METAvivor Announces the 2020 Research Award

BY METAvivor Board of Directors

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METAvivor Research Award

About METAvivor’s Research Program

METAvivor Research and Support Inc. is a charitable organization whose mission includes funding basic, translational, and clinical research with the goal of eradicating death due to metastatic breast cancer by relegating it to a chronic manageable disease. METAvivor’s research program was established in 2009 to specifically fund research focused on treating established breast cancer metastases to improve outcomes for stage IV metastatic breast cancer patients. This does not currently include Quality of Life studies, although we acknowledge these studies are important. METAvivor is led by volunteers, many of whom are living with metastatic breast cancer, and patient review is a critical part of our research program.

Research Award Description

METAvivor is offering the Research Award for established investigators in the field of metastatic breast cancer research:

Award type: Research Award

Brief description:

  • Awarded to established investigators in the field of metastatic breast cancer (MBC) research
  • Discovery and early phase basic, translational, and clinical research designed to address critical problems or barriers to progress in the field of MBC

Maximum: $250,000

Duration: Up to 2 years

Deadline to submit required LOI: March 18, 2020

Budget and justification: Detailed

Eligibility

Applicants to the award must hold a clinical doctoral degree or doctoral degree from an accredited institution and must hold an independent position beyond the level of a trainee (i.e. postdoctoral fellow, student, clinical fellow, resident, etc.) in the United States.

The Research Award include direct costs (including up to $1500 for travel), and indirect costs of up to 5% of the total award. We anticipate that approximately 20% of Research Award applicants that submit the required Letter of Intent (LOI) will be invited to submit a full application following the LOI review process. Only invited applications will be considered for funding.

Key Dates

Application Portal Opens: February 18, 2020 at https://metavivor.infoready4.com/

Required Letter of Intent Due: by 11:59 PM ET on March 18, 2020

Invitations to Submit Full Application Sent: on or by May 26, 2020

Invited Applications Due: by 11:59 PM ET on August 24, 2020

Announcement of Awardees: on or by December 4, 2020

Research Objective

The goal of METAvivor’s Research Award is to provide a supporting foundation for basic, translational, and clinical research designed to address critical problems or barriers to progress in the field of metastatic breast cancer. These awards can be also be discovery based as well for advanced research projects with more well-established/validated models, molecules, pathways, biomarkers, treatments, etc.

METAvivor ONLY funds research that has clear potential to benefit those who are living with metastatic breast cancer (i.e. the already-metastasized or stage IV patient). Preference for funding will be given to research with potential to lead directly to improved clinical outcomes, or that is meant to provide a clear conceptual foundation for improving the treatment of metastatic breast cancer in the future, as in the case of mechanistic or pre-clinical animal studies for example. Applications focused on the prevention of or diagnosis of metastatic breast cancer or improving Quality of Life will be administratively withdrawn. Strong applications must have a clear focus on and rationale for studying established breast cancer metastases.

The applicant’s expertise may represent diverse fields such as genetics, chemistry, or oncology. It is important for applicants to identify their clear qualification to perform the proposed aims in their biosketches in conjunction with support from possible collaborators. Please note that METAvivor also strongly encourages the incorporation of experienced patient advocates in the application and review process for all grants. The application packet should provide details of advocate involvement in the preparation of the application and plans for involvement during the funding period.

Examples of research areas that could be supported by this RFP include, but are not limited to:

  • Identification of biomarkers for metastatic breast cancer treatment response
  • Identification and validation of novel targets for treatment
  • Development of treatment regimens, including immunotherapy
  • Development and characterization of novel animal models of metastatic breast cancer
  • Research into novel methods to stop progression, shrink existing breast cancer metastases or prevent metastases from forming in the already-metastasized patient
  • Identify determinants and carriers of breast cancer metastasis
  • Conquer the problems of potential overtreatment of breast cancer metastases
  • Identify tumor microenvironment factors important in breast cancer metastases growth and determine the approaches to inhibit tumor metastases growth
  • Revolutionize breast metastases treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival
  • Eliminate the mortality associated with metastatic breast cancer
  • Collaborative Research Projects to Enhance Applicability of Mammalian Models for Translational Research in breast cancer metastases: To encourage submission of multidisciplinary projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit.
  • Breast cancer Immunotherapies: To study: (a) the mechanistic understanding of the metabolic processes that support robust anti-tumor immune responses in vivo, (b) To assess how the metabolic landscape of the tumor microenvironment affects immune effector functions, and (c) To improve cancer immunotherapy.

