Accelerator Award RFA

Updated: December 13, 2017

IMPORTANT NOTE FOR THE SPRING 2018 APPLICANTS:

Applicants, if selected, MUST be available to present their projects at a CBCAN meeting on February 1 and/or February 8, 2018. Both meetings will be held on a Thursday, from 4:00-7:00 PM, at Prentice Women Hospital Conference Center downtown Chicago. MARK YOUR CALENDARS!

 

Key Dates for 2018:
 
Applications to the CBC’s Accelerator Award program are invited usually twice a year (spring and fall submission rounds). Please note that the online proposal submission closes at 5:00 PM on the final day listed for each submission round.
 

Application Round LOI Online Submission Invitation to Submit a Full Proposal Full Proposal Online Submission Funding Decisions Anticipated Start Date
Spring 2018 January 8-12, 2018 March 1, 2018 April 9-13, 2018 May 14, 2018 July 1, 2018

 

REQUEST FOR APPLICATIONS:

The Accelerator Award program will be a key component of the CBC’s Phase 2 strategy. New in 2018, Accelerator Awards intend to support research leading to the development of therapeutics at the early stages of translation. The award is intended to enable the initial steps toward potential commercialization of intriguing basic research discoveries with significant translational potential. Applicants for Accelerator Awards should present a compelling hypothesis about the therapeutic potential of the system/entity to be studied, and propose a research plan that addresses one or more key components of the hypothesis and can generate robust data to advance the program.

Accelerator Awards offer up to $100,000 for one year. Quarterly progress reports will be required and funds will be distributed in tranches based on progress towards pre-specified milestones. Awardees may be invited to apply for an additional award of $150,000 for a second year if adequate progress is made towards milestones during the first year.

In addition to providing financial support, Accelerator Awards will support investigators by providing mentoring by various experts from industry and the universities. Those seeking Accelerator Awards will receive frequent feedback, beginning with the Letter of Intent submission and continuing into performance of approved projects.

Unlike other CBC awards (and NIH grants), Accelerator Awards will be made only to support early-stage translational research. The multipart application process is initiated with the submission of a Letter of Intent (LOI) and will require well-thought-out and clear, detailed explanations of translational potential, and the proposed work must explicitly address questions pertaining to translation. Applicants with promising LOIs will be required to present their projects at a CBC Accelerator Network (CBCAN) meeting and address/incorporate feedback into the final proposal.

Accelerator LOIs and proposals will be evaluated by the Accelerator Review Board (ARB), composed of representatives from the Pharmaceutical industry, the Universities’ Technology Transfer Offices, and mentors identified from the CBC and its member institutions. The Board will approve projects based on significance, translational potential, marketability of the proposed product, preliminary data, and the soundness of the proposed milestones to discharge key elements of risk.

Since this is a new program, please see the Appendix for several examples of the type of projects that would be appropriate for an Accelerator Award. As the Accelerator Award is intended to stimulate new translational efforts, such funds may not be used for correlative studies associated with ongoing clinical trials.


ELIGIBILITY:

  • Applicants must be tenured or tenure-track faculty with research programs at Northwestern University, the University of Chicago, and/or University of Illinois at Chicago.
  • Although collaborative proposals are encouraged there is no specific requirement for cross-institutional collaboration.
  • Applicants may have created a company to pursue translation of their innovation, but there is no expectation or requirement for so doing. The CBC encourages applications prior to or without company formation.
  • Multiple applications can be submitted from each institution.
  • There is no expectation that Accelerator Awards will be distributed evenly among the CBC institutions.
  • Proposals should show both innovation and scientific merit.
  • The project should be focused on the development of a therapeutic or associated diagnostic or biomarker, built around a compelling hypothesis and focus on gathering data that advances the hypothesis and discharges key translational risks.
  • Research teams should not already be funded for the same specific aims and/or milestones.
  • Research projects described in Accelerator applications cannot be under review at other funding institutions/agencies to support the same specific aims and/or milestones. If parallel funding is being pursued, PI must explicitly describe how the Accelerator Award funding will address unique translational risks.
  • A PI may participate in only one application per round.
  • Ongoing and active participation in the CBCAN program is a requirement for Accelerator Award recipients.

AVAILABLE FUNDING:

  • Grants can range up to $100,000 for use over 1 year. Awarded projects that have met proposed milestones during the first year may be invited to apply for $150,000 for one additional year. Please note that the three CBC institutions have waived all indirect costs.
  • Accelerator Awards are one-time awards, with no expectation of continuation or renewal by the CBC.

 

APPLICATION PREPARATION:
I. LOI Preparation

All LOIs MUST be prepared according to the guidelines listed below. All pages and documents listed below should be assembled into a SINGLE PDF document in the order listed. Portfolios will NOT BE ACCEPTED.

