only. Peer Reviewed Medical Research Program (PRMRP) All applications submitted to the PRMRP must address at least one of the FY18 PRMRP Congressionally directed topic areas. As of the release date of this preannouncement, the FY18 PRMRP Topic Areas have not been finalized. The potential FY18 PRMRP Topic Areas can be found at Award Eligibility Key Elements Funding Clinical Trial Award Assistant Professor level or above (or equivalent) Preproposal submission is required; application submission is by invitation only. Supports the rapid implementation of clinical trials of novel interventions with the potential to have a significant impact on patient care in the topic area(s) of interest. Proposed projects may range from small proof-of-concept trials through large-scale, definitive trials. Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Funding limit not defined; requested funding must be appropriate for the scope of work proposed Maximum period of performance is 4 years

8 Administration by the PRMRP application submission deadline. Discovery Award Focused Program Award Postdoctoral fellow or clinical fellow (or equivalent) and above Full Professor level or above (or equivalent) Supports the exploration of a highly innovative new concept or untested theory. Not intended to support the logical progression of an already established line of questioning. Clinical trials will not be funded. Reviewers will be blinded to the identity of the Principal Investigator (PI), collaborators, and their organization(s). Preproposal submission is required; application submission is by invitation only. Supports a synergistic, multidisciplinary research program of at least four distinct but complementary projects addressing an overarching goal. Projects should work together to answer critical questions, resolve differing hypotheses, and translate laboratory findings to clinical applications. Projects may range from exploratory/hypothesisdeveloping through small-scale clinical trials that together will Maximum of $200,000 for direct costs (plus indirect costs) Maximum period of performance is 18 months Maximum of $10 million for total costs (includes direct and indirect costs) Maximum period of performance is 4 years

9 Investigator-Initiated Research Award Technology/ Therapeutic Development Award Assistant Professor level or above (or equivalent) Assistant Professor level or above (or equivalent) address the overarching goal/question. Research team of highly qualified, multidisciplinary project leaders should be led by a PI with demonstrated success in directing large, focused projects. Preproposal submission is required; application submission is by invitation only. Supports research that will make an original and important contribution to the field of research or patient care in the topic area(s) of interest. Partnering PI Option available. Clinical trials will not be funded. Supports the translation of promising preclinical findings into clinical applications for prevention, detection, diagnosis, treatment, or quality of life. Product-oriented (e.g., device, drug, clinical guidelines). The product(s) to be developed may be a tangible item such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product. Clinical trials will not be funded. Preproposal submission is required; application submission is by invitation only. Maximum of $1.2 million for direct costs (plus indirect costs) Maximum of $1.5 million for direct costs (plus indirect costs) for applications including a Partnering PI Option Maximum period of performance is 3 years Maximum of $3.0 million for direct costs (plus indirect costs) Maximum period of performance is 3 years

10 Parkinson's Research Program Award Eligibility Key elements Funding Investigator-Initiated Research Award Independent investigators at or above the level of Assistant Professor (or equivalent). Supports highly rigorous, multi-disciplinary, high-impact research projects that have the potential to make an important contribution to Parkinson s disease research and/or patient care. Potential impact of research may be near-term or longterm, but it must be significant and go beyond an incremental advancement. Preliminary data to support feasibility are required. Partnering PI Option: Provides a higher level of funding to support synergistic partnerships between two or three independent investigators collaborating on a single application. Principal Investigators (PIs) are expected to demonstrate within the application the synergistic components that will significantly advance the project, such that the research outcomes could not otherwise be accomplished through the independent efforts of a single PI. Individual PI: Maximum funding of $1.5 million (M) in total costs Maximum period of performance is 3 years Partnering PI Option: Maximum funding of $2M in total costs Maximum period of performance is 3 years Applications to this award mechanism must address at least one of the Focus Areas noted below: Genetic stratification of quantifiable, suspected environmental factors on the risk of Parkinson s disease Biological mechanism of impact of exercise on neurodegeneration in Parkinson s disease.

