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8th October 2024
The pathway through to translation is often called the ‘valley of death’ in research, where preclinical promises within academia can turn to disappointment as it is pushed further along. This is an oft trodden path within neuroscience, where there have been particular challenges to achieving successful translation of new treatments for treating disorders of the brain and nervous system. The process of translation goes beyond just industry and academia to encompass other interactions, with research funders, clinicians, government and regulators.
On 11 May 2022, the BNA held a meeting on Improving translation in neuroscience at the Sainsbury Wellcome Centre in London. This meeting brought together representatives from industry and academia, as well as charities and funders, to explore some of the key factors inhibiting effective translation of neuroscience research, and opportunities for overcoming these in the future. The findings presented many useful tips for improving translation.
Here are some recommendations for achieving succesful translation from experts in the field:
Dr Jina Swartz suggests a translation relay team, with translation like passing a baton in a relay race...
For academics to engage at an early stage with a commercial partner, reproducibility is key. Reproducibility of data needs to be demonstrated to provide confidence for the commercial partner that the preclinical data are reliable.
While many academics transition into industry roles, there is a very different research base in industry, where interactions with different teams or areas of expertise are fostered.
Industry has a heterogeneity, requiring divergence of geographies, expertise, study conduct and standard of care.
While academia can be highly specific with strengths in conceptualisation, industry is more broad-base in approach with a greater breadth of expertise, allowing research to be pushed forward.
Funding can be challenging in academia, and where the funding comes from can influence what they can do with it. Industry too has its own set of funding uncertainty - if an industry project is not showing it can compete, this can be ruthlessly cut at relatively short notice.
Safeguarding of IP, and licensing in terms of IP rights and patents is key for a successful collaboration.
Even at the earliest stage of translation, there needs to be up-front thought given to what will need to be successfully demonstrated to regulators to take a product from bench to bedside. Within neuroscience, challenges can arise from its lack of biomarkers that can easily demonstrate effect to a level acceptable to regulators. For example, the Biogen drug Aducanumab for Alzheimer’s disease received a licence in the US from the Food and Drug Administration, but the European Medicines Agency did not grant a similar licence based on the clinical trial data failing to demonstrate clinical benefit.
Industry tends to be risk averse, opting to invest where there is a safe bet for a return. It is therefore important that academia considers upfront what the level of risk is, and how to counter/manage this.
While academic researchers can be more easily maintained if funded, in industry the focus is changing all the time so maintaining it can be challenging – particularly within fields perceived as high risk such as neuroscience.
Professor Geraint-Rees, Vice-Provost (Research, Innovation & Global Engagement) at University College London sets out how he believes a successful translation pathway should be structured like an ecosystem requiring strong fundamentals to foster excellence...
Linking AI neuroscience and computational excellence at the Gatsby Computational Neuroscience Unit, located alongside experimental neuroscientists at the Sainsbury Wellcome Centre, has fostered collaboration and enabled them to tap into expertise in algorithmic governance.
A solution to combat miscomprehensions about the different academia-industry perspectives is immersion in the other end of the translational pathway. For example, basic scientists immersing themselves in an operating theatre to try to understand all the elements of the clinical pathway and complexities of patient journey.
Geraint highlighted the role of what he described as the “underappreciated businesses”, technology transfer companies, to help translation to flourish. Translational research offices can also act as further support for academics looking to translate their research by providing additional expertise that the tech transfer company could not take on, such as critical project management for academics.
Here is some advice on how, as a sector, we can improve translation in Neuroscience.
Transparency and usefulness of research
There is often a lack of transparency born from a fear of one company being scooped up by another, however there is a responsibility on academia and industry to maximise use of resources by avoiding unnecessary duplication of efforts, while also helping to ensure reproducibility of research. This lack of transparency can lead to a lack of trust, between project partners and in the research overall.
We can improve this from the outset by being open with expectation about IP and publication at the very beginning. Researchers should make data as open as possible, utilising tools such as e-lab notebook to build credibility in the work. A BNA initative to help increasing transparency and usefulness of research is our Credibility in Neuroscience campaign. The campaign's vision is to ensure that neuroscience research is as robust, reliable, replicable, and reproducible as possible; in short, to ensure the credibility of neuroscience.
Good Engagement
The interpersonal relationships between academia and industry are at the heart of successful translation. Institutions such as the University of Sheffield have established institutes of translational neuroscience, where other institutes can learn and implement training on how to engage to foster successful translation. Engagement also needs to expand past simply academia and industry to include clinicians, the NHS, funders such as Innovate UK, and the relevant regulatory authorities.
The BNA aims to provide simple guidance to help exchange understanding on what works well, along with increased opportunities for academia and industry to meet on a topic-specific basis. This is showcased successfully in the response to The Psychiatry Consortium's webinar series, Building bridges along the psychiatric drug discovery pipeline. The series has encouraged more topic based collaboration events, for instance with Eli Lilly on Treatments of Pain in Sheffield. Culture within academia also needs to be shifted to support mobility between both sectors, ensuring that academic researchers who collaborate with industry are valued. The BNA will continue to provide opportunities for workshops between academia and industry to share best practice.
Effective Collaborations
For collaboration to be effective there needs to be a facilitative environment that promotes networking, engagement and enables academia and industry to share best practice and advice. Ensuring that data is presented to potential partners at the right time and in the right format is key to effective collaborations and ensures studies have sufficient power to build industry confidence.
During BNA's Improving translation in neuroscience meeting, it was suggested that industry and academia can take a bolder approach to promote translation. This might be by publishing a collaboration whether it shows positive or negative results and being more comfortable with the idea of failure. Effective collaborations can also be fostered by shifting the regulatory thinking away from phenotypic disease to a more pathway-driven, involving patients in seeking input in what collaboration should determine are the endpoints.
The BNA aims to help improve awareness of the importance of translation and neuroscience course organisers in HEIs should seek to include information on translation where possible, for example by inviting guest speakers from a range of industry to share knowledge related to research. Find out more about our Collaborations within neuroscience and how they can help secure the future and inclusivity of the sector.