Pre-Conference Workshops (am) & Main Conference Day 1 Plenary (pm) - CET (Central European Time, GMT+01:00)
Workshop Overview:
The workshop will give an overview of manufacturing processes and CMC strategies for oligonucleotides, like siRNA, antisense, sgRNA or aptamers. It will emphasize the CMC development from early discovery throughout the clinical phases. We will explore technical and operational aspects across the lifecycle, with a spotlight on cleaning/carryover, process and analytical development, raw materials selection and control, impurity characterization, and specifications setting. Additionally, it will highlight how operational excellence frameworks can enhance cross-functional and external interfaces, support effective troubleshooting, mitigate risks, and improve overall efficiency. The workshop will be divided into three parts, focusing on operational and manufacturing topics, and analytical and control aspects. After the presentations, the speakers will jointly lead a discussion on key CMC challenges and strategies.
Topics to be Discussed:
- Bridging Science, manufacturing, and operational execution
- Mandatory CMC activities for oligonucleotide therapeutics or theranostics
- Scale-up challenges
- Understanding and controlling process and product-related impurities
- Operational and business aspects of CMC for efficiency, consistency, and risk control
Who Should Attend?
Anyone interested in CMC, MSAT, Impurity Control Strategies, and in-house or outsourced manufacturing of oligonucleotide therapeutics during pre-clinical and clinical development of synthetic RNA Therapeutics or Theranostics. This includes R&D Researchers, Manufacturing Personnel, Quality Assurance, Project Management, and those involved in Operations and Business within Oligonucleotide Development and Manufacturing.
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting AG
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
We will explore the technical and operational aspects of process development and manufacturing across the oligonucleotide CMC lifecycle. The focus will be on actionable frameworks demonstrating how Operational Excellence methodologies can enhance internal and external interfaces (e.g., with CDMOs), support effective troubleshooting, mitigate risks, improve efficiencies, and address other critical challenges.
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
- Chris Oswald - Founder, Owner, and Principal Consultant, Coswald Consulting LLC
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting AG
- Nadim Akhtar, PhD - Principal Scientist, AstraZeneca
- Nadim Akhtar, PhD - Principal Scientist, AstraZeneca
At CPI’s we are working with partners on a range of technologies to transform oligonucleotide manufacturing, including strategies and systems to digitise process development and manufacturing. These approaches include automating the handling of data, equipping Intellegens’ Alchamite™ software with an impurity identification logic that identifies potential impurities based on the input oligonucleotide sequence and mass spectrometry data, and training the Alchemite™ advanced machine learning capabilities to accelerate oligonucleotide process optimisation.
- Barrie Cassey, PhD - Medicines Manufacturing Technology Director, CPI
- Ross Kelly, PhD - Associate Principal Scientist, AstraZeneca
- Martin Olbrich, PhD - Head of Process Chemistry 3, F Hoffmann-La Roche Ltd.
- Guido Creusen, PhD - Senior Scientist, Synthetic Molecules Technical, F. Hoffmann-La Roche Ltd.
- Philipp Weber - Junior Scientist, F. Hoffmann-La Roche AG
- Lucrece Nicoud, PhD - Co-CEO, Ypso-Facto
- Bruce Morimoto, PhD - Independent Consultant, TIDES Advisor
- Robert Hagopian - Director Business Development, PolyPeptide Group
- Alaric Desmarchelier, PhD - Business Development Manager - Peptides, Almac Group
- Marc Jacob, PhD - Head of Strategic Development, Chromatography Products, YMC America
Targeted drug delivery of oligonucleotides to the heart is a rapidly evolving field aimed at improving the precision and efficacy of treatments for cardiovascular diseases. Therapeutic oligonucleotides such as antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), have the potential to modulate gene expression and protein synthesis for precision medicine approaches for patients with heart diseases. Targeted delivery of oligonucleotides to the heart holds great potential for treating cardiovascular diseases more effectively by maximizing therapeutic benefits while minimizing side effects.
- Shalini Andersson, PhD - Vice President of Oligonucleotide Discovery, AstraZeneca
The proper processing of mRNA plays a major role in disease and is regulated by RNA-binding proteins. Inhibiting such proteins can be challenging as the interface between protein and RNA is often devoid of well-defined binding pockets. I will describe our work using stabilized peptides to target such interfaces and highlight how the design of such peptides can be driven by generative AI.
- Peter't Hart, PhD - Professor of Molecular Biochemistry, University of Münster
AI in drug discovery has traditionally been built with narrow models that target isolated tasks. But drug development demands end-to-end precision, so this siloed approach sees limited success. AI foundation models represent a breakthrough, as they benefit from breadth of application, synergies between tasks during training and prediction, and scaling of accuracy with data and model size. Brendan will discuss how this tech is transforming AI for drug discovery with applications to ASOs, siRNAs, mRNAs, DNA / RNA editing, and target discovery, and will highlight real-world use across Deep Genomics’ internal programs and collaborations.
- Brendan Frey, PhD - Founder and Chief Innovation Officer, Deep Genomics
- Andreas Vegge, PhD - Project Vice President, Amycretin Cardiometabolics, Novo Nordisk