Pre-Conference Workshops (am) & Main Conference Day 1 Plenary (pm)
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting
- Chris Oswald - Founder, Owner, and Principal Consultant, Coswald Consulting LLC
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting
- Pablo Lores Lareo, PhD - CMC Director, Sylentis
Workshop will cover the following topics:
The workshop will provide insight into decisions made to enable a multi-product facility that can accept many oligonucleotide types/designs and scales, all the while ensuring proper alignment of large scale and downscale processes. Critical Quality Attributes are suspected to influence efficacy, safety, and quality of final products, therefore consideration of CQAs for large scale manufacturing will be discussed. Participants will gain an insight into Large Scale manufacturing of oligonucleotide API and to the design of a facility. Major themes of the workshop will include:
- Large Scale Manufacturing: Challenges and Solutions
- Designing a Facility: Challenges and Solutions
- Critical Quality Attributes (CQA): How to Maintain during Upscaling
Who should attend?
Anyone interested in understanding the challenges that might exist if oligonucleotide manufacturing were to be build-up in-house rather than depending on a CDMO. Manufacturing personnel, quality assurance (QA), and project management (PM) would realize the most benefit out of this workshop.
- Bruce Morimoto, PhD - Independent Consultant, TIDES Advisor
- Robert Hagopian - Global Director, Biotech Partnerships, PolyPeptide Group
- El Djouhar Rekaï, PhD - Head of Peptide Process Development & Manufacturing, PolyPeptide Group
The clinical journey of a drug candidate goes hand in hand with analytical development, validation, and characterisation. This crucial component evolves in scope and depth as the API advances through clinical stages. We will review how a phased approach to analytical topics is key to a successful development program, and show case studies highlighting how indication, posology, and the peptide itself impact the analytical strategy.
- Alaric Desmarchelier, PhD - Business Development Manager - Peptides, Almac Group
Peptide pharmaceuticals are increasingly central to modern medicine, particularly in the treatment of diabetes and obesity, yet their large-scale purification remains a critical cost driver. This presentation will trace the evolution of preparative chromatography from its early developments to current large-scale applications, highlighting key innovations that have improved efficiency and scalability. Recent advances in stationary phase chemistry—offering greater stability, selectivity, and mechanical strength—have significantly enhanced process robustness. At the same time, progress in instrumentation and automation has streamlined operations, reduced variability, and lowered manufacturing costs. Together, these innovations are reshaping the economics of peptide production and enabling industry to respond to unprecedented demand for GLP-1 receptor agonists, insulin analogs, and related therapeutics. By integrating modern materials and advanced engineering tools, peptide purification can now achieve both high purity and cost-effectiveness, ensuring broader access to new and improved medicines.
- Marc Jacob, PhD - Head of Strategic Development, Chromatography Products, YMC America
Parallel SPPS approaches optimally discover clinical candidates, with automated methods maximizing efficiency. Automated SPPS is a useful method not only in early drug discovery but also for the rapid supply of large-scale non-clinical API. We present advanced yield-maximizing methodologies demonstrated in our clinical candidate.
- Manabu Wadamoto, PhD - Chief Scientist, Chugai Pharmaceutical Co., Ltd.
I will report on oligo-D-2,6-diaminogalactose (ODAGal) and oligo-L-2,4-diaminobutyric acid (Dab) as effective stabilizers and carriers of siRNA. In particular, folic acid-conjugated Dab will be reported for its pancreatic cancer-specific delivery and therapeutic efficacy of siRNA.
- Takeshi Wada, PhD - Professor of Organic Chemistry, Tokyo University of Science
TMOs have been used for many biological applications. TMOs as cap/gapmers are very active in controlling the expression of glioblastomas, U4 noncoding RNA, allele specific knockdown of SLC6A1, multicentric carpotarsal osteolysis and several other genetic diseases. Similarly, via exon skipping experiments, TMOs control expression of DMD, STAT3 in head/neck tumors, inflammation via ITGA4, PKM, TUG 1 lncRNA, psoriasis, recessive dystrophic epidermolysis bullosa, and other genetic diseases as well. Recent research has also focused on controlling expression of peroxiredoxin (PRDX) 6 via TMO modified siRNA and using TMOs to control PEG 10 translation. These results will be outlined in my lecture.
- Marvin Caruthers, PhD - Distinguished Professor, Biochemistry, University of Colorado
- Muthiah (Mano) Manoharan, PhD - Senior Vice President of Drug Innovation and Distinguished Research Scientist, Alnylam Pharmaceuticals
Oligonucleotide therapies have long been associated with rare and orphan diseases, which have been critical in addressing unmet medical needs as well as providing clinical validation for this powerful therapeutic modality. This has accelerated the industry and driven interest in treating ever larger patient populations such as cardiovascular disease. As demand for oligonucleotides increases, this puts intense pressure on the industry to develop innovative solutions to environmental, cost, and efficiency concerns in the manufacture of these drugs. This talk will highlight Eli Lilly’s efforts to develop new synthesis technologies such a fluidized bed reactor (FBR) and enzymatic ligation as well as drive practical advances such as implementing frozen solution API (vs lyophilization) which help drive efficiency and improved reliability for large scale products.
- Scott May, PhD - VP of Chemistry, Synthetic Molecule Design & Development, Eli Lilly and Company
- Lei Qian, MD, PhD - Chief R&D Officer, General Biomedicine, Innoventbio
Glucagon-Like Peptide-1 receptor agonists (GLP-1RAs), such as liraglutide and semaglutide, offer diverse biological applications and are sanctioned for treating diabetes with established cardiovascular benefits, encompassing stroke prevention, and obesity management. Physiologically, GLP-1 plays a crucial role in glucose equilibrium, appetite control, and various other functions. Notably, long-acting pharmacological agents are pivotal for treatment success. These GLP-1RAs influence weight loss, potentially through brain GLP-1R-mediated mechanisms, and also demonstrate promise in mitigating systemic inflammation. Ongoing research is exploring their potential in addressing liver disease and Alzheimer's disease. This underscores the wide-ranging impact of GLP-1 physiology in various clinical domains.
- Lotte Bjerre Knudsen, PhD - Chief Scientific Advisor & Head of GLP-1 CoE, Novo Nordisk A/S