Name the PDF file with “accelerator_LOI” followed by the last name of the PI designated as contact person (e.g. accelerator_LOI_smith.pdf).

LOIs not conforming to these guidelines will NOT BE ACCEPTED.


Section 1:

  • Page 1: Title Page
    • Download the LOI Title Page form FROM HERE (revised: Dec. 1, 2017), fill out and append as page 1 of your proposal.
    • Complete all checkboxes by selecting either YES or NO and provide information when needed.

Section 2:

  • Pages 2-5: The body of the LOI is limited to 4 pages; append as pages 2 – 5 of your application. Include the following sections with the indicated titles and in the indicated order. Use at least size 11 font, 0.5 inch margins and standard letter paper size (8.5” x 11”).
    • One-paragraph lay-language summary of project (max. 150 words; append as page 2 of your LOI)
    • A separate, one-page discussion (append as page 3 of your LOI) of the basic research findings that are the basis of the hypothesis and project, including:
      • Its significance
      • The compelling data that suggests clinical/translational potential
      • Does this research have the potential to change or modify current paradigms?
    • A separate, two-page discussion (append as pages 4 and 5 of your LOI) of the translational potential of the project, describing:
      • The diagnostic, biomarker or therapeutic you have in mind and its significance
      • The patient population that will benefit from your discovery
      • The clinical or therapeutic need, i.e. the marketability
      • How the proposed therapeutic differs from existing ones and/or benefits patients in a new way
      • The experiments you intend to do and how they will address key translational risks (see Appendix for relevant examples)
      • The translational goal(s) for your Accelerator project and proposed quarterly milestones (ensure that these are adequately quantitative for demonstrating progress)
      • Describe interactions with your Technology Transfer Office and the status of your intellectual property for this project. Has a company been formed?
      • Has this project received any funding for translational work? If yes, please elaborate and indicate the relationship of this proposal to otherwise funded work.


Section 3:

  • Page 6: Relevant Cited Scientific References (not to exceed one page; please follow the NIH format)

Section 4:

  • Page 7 and beyond:
    • 2-page budget (if more than one PI, include a budget from each participating PI).
    • By special arrangement with the Research Administration Offices at the CBC universities, it is not necessary to obtain institutional endorsement of proposals before they are submitted to the CBC. However, the CBC may share proposals with Research Administrators during the review process, and the CBC will require institutional endorsements before any final funding decisions are made. The proposed research activities and budget requests must thus be within institutional guidelines in order for a proposal to be successful. (Note: PIs may claim up to 2% effort/salary relief. Graduate student tuition and tuition remission is not allowed on CBC awards. Award funds cannot be used for correlative studies associated with ongoing clinical trials.) All expenses from a single institution should be entered on a university-specific budget form (fillable PDF) downloadable from here: NU budget form, UChicago budget form, UIC budget form (printed and scanned pdf of the budget form is also acceptable). Travel expenses of $1000 per PI and publication expenses of $500 may be included. Additional continuation pages may be used as needed for Budget Justification.

Section 5:

  • Continue with consecutive page numbering:
    • Up-to-date NIH Biosketch (NEW FORMAT; not to exceed 5 pages) for the PI, including current and pending funding and relevant business experience.
    • Applications that are pending at national funding agencies can have no scientific overlap with this LOI. Program staff will review this information to determine eligibility.

Section 6:

  • Continue with consecutive page numbering:
    • Letters of Support
    • If a research project requires special expertise that is not substantially and readily apparent in the PIs’ biosketches, a letter confirming and describing consultation with a core director or colleague recognized in that field is recommended. Please note that the CBC is not allowed to fund researchers from non-CBC institutions, but will accept their letters of support. CBC funds can be used to pay for services provided by core facilities at non-CBC institutions.

 

II. LOI Submission

Completed LOIs MUST be submitted online. The Accelerator LOI submission site will open at 8:00 AM on the initial day in the stated range and will close at 5:00 PM on the final day in the stated range as indicated in the Key Dates section above. Clearly designate the contact person on the LOI. The contact person will be responsible for submitting the LOI.

Following evaluation of LOI, the review panel will invite selected applicants to submit a full-proposal. Full-proposal guidance will be provided at that time.


If you have questions, please contact:

Jim Audia CBC Executive Director
Nancy Tyrrell Associate Director, Translational Activities

or contact the CBC Scientific Director on your campus:

NU: Richard Morimoto
UChicago: Lucy Godley
UIC: Brian Kay

 

APPENDIX:

To view examples of projects that might be suitable for Accelerator funding, click on the tabs below labeled Example #1, #2 or #3. If you are printing the RFA choose the option Expand all. Please note that this is not an exhaustive or prescriptive list.