Some aspects of the proposed research may reduce over-treatment of patients; reduction of toxic side effects; or mechanistic studies to explain (lack of) efficacy against metastatic disease. Collaborative, multi-investigator and multi-disciplinary projects are encouraged but not required.

Eligibility

  1. Applicants must be from a United States sponsoring academic, nonprofit or governmental institution. US citizenship is not required. Proof of permanent resident status or a valid a work visa is required if the applicant is not a US citizen. All research must be conducted within the US.
  2. Treatments and therapies that are a result of the research funding received from METAvivor may require profit sharing of up to 3%.
  3. Applicants must hold a clinical doctoral degree (e.g., M.D., D.V.M., D.O) or doctoral degree (e.g., Ph.D., M.D., D.Ph.) from an accredited institution and must hold an independent position beyond the level of a trainee (i.e. postdoctoral fellow, student, clinical fellow, resident, etc.).
  4. METAvivor will not discriminate based on gender, race, ethnicity, creed, religion, sexual orientation, disability, nationality, age or any other factor irrelevant to the quality of the application.
  5. Applicants may serve as the primary investigator on only one Letter of Intent/application. Applicants serving as the primary investigator on one application may also serve as a co-applicant on one other application (limit two applications). A person may serve as a co-applicant on multiple applications if they are not also a primary investigator on a submission. METAvivor will only contract with one institution, that of the primary investigator. METAvivor does not limit the number of co-applicants per application, but does require a letter of support from each co-applicant listed.
  6. Similar research projects (similar/same scope and aims) may not be submitted to both the Research Award and Founder’s Award even if the primary investigator is different on each submission.
  7. Sponsoring institutions must provide the necessary facilities and infrastructure for the research. This will be evidenced through a required Letter of Support from the institution or Department Chair (or equivalent) as described under “instructions for submission of invited applications.”
  8. Funded applicants can request to keep their award upon transfer to a different US institution pending approval by METAvivor’s board.

Resubmissions

METAvivor does not currently differentiate resubmitted applications in our review process and we do not provide a space to address previous reviewer concerns. Each application is treated as an initial submission and is not likely to be reviewed by the same previous reviewers. If an application scored strongly in a previous year, but was not funded, the applicant may choose to note this in the Letter of Intent.

Instructions for Submitting the Required Letter of Intent

**Failure to adhere to RFP instructions (for both the Letter of Intent and invited application) will result in administrative withdrawal**

Interested applicants who meet award eligibility requirements above must submit a letter of intent (LOI) to apply for the Research Award before 11:59 PM ET on March 18, 2020. The LOI with a cover page must be uploaded as one PDF file named applicantlastname_firstinitial_LOI_2020, and submitted via the grant portal (https://metavivor.infoready4.com/). Applicants of the most competitive LOIs (approximately 20%) will be invited to submit a full proposal following a scientific and patient review process described under ‘Review Process.’

Components of a Competitive LOI

(format: size 11 Arial, Times New Roman or Helvetica font with .5” margins)

  1. 1-page LOI cover page that includes.
    1. Name of award (METAvivor Research Award)
    2. Name, title, address, and phone number of the submitting applicant and co-applicant(s) if applicable.
    3. Descriptive title of project (Note: This letter does not need to be on institutional letterhead).
  2. 1-page LOI with applicant name and descriptive title of the project at the top and the following components:
    1. Significance: A brief description of the important problem or critical barrier to progress in the field of Metastatic Breast Cancer that the proposed work will address.
    2. Impact: A brief description in lay terms of how the proposed work is anticipated to positively impact the clinical treatment of metastatic breast cancer in the already metastasized patient.
    3. Background/Rationale: A brief description of the key findings that support the proposed project. References (Cancer Research citation style) are allowed and are not included in the page limit.
    4. Approach: A generalized description of what will be achieved and how during the 2-year funding period. Goals in the form of clear specific aims are strongly encouraged.

Instructions for Submission of All Invited Applications

Only applicants invited to submit a proposal following the LOI review process on/by June 26, 2020 will be considered for funding. Invited applicants must submit their full application using the METAvivor Grant Portal (https://metavivor.infoready4.com/) by 11:59 PM ET on August 24, 2020. Invited applications accepted for review will be reviewed by one patient advocate and two independent peers as described under ‘Review Process.’

