• Status: Closed

  • Key features: Investment of up to £8 million in collaborative R&D projects to stimulate the development of regenerative medicines and cell therapies in the UK

  • Programme: Collaborative research and development

  • Award: Up to £8m

  • Opens: 08 Jul 2015, 00:00

  • Registration closes: 26 Aug 2015, 12:00

  • Closes: 02 Sep 2015, 12:00

  • Support phone number: 0300 321 4357

Developing regenerative medicines and cell therapies

Summary

Innovate UK is to invest up to £8 million in collaborative R&D projects to stimulate the development of regenerative medicines and cell therapies in the UK.
 
The aim of this competition is to address the challenges of developing regenerative medicines and cell therapies as clinical treatments and commercial products. We are seeking proposals that advance the development and commercialisation of novel regenerative medicines and cell therapies. The focus is on the preclinical testing, clinical development and manufacture of regenerative medicines and cell therapies, and the development of underpinning tools and technologies.
 
Proposals must be collaborative and led by a business. We expect to fund mainly industrial research projects. Small businesses could receive up to 70% of their eligible project costs, medium-sized businesses 60% and large businesses 50%.
 
We expect projects to range in size from total costs of £500,000 to £2.5 million, although we may consider projects outside this range.
 
This is a two-stage competition that opens for applicants on 8 July 2015. The deadline for expressions of interest is at noon on 2 September 2015.
 
There will be a briefing webinar for potential applicants on 16 July 2015

Scope 

Turning promising discoveries into therapies, products, services and sustainable businesses is crucial if the UK is to fulfil its potential in the commercialisation of regenerative medicine and cell therapies. It calls for truly innovative thinking and strong interdisciplinary collaboration, with projects linking to the engineering, manufacture, distribution and supply of potential new treatments. This competition aims to advance the commercial development of regenerative medicines and cell therapies, by supporting a number of projects that together will connect up the research pathway, from early discovery to clinical development and commercial application. 

We are looking for projects that address one of the following two streams: 

  1. support for clinical development of novel therapies 
  2. support for development of enabling platform tools and technologies 
Stream 1: Some of the specific clinical development issues that products face, and that proposals in this competition could address, may include (but are not limited to) one or more of the following: 
 
  • preclinical, eg testing for safety and/or efficacy, developing quality control protocols and metrology of identity, purity and potency for particular products
  • formulation and delivery, eg incorporating products into delivery devices and scaffolds, delivering product combinations, optimising delivery efficiency 
  • clinical trials, eg preparing for regulatory submission, preparing clinical plans and embarking on early stage (Phase 1 and 2) clinical studies
  • scale-up and manufacturing, eg planning and executing manufacturing of batches for preclinical and clinical studies, overcoming scale-up problems

Stream 2: Particular challenges faced by developers of regenerative medicines and cell therapies include the ability to assess the safety and/or efficacy of therapeutic products, or challenges in being able to develop reproducible and robust manufacturing processes. The focus of projects should therefore be around key platform technologies to address:

  • product safety and/or efficacy, eg animal and in vitro models, imaging technologies, biomarker analysis, monitoring 
  • manufacturing challenges, eg bioprocessing, cell control and differentiation, product characterisation, cell sorting, solutions around formulation and delivery, transportation, storage, tracking, automation 

We welcome applications using nascent gene-editing technologies, such as CRISPR-Cas9, to address relevant issues outlined above. 

For projects that are closer to the market, we encourage proposals to address broader challenges in advancing the path to commercialisation. These may include proposals to update current practices around regulatory submission and validation, outcome monitoring and assessment, reimbursement and economic modelling, as well as novel business approaches.

Out of scope 

In this competition we are not funding projects relating to the discovery of new therapies.


Key dates

 

Competition opens  8 July 2015
Competition briefing webinar 16 July 2015
Registration deadline noon 26 August 2015
Expressions of interest (EOI) deadline noon 2 September 2015
Stage 2 opens for invited applicants 28 September 2015
Deadline for invited applications 4 November 2015