New Agents Committee Trials Funding

The New Agents Committee (NAC) provides a one-step process for selecting new anti-cancer treatments and diagnostics and taking them into early clinical trials.

The NAC was set up by Cancer Research UK's Drug Development Office (DDO) in 1998. All submissions to the NAC as well as meeting are confidential.

The NAC meets four times a year and comprises clinicians expert in early clinical trials of novel agents as well as other experts in drug development.

Research Areas

The NAC reviews, selects and funds novel, unregistered, anti-cancer agents for:

• Exploratory and preclinical development
• Phase I trials, including First in Man
• Combination trials of unregistered and registered agents
• Early Phase II hypothesis-testing clinical trials

About NAC funding

NAC trials are managed and sponsored by Cancer Research UK's Drug Development Office (DDO) and run in academic clinical centres throughout the UK.

The NAC will assess:

• The novelty of the proposed target and/or anti-cancer agent.
• The scientific rationale for the target and for taking a new therapeutic against this target into man.
• The adequacy of the preclinical data package to support clinical development.
• The quality and feasibility of the clinical research proposal.
• The translational research aspects of the proposal, e.g. pharmacokinetic, pharmacodynamic, immunological, biological and functional imaging endpoints.

To check whether the NAC is the right committee for your trial, please see our Guide to Which Clinical Trial Funding Scheme to Apply For (PDF, 19KB).

NAC funding managed by the DDO can include:

• Process development;
• Drug characterisation & physico-chemical analysis;
• Formulation development;
• Stability studies;
• Preclinical toxicology/safety studies;
• GMP manufacture;
• Clinical trial supplies;
• Clinical assay development & validation

NAC grants can provide clinical trial and laboratory funding in the UK, e.g. to support assay work in connection with the trial.

The NAC is interested in proposals for scientifically-driven trials of any novel cancer agents and has a current, strategic focus on:

• Combinations of molecularly targeted agents
• Early clinical trials for indications with an unmet clinical need
• Hypothesis-testing Phase II trials
• Promising cancer agents de-prioritised by companies, via the Clinical Development Partnerships initiative.
• Paediatric trials

Eligibility

Individuals based in academic institutions and industry collaborators worldwide are eligible to submit proposals to the NAC.

Trials are only carried out in the UK and grant funding can only be provided at UK institutions.

Where a grant is part of the proposal, applicants should refer to the standard Cancer Research UK funding Terms and Conditions.

Period of funding

A project budget and DDO staff to manage the development process are allocated for the duration required to develop the agent and undertake the trial.

Funding is provided for an average of 24 months. The length of time awarded depends on how long support is required, and can be justified, for that part of the project.

Funding value

No set value. NAC decisions are made on the basis of scientific and clinical merit and development budgets are allocated as required. For all full proposals the DDO prepares a resource paper with estimated costs following discussions with the applicant.

How to apply

Applicants should email a brief outline proposal to Dr Juliana Callaghan Team for an informal discussion. The outline should include, if possible:

• Project background and stage of development
• Nature of agent(s) (e.g. small molecule, antibody, cell or gene therapy) and any information on manufacture /production and physicochemical properties
• Target and rationale
• Any in vitro and in vivo data, including; mechanism of action, efficacy, toxicology, PK/PD and, if appropriate, combination data
• Summary of studies proposed (non-clinical, clinical)
• Summary of IP if known

The DDO will then provide advice regarding your NAC application and whether to submit a preliminary or full proposal. Relevant issues include the novelty and strength of the scientific rationale, the completeness of the data package, and the nature of the proposed clinical trial.

Preliminary proposals are given feedback and, if approved, can be resubmitted as a full proposal. Full proposals are scored and, if successful, are approved. If the NAC considers that a full proposal requires additional data the application maybe treated as preliminary.

To apply to the NAC, you will need to submit the following:

1. NAC general proposal form
2. NAC supplementary forms as appropriate (Novel Biotherapeutics, Small Molecules, Combination Toxicology, Trial Grant Form)
3. A written proposal with all supporting data appended and send to the address below.

Submission deadlines

Additional notes

Review Committee: New Agents Committee

All NAC proposals and meetings are confidential.

NAC proposals are also reviewed by the Pharmacodynamic/Pharmacokinetic Technologies Advisory Committee (PTAC). For further information see PTAC guidelines (also available from the right hand navigation.)

Applicants with full proposals are invited to attend the NAC meeting to address any questions or issues that the Committee raise.

Contact details

For enquiries about this scheme, please contact:

Kate Searle
Research Manager (Drug Development)
Drug Development Office (AH)
Cancer Research UK
PO Box 123
61 Lincoln's Inn Fields
London
WC2A 3PX
UK

Tel: +44 (0) 20 7121 6929
Email: kate.searle@cancer.org.uk