Translational Therapeutics Accelerator

Innovation in Translational Science and Biomarkers

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Overview

The Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) is a global drug discovery and development program focused on supporting academic scientists in defining optimal strategies for advancing new, cutting-edge therapeutics from the lab to patients.

The Problem

Drug development has several phases that are categorized as discovery (preclinical), development (clinical trials), and commercialization, once approved by regulatory agencies such as the U.S. Food and Drug Administration. For many reasons, the transition from discoveries in the academic environment to drugs entering the pipelines of pharmaceutical companies is often a place where significant opportunities for innovative therapies are lost – frequently referred to as the drug development “valley of death.”

Video: Funding and Guidance Opportunities for Academic Drug Discovery Projects

_{How does TRxA Help Bridge the Drug Development “Valley of Death?”}

The Solution

TRxA leverages C-Path’s proficiency in translational and regulatory science to bridge the drug development “valley of death” by providing academic researchers with funding and guidance for the advancement of novel therapeutics from the lab to clinical trials and, ultimately, commercialization and patient care.

The Impact

TRxA is uniquely positioned to leverage the expertise available through C-Path’s >20 disease-based consortia, to empower academic drug discovery programs to succeed and deliver new treatments for diseases with high unmet medical need.

TRxA operates as a drug accelerator program within C-Path, providing the following for academic researchers who have applied for and received a grant award:

Funding to advance drug development initiatives
Tactical and strategic drug discovery and development leadership, including regulatory science considerations

Resources and hands-on guidance, working closely with researchers to develop comprehensive data packages for potential drug candidates-a key to garnering interest from biotechnology and pharmaceutical companies to invest in further development.

To learn more about TRxA, be informed when the award application period opens, and how to apply for an award, contact us at TRxA@c-path.org or subscribe to our updates. PIs are also encouraged to review the FAQ section of this website and the annual Guidance Document for Applicants for additional details about the program.

Funding Opportunities

TRxA accepts applications for its Bridging Research and Innovation in Drug Development Grants (BRIDGe awards) during its annual Request for Proposals (RFP), which is announced in January of each year on this website and via email to those who subscribe to TRxA news and updates. Off-cycle, limited-scope RFPs may be announced periodically.

Eligibility Criteria for TRxA BRIDGe Awards

To be eligible for BRIDGe funding and support, investigators need to hold a faculty appointment at a university or non-profit research institution (anywhere in the world), and intellectual property (IP) associated directly to the project cannot yet have been exclusively optioned or out-licensed.

Eligible platforms and therapeutic areas, as well as entry and success criteria for TRxA-funded projects, will be detailed in the annual Guidance Document for Applicants.

The 2025 Guidance Document

Funding levels offered by TRxA vary depending upon the stage of the project (see details in Guidance Document for Applicants). Funds awarded are provided for the purpose of carrying out research studies directly related to the project as documented in the approved research plan (either at the institution or through a contract research organization). Principal investigators are required to concisely outline and justify direct project costs during the application process. Indirect costs are capped at 10%.

Recipients of TRxA awards are expected to participate in monthly teleconferences with TRxA’s team of drug discovery and development experts to discuss the project’s progress and troubleshoot any challenges encountered, as well as submit an interim and final report summarizing scientific progress and project expenditures.

How to Apply

It is recommended that principal investigators (PIs) coordinate with their university’s technology transfer and/or grants and contracts office in advance of applying to 1) make them aware of plans to submit an application and 2) provide an opportunity for review of the TRxA award agreement template to ensure the terms of a TRxA award are, in principle, acceptable.

Principal investigators will submit a non-confidential pre-proposal through the grant portal that will be reviewed by C-Path’s scientific experts and TRxA’s Programmatic Review Board (PRB), which has broad expertise in drug discovery and development. Details about elements required in pre-proposals, as well as criteria by which proposals will be reviewed, are provided in the annual Guidance Document for Applicants.

