Peptide Discovery to CMC: From Early Design to Scalable Development
The next 3-5 years are defining for peptide therapeutics. Moving from niche modality to mainstream medicine, peptide therapeutics will be driven by breakthroughs in computational design, oral delivery, intracellular targeting, and scalable manufacturing. This track connects discovery science, translational development, and CMC strategy to show how leading teams are turning complex peptides into clinically and commercially viable drugs. Are you ready to advance peptide therapeutics from concept to clinic?
What are the key topics for this track?
AI-Driven & Computational Peptide Design
The explosion of peptide chemical space has made traditional discovery approaches too slow and inefficient to keep pace with therapeutic ambition. AI-driven platforms, generative models, and structure-based design pipelines are now transforming how peptides are discovered, enabling rapid exploration of noncanonical amino acids, macrocycles, and novel conformations that were previously impossible to design systematically.
Why this matters now:
As peptide programs expand into oncology, metabolic disease, and intracellular targets, success depends on rapidly identifying viable candidates with drug-like properties before entering costly experimental cycles.
Key Session to Attend:
AI and NCAAs to Unlock the Design of Peptide Drugs - Learn how XtalPi’s PepiX™ platform integrates AI, automated synthesis, and high-throughput screening to accelerate peptide discovery.
Novel Peptide Scaffolds for Intractable Targets
Peptide scaffolds are evolving beyond linear sequences into macrocycles, cyclotides, helicons, and antibody-inspired structures that combine high specificity with improved stability and permeability. These new designs are unlocking protein-protein interactions and intracellular targets long considered unreachable.
Why this matters now:
As traditional modalities hit biological limits, next-generation peptide scaffolds offer a path to target disease-driving proteins that small molecules and antibodies cannot access.
Key Session to Attend:
Engineering Cyclotides as Orally Bioavailable Cytokine Antagonists - Discover how circular peptide scaffolds enable oral delivery and antibody-like target engagement.
Peptide Modalities in Oncology & Precision Medicine
Peptide therapeutics are enabling a new wave of precision oncology, from radioconjugates and immune modulators to tumour-targeting delivery vehicles. Their small size, modularity, and rapid clearance make them ideal for highly targeted therapeutic strategies.
Why this matters now:
With oncology pipelines demanding greater selectivity and safety, peptides are emerging as a preferred modality for delivering potent payloads directly to tumors.
Key Session to Attend:
Discovery of 225Ac-ETN029: A Peptide-based Radioligand Therapy - Follow the design and validation of a macrocyclic peptide radioligand driving tumor regression in vivo.
Translating Peptides from Discovery to Scalable CMC
As peptide therapeutics progress into late-stage development, manufacturing, sustainability, and regulatory strategy are becoming decisive success factors. Hybrid synthesis, improved strategies for starting materials, advanced analytics, and greener chemistries are reshaping peptide CMC.
Why this matters now:
Peptides now sit in a unique regulatory and manufacturing space, and early CMC decisions can determine whether programs scale efficiently or stall at commercialization.
Key Session to Attend:
Building Robust Control Strategies for Peptide APIs - Gain practical insight into manufacturing, impurity control, and regulatory readiness for peptide drug substances.
Who's Speaking on the Peptide Discovery to CMC track?
FAQs
What does peptide discovery to CMC involve?
Peptide discovery and CMC spans the design, optimization, and scale-up of peptide therapeutics, from identifying active sequences to ensuring manufacturability and regulatory compliance.
This includes rational design, chemical synthesis, formulation, and characterization to prepare candidates for clinical and commercial use.
Why is oral peptide delivery such a major focus?
Oral delivery remains a major challenge for peptides due to degradation in the gastrointestinal tract and poor absorption. Successfully developing oral peptides can significantly improve patient convenience and treatment adherence.
This track covers oral peptide strategies, including cuclotides, helicon peptides, and GLP-1 analogues, case studies on formulation solutions, and real-world examples from clinical candidates to demonstrate therapeutic potential.
How is AI and computational design transforming peptide discovery?
AI and computational models are expanding the accessible chemical space, predicting stable structures, and identifying high-potential sequences more efficiently than traditional trial-and-error methods.
What are the main CMC challenges for peptides at scale?
Scaling peptide therapeutics requires careful control over synthesis, purification, and quality, while managing impurities, solvent use, and reproducibility. Regulatory expectations are distinct from small molecules or biologics, requiring robust characterization and compliance strategies.
What trends will define peptide discovery and CMC over the next five years?
Key trends include AI-assisted design, new oral delivery modalities, hybrid and sustainable synthesis methods, and enhanced analytical and regulatory approaches.
This track specifically highlights the:
AI and generative platforms accelerating peptide discovery and validation.
Oral bioavailability and tissue-targeted delivery strategies for clinical translation.
Hybrid and sustainable synthesis methods reducing cost, environmental impact, and regulatory hurdles.
Advanced analytical characterization and robust control strategies ensuring clinical and commercial success.