Pre-Conference Workshops (am) & Main Conference Day 1 Plenary (pm) - Europe/Amsterdam
Workshop Overview:
Process economics and manufacturing complexity are inherent to every oligonucleotide therapeutic project. The key question is when in the development lifecycle these challenges are recognized and addressed, and ideally before they become constraints. This workshop addresses interdependent scientific, technical, operational, and quality considerations that shape cost of goods (COGs) and long-term commercial viability. Through head-to-head comparisons of manufacturing approaches, practical decision frameworks, and case studies presented by invited experts, participants will develop a methodology for integrating molecule design, chemistry, therapeutic indication, anticipated commercial volumes, and manufacturing strategy into evidence-based, fit-for-purpose development and manufacturing decisions. Participants will gain a deeper understanding of key process trade-offs, technical and operational decisions that influence manufacturability – enabling informed choices at the right development stage, before expensive late-stage remediation becomes necessary.
- Thomas Rupp - Vice President, CMC Strategy, Axolabs Berlin GmbH
- Sonja Merkas, PhD - Founder and CEO, Livinovea
Workshop Overview:
Getting oligonucleotide therapeutics from bench to patient requires more than scientific ingenuity — it demands a CMC strategy that is integrated, forward-looking, and built to survive regulatory scrutiny from preclinical to market. Too often, CMC functions are compartmentalized, reactive and even under-resourced until a filing deadline forces response. This workshop challenges that model. Several industry experts share perspectives on what it takes to build and sustain an oligonucleotide CMC program.
- A quality leader will make the case for early quality integration – why waiting until Phase I or Phase II to build your control strategy costs time, money, and even credibility with regulators.
- An analytical and bioanalytical expert will address the practical realities of method selection, qualification timelines, and the bioanalytical challenges unique to oligonucleotide modalities.
- A drug substance and drug product specialist will tackle how modification chemistry — 2'-substitutions, phosphorothioate stereochemistry, LNA, and conjugate architectures — can reshape the purification landscape, can redefine the impurity profile, can complicate formulation development, and alter specifications.
- A starting materials expert will address amidite sourcing, supplier qualification, and building a supply strategy resilient enough to survive scale-up and commercial demand.
Together, these perspectives frame oligonucleotide CMC not as a series of sequential handoffs, but as an integrated, lifecycle-spanning discipline.
- Chris Oswald - Founder, Owner, and Principal Consultant, Coswald Consulting LLC
- Marc Lemaitre, PhD - Principal, ML Consult
- Nadya Brady - Founder, LuminaBio Advisory
- Steven Wolk, PhD - Founder and Chief Consultant, Sinawali Biotechnology Solutions
- Chris Oswald - Founder, Owner, and Principal Consultant, Coswald Consulting LLC
- Bruce Morimoto, PhD - Independent Consultant, TIDES Advisor
- Robert Hagopian - Global Director, Biotech Partnerships, PolyPeptide Group
- El Djouhar Rekaï, PhD - Process & Analytical Development Director at PolyPeptide Group, PolyPeptide Group
- Beatriz De La Torre, Ph.D. - Research Professor, Laboratory of Medicine and Med, University Of KwaZulu-Natal
- Alaric Desmarchelier, PhD - Business Development Manager - Peptides, Almac Group
- Marc Jacob, PhD - Head of Strategic Development, Chromatography Products, YMC America
- Thomas Müller-Späth, PhD - CEO, ChromaCon AG
- Stephen Lock, PhD - Senior Market Development Manager, Biopharma, EMEAI, SCIEX
- Nour Fahmi, PhD - Director, Chemistry, Eli Lilly and Company
GLP-1–based therapies have transformed the treatment of metabolic diseases, evolving from first-generation peptides such as liraglutide to long-acting analogues like semaglutide. This talk will explore the scientific and technological journey behind these advances, with a focus on extending dosing intervals toward even more infrequent administration, as well as enabling oral peptide delivery.
- Jacob Challand Kofoed, PhD - Scientific Director, Peptide Research 1 , Novo Nordisk A/S
Retatrutide, a novel GIP, GLP-1, and glucagon receptor agonist, has demonstrated efficacy and an acceptable safety profile to date across the Phase 3 TRIUMPH program (obesity, obstructive sleep apnea, and osteoarthritic knee pain) and TRANSCEND-T2D program (type 2 diabetes). This keynote delivers an in-depth CMC perspective on the manufacturing innovation enabling global-scale supply: the convergent liquid-phase peptide synthesis (LPPS) platform — encompassing fragment strategy, protecting group design, and process intensification — and the ICH Q11-grounded starting material justification framework. Together, these advances yield a commercial process of exceptional efficiency, dramatically reduced PMI, and new benchmarks for sustainable large-molecule manufacturing.
- Michael Kopach, PhD - Associate Vice President, Synthetic Molecule Design and Development, Eli Lilly and Company
- Claudia Höbartner, Ph.D. - Professor of Organic Chemistry, University of Würzburg