• Register for a new webinar, “Artificial intelligence in drug discovery: what is realistic, what are illusions?” on Wednesday, September 8^th, at 8 am PST (11 am EST, 4 pm London). Our speaker is Andreas Bender, PhD QJ, Reader for Molecular Informatics, University of Cambridge, and Director of Digital Life Sciences, Innovation Campus Berlin (ICB)/Nuvisan. Although artificial intelligence (AI) has had a profound impact on areas such as image recognition, comparable advances in drug discovery are rare. We will discuss the stages of drug discovery in which improvements in the time taken, success rate or affordability will have the most profound overall impact on bringing new drugs to market. Changes in clinical success rates will have the most profound impact on improving success in drug discovery; in other words, the quality of decisions regarding which compound to take forward (and how to conduct clinical trials) are more important than speed or cost. Although current advances in AI focus on how to make a given compound, the question of which compound to make, using clinical efficacy and safety-related endpoints, has received significantly less attention. As a consequence, current proxy measures and available data cannot fully utilize the potential of AI in drug discovery, in particular when it comes to drug efficacy and safety in vivo. Thus, addressing the questions of which data to generate and which endpoints to model will be key to improving clinically relevant decision-making in the future.
• View the recording of our recent webinar, “Challenges in the regulation of AI Software as a Medical Device.” Software as a medical device (SaMD) that leverages artificial intelligence (AI) has the opportunity to reshape healthcare. It also raises unique challenges for developers and regulators. As healthcare advances and digital solutions leveraging AI becomes more prevalent, it is important that medical device regulatory frameworks also advance to match the speed of innovation. Our panelists were Loganathan Kumarasamy, Head of Scientific Informatics, Validation and Compliance services, North America, Zifo R&D; Pat Baird, Regulatory Head of Global Software Standards, Phillips; Nathan A. Carrington, Ph.D., Head of Digital Health and Innovation, Global Regulatory Policy and Intelligence, Roche Diagnostics. The panel reviewed key terms related to AI SaMD and described unique regulatory challenges associated with devices that leverage AI, and discussed novel approaches to the regulation of AI SaMD currently under consideration by international regulatory authorities.
• There will be no webinars in the months of August and October. Instead, we are planning a panel discussion event as part of the Pistoia Alliance Fall Annual Conference on October 20. The panel discussion will focus on the challenges and opportunities in federated learning, and will be run as a hybrid event, allowing anyone not able to come to Boston to attend virtually. The Fall Annual Conference will be available to members only and the registrations will open at the end of August. Stay tuned for the conference program!

The Artificial Intelligence and Machine Learning Community is a great example of the value the Pistoia Alliance delivers to its members. There has never been a more important time to collaborate as an industry, and we hope you find our CoE inspiring and informative.  If you would like to find out more about the benefits of Pistoia Alliance membership and how you can get involved with all the different initiatives we run, please send an email to Membership@PistoiaAlliance.org.