Publications & Blog

A recent workshop on the "Convergence of AI and Digital Measures for Seamless Preclinical to Clinical Translation" brought together, for the first time, experts from clinical and preclinical into one room to explore the transformative potential of combinatorial power of digital measures and AI technologies in drug development. Through focused sessions and case studies, we explored the current implementation and validation processes for AI/ML-derived digital measures and addressed the challenges and obstacles to their adoption. Our goal was to identify strategies for integrating digital measures and AI to enhance the translation from preclinical to clinical stages, improve data precision, and create a synergistic effect for a comprehensive understanding of these technologies.

DATAcc’s’s latest initiative, "Building the Business Case for Digital Endpoints," aims to catalyze investment in digital measurement development and deployment within clinical trials. Through the development of a comprehensive value framework, benchmarking tools, ROI forecasting models, and a modular business case template, both of our organizations strive to empower innovators across the industry to embrace digital endpoints and drive their universal adoption and scalability in clinical research. VeriSIM Life has joined this groundbreaking project as a partner to boost investment and utilization of digital endpoints by equipping decision-makers with tangible data to articulate the value of integrating these strategies into their business operations.

Understanding the context-of-use for each AI shade is crucial to address biases, ensure transparency, and enhance decision-making processes within regulatory frameworks. In this article, the authors emphasize the need for tailored regulatory measures to accommodate AI’s diverse roles, ensuring AI enhances rather than complicates regulatory processes.

The following transcript was taken from a recorded conversation between Dr. Jo Varshney, CEO of VeriSIM Life, and Dr. Annick Menetrey, Clinical Pharmacology Lead at Debiopharm. Read on to understand how VeriSIM Life and Debiopharm partnered to scalably investigate first-in-human (FIH) dosing strategies for antibody-drug conjugates to reduce tumor burden safely and effectively. (Edited for clarity and length.)