Clinical trials and AI – legal challenges and pitfalls: Penningtons Manches Cooper’s inaugural life sciences conference

Posted: 12/12/2024

The life sciences sector group at Penningtons Manches Cooper chose the topic of AI for its inaugural life sciences conference, given its relevance to all life sciences companies wishing to put their products into clinical trials, both now and in the future.

The conference began with its keynote, ‘Unlocking Potential - Using AI in Clinical Research’, delivered by Professor Martin Wilkins, professor of clinical pharmacology at Imperial College London. Martin provided an overview of the various ways in which AI is being used in clinical research, with detailed examples to bring the subject to life. This set the scene for the remainder of the conference.  
 
Partner Lisa Page presented the next session, ‘Harnessing AI for Clinical Trials: Navigating the Options and Ensuring Regulatory and Data Protection Compliance’, alongside partner Joanne Vengadesan, who covered the data protection aspects. Lisa provided examples of the transformative impact of AI on clinical trials, with a particular focus on the use of AI on pre-existing clinical data, looking at the legal considerations for ownership and licensing of data to drive an AI model, and examples of how that works in practice. 

Joanne finished the session by providing example data flows and case study data protection analysis when AI is utilised as part of a clinical trial. This prompted a number of questions from attendees, as this area of law is particularly challenging for organisations seeking to use AI in clinical trials. 

The conference’s remaining sessions were then led by three excellent external speakers.

Professor Steve Niederer, from The Alan Turing Institute, provided insights into the FDA’s approach to the evaluation of modelling and simulation evidence, and the evolution of its thinking behind this. He discussed the evaluation of modelling and simulation evidence guidance and provided fascinating real-world practical issues for organisations to consider when looking at potential future uses of this type of evidence.

Cécile Théard-Jallu, partner at De Gaulle Fleurance, then spoke about the European landscape of AI and data regulation and covered the huge breadth of the key regulatory requirements in Europe. This was complemented by useful examples of her expertise in helping clients in the life sciences sector navigate those key healthcare sector regulations related to their products and services.

Danish Memon, team lead bioinformatician at Molecule to Medicine (MTM), described the organisation’s use of AI specifically as it relates to the analysis of high-resolution biological data sets, in preclinical analyses and to integrate precision medicine in clinical trials, with a real world example of MTM’s OncoSelect Grant project, to build a platform that can develop predictive biomarkers in renal cell carcinoma.

The day concluded with a panel session on the real world applications of AI in clinical trial data. The industry speakers returned and were also joined by Shini Pattni, head of legal at Lindus Health, an ‘anti-CRO’ that makes extensive use of software and AI. She provided examples of Lindus’ use of AI in clinical trial design. The discussion covered other examples from the panel on their current and future use cases for AI and the challenges they are currently facing, as well as the ‘black box’ nature of AI systems, their transparency and explainability, and the value of patient stratification. 

The conference was well received by participants and the life sciences group looks forward to continuing the discussion on this incredibly topical subject. 

The new world of AI in clinical trials is here, and we as specialist life sciences sector lawyers are up-skilling ourselves to be able to advise our clients and help them to navigate this changing landscape. If you would like to receive advance notification of future life sciences events that we run, please email rich.morley@penningtonslaw.com. 

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