Agenda
Designed for senior pharma professionals, this event includes case studies and presentation by subject matter experts, with topics including:
"Towards Insight-Driven Experimentation: Automating Model Development in Bioprocessing", Kallum Doyle, ME PhD, Research Fellow, Innovation – In cell culture processes, understanding complex, time-dependent interactions remains challenging, with data variability and resource constraints limiting the use of dynamic kinetic models. Hybrid dynamic models, combining mechanistic and machine learning methods, offer promise but rely on efficient data workflows. This presentation outlines how automating data cleaning, processing, and model assembly can streamline development, enabling real-time interpretation of experiments and supporting faster, more robust, and insight-driven bioprocess innovation.
“Engineering the Future of Synthetic Drug Substance Development”, Gary Morris, Principal Scientific Advisor, Small Molecule – Advances in digital process design, automation, and continuous processing are transforming how synthetic drug substance manufacturing processes are developed and scaled. This presentation will highlight how these approaches work together to improve process understanding, accelerate development timelines, and enable robust and scalable manufacturing processes. Case studies and forward-looking perspectives will illustrate how these methods position organizations for Pharma 4.0 and beyond.
“Digital Strategies leveraging iAchieve to Accelerate End-to-end Process Characterization”, Kallum Doyle, ME PhD, Research Fellow, Innovation – Discover how iAchieve® enabled full process characterization in 12 months through digital integration, team alignment, and smarter CMC decisions.
"Digital CMC in Practice: Intro to iAchieve", Mark Walsh, Business Development Director – CMC programs stall when data, context, and decisions live in different places. iAchieve® brings them together in a secure, live workspace used across APC and VLE to move programs from design to tech transfer with fewer surprises. The platform unifies expert-led experiments, live process data, and program context into a single source of truth, supported by agentic intelligence for fast, defensible choices. Attendees will see how iAchieve works, where it adds value in real projects, and how it fits into a modern digital CMC strategy that reduces risk while accelerating timelines.
A networking event will take place at the same venue, once the presentations are complete!