Discovery & Development US 2026
Hilton San Diego Bayfront, CA
The Power Of Partnerships: Aligning Pharma, Biotech, And Academia To Accelerate Development & Innovation
Panel Discussion• Bridging cultures and goals
• Shared resources and expertise
• Accelerating translation
• How partnerships can streamline moving discoveries from the lab to clinical development and market
Small-Angle X-ray Scattering for Early Detection of High-Concentration Antibody Viscosity
Industry PresentationHT-SAXS predicts viscosity early: Low-q structure factor changes at ≤10 mg/mL reliably flag high-viscosity mAbs long before high-concentration testing is needed
More accurate than kD: SAXS structure factor upturn/downturn directly captures attractive vs repulsive interactions and outperforms kD in viscosity classification (100% vs 82% accuracy)
High-throughput, low sample demand: Automated SAXS enables rapid, scalable developability screening using minimal material, suitable for early discovery workflows
Multi-Agentic AI For Drug Discovery and Development
Industry PresentationAI for drug discovery has largely focused on individual tasks such as target identification and molecular design, using machine learning, generative models, and, more recently, generative AI. A major limitation of many AI approaches, however, is that they remain point solutions addressing only one part of the drug discovery and development process. This presentation will explore how multi-agent AI systems can integrate multiple specialized tasks into a coordinated, end-to-end approach to drug discovery and development.
Design And Formulation Of Long Acting Entecavir Prodrugs For Improved Hepatitis B Treatment Adherence
Industry PresentationOverview Of The Challenges Of CMC
Industry PresentationWhy Formulations Fail — Lessons Learned Across Modalities
Panel Discussion• Common reasons for failure (e.g., stability, delivery barriers, patient compliance)
• Case studies: when a formulation didn’t meet expectations
• The role of biological barriers (e.g., blood-brain barrier, tissue penetration) in failure
• How early-stage decisions can set projects up for success or failure
• Creating a culture that shares failures constructively
Formulating Next-Gen Biotherapeutics: Strategies To Enhance Stability, Quality, And Scalability
Panel Discussion• Stabilising complex modalities
• Evaluating non-traditional formulation strategies — including lyophilisation, coformulation, microencapsulation, or amorphous systems
Machinability Of Spray Freeze-Dried Engineered Microparticles
Industry PresentationSpray freeze drying enables the production of highly porous engineered powders ideal for thermosensitive molecules, including biologic drugs. The process generates distinctive microstructures that strongly influence flowability, mechanical behavior, and downstream processability. This talk examines how particle architecture governs machinability, highlighting implications for pharmaceutical manufacturing.
RNAi Delivery, LPN, & Conjugate Approaches
Industry PresentationCan Oral Peptides Finally Replace Injections? From Breakthroughs To Biological Limits
Panel Discussion• Is oral delivery of peptides a solved engineering problem or a biological limit?
• What level of oral bioavailability is actually “good enough” for clinical success?
• Will oral GLP-1s redefine the market or remain niche alternatives?
Breaking Out of Trial-and-Error: ML and Robotics for Predictive Drug Delivery Formulation
Industry PresentationDrug delivery formulation still relies on manual, iterative experimentation. This talk shows how combining robotic formulation and characterization with ML models trained on continuous testing data creates a closed loop: simulate, formulate, validate. Real-world case studies demonstrate faster development timelines and predictable performance before entering preclinical studies.
From Formulation To Market: What Makes A Nasal Product Commercially Viable?
Panel DiscussionRecognize how unmet clinical needs and therapeutic advantages determine the commercial success of nasal drug products.
Evaluate the critical interplay between formulation, device design, patient usability, manufacturability, and cost in determining market adoption.
Apply regulatory, scalability, and differentiation considerations early in development to assess the commercial viability of nasal drug products.
Bio-inspired Fused-Core Ionizable Lipids Enable Efficient Endosomal Escape & mRNA Delivery
Industry Presentation• Novel fused bicyclic core-based lipids from renewable biomass outperform industry benchmarks in endosomal escape, protein expression, and antibody generation when used for delivering mRNA vaccines.
