Agenda
Join us for this exclusive workshop designed for senior pharma professionals:
10:00 Registration & Coffee
10:15 Welcome
10:30 Engineer. Model. Simulate. Optimize: Better Pharma Processes Through Digital Innovation, by Niall Brady, Digitalisation Engineer
Digital tools are transforming pharmaceutical engineering—from process design to commercial manufacturing. This session explores how modeling, simulation, advanced analytics, and PAT can unlock faster, more robust development. Real-world case studies will demonstrate how these methods improve quality, scalability, and compliance while supporting smarter, more agile decision-making.
11:00 From Crystallization to Compression: Leveraging Co-Processing to Improve Powder Flow in API Development, by Niamh McKeever, Process Development Scientist
Bridging drug substance and drug product development is often hindered by poor powder flow. This talk highlights co-processing strategies that integrate crystallization, milling, and excipient engineering to enhance material properties. The result: smoother downstream processing and fewer scale-up barriers.
11:30 From Lab Chemistry to Scalable Synthesis: A Data-Driven Workflow for Streamlining Early-Phase Development of Multistep Routes, by Ciara McDonnell, Process Development Scientist
The development of robust, scalable processes for multistep synthetic routes remains a central challenge in pharma manufacturing. This session presents an integrated workflow designed to streamline process development, integrating batch and flow chemistry to accelerate development timelines and enhance process control. The workflow leverages high-throughput experimentation, DoE, kinetic modelling, and PAT to rapidly optimize steps and enable real-time monitoring and control.
12:00 Lunch
1:00 Computational Solvent Selection: Optimizing Crystal Morphology in API Crystallization, by Jacek Zeglinski, Senior Process Development Scientist
Crystal shape impacts every stage of solid drug processing. This session introduces a computational workflow for predicting how solvents influence particle morphology—enabling smarter solvent screening and faster crystallization development. In silico predictions are validated against experimental data to illustrate the method’s real-world utility.
1:30 Accelerating ATMP Development: From Lab to GMP in Under 12 Months, by Kate O'Dwyer, CMC Specialist
ATMP development demands a faster, more flexible model. This case study details how APC and VLE Therapeutics achieved GMP readiness in less than 12 months, reducing COGS by 94%, increasing yield fourfold, and cutting processing time by over 60%. The session examines how digital CMC tools enabled these outcomes and redefined the tech transfer process.
2:00 Leveraging a Tech-CMC Approach to Accelerate End-to-End Process Characterization, by Rory Vignoles, Senior Process Development Engineer
This session explores how The Medicine Accelerator's digital platform, iAchieve®, enabled a full process characterization (PC) program—from FMEA through regulatory documentation—in just 12 months. Learn how digital integration, cross-functional alignment, and contextualized CMC decisions support faster timelines and higher confidence in process understanding.
2:30 Open Discussion & Networking
3:00 Event Concludes