Experts at The University of Nottingham are among 17 research and development teams across Europe to be awarded £100,000 each to help solve five of the pharmaceutical industry’s biggest drug discovery and development challenges – where the replacement, reduction and refinement of animals in research (the 3Rs) is a central goal.
Chris Denning, a Professor in Stem Cell Biology in the School of Medicine, will lead a research project aimed at generating physiologically-relevant 2D and 3D cell-based models to replace the use of animals in studies to test how new drugs developed for a range of diseases affect the heart.
The CRACK IT Challenges programme, which has awarded a total of £1.56m for proof of concept studies, is an open innovation platform set up in 2011 to solve scientific and business problems with a 3Rs theme. It is led by the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).
The latest round of preclinical challenges, identified with companies such as GlaxoSmithKline, Pfizer and Roche, focus on the development of new non-animal drug safety assays, a virtual infectious disease research platform and an approach to reduce animal use in the development of chronic inflammatory disease treatments.
Unexpected side effects of many drugs on the cardiovascular system are one of the most common reasons why a new drug fails to reach the market. Important classes of drugs, such as the anti-cancer tyrosine kinase inhibitors, face particular safety challenges in this area, with dogs and mice typically used for their safety assessment. While there is currently no reliable approach available for cardiotoxicity studies using human cells, assays using induced pluripotent stem cell-derived cardiomyocytes have shown promise.
Professor Denning will head one of three teams tasked with the Challenge of using these cells to generate physiologically-relevant 2D and 3D in vitro models to replace the use of animals in these studies and reduce the number of animals required to assess the mechanism of action of drug-induced effects. Once validated, such a platform could be used widely to screen drug compounds and provide earlier go/no-go decisions on the further testing of drug candidates that would otherwise fail in later development.
CRACK IT’s staggered funding approach enables applicants to look at higher-risk, more innovative technologies.
Phase One finalists will have six months to develop the most successful proof-of-concepts for each of the five preclinical challenges, with the most successful group winning a three-year contract per challenge of up to £1m for further development and validation. This approach is intended to improve the chances of viable products emerging onto the market from the programme.
The competition was run through the UK’s innovation agency, the Technology Strategy Board, as part of the Small Business Research Initiative – with a total budget of £7 million. This includes £2 million from the government-backed Technology Strategy Board – a doubling of its contribution compared with the previous year.
Stephen Browning, Head of SBRI & SMART at the Technology Strategy Board, said: “It’s great to see the NC3Rs expanding the use of SBRI as part of the CRACK IT programme to enable SMEs and start-ups coming from universities to develop new and innovative technology solutions to reduce the need for animals in research and testing.”
Dr Vicky Robinson, Chief Executive at the NC3Rs, said: “In many cases drug-induced toxicity results in a significant number of new drugs failing before they reach the market place; often this is not identified until animal studies have taken place. By developing more predictive technologies and approaches for use in the earliest stages of drug development, industry scientists will be better equipped to identify whether a new drug is suitable for later-stage testing in animal studies and humans. This is not only more cost-effective, but has the potential to significantly reduce the number of animals needed overall.”
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