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Challenges and opportunities for bio innovation: Views from the ON Helix 2024 conference

Last week, Adam Coughlin and Luca Cericola from Bristows’ Commercial IP team attended ON Helix 2024, an annual conference hosted by One Nucleus in Cambridge. The conference, aptly titled ‘New Horizons for Bio Innovation’, addressed key advances, challenges and opportunities in diagnostics, technology, therapeutics and ecosystems that are enabling future innovation in the life sciences industry. 

New Therapeutic Modalities

The opening session explored developments in new therapeutic modalities, such as RNA and gene therapeutics, as well as the associated regulatory and commercial considerations to support the future of these emerging fields. 

The keynote presentation highlighted that, despite small molecules comprising roughly 90% of all drugs sold globally, the pipeline of new therapeutic modalities is looking increasingly more diverse. In particular, 2023 represented a breakthrough year for cell and gene therapies (CGTs) and, with no signs of the CGT industry slowing down, companies looking to harness the potential of this (and other new modalities) should be cognisant of some common challenges to extracting maximum value and patient benefits from such modalities.[1]  

It was clear from the panel discussion, that regardless of the modality, early engagement with regulatory authorities is imperative in helping to navigate the regulatory landscape. Some of the panellists noted that, from their own experience, prompt and substantive dialogue with the UK Medicines and Healthcare products Regulatory Agency (MHRA) was crucial in helping to shape their own company’s clinical strategy and expedite the clinical trial authorisation application process. 

Despite a focus on more novel modalities, the panel also emphasised that there is unquestionably still a space for small molecules in the future. Not least due to issues of patient accessibility and the high costs associated with many new modalities, small molecules will continue to provide patients and clinicians with a range of therapeutic options. Additionally, there is a wealth of contemporaneous and historic data for small molecules, such that the implementation and application of artificial intelligence (AI) and machine learning (ML) in the small molecule drug discovery process holds real promise. 

However, on the topic of AI and ML – an inevitably pervasive subject throughout the conference – the panel stressed the importance of capturing and standardising high-quality “clean” data in order to truly leverage such technologies in the life sciences industry. Without such standardisation, it was noted that the plethora of historic data holds limited value in training AI models.

Biomarker Technologies 

Biomarkers are highly valuable tools in translational research that offer significant opportunity for steering drug discovery and development decisions. This session addressed the purported usefulness of biomarkers for advances in diagnostics, therapeutics and personalised healthcare. 

Following two insightful pitches on the potential of biomarkers within non-invasive breath analysis and digital biomarkers in neuropsychiatric research, the panel collectively agreed that one of the main challenges associated with developing biomarker diagnostic tools is the difficulty in obtaining investment. 

The panel opined that demonstrating a valuable business model to investors has often been a challenge that has held many applications of biomarkers back, with some of the most innovative biomarker companies garnering significantly less investment than typically seen within the pharmaceutical industry. In addition, in respect of collaborations between pharmaceutical and diagnostic companies, the panel noted the challenges that can arise in deal-making as a result of the disparities between the “therapeutic value” (i.e. projected sales for the therapeutic product) and the “diagnostic value” (i.e. the projected sales for the diagnostic).  

Again, navigating the complex and ever-evolving regulatory landscape also continues to present significant challenges to companies wishing to develop and commercialise biomarker applications. 

On the obligatory question of the application of AI and ML in this space, the panel agreed that (again dependent on the quality of data available) there are some exciting potential applications of such technology in this space, including the possibility of AI- and ML-assisted diagnosis of neurological disorders using data captured from an individual’s personal mobile device. Whilst not addressed specifically during the panel, this sort of use case would invariably pose numerous legal considerations… best reserved for a future article!

TechBio – Is it truly simplifying complexity?

Techbio is generally understood to encompass leveraging cutting edge data-driven techniques and technology to impact all facets of drug discovery. Now more than ever, it is a ubiquitous topic in the forefront of the minds of those operating in the life sciences industry. 

This sentiment was echoed throughout the conference and, as alluded to above, the main theme concerned the importance of collecting structured, standardised data in order to obtain meaningful outputs from any employed AI or ML technologies. Furthermore, training AI models requires both significant computational power and vast amounts of data, such that novel therapeutics lacking swathes of available data may struggle to make best use of such models.

A final point of note from the conference came from a live hacking demonstration that showed, in real-time, the consequences of unwittingly falling foul of the dreaded phishing email link. Intellectual property is one of (if not the most) important assets to companies operating at any level in the life sciences sector; however, it is particularly important to early stage life sciences companies trying to obtain financing. Therefore, such a compromising breach, where a hacker gains control of a company’s data and confidential files, is nothing short of catastrophic to the company’s prospects. If nothing else, the demonstration proved a stark reminder of the importance of robust IT/data security and infrastructure.

Concluding remarks

Amidst the complex topics addressed throughout the conference, one thing was certainly clear – there is an abundance of innovation across the sector, with exciting new modalities, treatment options and technologies on the horizon. However, companies operating in the industry must be aware of, and actively take steps to address, the various challenges that could diminish the potential of such innovation.  

Thank you to One Nucleus for arranging an excellent event and we already look forward to next year’s instalment! 

[1] We reported on the insights gleaned from One Nucleus’ BioWednesday panel event on deal-making for CGT companies in this article last month. 

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biotech, health tech, life sciences, life sciences regulatory, technology, article