Are there ‘hidden costs’?
As a charity, we work to help research get to the patient, not to make money:
We are not a contract research organisation (CRO) or a biotech and we don’t charge you.
We invest our money in de-risking your diagnostics so that they can be partnered with industry. You will be funding your own research.
This is a truly collaborative model and any research tools, value or income generated will be accessible by you and/or shared with your organisation.
What happens to my IP and will I lose control of my project?
Working together we can progress patient diagnostics:
- We work collaboratively with academic organisations, SMEs and industrial partners from all over the world.
- You will be able to work closely with our scientific experts and will be part of the team as projects progress. You retain your IP, we bring the diagnostic expertise.
- We carry out project management on your diagnostic, relieving you of the burden.
- We can identify best route to clinic for your work.
What does de-risk actually mean?
Your project might demonstrate promising early stage clinical utility but industry is typically looking for well validated, robust assays with well characterised performance characteristics on clinical samples. We help add this value to your work. As part of the project management team you will work closely with us to collaboratively develop the diagnostic.
How do you fund the work?
We work closely with you and your organisation to negotiate any partnership. If a project is successful and can be partnered with industry, we ensure any income from industry partners is secured and distributed equitably. We would want a share for our work and make sure you got an equitable share for yours. Our share goes on to fund further collaborative work. You retain your background IP.
What do I / my organisation get?
- Access to diagnostic assay development specialists with expertise on a number of platforms and detection technologies.
- Assay development to industry quality standard.
- Robust assay development, standardisation and validation.
- Access to our scientific and clinical network.
- Work carried out under a Quality Management System.
- Dedicated project management.
- Business development to commercialise your opportunity.
- Potential tools for research use.
- Your research will hopefully progress to the clinic where it can have a positive impact on patient lives.
What sort of projects do you work on?
We have collaborated with Renishaw Diagnostics Ltd. to develop an antimicrobial resistance assay for use on their proprietary technology platform. Our criteria are:
Unmet medical need
We will consider any disease area, providing there is unmet medical need. However, we currently have a preference for diagnostics in the areas of personalised oncology, antimicrobial resistance, neuroscience and respiratory diseases.
We develop diagnostic assays against defined molecular targets. Ideally credible basic research assays will have been used to generate convincing data to suppor the diagnostic hypothesis.
We develop diagnostics against novel or known targets where a novel assay offers clinical benefits like higher sensitivity. We are interested initially in RNA/DNA-based diagnostics.
What is the application process?
First you need to speak to someone in our dedicated team. As scientists, they understand your work.
Next we ask you to complete an initial online non-confidential application outlining your diagnostic. We have regular reviews as listed on our website.
The form then goes to our review team who will compare your work against the literature and assess clinical need in order to make an initial assessment. At this stage we may suggest that you carry out additional work.
If appropriate, we may commence feasibility work, e.g. assay evaluation. This would usually involve running your assay in our laboratories and assessing its performance with additional samples, alternative reagents or platforms. If feasibility work is successful, we agree terms of collaboration with you and your organisation and move to project launch.
At this stage a project team is created with you and the Centre for Diagnostics Development (CDD). We would then agree a body of work (‘deliverables’), based on requirement specifications that would be deemed necessary to progress the diagnostic to a viable commercial prototype.
Are there other things you will consider in an application to collaborate?
It is important to understand how the diagnostic test will lead to an improved clinical outcome. The resulting assay must also address a market need and have a unique position over other similar tests in the field.
Data that shows clinical significance of the analyte target is desirable. If data is emerging then a proposed mode of action and rationale regarding how the target fits with clinical utility is desirable. In addition, clarity around the target sensitivity required to perform clinically meaningful tests is needed.
Access to reagents and controls
Reagents, controls and test material required to develop the assay should ideally be readily available. To that end, sources of materials at scale are desirable. Ideally, these will include binding molecules, reporter systems, controls, clinical samples and sources of purified analyte.
Understanding the extent and experience of your in-house team will help us identify gaps (if any) as the project progresses through to a commercial end point. We also need to know if your team can transfer the technology through the development life cycle or are involved in subsequent business development or technical sales.
Freedom to operate
We will carry out searches of the relevant intellectual property around the proposed diagnostic target. This will include reagents and assays and other markers against the clinical condition. It is important that we and our collaborators have the necessary freedom-to-operate before commencing a diagnostic development project.
Potential to generate protectable intellectual property
It is desirable to have background IP protection or the potential to generate patentable IP around the relevant diagnostic assay or target analyte developed under the program. However, it is not essential.
We can progress diagnostic assay development projects to the point of demonstrating clinical utility and early pre-clinical validation. We then seek to identify a partner to progress this further.