Required Documents for Invited Applications

Contact information in the online grant portal should be that of the submitting primary investigator. Please format all documents to size 11 Arial, font with .5” page margins and include page numbers.

Public/Lay Abstract (1- page limit)

Using language readily understood by lay persons, please clearly address the rationale and goal of the research proposal. Explain anticipated clinical applications or benefits for stage IV metastatic breast cancer patients that could result from the proposed work. If the research is basic, explain the interim outcomes and how the research is significant to persons with established breast cancer metastasis. The public abstract will be published on the METAvivor website if the grant is awarded. Please upload this file as a PDF named applicantlastname_firstinitial_PublicAbstract_2020.

Research Plan (includes the research plan, scientific abstract and development plan)

The proposed research plan must be submitted as a single PDF document named

applicantlastname_firstinitial_ResearchPlan_2020 and must contain the following components in order:

  1. Title Page (1-page limit)
    1. Please include the award name (Research Award or Founder’s Award) your name, contact information (co-applicant’s as well), and the title of the proposal. If your proposal title is substantially different from the title submitted in the LOI, your application may not be accepted, unless METAvivor is notified of the title change.
  2. Table of Contents with reference to page numbers (1-page limit)
  3. Scientific Abstract (500 words or less)
    1. Please briefly summarize the background, hypothesis, specific aims, study design, and potential impact of the research plan in regard to advancing the field of Stage IV Metastatic Breast Cancer Research. Please include the scientific abstract in the PDF submitted for the research plan AND paste this abstract into the space provided for the scientific abstract within the application form.
  4. Research Plan (5-page limit with PI name in the header of each page)
    1. The research plan should include the following sections: Background and Significance, Specific Aims, Preliminary Data and Research Design. Please provide appropriate detail of methods and materials in the Research Design section, address caveats/alternative approaches and include a brief plan that identifies critical milestones and technical solutions that will be implemented to accomplish the milestones.
    2. For Full grant applications: If using vertebrate animals, please provide information on the approved animal protocol and the institute approval letter if available. If not, and there is not yet an approved protocol, please provide the experimental protocol including species, sex, strains and number of animals used (power analysis).
    3. If your research involves Human subjects, please provide the approved Human protocol together with the institutional approval letter. If using human subjects or human anatomical substances, briefly justify such use and describe the clinical protocol.
    4. Biohazards: If Materials or procedures are proposed in your proposed your study that are potentially hazardous to research personnel and/or environment, please provide details and institutional approval. Also please provide details on adequate protection that is provided.
    5. Please include a list of references in the Cancer Research citation style. These do not count toward the 5-page limit.
  5. 1. Development Plan (1-page limit)
    1. The development plan should clearly discuss how anticipated findings from the METAvivor award will be leveraged to obtain additional funding support for research intended to improve outcomes for those already living with stage IV metastatic breast cancer. This plan should be as specific as possible.

Budget with Budget Justification

The METAvivor Research Award is for up to $250,000 over two years ($125,000 per year maximum). This amount includes direct costs (salary, materials and supplies, and travel up to $1500/yr), and indirect costs of up to 5% of each award total. METAvivor funds cannot be used for the purchase of equipment or tuition remission (without prior approval). A detailed explanation justifying the budget for these categories is required. Please use the budget with justification format template that is available for download in the portal for each award and upload this completed template as a PDF file labeled as applicantlastname_BudgetandJustification_2020.pdf.

‘Other Support’ Document

The applicant (and all co-applicants if applicable) are required to submit one PDF file named applicantlastname_firstinitial_OtherSupport_2020 that lists all current and pending support and a brief summary of overlap with the proposed project for each individual. Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, that directly supports the applicant’s research. Examples include, but are not limited to research grants, contracts, and/or institutional awards. Applicants are welcome to upload an NIH Other Support page for this if they have a current one (available at https://grants.nih.gov/grants/forms/othersupport.htm). If awarded a METAvivor research grant, you will be required to disclose other funding for the same research project and submit a new budget if awarded after METAvivor announces awards.

Biographical Sketches (5-page limit per biosketch)

All applicants (and co-applicants) are required to upload their biosketch(es) as a PDF file named as applicantlastname_firstinitial_ApplicantsBio_2020. You may also upload biographical sketches of important project supporters including collaborators. Please combine supporting biosketches into one PDF file named applicantlastname_firstinitial_SupportingBios_2020.pdf.