• Rational design and evaluation of 60+ lipids uncovered key design principles governing mRNA delivery efficiency and LNP thermostability
• With good manufacturability, superior thermostability, and robust protein expression, these lipids demonstrated great potential as next generation LNP components for the delivery of stable and scalable mRNA vaccines and therapeutics
Developing BBT-101 - A First-In-Class, Intranasal Formulation
Industry PresentationThis discussion will focus on the challenges of repurposing a drug and delivering it intranasally. Topics to be discussed will include the recent acceptance of intranasally delivered drugs, IP, the 505(b)(2) pathway, fundraising, non-dilutive funding, partnering, and more. Discussion will be based on our experience developing an intranasally delivered therapeutic for disorders of the CNS, with a focus on concussions.
Balancing Biopharmaceutics, Stability & Manufacturability In LAI Suspension Formulation Design
Industry PresentationFirst Line Of Defense: Nasal Delivery Of Low-Cost Biologics For Pan-Viral Defense
Industry PresentationDelivering spirulina-based biologics for respiratory viral defense demands tight integration across production, processing, and formulation. This talk covers how Lumen's cGMP-scale spirulina cultivation, downstream extraction, intranasal formulation and device selection work together as a single pipeline—transforming a low-cost, photosynthetically-grown protein source into a stable nasal therapeutic capable of protecting against a broad spectrum of upper respiratory viruses.
AI Driven Formulation For Small Molecules
Industry PresentationDealing With High Manufacturing And Product Costs In The Gene Therapy Space
Roundtable DiscussionFrom Oral to Inhaled: Lifecycle Delivery Strategies for Pulmonary Disease Therapeutics
Roundtable DiscussionWhen and why to consider alternative delivery routes as lifecycle extensions for oral drugs
Practical formulation, device, and regulatory considerations when repurposing a candidate for inhalation
Lessons learned and open questions across industry and academia
Unlocking AI/ML In Drug Delivery — Overcoming Data Quality & Access Barriers
Panel Discussion• What types of data are most valuable for formulation and delivery research?
• Current barriers: access, standardization, quality, and reproducibility
• Strategies for data sharing across pharma, biotech, and academia
• Case examples of successful AI/ML applications in drug delivery
• Building collaborations to create usable, high-quality datasets
Delivering Therapies Across The Blood-Brain Barrier
Panel Discussion• Developing optimized BBB models for drug discovery
• Predicting future
• Recent technological advancements & platforms
• Challenges and unities for the delivery of biopharmaceuticals
• Using nasal to brain route
Overcoming Formulation Challenges For Inhaled Biologics
Industry PresentationOligonucleotide Formulation, Design, & Delivery
Industry PresentationPeptide Engineering And Advances In ORALINK® Formulation For Oral Delivery Enhancement
Industry PresentationDeveloping Small Molecule Drugs To Mitigate Cisplatin Toxicities
Industry PresentationKeeping It Together: Understanding And Mitigating Liquid-Liquid Phase Separation In Biologics Formulations
Industry PresentationLiquid-liquid phase separation (LLPS) is a critical development challenge in high-concentration protein formulations, driven by weak, reversible protein-protein interactions that can manifest as opalescence, viscosity changes, or visible phase separation.
Strategies to identify and characterize LLPS will be covered. Formulation composition, the primary means to control LLPS, can serve as both a diagnostic and mechanistic probe: strategic modulation of excipients can isolate the dominant interaction forces driving LLPS, allowing mechanism-specific characterization and targeted intervention.
CMC Considerations For Combination Products And Smart Delivery Systems
Industry Presentation• Strategic FDC value: move beyond convenience by proving therapeutic contribution, patient benefit, and lifecycle quality.
• Innovation-led differentiation: use multilayer tablets, microencapsulation, hot-melt extrusion, and 3D printing to enable complex combinations while reducing incompatibility risk.
• Digitally enabled readiness: leverage connected systems for adherence, safety, and insights while meeting evolving cybersecurity, SBOM, and lifecycle expectations.