Prior to submission of the pre-proposal, the TRxA team is available to PIs via email (TRxA@c-path.org) to answer any questions about pre-proposal requirements, the award process, or to seek feedback on how to optimize your submission.

To start building your pre-proposal, click here for access to TRxA’s grant portal. You will be asked to set up a username and password before starting the pre-proposal application (click here to access the grant portal User Guide). If you encounter any technical issues with the portal, please email us at TRxA@c-path.org.

Based on reviews of pre-proposals, selected applicants will be invited to enter into a confidentiality agreement (CDA) with C-Path, after which the applicant will upload confidential information related to the project (e.g., chemical structures) to the grant portal. Scientific experts will assess the confidential information to further determine which applicants will be invited to submit a full proposal.

Full proposals will be reviewed by at least three external scientific advisors, including members of TRxA’s Scientific Advisory Committee and expert ad hoc reviewers, and scored for novelty, scientific and technical merit, as well as commercialization potential. Additional information about review criteria is available in the annual Guidance Document for Applicants.

Timeline and Award Notifications

A typical timeline is illustrated below:

Deadlines and notification dates for the current year RFP are outlined in the annual Guidance Document for Applicants.

TRxA is made possible by a grant from  Research Corporation Technologies, Inc’s  Frederick Gardner Cottrell Foundation.

FAQs

Who We Fund

Who is eligible for TRxA BRIDGe Awards?

Faculty at universities and nonprofit institutions, anywhere in the world.

Are there any institutional commitments required, if funded?

The institution will be expected to engage with TRxA and negotiate a reasonable project agreement commensurate with the funding provided. A template of this agreement is available here. TRxA welcomes and encourages engagement of technology transfer offices (TTOs) throughout the project. In fact, if invited to submit a full proposal, a letter of support from the TTO is required.

What We Fund

What therapeutic areas are eligible for TRxA BRIDGe awards?

Eligible therapeutic areas are defined annually and detailed in TRxA’s Guidance Document for Applicants.

Do you fund only therapeutic projects or diagnostics projects as well?

The funding is open to therapeutics. Diagnostics are outside of TRxA’s scope.

I have a small molecule drug. I know the target but do not know the binding site. I have a phenotypic in vitro and mouse model. And I don't have a group of compounds with similar structures. Is this project appropriate for TRxA?

This would be considered a very early Stage 1 application and will likely be less competitive than projects with demonstrated Structure-Activity-Relationship (SAR) around their compound. We recommend building the SAR and apply when you have more data.

Does TRxA fund work on repurposed drugs?

Projects around drug repurposing are currently out of scope.

How TRxA Funding Works

What levels of funding are available for TRxA BRIDGe awards?

Funding levels offered by TRxA vary depending upon the stage of the project (see Guidance Document for Applicants for details).

If we apply for Stage 1, is the project still eligible to apply for Stage 2 or 3 in subsequent RFPs?

Once an applicant has received a BRIDGe award and successfully achieved defined deliverables, opportunities for additional funding, although not guaranteed, can be discussed with the TRxA team without having to wait for the next RFP cycle.

Does TRxA funding come to my lab?

Funds awarded through BRIDGe are provided for the purpose of carrying out research studies directly related to the project as documented in the approved research plan (either at the institution or through a contract research organization). Principal Investigators are required to concisely outline and justify direct project costs during the application process.

Funds are awarded to the project, not necessarily the PI’s laboratory – this may mean that part of the funds, or perhaps even all of them, go to CROs to help execute the project. This, combined with the support TRxA provides to define the Target Product Profile (TPP) and associated regulatory strategies, will make your project more valuable for potential future licensing deals, and move towards the clinic.

What are allowable costs?

Those associated with executing defined project tasks, such as procuring assay specific lab supplies, animals, or core services. Salary support is only allowed if associated with a specific task in the project’s plan, subject to the current NIH salary cap.