MILESTONES should contain the following components: 1) goal or objective, 2) timeline to achieve goal, 3) prospectively defined evidence that goal achieved based on quantitative criteria.
 

  • PROJECT TYPE:
    Compound testing scheme for identification and characterization in support of therapeutic development.

    • Requirement of target selected and established hypothesis/evidence for validity in disease context.
    • Goal is testing cascade for triage and characterization of compounds and collection of compounds suitably characterized for subsequent studies.
    • Milestones to reflect assay readiness to support high throughput screen, compound triage and characterization for activity against primary target, specificity against relevant off-targets, cellular target engagement, cellular functional/phenotypic activity; appropriate activity of positive and negative controls in all assays; loss of activity in cellular systems lacking functional target.
    • Milestones to support small molecule therapeutic development to include preparation and validation of chemical matter including confirmation of structure, purity, chemical stability/reactivity, assessment of physicochemical properties in vitro and in silico (including lipophilicity, polar surface area, solubility, permeability and efflux), initial assessment of in vitro ADME/PK characteristics such as plasma protein binding, microsomal metabolism/stability, induction of metabolic enzymes and affinity for transporters.
  • PROJECT TYPE:
    Development/validation of pharmacodynamic and/or in vivo efficacy animal model

    • Requirement is translational rationale, pre-clinically validated target and in vitro measures of target engagement and functional/phenotypic response and well-characterized in vivo probes. or other suitable means of target perturbation (CRISPR, etc)
    • Goal is demonstration of dose-dependent in vivo PD/efficacy response quantitatively related to target engagement suitable for supporting in vivo optimization program.
    • Milestones to reflect readiness to support in vivo PK/PD-driven compound optimization including relevant activity of positive/negative controls, adequate dynamic range and reproducibility for differentiation; appropriate correspondence demonstrated for target engagement versus efficacy.
  • PROJECT TYPE:
    Pharmacodynamics and/or in vivo efficacy study

    • Requirement of validated/characterized animal model and pharmacodynamics measure (both functional and target engagement), testing protocol and well-characterized therapeutic agents.
    • Goal is well characterized early stage in vivo validated agents suitable for lead optimization.
    • Milestones to reflect readiness to progress to lead optimization for small molecule therapeutic or biologic including pharmacokinetics that would allow adequate systemic free drug concentration in relevant compartment/tissue to support therapeutic hypothesis, biophysical characteristics that support further optimization against target access, duration of action and intended route of administration.
  • PROJECT TYPE:
    Compound testing scheme for identification and characterization in support of therapeutic development.

    • Requirement of target selected and established hypothesis/evidence for validity in disease context.
    • Goal is testing cascade for triage and characterization of compounds and collection of compounds suitably characterized for subsequent studies.
    • Milestones to reflect assay readiness to support high throughput screen, compound triage and characterization for activity against primary target, specificity against relevant off-targets, cellular target engagement, cellular functional/phenotypic activity; appropriate activity of positive and negative controls in all assays; loss of activity in cellular systems lacking functional target.
    • Milestones to support small molecule therapeutic development to include preparation and validation of chemical matter including confirmation of structure, purity, chemical stability/reactivity, assessment of physicochemical properties in vitro and in silico (including lipophilicity, polar surface area, solubility, permeability and efflux), initial assessment of in vitro ADME/PK characteristics such as plasma protein binding, microsomal metabolism/stability, induction of metabolic enzymes and affinity for transporters.

    • PROJECT TYPE:
      Development/validation of pharmacodynamic and/or in vivo efficacy animal model

      • Requirement is translational rationale, pre-clinically validated target and in vitro measures of target engagement and functional/phenotypic response and well-characterized in vivo probes. or other suitable means of target perturbation (CRISPR, etc)
      • Goal is demonstration of dose-dependent in vivo PD/efficacy response quantitatively related to target engagement suitable for supporting in vivo optimization program.
      • Milestones to reflect readiness to support in vivo PK/PD-driven compound optimization including relevant activity of positive/negative controls, adequate dynamic range and reproducibility for differentiation; appropriate correspondence demonstrated for target engagement versus efficacy.

      PROJECT TYPE:
      Pharmacodynamics and/or in vivo efficacy study

      • Requirement of validated/characterized animal model and pharmacodynamics measure (both functional and target engagement), testing protocol and well-characterized therapeutic agents.
      • Goal is well characterized early stage in vivo validated agents suitable for lead optimization.
      • Milestones to reflect readiness to progress to lead optimization for small molecule therapeutic or biologic including pharmacokinetics that would allow adequate systemic free drug concentration in relevant compartment/tissue to support therapeutic hypothesis, biophysical characteristics that support further optimization against target access, duration of action and intended route of administration.

 
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