11 Early Investigator Research Award Investigator must be a postdoctoral or clinical fellow, instructor, or assistant professor within 5 years of advanced degree or residency training (or equivalent). Verification of eligibility criteria must be provided in an Eligibility Statement signed by an appropriate institutional official and the PI. Supports early-career investigators who have innovative, high-impact ideas or new technologies applicable to Parkinson s disease research and/or patient care. PIs must have a designated mentor who is an experienced Parkinson s disease researcher. The application must include an individualized, Parkinson s disease-focused researcher development plan. Preliminary data are not required. Clinical trials are not allowed. Applications to this award mechanism must address the following Focus Area: Mechanism of cognitive and psychiatric symptoms of Parkinson s disease. Maximum funding of $340,000 in total costs. Maximum period of performance is 2 years. Lung Cancer Research Program Applications submitted to the FY18 LCRP must address at least one of the eight Areas of Emphasis listed below: Identify, develop, or optimize noninvasive or minimally invasive tools to improve the detection of the initial stages of lung cancer, such as, but not limited to, optimizing strategies for management of indeterminate nodules. Identify, develop, and/or build upon already existing tools for screening or early detection of lung cancer. Screening may include, but is not limited to, imaging modalities, biomarkers, genetics/genomics/proteomics/metabolomics/transcriptomics, and assessment of risk factors. Understand the molecular mechanisms of initiation and progression to clinically significant lung cancer. Identify innovative strategies for prevention and treatment of lung cancer. Understand predictive markers to identify responders and nonresponders. Understand mechanisms of resistance to treatment (primary and secondary). Understand contributors to lung cancer development other than tobacco. Identify innovative strategies for lung cancer care delivery (clinical management/ surveillance/symptom management).

12 Award Eligibility Key elements Funding Concept Award Investigators at all academic levels Supports highly innovative, untested, potentially groundbreaking concepts in lung cancer Emphasis on innovation Clinical trials not allowed Preliminary data discouraged Military relevance strongly encouraged Career Development Award Idea Development Award Principal Investigator: Independent investigators at the level of Assistant Professor, Instructor, or equivalent; must be within 5 years of first faculty appointment Mentor: At or above the level of Associate Professor (or equivalent); have a proven publication and funding record in lung cancer research Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent); or New Investigators: Investigators that meet the following criteria at the application submission deadline date: Have not previously received a LCRP Idea Development Award or Early Investigator Synergistic Idea Award Supports early-career, independent researchers to conduct research under mentorship of an experienced lung cancer researcher Clinical trials not allowed Preliminary data not required Military relevance strongly encouraged Supports new ideas in the early stages of development representing innovative, highrisk/high-gain research Emphasis on innovation and impact New Investigator category supports applicants early in their faculty appointments or in the process of developing independent research careers Clinical trials not allowed Maximum funding of $100,000 in direct costs (plus indirect costs) Period of performance should not exceed 1 year Maximum funding of $250,000 in direct costs (plus indirect costs) Period of performance should not exceed 2 years Maximum funding of $350,000 in direct costs (plus indirect costs) Period of performance should not exceed 2 years

13 Investigator-Initiated Translational Research Award Are within 10 years of first faculty appointment (or equivalent) Independent investigators at or above the level of Assistant Professor (or equivalent) Preliminary data required, but may be from outside of lung cancer Military relevance strongly encouraged Supports translational research that will develop promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following: Maximum funding of $400,000 in direct costs (plus indirect costs) Period of performance should not exceed 2 years o o o Studies advancing /translating in vitro and/or animal studies to applications with human samples/cohorts. Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug submission. Correlative studies that are associated with an ongoing or completed clinical trial and projects that develop endpoints for clinical trials.