What’s not allowed? – General laboratory expenses, travel, equipment, tuition, or IP costs. IDCs are capped at 10%. Pass through costs to consultants or CROs are not subject to IDCs.

Do I need to worry about overlap with other funding sources for my project?

No, provided that different aspects of the work are funded by other sources. In fact, it may be beneficial as the project will likely need more than just TRxA funds to get to the clinic, and availability of other funds will be a positive attribute.

Can a project accept financial support from various grantmaking entities at the same time, allowing them to fund different aspects of their project?'

Yes, we understand that TRxA funding will not provide all of the funding for the work required to file IND and we would welcome other funders contributing to compile the package of data necessary

Application and Review Process

How many calls for proposals does TRxA conduct each year?

Generally, TRxA accepts applications once per year (with the Requests for Proposals being announced in January). Off-cycle, limited-scope RFPs may be announced periodically.

How many projects do you fund?

Depending on the Stage of projects, we anticipate funding 3-7 projects per year, in the coming years. We hope to grow our available resources to increase the number of projects we can support.

Will you guide applicants on what stage they should apply for (e.g., how to proceed if research is somewhere between Stage 1 and 2)?

Prior to submission of an application, you can  email the TRxA team at TRxA@c-path.org for guidance on applying for the appropriate funding level.

Can our Tech Transfer Office (TTO) apply on behalf of the investigators?

Yes, but during the project, TRxA’s interaction with the PI is essential, so they have to be involved. TRxA welcomes and encourages engagement of TTOs throughout the project. In fact, if invited to submit a full proposal, a letter of support from the TTO will be required.

What does TRxA get out of this?

TRxA’s primary objective is to support promising drug development projects so that innovative therapeutics can reach patients as efficiently as possible. To sustain its efforts, TRxA does request a small percentage of income to the institution, when the project is successfully out-licensed, but we do not claim any IP ownership. These terms and conditions are included in the template of the TRxA project agreement available  here.

How do I apply?

To submit a pre-proposal application in response to an RFP,  click here to access TRxA’s grants portal.

Engagement of Contract Research Organizations (CROs)

How do I deal with CROs?

If needed, TRxA will help identify suitable CROs to do (part of) the work. The PI’s institution is responsible for entering into contracts with CROs as needed and appropriate and paying CROs directly for services. TRxA has no geographic restrictions on use of CROs.

Do you help to find CRO/CDMOs globally? Then do you join the management?

Yes, TRxA can help identify a suitable CRO/CDMO for work needed to be performed, should the PI or institution not have existing relationships in place they may want to use. TRxA has no geographic restrictions regarding which CROs/CDMOs can be engaged to provide the required service.

Intellectual Property

Are there intellectual property (IP) considerations that I should be aware of before applying for a BRIDGe or BioBRIDGe award?

Intellectual property associated directly with the project cannot yet have been optioned or out licensed. Applicants should be cognizant of the need to preserve patent rights and disclose technology to their respective institutions’ TTO in advance of any public dissemination.

Is it required that IP protection be in place for chemical matter at the time of application in order to be considered for TRxA funding?

It is not a requirement that the technology has IP protection in place at the time of application, rather that the chemical matter may be eligible for protection (i.e., it is not disclosed in advance of any established priority date).  Ideally, the PI will discuss a prosecution strategy with their University’s Tech Transfer Office (TTO) to advance the project to a stage that an identified licensee will assume the significant costs of national filings within 30-months of priority for an application filed under the Patent Cooperation treaty (PCT). To clarify, TRxA does expect that IP will be filed under PCT, and nationalized not just in the U.S., leading to patent rights in multiple jurisdictions.

Is a granted method-of-use patent acceptable?

Typically, projects with method-of-use rather than composition of matter IP will not be competitive.

If an academic PI has launched a startup company and has the license for the IP, can the PI work with TRxA?

Once the project is licensed or optioned to a startup entity it would no longer be eligible for TRxA funding.