Breaking The Bottleneck For Biologics & Small Molecules Drug Delivery
Panel Discussion• What makes oral delivery so attractive—and so difficult—for biologics/oligos?
• Novel approaches: nanoparticle carriers, permeation enhancers, and formulation tricks
• Case studies of progress (in oral biologics
• Balancing patient convenience vs. technical feasibility
• How AI/ML can help accelerate innovation
ABI-171: Exploring Inhaled Delivery As A Lifecycle Strategy For An Oral Anti-Fibrotic Drug In IPF
Industry PresentationOverview of ABI-171 as a novel oral anti-fibrotic therapeutic for IPF with orphan designation and preclinical proof of concept
Rationale for exploring inhaled/intranasal delivery as a lifecycle management strategy: direct pulmonary targeting, potential for reduced systemic exposure, and expanded therapeutic utility
Key formulation and delivery challenges in transitioning an oral candidate to an inhaled route and early learnings
Oral Inhalation Through Nebulizers
Industry PresentationDevelopment In Fever Launched Antibodies
Industry PresentationTranslational Nasal Drug Delivery Platforms for Targeted CNS Therapeutics
Industry PresentationDemystifying Fogging In Lyophilized Products
Industry PresentationThe talk would cover recent work aimed at establishing a mechanistic understanding of factors affecting fogging in freeze-dried products. While fogging is a routinely encountered cosmetic defect in freeze-dried formulations, it can potentially impact container closure integrity. Hence, vials with fogging above the shoulder and neck are often rejected during visual inspection. This, in-turn, can result in high batch reject rates during clinical and commercial manufacturing. The severity of fogging in lyophilized products is impacted by a varied range of factors. These can be broadly classified as: formulation composition, pharmaceutical processing conditions and primary packaging. Hence, a systematic study to investigate the influence of each of these factors on fogging enables a mechanistic understanding and consequently, the design of suitable mitigation strategies.
Utilizing Nanotechnology Approaches
Industry PresentationFormulation Strategies to Overcome Peptide Gelation During Lyophilization
Industry PresentationPeptide gelation complicates lyophilization scale-up by affecting primary drying rates and heat transfer. This case study examines gelation behavior of an investigational peptide and its impact during freeze-drying, showing how understanding this interplay enables robust, transferable lyophilization cycles. The findings offer practical solutions for advancing peptide therapeutics from lab to market.
AI & In Silico Tools In Formulation Development
Roundtable DiscussionOvercoming Challenges In RNA Delivery
Industry PresentationDesign Considerations For IV In-Use Studies To Support Clinical Administration
Industry PresentationA thoughtful design of in-use studies ensures drug stability and compatibility during dose preparation and clinical administration. An overview of study design considerations such as the regions and number of clinical sites and anticipated dose preparation and administration procedure is presented. A case study walks through an example of in-use studies to support an early phase program with clinical sites in multiple regions, weight-based dosing, and a switch from undiluted to diluted administration.
Novel Tumour Targeting Peptide Therapies
Industry PresentationOncoloytic peptides as next generation cancer therapies
Abscopal vaccination - amplifying local cell celling through systemic immune engagement
Insights Into Successful Industry Clinical Collaborations
Industry Presentation• Why do we establish clinical collaborations with external companies?
• Industry Clinical Collaborations (ICC) at Roche
• Drugs combinations in ICC
• Successes & challenges with commercial drugs & novel combinations
Formulation & Delivery Challenges For Oral Peptides
Industry PresentationReimagining Abuse Deterrence Through Controlled-Release Engineering
Industry PresentationThe talk highlights innovation-oriented evaluation strategies, including stress-based dissolution testing, extraction resistance profiling, and kinetic descriptors such as partial area-under-the-curve (pAUC) to characterize early exposure behavior. These tools provide mechanistic insight into how formulation design choices translate into exposure profiles relevant to abuse liability assessment.
