The NAC was set up by Cancer Research UK's Drug Development Office (DDO) in 1998. All submissions to and meetings of the NAC 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. NAC expertise includes:

Eligibility
The NAC will consider proposals from individuals based in academic institutions and industry collaborators worldwide for undertaking:

• the late stage preclinical development of a novel agent for clinical trial; and/or
• the testing of a novel agent in mechanistic/Phase I clinical trials in the UK; and/or
• the testing of a novel agent in early Phase II clinical trials in the UK.

On approval of a project, the NAC allocates Drug Development Office staff resources to manage the drug development process for the duration of the project, including: preclinical and clinical project management, monitoring and data management.

The NAC can also allocate funding to the project budget for:

• manufacture, toxicology, formulation development;
• clinical trial and laboratory support in the UK in the form of a grant to provide, e.g. clinical assay development and validation, a research nurse, a clinical research fellow.

Assessment Criteria
In assessing the quality of a proposal, the NAC gives consideration to the following issues:

• The novelty and strength of the scientific rationale.
• Whether the structure of a compound and its mechanism of action are novel.
• How important scientifically are the answers to the questions which can be tested by the proposal.
• What is the clinical need which could be met by the development of the treatment as a product.
• The quality and completeness of the preclinical data.

In addition, new applications are also reviewed by the Pharmacodynamic/Pharmacokinetic Technologies Advisory Committee (PTAC).

Guidelines are available to advise potential applicants on what is required by PTAC for a full review of each proposal. It is recommended that applicants read these guidelines before submitting an application to the NAC.

For further information about PTAC and NAC guidelines can be found in Resources the box on the right

Period of funding
DDO staff resources are allocated to NAC approved projects for the duration of the project.

NAC grants are only awarded to provide support in the UK for an approved NAC project and are for an average of 2 years. The length of time awarded depends on how long the support is required and can be justified for that part of the project.

Applications for extensions to NAC grants are considered if they can be fully justified by the project plan.

Place of tenure
Applicants with NAC proposals can be based anywhere in the world. However, NAC approved trials can only be undertaken at a UK clinical centre and NAC grants can only provide support for an NAC trial at a UK university or clinical centre.

Value
No set value. NAC decisions are made on the basis of scientific and clinical merit. For all full proposals the DDO prepares a resource paper with costs and DDO staff resource requirements following discussions between the applicant and a DDO representative.

Number offered
10 new agents were approved by the NAC and taken on by the DDO in 2007. Cancer Research UK's Drug Development Strategy aims to increase the number of new agents taken on by the DDO.

Apply
The decision whether to submit a preliminary or full proposal is taken by the applicant in conjunction with the Drug Development Office. Relevant issues will include the novelty and strength of the scientific rationale in the proposal, the completeness of the data package, and the nature of the proposed clinical trial.

Prior to submitting an application, preliminary discussions on the proposed project should take place with the DDO. Please contact:

Victoria John
Head of Clinical Partnerships
Cancer Research UK
P O Box 123 61 Lincoln's Inn Fields
London
WC2A 3PX
UK
Tel: +44 (0) 20 7121 6965
Fax: +44 (0) 20 7121 6901
Email: drugdev@cancer.org.uk

A full proposal consists of the following information (documents can be downloaded from the Resources box on the right):

1. A completed NAC General Proposal Form;
2. NAC supplementary form(s) as appropriate:
   • Novel Biotherapeutics Form
   • Small Molecules Form
   • Combination Pharmacology and Toxicology Form
   • Clinical Research Fellowship/Grant Form. For further information about applying for a clinical fellow to support an early clinical trial.
3. A written summary according to the instructions/guidelines - these can be downloaded from Resources Box on the right;
4. Appropriate data to support the application;
5. A resource paper prepared by the DDO following discussions between the applicant and a DDO representative with time-lines, costs and DDO staff resource requirements.

A preliminary proposal can consist of as much of the above as the applicant chooses to submit or has available, (excluding item 5, the DDO prepared resource paper).

Preliminary proposals are designed to obtain an indication, in principle, from the NAC of likely interest in the study. The NAC might also indicate what additional data should be provided in a full proposal.

If a preliminary proposal is approved it can be resubmitted (if necessary revised and with additional data) as a full proposal for final approval and resource allocation at a later NAC meeting.

Please ensure that the images and diagrams contained in your proposal are reproducible and can be read and understood when printed in black and white.

To submit an application for a project, please complete the appropriate form (Word file, downloaded from the Resources box on the right) and return to the attention of:

Kate Searle
New Agents Committee (NAC) Research Manager
Cancer Research UK
P O Box 123
61 Lincoln's Inn Fields
London
WC2A 3PX
UK
Fax: +44 (0) 20 7121 6901
Email: drugdev@cancer.org.uk