October 2025
TIDES EU 2025: Four Must-Attend Sessions Shaping the Future of Biologics
#TIDESEU #Oligoneuclotides
As oligonucleotide and peptide therapeutics enter a new phase of clinical maturity, these sessions tackle the most pressing challenges facing the field — from regulatory readiness and delivery innovation to emerging therapeutic areas and next-generation conjugates. Attendees will walk away with actionable strategies, early insights, and practical tools to accelerate development and stay ahead in a rapidly evolving landscape.
💊 Regulatory CMC Strategies for Oligonucleotides
Why it’s valuable:
- As oligonucleotide pipelines mature and more assets advance toward clinical and commercial stages, CMC (Chemistry, Manufacturing, and Controls) is becoming a strategic bottleneck.
- This session equips attendees with practical guidance to navigate evolving regulatory expectations (FDA, EMA, PMDA, etc.) — especially around analytical characterization, impurity profiles, process validation, and documentation unique to oligos.
- Attendees gain insights on how to de-risk filings, streamline approval pathways, and future-proof their development plans in a space where regulatory frameworks are still being defined.
✅ Who will benefit: Regulatory affairs leaders, CMC specialists, manufacturing and quality teams, program leads preparing INDs/BLAs.7
🧬 Oligonucleotides for Obesity and Metabolic Disease
Why it’s valuable:
- With metabolic disorders (like obesity, NASH, and type 2 diabetes) reaching global epidemic levels, oligos are emerging as a completely new modality in an area long dominated by small molecules and peptides.
- This session provides early, actionable intelligence on how oligos are being designed to target metabolic pathways, including insights into delivery challenges, tissue targeting beyond the liver, and clinical progress.
- Attendees will understand how this therapeutic class could reshape competitive pipelines — and where partnering, licensing, or investment opportunities may lie.
✅ Who will benefit: R&D scientists, business development teams, pipeline strategists, therapeutic area leads.
⚗️ Strategies for Antibody-Oligonucleotide Conjugates (AOCs)
Why it’s valuable:
- AOCs represent one of the most exciting “next-gen” modalities, combining the specificity of antibodies with the precision of oligonucleotides.
- This session explores cutting-edge conjugation techniques, linker technologies, and delivery innovations that are unlocking tissue- and cell-specific targeting — one of the field’s biggest challenges.
- Attendees will leave with a clear picture of what’s possible now, where the science is heading, and how AOCs could transform therapeutic strategies across oncology, rare disease, and beyond.
✅ Who will benefit: Discovery scientists, platform innovation teams, translational researchers, BD & alliance management professionals.
🧪 Peptide CMC Strategies and Case Studies
Why it’s valuable:
- As the peptide market expands — driven by GLP-1 agonists and novel therapeutic formats — CMC considerations are critical to speed, quality, and scalability.
- This session brings real-world case studies from leading developers, highlighting how they overcame challenges in purification, characterization, process scale-up, and regulatory submission.
- Attendees will gain tangible best practices they can apply directly to their own programs, helping reduce development risk and accelerate time-to-market.
✅ Who will benefit: CMC teams, process development scientists, QA/QC specialists, regulatory strategists.