14 Translational Research Partnership Award Investigators at or above the level of Assistant Professor (or equivalent) Preliminary data required, but may be from outside of lung cancer Military relevance strongly encouraged Supports partnerships between clinicians and laboratory scientists that accelerate ideas in lung cancer into clinical applications o One partner is strongly encouraged to be from either a Military Treatment Facility or a VA medical center Maximum funding of $900,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years Non-Traditional Partnerships are encouraged Small-scale clinical trials allowed Preliminary data required, but may be from outside of lung cancer Military relevance strongly encouraged Breast Cancer Research Program Applications submitted to the FY18 BCRP must address one or more of the following overarching challenges: Prevent breast cancer (primary prevention) Identify determinants of breast cancer initiation, risk, or susceptibility Distinguish deadly from non-deadly breast cancers

15 Conquer the problems of overdiagnosis and overtreatment Identify what drives breast cancer growth; determine how to stop it Identify why some breast cancers become metastatic Determine why/how breast cancer cells lie dormant for years and then re-emerge; determine how to prevent lethal recurrence Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival Eliminate the mortality associated with metastatic breast cancer Award Eligibility Key Elements Funding Breakthrough Award Breakthrough Fellowship Award Investigators at all academic levels (or equivalent) Senior postdoctoral fellows who do not meet the eligibility requirements of the Breakthrough Fellowship Award are encouraged to apply under Funding Levels 1 and 2 Successfully completed the requirements for a doctoral or medical degree, and Been in the laboratory or clinical research setting in which the proposed research is to be performed for no Supports promising research that has the potential to lead to or make breakthroughs in breast cancer. Potential impact of the research may be near-term or long-term, but it must be significant and go beyond an incremental advancement. Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to collaborate on a single application. Four different funding levels, based on the scope of research, are available. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget. Further information in regards to funding levels can be found here Supports exceptionally talented, "best and brightest" recent doctoral or medical graduates in pursuit of promising research that has the potential to lead to or make breakthroughs in breast cancer. Potential impact of the research may be near-term or long-term, but it must be significant and go beyond an incremental advancement. Individualized researcher development plan and mentorship should prepare the PI for an independent career at the forefront of breast cancer research or patient care. The PI is not required to have previous experience in breast cancer research. Further information about Funding for each level can be found here /18bcrppreann Maximum funding of $300,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years

16 Era of Hope Scholar Award Innovator Award Distinguished Investigator Award more than 2 years, and A total of less than 4 years experience in a postdoctoral fellowship or mentored clinical research training program (excludes any clinical residency or fellowship training) Independent, nonmentored investigators within 6 years of their last training position (e.g., postdoctoral fellowship, medical residency, clinical fellowship) as of the application submission deadline Associate Professor or above (or equivalent) Assistant Professor or above (or equivalent) and more than 6 years beyond the PI s last training position as of Submission of a Letter of Intent is required prior to full application submission. Supports exceptionally talented, creative early-career scientists who have demonstrated that they are the best and brightest in their fields. PIs should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention. PIs must exhibit strong potential for leadership in breast cancer. PIs are required to include breast cancer advocates on their research team. Supports visionary individuals who have demonstrated creativity, innovative work, and leadership in any field. Provides opportunity to pursue novel, visionary, high-risk ideas that will accelerate progress toward ending breast cancer. PIs must include breast cancer advocates on their research team. Preproposal is required; application submission is by invitation only. Seeks new paradigms in breast cancer research by supporting investigators who are established and recognized leaders in their field and who propose a fundamental shift from their track record of research. Does not support continuation of or minor advancement from the PI s published line of research. Maximum funding of $2.5M for direct costs (plus indirect costs) Maximum period of performance is 4 years Maximum funding of $5M for direct costs (plus indirect costs) Maximum period of performance is 4 years Maximum funding of $3M for direct costs (plus indirect costs) Maximum period of performance is 4 years

17 the application submission deadline If the PI is not an established breast cancer researcher, he/she must clearly articulate a motivation and commitment for proposing a conceptual shift in his/her research and must include at least one collaborator with breast cancer expertise. PIs must include two or more breast cancer advocates on their research team. High-risk/high-reward projects pursuing innovative new paradigms are encouraged, but not required. Preproposal is required; application submission is by invitation only. Tick-Borne Disease Research Program Applications submitted to the FY18 TBDRP must address at least one of the following specific Focus Areas in Lyme disease and other tick-borne diseases: Diagnosis o Accurate diagnostics for Lyme disease and co-infections and/or other tick-borne diseases o Biomarkers to identify tick-borne diseases or their products in humans o Diagnostic biomarkers for Lyme disease that distinguish between active infection and previous exposure, and/or monitor response to treatment Pathogenesis o Immunological mechanisms of immune protection for Lyme disease or other tick-borne diseases o Complex biology of Lyme borrelia in the host (beyond in vitro studies), including its survival, evasion of the host immune system, and subversion of the effectiveness of antibiotics o Biomarkers that aid in exploring underlying mechanisms of persistent symptoms associated with Lyme disease Prevention o Identification, validation, and/or improvement of tick-targeted prevention and control interventions o Human vaccines for tick-borne diseases Treatment o Antibiotic combinations and/or therapeutic options for treating acute and persistent illness

