Drug Development Project
About this scheme
We consider applicants that:
- Have a novel cancer agent needing preclinical and/or clinical development
- All technology areas are considered, including small molecule, biological and other therapeutics
- Have supporting in vivo efficacy data
- Are based at a UK academic institution or;
- Are a pharmaceutical or biotech company (UK or international)
- Are working with a UK-based Clinical Investigator (we can help you identify one)
- Have already been in touch with our Centre for Drug Development to discuss the suitability of their proposal
Examples of eligible projects include those requiring:
- Preclinical development, including biomarkers, assays. GMP manufacture and formulation prior to a phase 1 trial
- Phase 1 trials, including phase 1a and 1b, first-in-man and first-in-class
- Combinations of unregistered and registered agents
- Early phase 2 proof of principle trials
- Studies on unlicensed agents in active commercial development that are off the company’s critical path or repurposed novel agents
Drug Development Projects are not grant funding awards. Approved projects are sponsored, funded and managed by our Centre for Drug Development (CDD), and a project team is allocated to work in partnership with you.
The CDD fund and manage the project for as long as necessary to support preclinical and early clinical development of the novel agent. This includes:
- Managed preclinical and clinical development
- Management of regulatory documents and communication with relevant authorities throughout the trial
- Protocol design and trial management
- Oversight of trial safety and clinical data
- Treatment of patients in a UK-wide network of clinical centres with world-leading scientific investigators and expertise in early clinical trials
How to apply to this scheme
Before making your application
- You must read the application guidelines
- You must discuss the suitability of your proposal with the Centre for Drug Development
Overview of the application process
Applications follow a two-stage process:
- Confidential, informal discussion with the Centre for Drug Development to establish eligibility and suitability
- Formal application and review by the New Agents Committee (NAC)
Email us to request a discussion. If required we will set up a Confidential Disclosure Agreement to protect your data.
Please include a short project outline. For us to conduct an internal review to determine suitability under this scheme, we typically require the following information:
- Project background and stage of development
- Agent manufacture information and physicochemical properties
- Target and scientific rationale, including mechanism of action
- In vitro and in vivo data including efficacy, toxicology and PK/PD
- Data or hypothesis-driven rationale for proof of mechanism biomarker and proof of principle/efficacy biomarker
- Summary of preclinical or clinical studies proposed
- The criteria that would constitute a successful study
- IP position
- Next steps in development
- Agent’s USP or competitive advantage over other similar agents in development
Key considerations we look for in projects at this stage include:
- Strength of scientific rationale
- Data package completeness
- Nature of the proposed clinical trial (patient population, stage, feasibility)
You must have a UK-based lead Clinical Investigator with relevant phase 1 expertise in your team. If needed, we can help you identify a suitable investigator from our network.
We will provide feedback on your proposal and advise if it is ready for a formal application and review.
- You must submit a full proposal with supporting data through our online Grants Management System.
- Your application is confidentially peer reviewed by international experts.
- You are invited to respond to the reviews and, if needed, supply additional data.
- New Agents Committee meeting: you will be invited to attend the meeting to give a brief overview and address any questions from Committee members. The Committee will consider your application, the reviews and your response.
- You will receive the Committee's decision and feedback within 3 weeks.
All NAC proposals and meetings are confidential.