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Hit-to-Lead Platform

Current Open RFP

GHIT Fund RFP Hit-to-Lead Platform 2019-002

The Hit-to-Lead Platform (HTLP) is designed to leverage medicinal chemistry expertise in Japan and facilitate access to Japanese companies or academic organizations’ relevant and diverse compounds for drugs development to address malaria, tuberculosis, Chagas disease, and Visceral leishmaniasis.

 

HTLP projects will focus on the aspect of the drug discovery and development process that progresses hits, identified through compound library screening, into lead compounds that can then be optimized into drug candidates. This platform will provide a bridge from early drug discovery to our product development platform that begins with the lead-optimization step.

 

The key requirement of the Hit-to-Lead Platform is to convert drug hits originated from Japanese compound libraries into lead series through a comprehensive assessment of chemical integrity, synthetic accessibility, scalability and novelty, functional behavior, and structure-activity relationships (SAR), as well as bio-physiochemical and absorption, distribution, metabolism and excretion (ADME) properties.

 

Interested applicants can find detailed information on the RFP and the Intent to Apply (ITA) form below. An ITA should be submitted first and upon an eligibility assessment, approved applicants will be notified and request to submit a full proposal to the GHIT Fund.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

August 1, 2019

Intent to Apply

No later than 10:00 am Tokyo time on September 2, 2019

Submit Intent to Apply form to HTLPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-HTLP-2019-002_Intent to Apply

Q&A

No later than 10:00 am Tokyo time on September 25, 2019

Submit questions to HTLPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-HTLP-2019-002_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on October 1, 2019

Submit proposal to HTLPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-HTLP-2019-002_Proposal

Proposals Evaluation and Interview Processes

October 2019 – February 2020

Award Notification to All Applicants

February 2020

Investment Agreement Fully Executed (Awarded Proposals)

March 2019

|Investment Process

process1

Applicants

ITA Submission

Interested applicants must complete the Intent To Apply (ITA) document and return it by email to HTLPResponse@ghitfund.org. Applicants who submit the ITA document will receive a confirmation email. Projects will require a commitment to collaborate with one of the three leading drug development PDPs: Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases Initiative (DNDi), and the Global Alliance for TB Drug Development (GATB). A partnership with a PDP needs to have been solidified at the time of proposal submission.

process2

Management Team

Eligibility Review

Applicants who successfully submit the ITA document will receive a confirmation email. GHIT Fund staff will then perform an initial partnership and scope eligibility assessment. Eligible applicants will receive a confirmation email with GHIT Fund Proposal, Timeline, and Budget templates to support proposal development. If the project does not meet the eligibility requirements, the applicant will be notified that the project as proposed is not eligible for consideration. Applicants can remedy any eligibility issues and resubmit an ITA form up until the RFP-designated due date.

process3

Applicants

Full Proposal Submission

Applicants are required to submit their completed proposal to HTLPResponse@ghitfund.org. Applicants who successfully submit their proposal document will receive a confirmation email. Proposals may not be modified after the submission due date. Proposals will initially be examined to determine whether:

  • The partnership meets GHIT Fund eligibility criteria
  • Project objectives are aligned with the RFP-specified scope
  • The proposal is complete and addresses all required content
process4

HTLP Expert Panel

Review and develop funding recommendation

Each eligible proposal will be reviewed by the External Panel, which is comprised of several experts in the discovery and development of global health technologies, each of whom possesses the experience to objectively evaluate the proposal content. All proposals passing the preliminary examination will be evaluated and prioritized based on the following criteria:

  • Scientific and technical merit (e.g., sound approach and methodology, level of innovation, overall quality and comprehensiveness)
  • Potential Impact (e.g., how it will address a global health priority)
  • Partnership and project management (e.g., collaboration capabilities and expertise, project history and performance, risk management, budget)
process5

HTLP Sub-Committee

Review and approve funding recommendation

Proposals selected by the External Panel will be passed to the HTLP Sub-Committee, which is comprised of GHIT Board of Directors and Selection Committee members who review and approve funding recommendations.

process6

Board of Directors

Review

Proposals approved by the Sub-Committee will be passed to the GHIT Fund Board of Directors whose members review investment award decisions. The GHIT Board directs portfolio strategy and awards funding using a milestone-based approach to ensure return with minimal risk.

process7

Management Team and Product Development Partners

Award Notification, Investment Agreement and Investment

The GHIT Fund will notify applicants of their selection status by email. If the proposal is selected and the applicant receives an award notification, they are required to sign the Investment Agreement with the GHIT Fund and also submit a collaboration partners contractual agreement which clearly defines the roles and responsibilities of all collaboration partners, all within one month from award notification. Please be aware that the award may be void if this condition is not met. Applicants are required to identify the designated development partner (investment recipient) and all other collaboration partners. The designated development partner will be responsible for the performance of all its collaborating partners. A representative of the designated development partner will serve as the main GHIT Fund point of contact and will be responsible for all GHIT Fund discussions and negotiations.

process8

Management Team

Initiation of Monitoring and Evaluation

Once the agreement enters into effect, the GHIT Management Team will initiate the Monitoring and Evaluation process. The data and information regarding the project will be put into the system.

process9

Management Team and Product Development Partners

Monitoring and Evaluation

To track the progress of each project, GHIT conducts progress updates twice a year. This enables us to keep track of the progress of investments and decide on whether to continue, modify, or terminate the investment contingent upon milestone achievement. With this system, data pertaining to the progress of each project is gathered via an electronic system and the GHIT Management Team holds a conference with all product development partners based on the collected data prior to the meeting.