18 Award Eligibility Key Elements Funding Investigator-Initiated Research Award Idea Award Independent investigators at or above the level of Associate Professor (or equivalent). Independent investigators at or above the level of Assistant Professor (or equivalent) To fund highly rigorous, highimpact studies that have the potential to make important contributions to Lyme disease and other tick-borne disease research, patient care, and/or quality of life. Applications should articulate both the short and long-term impact of the proposed research, as well as the public health burden of the disease being addressed. Preliminary or published data to support feasibility are required. Promotes any phase of research from basic through translational, including preclinical studies in animal models or human subjects, as well as correlative studies associated with an existing clinical trial to establish proof-of-principle for further development in future studies; however, clinical trials are not allowed. Preproposal is required; application submission is by invitation only. To fund conceptually innovative, high-risk/potentially high-reward research in the early stages of development that could lead to Maximum funding of $650K for direct costs (plus indirect costs). Maximum period of performance is 3 years. Maximum funding of $250K for direct costs (plus indirect costs).

19 Career Development Award Principal Investigator (PI): Investigators within 10 years of completing terminal degree (excluding time in medical residency or on family medical leave) at the time of application submission, working to become independent investigators who exhibit a strong desire to pursue careers in tick-borne disease research; time spent as a postdoctoral fellow is not excluded Mentor: Independent investigators at or above the level of Associate Professor (or equivalent); must have a proven publication and funding critical discoveries or major advancements that will accelerate progress in improving outcomes for individuals affected by Lyme disease and/or other tick-borne illnesses. Applications should articulate the qualities that make the research innovative (not merely an incremental advance), as well as the public health burden of the disease being addressed. Preliminary data that are relevant to the proposed research project are encouraged, but not required. Clinical trials are not allowed. Preproposal is required; application submission is by invitation only. To fund early-career investigators to conduct impactful research under the mentorship of an experienced tick-borne disease researcher. Career Development Plan is required. Plan should be prepared with appropriate guidance from the Mentor, should clearly articulate a strategy for acquiring the necessary skills, competence, and expertise to establish a career at the forefront of tick-borne disease research, and should outline how the PI will gain Maximum period of performance is 2 years Maximum funding of $300K for direct costs (plus indirect costs). Maximum period of performance is 3 years.

20 record in tick-borne disease research The PI and Mentor do not need to be located at the same organization. experience in tick-borne disease research. PI s institution must demonstrate a commitment to the PI through a minimum of 30% protected time for tick-borne disease research. Preliminary or published data to support feasibility are required. Clinical trials are not allowed Peer Reviewed Orthopaedic Research Program (PRORP) The mission of the PRORP is to address the most significant gaps in care for the leading burden of injury for facilitating return-to-duty by funding innovative, highimpact, clinically relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries sustained during combat and combat-related activities. Prolonged Field Care (PFC) has been identified as the number one capability gap across the Army. PFC includes field trauma care extended beyond doctrinal timelines until the patient can be transported from the point of injury to an appropriate level of care. In order to address this gap and prepare the orthopaedic field for the next conflict or mass event, the FY18 PRORP has identified several orthopaedic areas of focus for funding that will support patient care closer to the point of injury and to allow patients to more quickly return to duty/work. The PRORP will solicit research applications that specifically address at least one of the following FY18 Focus Areas: Animal Models - Develop animal models that replicate Prolonged Field Care-related injuries, including ischemia reperfusion injury and compartment syndrome. Device Development - Develop offloading and stability devices (e.g., braces, casting) for ligamentous injuries, small extremity fractures, and /or other nonsevere common battlefield musculoskeletal injuries for immediate return to duty. Wound Infection Evaluate and /or translate promising available clinical interventions in prevention and control of combat extremity wound infections (e.g., for long bone open fractures) to improve their durability to treat Service member injuries as close as possible to the point of injury. Projects that further develop novel wound protectants for this population will also be considered. Treatment Techniques and Outcomes - Develop and /or evaluate optimal non-surgical and /or surgical treatment strategies and intervention delivery parameters (e.g., frequency, intensity, time, and intervention type) to rapidly remediate duty-limiting impairments, functional limitations, or barriers to full

