Urgent collaboration is needed to tackle challenges around AI regulation and use in life sciences, say experts.
A survey by the Pistoia Alliance reveals that 70% of life sciences experts recognise AI’s potential, but struggle to get started or implement it at scale.
The findings emerged at the Alliance’s largest ever European conference, ‘Collaborate to Innovate’.
Speakers included pioneer of structural bioinformatics Dame Janet Thornton, lead scientist for the FDA Global Substance Registration System, Dr Larry Callahan, and experts in R&D from AbbVie, AstraZeneca, GSK, Elsevier, Roche, and J&J.
Dr Becky Upton, president of the Pistoia Alliance, said, “The impressive attendance at our conference is testament to the willingness of the industry to collaborate and overcome common research and legislative hurdles.
“As technology develops at pace, the life sciences sector cannot afford to fall behind. Companies must run this race alongside each other, as a unified front, to ensure that everyone benefits equally from AI.”
The survey also revealed worries around AI’s trustworthiness, with 63% of respondents expressing concern that poor data quality could lead to incorrect AI conclusions and potentially harmful clinical decisions.
Data quality was also a central theme of the keynote talk given by Dr Callahan who discussed the Pistoia Alliance’s influence over the widespread adoption of data standards to make regulatory submissions more efficient. Dr Callahan cited the Alliance’s In Vitro Pharmacology Group and Global Substance Registration System (GSRS) Consortia as successful examples of this.
The Alliance also announced several new projects and initiatives, including:
- Clinical Operations Ontology for clinical trial site feasibility: Clinical trial investigator site selection relies on manually collecting data via questionnaires, which assess whether a site has the right equipment, necessary staff, and diversity of patients to conduct a study.
- Since much of this information is lost after a trial commences, questionnaires must be repeated for each new trial. The ClinOps project will create a data model to improve the management, analysis, and exchange of clinical operations data, so companies can choose the best investigator site for their study at a lower cost and with reduced manual data collection.
- The project marks a significant advancement in modelling domain-specific clinical trial design knowledge in a machine-readable format. Digital accessibility guide: The freely available guide, published by the Alliance’s User Experience Life Sciences Community (UXLS), will inform hardware and software designers how to develop R&D tools that are accessible to all users to encourage technology adoption. For example, having audio descriptions for users with visual impairments, offering transcripts for those with hearing issues, and making websites easy to navigate.
- FAIR Maturity Matrix: The concept of FAIR data (Findable, Accessible, Interoperable, Reusable) has been around for nearly a decade, and is an essential step to making R&D data AI-ready.
While many pharma companies are well on their way to embedding the FAIR principles, there is no simple, agreed, maturity assessment model for FAIR implementation. The Alliance’s FAIR Implementation Project has designed a matrix to address that gap, with the first draft freely available now.
Labs2030: This relaunch of the Alliance’s successful Lab of the Future Community will tackle integrating the next wave of disruptive technologies into scientific workflows, including generative AI and virtual lab environments. Labs2030 will bring together scientists and technologists to build the next-generation laboratory environment from a data standards, process, instrument, and knowledge sharing perspective.
“What makes the Alliance stand out is our commitment to launching projects that our members have asked for and that will deliver tangible change to the life science industry,” added Dr Christian Baber, Chief Portfolio Officer at the Alliance.
“These new projects, organised under our strategic priorities, will empower companies to navigate change and overcome challenges faster than going it alone.
“As 2024 progresses, we’re also excited to strengthen our ties with global regulatory agencies, involving them further in our projects and communities.” The Pistoia Alliance is now welcoming registrations for its next member conference in Philadelphia, 12-13 November. To find out more about membership visit www.pistoiaalliance.org.
The global, not-for-profit members’ organisation is made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D.
