You should not apply for this call if:

• You intend to carry out activities which involve the transfer of funds into mainland China.
• You cannot demonstrate that you can dedicate enough time and resources to the project, if funded.
• You are already an applicant on two applications for this funding call:
  • you can only be a lead applicant on one application and a coapplicant on one other application
  • you can be a coapplicant on two applications
• You must demonstrate that you have sufficient capacity for both projects if funded. The applications should be for different projects with no overlap of activities.
• You already have applied for, or hold, the maximum number of Wellcome awards for your career stage. Find out how many Wellcome awards you can apply for, or hold, at one time depending on your career stage.
• Your project is not within the remit of this call. Check what kinds of research projects are not in scope for this funding call.

Any eligible organisation must sign up to Wellcome’s grant conditions and grant funding policies. We expect organisations based in the UK to meet the responsibilities required by the Concordat to Support the Career Development of Researchers for institutions, managers and researchers. Any organisation with Wellcome funding that is based outside the UK is expected, as a minimum, to follow the principles of the Concordat.

We also expect organisations to: 

• Guarantee that the space and resources you need have been agreed and will be made available to you from the start date through to the end date of the award.
• Explain how your research fits with the strategic aims of the organisation.
• Give you, and any staff employed on the grant, 10 days a year (pro rata if part-time) to undertake training and continuous professional development (CPD) in line with the Concordat. This should include the responsible conduct of research, research leadership, people management, diversity and inclusion, and promotion of a health research culture.
• Provide a system of onboarding, embedding and planning for you when you join the organisation and/or start the award.

Collaboration agreements

If your application involves a collaboration or partnership between multiple organisations, the partners must enter into a suitable collaboration agreement, including provisions that cover:

• confidentiality
• publication rights

If there is potential for foreground intellectual property, the collaboration agreement must include provisions on:

• access to background intellectual property
• ownership of foreground intellectual property
• arrangements for the protection, management and exploitation of foreground intellectual property

The lead applicant’s administering organisation is required under our grant conditions to own all the foreground intellectual property arising from the project and to take the lead in any commercialisation activity. For guidance, applicants are advised to read Wellcome’s intellectual property policy.

What your proposal must include

Please also refer to the assessment criteria to inform what your proposal must include.

• Novelty: A clear explanation as to the target’s novelty with supporting evidence.
  • By ‘novel targets’ we mean those that are not currently the subject of ongoing drug discovery and development programmes for any of the in-scope conditions, based on currently available public information. For instance, if there is an existing phase I drug candidate for target A in depression, proposals on target A would not be considered novel in this funding call.
  • Alternatively, we will consider target novelty in other ways. For example, a novel binding site on a non-novel target; a new approach to a target that has been investigated previously but where resulting drug development has been unsuccessful; or other innovative target approaches.
  • Proposals adopting a precision-psychiatry approach alone would not be considered novel. Instead, this should be considered on top of target novelty.
• Rationale and evidence: A clear rationale supporting the target including the therapeutic concept (for example, detailing the mechanism of how target modulation would lead to clinical efficacy). The applicant should consider the latest converging lines of evidence and the latest relevant knowledge on the target.
• Patient impact: A clear description of the potential patient population with appropriate justifications as to why the symptom(s) are a priority focus for people with lived experience. There must also be a description of how the proposal has the potential to create a step-change in early intervention.
• Proposal plan: A feasible plan to generate a robust validation data package supporting the target’s therapeutic potential.
  • The plan should include experiments to demonstrate:
    • the target’s potential for modulation by a drug,
    • target modulation leading to clinical efficacy,
    • and target-based safety
  • We encourage applicants to consider how their data package would encourage the inclusion of under-researched populations in future drug development programmes. The plan should have appropriately justified go/no-go milestones and cover the development of/access to necessary tools.
• Expertise and skills: Clear evidence to show that the team and any consultants is comprised of necessary expertise. The team must include at least one person with knowledge relating to the biological mechanisms of the relevant mental health condition(s). Proposals should clearly describe and justify the role of each team member and any consultants.

Relevant research activities include, but are not limited to, the use of:

• in-vitro models/assays including cells, iPSCs and organoids
• in-vivo mechanistic animal models/studies including knockouts
• in-silico target modelling and structural biology
• ex-vivo animal models, such as animal brain culture slices
• computational neuroscience, including neural circuit and network analysis
• electrophysiology
• imaging
• bio- and chemo- informatics and structural biology
• genomics, including CRISPR technology
• proteomics and transcriptomics including mRNA interference, if focused on validating a specific target
• optogenetics and chemogenetics
• in-vivo human studies if focused on novel target validation
• development and/or use of molecular tools for the purposes of target validation
• drug repurposing with a novel target and a focus on target validation

If you are conducting studies with human participants or animals, refer to our relevant policies:

• Research Involving Human Participants
• Use of Animals in Research
• Clinical Trials Policy

Research that is not right for this call includes:

• Validating targets for mental health problems outside of the in-scope conditions. For example, eating disorders, attention-deficit hyperactivity disorder or substance use disorders.
• Research on non-pharmacological interventions.
• Research on target identification (genetics/genomics data) or research that is focused on generating hypotheses for target validation. Target identification research should be completed prior to this award.
• Research exploring or developing new animal or cellular models with no validation of novel targets.
• Hit screening campaigns or similar drug discovery projects.
• Drug repurposing without a novel target.
• Research using holistic animal disease models that have limited/no mechanistic understanding.