21 duty readiness following orthopedic injuries. Interventions may include, but are not limited to: combination therapies (simultaneous application of multiple treatment modalities), injections, dry needling, manual therapy, therapeutic exercise, or other techniques to return Service members to duty within 72 hours. Surgical Care - Translate early research findings, in any of the below Surgical Care Areas, to humans. o Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines ( Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis Surgical Techniques and Outcomes - Evaluate optimal surgical treatment strategies, tools, and delivery parameters to improve functional outcomes of Service members who have sustained orthopaedic injuries. The proposed research should address at least one topic from the Surgical Care Areas (listed below), and strategies to return the patient to duty and potentially shorten recovery in theater. o Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines ( Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis Rehabilitation Techniques and Outcomes Evaluate optimal rehabilitation treatment strategies, tools, and delivery parameters to improve functional outcomes for immediate return to duty of Service members who have sustained orthopaedic injuries. Acute Pain - Evaluate promising available or emerging clinical interventions to control acute pain (e.g., analgesics, anti-inflammatory agents, nerve blocks) following orthopaedic injuries in the pre-hospital setting. Projects that investigate a pathway to enhance non-physician capabilities to deliver rapid, long lasting, analgesia with minimal cognitive side effects in an austere environment are encouraged. Improved Surgical Interventions - Develop or optimize orthopaedic surgical interventions to support their use in the pre-hospital environment. Tissue Regeneration: o o o Development and preclinical testing of therapies for volumetric muscle loss due to traumatically damaged tissues of the extremities. Develop and /or evaluate regenerative medicine therapies (devices, drugs, biologics, and /or techniques) for traumatically injured tissues of the extremities. Evaluate advanced regenerative medicine therapeutics for restoration of traumatically injured extremity tissues. Award Eligibility Key Elements Funding Applied Research Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications. Pre-application is required; Full application submission is by invitation only. Supports applied research applications focused on advancing optimal treatment and restoration of function for military personnel with Maximum funding of $750,000 for total costs Maximum period of performance is 3 years

22 Clinical Trial Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications. musculoskeletal injuries sustained during combat or combat-related activities. Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation. Clinical trials are not allowed under this award mechanism. Applications must address one the following FY18 PRORP Focus Areas: o Animal Models o Device Development o Wound Infection o Tissue Regeneration Pre-application is required; Full application submission is by invitation only. Supports rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries, or non-battle injuries that significantly impact unit readiness and return-toduty/work rates Funding must support a clinical trial and may not be used for preclinical research studies. Collaboration with military researchers and clinicians is encouraged. Maximum funding of $3 million (M) for direct costs (plus indirect costs) Maximum period of performance is 4 years

23 Clinical Translational Research Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications. Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered. Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date. Applications must address one the following FY18 PRORP Focus Areas: o Surgical Techniques and Outcomes o Rehabilitation Techniques and Outcomes o Acute Pain o Improved Surgical Interventions o Tissue Regeneration Pre-application is required; Full application submission is by invitation only. Supports high-impact and/or emerging research that may or may not be ready for a full scale randomized controlled clinical trial. Funding must support clinical research studies involving humans. Preliminary or published data relevant to the proposed research project are required. Maximum funding of $2M for direct costs (plus indirect costs) Maximum period of performance is 4 years

24 Collaboration with military researchers and clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered. Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date. Applications must address one the following FY18 PRORP Focus Areas: o Treatment Techniques and Outcomes o Wound Infection o Surgical Care o Tissue Regeneration