Letter(s) of Support (2-page limit per letter)

Institutional support: All applicants are required to upload a Letter of Support from the sponsoring institution or Department Chair (or equivalent) of the primary investigator (i.e. applicant). This letter should clearly indicate that the sponsoring institution is able to provide the necessary facilities and infrastructure for the proposed research. Please upload this letter as a PDF named applicantlastname_firstinitial_institutionLOS_2020.

Collaborator and/or co-applicant support: Letters of support from co-applicants are required. Applicants citing support from additional collaborators and/or investigators providing key reagents/equipment access are also required to upload letters of support from them. Please combine letters of support from scientific collaborators/co-applicants into one PDF file named applicantlastname_firstinitial_LOS_2020.

Advocate support: Letters of support from patient advocates are strongly encouraged, but not required. These should be uploaded as a separate PDF file named applicantlastname_firstinitiation_advocateLOS_2020. If the supporting advocate also has a biosketch to share, this can be combined with the letter of support and uploaded as one file.

Additional Documents

The following additional documents may be required prior to funding approval:

  1. Protection of Human Subjects from Research Risk

    1. All research involving human subjects, human anatomical substances and/or human data must follow the rules and recommendations of the local Institutional Review Board (IRB). Documents attesting to approval of the clinical protocol by the local IRB will be requested by METAvivor at the time of funding. It is therefore advisable to submit the protocol for IRB review prior to funding approval.

  2. Care and Use of Vertebrate Animals in Research

    1. A document detailing use of vertebrate animals in the research proposal along with approval of the protocol by the institutional Animal Welfare board will be required prior to funding approval. The document should 1) justify use of animals as described in the research proposal, including strain, number and sex of the animals; and 2) provide detailed information on the veterinary care of the animals used, including procedures used to minimize discomfort and pain, and methods of euthanasia in accordance to the American Veterinary Medical Association Guidelines on Euthanasia.

  3. Investigational New Drugs (IND)

    1. Applications involving an IND must receive approval from their Institutional Review Board. Documentation of IND approval must be provided to METAvivor prior to distribution of the Award and for each year of funding.

Review Process

Any LOI or invited full application that does not meet the requirements of this RFP will be administratively withdrawn and will not enter the review process. Applicants will be notified as to whether their LOI and/or invited full application has been accepted or rejected for review.

Review of Letters of Intent (LOI)

LOIs accepted for review will be peer reviewed for overall impact, taking into account the proposed project’s significance, anticipated impact, rationale, and approach. Patients will review LOIs for significance only. A limited number of applicants that submit LOIs to the Research Award or Founder’s Award will be invited to submit a full application based upon results of the review process. Applicants will not receive review comments back on their LOIs, and the LOI will not enter into the review of a subsequent grant application.

Review of Invited Applications

Invited applications that have been accepted for the review process will be reviewed by one patient advocate and two qualified peers based on the criteria below. Applicants will be notified of whether or not they have been accepted for award in December of 2020 following discussions amongst METAvivor’s board and scientific advisors.

Patient Advocate Review

Patient advocates will evaluate invited applications based upon impact. Specifically, they will assess the likelihood for the project to exert a sustained, powerful influence on the treatment of metastatic breast cancer, or to be a foundation for future treatments in the already-metastasized metastatic breast cancer patient.

Written support from a patient advocate for an invited application is not required, but patient support that underscores the potential impact of the proposed project is strongly encouraged in the form of a Letter of Support. These letters, if submitted, will be provided to patient advocate reviewers.

Peer Review

Two independent qualified peers will evaluate applications based upon 1) Overall Impact, 2) Significance, 3) Investigator(s), 4) Innovation, 5) Approach, and 6) the Development Plan. Reviewers will also assess the appropriate use of vertebrate animals and/or human subjects when applicable and carefully review the budget and budget justification. Potential overlap with other funded awards not be allowed, and will be carefully assessed based on the ‘Other Support’ document.

Anonymous scores and comments from patient and peer reviewers will be provided back to invited applicants whose full proposals entered the review process.

Reporting for Awarded Grants

Awarded applicants must submit a progress report at 6 months, 1 year and 2 years after funding begins. Reporting requirements will be specified in the award contract. Continuation of support for the proposed research plan will depend upon satisfactory review of the 1-year progress report by the Scientific Review Officer and METAvivor leadership. Awarded grants can follow an applicant if they move to a new institution within the US, but this requires approval from METAvivor on a case-by-case basis.

For more information, please contact us at [email protected]

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