Conference Calls for Unity in Addressing Artificial Intelligence Regulation in Life Sciences Research and Development

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The Pistoia Alliance, a prominent non-profit advocating for increased collaboration in life sciences R&D, announced a call to action focused on addressing artificial intelligence (AI) regulation and adoption challenges. According to the company, the importance of this initiative was stressed at their largest European conference yet, with key survey findings indicating that 70% of life sciences experts acknowledge AI's potential; however, many are still determining how to properly implement it.¹

“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,” said Becky Upton, PhD, president, Pistoia Alliance, in a press release. “Our London conference is evidence of the Alliance’s ability to bring together multiple groups and create a forum for safe and effective collaboration. We look forward to progressing several new projects alongside our existing portfolio as we tackle both long-standing and emerging challenges together.”

In addition to the survey, the alliance also revealed a number of new projects aimed at supporting clinical trials and AI integration, which includes Clinical Operations Ontology, Digital Accessibility Guide, FAIR Maturity Matrix, and Labs2030, all of which work to different areas of implementation.¹

“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,” said Christian Baber, PhD, chief portfolio officer, the Pistoia Alliance, in the press release. “These new projects, organized under our strategic priorities, will empower companies to navigate change and overcome challenges faster than going it alone. Whether that’s accelerating the adoption of emerging technologies to get new drugs to patients faster or making headway on their diversity or sustainability goals. As 2024 progresses, we’re also excited to strengthen our ties with global regulatory agencies, involving them further in our projects and communities.”

According to USDM Life Sciences, the United States and the European Union both employ a risk-based approach to AI in the life sciences industry, agreeing on ethics such as accuracy, robustness, data privacy, accountability, transparency, safety, security, and more. Additionally, the value of AI can be demonstrated by factors such as efficiency, accuracy, cost-effectiveness, and reliability.²

“As regulatory requirements evolve for the use of AI and machine learning, we’re seeing guiding principles from the likes of the US Food and Drug Administration, Health Canada, and the Medicines and Healthcare products Regulatory Agency in the United Kingdom. The vision is that these principles will be used to: (1) adopt proven practices from other sectors, (2) tailor those practices to life sciences, and (3) create practices that are specific to medical technology and the healthcare sector,” reports USDM Life Sciences.”

References

1. PHARMA AND REGULATORY GIANTS TACKLE AI TRUST AND LEGISLATIVE CHALLENGES AT LARGEST EVER PISTOIA ALLIANCE ANNUAL CONFERENCE. Pistoia Alliance. May 8, 2024. Accessed May 9, 2024. https://www.pistoiaalliance.org/news/press-release-april-conference-2024/

2. Anticipating Regulatory Compliance for Artificial Intelligence in Life Sciences. USDM Life Sciences. February 9, 2024. Accessed May 9, 2024. https://usdm.com/resources/white-papers/anticipating-regulatory-compliance-for-artificial-intelligence-in-life-sciences#:~:text=Life%20sciences%20organizations%20depend%20on,for%20the%20use%20of%20AI.