25 Peer Reviewed Cancer Research Program The FY18 PRCRP Military Relevance Focus Areas are listed below: To address the cancer health needs of both deployed and non-deployed personnel, their dependents, retirees, and Veterans, the FY18 PRCRP seeks to support studies that are responsive to at least one of Military Relevance Focus Areas listed below: Militarily relevant risk factors associated with cancer (e.g., ionizing radiation, chemicals, infectious agents, environmental carcinogens, and stress) Gaps in cancer prevention, screening, early detection, diagnosis, treatment, and/or survivorship that may impact mission readiness and the health and well-being of military members, Veterans, and their beneficiaries and the general public Award Eligibility Key Elements Funding Career Development Award Idea Award with Special Focus Principal Investigator (PI): Independent early-career investigator within 10 years after completion of his/her terminal degree (excluding time spent in residency or on family medical leave) by the time of the application submission deadline Career Guide: Investigators at or above the level of Associate Professor (or equivalent); must have a proven publication and funding record in cancer research Independent investigator with a faculty-level appointment (or equivalent) Letter of Intent is required. An invitation to submit a full application is not required. Supports independent, earlycareer investigators to conduct impactful research with the mentorship of an experienced cancer researcher. Must address at least one of the FY18 PRCRP Topic Areas. Must address at least one of the FY18 PRCRP Military Relevance Focus Areas. Preliminary data are not required. Clinical trials are not allowed. Preproposal required; application submission is by invitation only. Supports innovative, untested, high-risk/potentially high-reward concepts, theories, paradigms, and/or methods in cancer research relevant to Service Maximum funding for the entire period of performance is $360,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years Maximum funding for the entire period of performance is $400,000 for direct costs (plus indirect costs) Maximum period of performance is 2 years

26 Translational Team Science Award At least two and up to three PIs must partner in one overarching correlative or translational research study At least one of the PIs is encouraged to be a military or Department of Veterans Affairs investigator members, their families, and other military beneficiaries. Emphasis on innovation and military relevance/impact. Must address at least one of the FY18 PRCRP Topic Areas. Must address at least one of the FY18 PRCRP Military Relevance Focus Areas. Preliminary data are not required. Clinical trials are not allowed. Preproposal required; application submission is by invitation only. Emphasizes multi-pi, multidisciplinary collaborations. Supports translational studies associated with an ongoing or completed clinical trial and/or translational study that can lead to a future clinical trial or clinical application in cancer research relevant to Service members, their families, and other military beneficiaries. Not intended to support high throughput screenings, sequencing, etc. Must address at least one of the FY18 PRCRP Topic Areas. Must address at least one of the FY18 PRCRP Military Relevance Focus Areas. Preliminary data are required.

27 Gulf War Illness Research Program The following mechanisms are planned for release: Award Eligibility Key Elements Funding Clinical Trial Award Independent investigators at all academic levels Qualitative Research Award Independent investigators at all academic levels Pre-application is required; full application submission is by invitation only. Supports rapid implementation of clinical trials with the potential to have a significant impact on GWI. Proposed projects may range from small proof-of-concept trials through large-scale, definitive trials. Early phase or pilot clinical trials (Phase 0, I, or I/II) do not require preliminary data. Larger, more definitive clinical trials, including expansion of promising pilot trials, must include preliminary data to include safety in a GWI Veteran population. Biorepository Contribution Option supports additional costs associated with submission of samples and data to the GWIRP supported Biorepository Resource Network. Pre-application is required; full application submission is by invitation only. Supports qualitative research on Gulf War (GW) Maximum funding of $825,000 for direct costs; funding requested must be commensurate with the phase and size of trial proposed Maximum period of performance is 3 years If applying for the Biorepository Contribution Option, additional direct costs up to $16,000 associated with contributions of samples and data to the Biorepository Resource Network Maximum funding of 450,000 for direct costs (plus indirect costs) Maximum period of performance is 3 years

28 Investigator-Initiated Focused Research Award Independent investigators at all academic levels Veterans with Gulf War illness (GWI) for the purpose of developing educational materials for Veterans, family members, caregivers, and healthcare providers. Qualitative research is defined as a form of social inquiry that seeks to understand the human experience by focusing on understanding the way that people interpret and make sense of their experiences and the world in which they live. Preliminary data are encouraged. Clinical trials are not allowed. Pre-application is required; full application submission is by invitation only. Supports research from idea generation through preclinical validation under two tiers: o o Discovery Tier: Supports basic research and proofof-concept research; preliminary data are not required. Applied Research Tier: Supports applied research in GWI aimed at diagnosis or therapeutic advancement. Preliminary data from the field of GWI are required. The maximum period of performance and maximum funding varies by tier: o Discovery: $250,000 for direct costs (plus indirect costs) over a maximum of o 2 years. Applied Research: $700,000 for direct costs (plus indirect costs) over a maximum of 3 years If applying for the Biorepository Contribution Option, additional direct costs up to $16,000 associated with the contribution of samples and data to the Biorepository Resource Network

29 Biorepository Contribution Option supports additional costs associated with submission of samples and data to the GWIRP supported Biorepository Resource Network. Clinical trials are not allowed. Prostate Cancer The mission of the PCRP is to fund research that will lead to the elimination of death from prostate cancer and enhance the well-being of Service members, Veterans, and all men experiencing the impact of the disease. Applications submitted to the FY18 PCRP must addresses one or more of the Overarching Challenges (revised for FY18): Develop treatments that improve outcomes for men with lethal prostate cancer Reduce lethal prostate cancer in African Americans, Veterans, and other high-risk populations Define the biology of lethal prostate cancer to reduce death Improve the quality of life for survivors of prostate cancer Award Eligibility Key Elements Funding Preproposal is required; application submission is by invitation only. Impact Award Independent investigators at or above the level of Assistant Professor (or equivalent) Supports high-impact, potentially high-risk studies (including clinical trials) that address a central question or problem in prostate cancer. As such, the primary emphasis of this mechanism is on impact. Maximum funding of $750K for direct costs (plus indirect costs) Maximum period of performance is 3 years

30 The potential impact of the research is expected to be nearterm and must be significant and go beyond an incremental advancement. Proposed projects may include basic, translational, or clinical research, including clinical trials, but must demonstrate clinical relevance. Preliminary data to support feasibility are required. Each Principal Investigator (PI) may submit only one application. Health Disparity Research Award Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent); or New Investigators: Investigators that meet the following criteria at the application submission deadline date: Have the freedom to pursue individual aims without formal mentorship Have not previously received a PCRP Health Disparity Research Supports new ideas for prostate cancer research that have the potential to make an important contribution to reducing and ultimately eliminating disparities in prostate cancer incidence, morbidity, and mortality. Research ideas should be innovative, but primary emphasis will be placed on the potential impact of the proposed work. Preliminary data are encouraged, but not required. Proposed projects may include basic, translational, or clinical research, including clinical trials. New Investigator Option supports applicants early in their faculty appointments or in the Established Investigators: Maximum funding of $750K for direct costs (plus indirect costs). New Investigators: Maximum funding of $450K for direct costs (plus indirect costs). Maximum period of performance is 3 years

31 Award and/or Idea Development Award process of developing independent research careers. Have completed at least 3 years of postdoctoral training or fellowship and are within 10 years after completion of a terminal degree (excluding residency or family medical leave) Physician Research Award At the time of application submission, the PI must be either: In the last year of an accredited medical residency or medical fellowship program; or Within 3 years of having initiated an appointment as Instructor, Assistant Professor, or equivalent Early Investigator Research Award By March 31, 2019 Postdoctoral Ph.D. or M.D. PIs: Must have successfully defended a doctoral thesis or possess an M.D. degree Supports mentored research experience to prepare physicians with clinical duties for careers in prostate cancer research. PIs must demonstrate a commitment to a career at the forefront of prostate cancer research and clinical practice. PIs must have a designated mentor with an established research program in prostate cancer. Institutions must provide at least 40% protection of PI's time for research. Projects that focus on basic research are highly encouraged. Supports research opportunities focused on prostate cancer for individuals in the early stages of their careers. PIs must have a designated mentor who is an experienced prostate cancer researcher. Maximum funding of $750K for direct costs (plus indirect costs) Maximum period of performance is 4 years Maximum of $200K for direct costs (plus indirect costs) Maximum period of performance is 2 years