Inhaled Delivery Of Biologics
Industry PresentationHigh Dose, High Volume Biologics
Industry PresentationWhere Smart Capital Meets Science: Investing In The Next Wave Of Drug Discovery Innovation
Panel Discussion• How investors evaluate emerging drug discovery technologies
o AI in drug discovery
• What drives funding decisions in a shifting biotech market
• Where capital is flowing next
• How investor are looking at non-dilutive founding
Beyond The Hype: AI, Data & The Industry Shift In Drug Discovery R&D
Panel Discussion• How industry dynamics are reshaping pharma R&D strategy & decision-making
• Digital transformation, AI & data-driven labs of the future
• What leaders need to prioritize to turn innovation into real scientific & business impact
Title TBC
Industry PresentationProtein Stability: A Drug Delivery Formulation Challenge
Industry PresentationmRNA Importance
Industry PresentationProgramming Skeletal Muscle As A Bioreactor: A Platform For Durable In Vivo Delivery Of Therapeutic Proteins
Industry Presentation• Application of MYO Technology™ and DNA electroporation to support sustained GLP-1 expression
• Broader platform potential for delivery of antibodies and other therapeutic proteins, with reduced dosing burden, manufacturing complexity, and cost
• DNA electroporation as a flexible, non-viral delivery approach offering scalability, durable expression, and the potential for repeat dosing
What If DNA No Longer Set the Timeline?
Panel DiscussionDNA is foundational to advanced therapies, yet traditional plasmid production can introduce delays before development has truly begun. Drawing on more than two decades developing nucleic acid medicines, Kate Broderick, PhD, will explore how cell-free synthetic DNA can remove that early constraint—enabling faster iteration, greater design flexibility, and a more direct path from promising science to scalable manufacturing and, ultimately, to patients.
Solution Provider Presentation
Solution Provider PresentationFrom Innovation to Impact: Market Strategies Driving the Next Wave of Drug Delivery Technologies
Panel Discussion• What actually defines a “successful” delivery innovation in the market?
• From lab breakthrough to commercial product: where do most strategies fail?
• Pharma vs biotech vs academia: who owns the pathway to market?
• Market access and reimbursement as the real gatekeepers of innovation
Sponsor Presentation
Solution Provider PresentationSubmission required
AI-Powered mPredict™ Co-Crystal Prediction Tool: Recent Advances & Experimental Validation
Solution Provider PresentationUp to 90% of APIs in development suffer from poor solubility, making co-crystallization a key solid-formulation strategy. We present an AI-based co-crystal prediction tool combining quantum chemical calculations and machine learning to rank co-former candidates for a given API.
Solution Provider Presentation
Solution Provider PresentationSolution Provider Presentation
Solution Provider PresentationSponsor Presentation
Solution Provider PresentationSubmission required
Solution Provider Presentation
Solution Provider PresentationPartnerships, Platforms Or Acquisitions: What Is The Winning Model For Brain Health Innovation?
Panel Discussioncollaboration models that actually work
• When to partner vs acquire vs build internally
• Data-sharing in a competitive landscape
• Public-private partnerships in USA: success stories & failures
Injectable & Sustainable Formulations For Oral Peptides
Roundtable Discussion• Overcoming bioavailability and stability challenges to enable effective oral peptide delivery through advanced injectable-to-oral formulation strategies
• Balancing patient convenience with sustainability by reducing waste, improving manufacturing efficiency, and designing greener peptide delivery systems
Critical Attributes For Successful mRNA Based Drug Products
Roundtable Discussion• What are critical elements for drug substance?
• What makes a good delivery system?
• How sustainable can mRNA-based drug products be?
Solution Provider Presentation
Solution Provider PresentationMaking Smart CMC Decisions In Early Drug Development: Strategies To Accelerate IND Readiness
Industry PresentationEarly CMC decisions on dosage form selection and what to lock versus defer have a lasting impact on development timelines and Phase 3 success. Establishing a robust design space before Phase 3 enables future manufacturing flexibility. With new FDA/EMA AI principles, AI-assisted development must meet rigorous traceability, validation, and risk-based expectations.
The Next Frontier In Inhalation Therapy: How Capsule Engineering Directs Fine Particle Delivery And Aerosolization Performance
Solution Provider PresentationPulmonary delivery is expanding from respiratory to systemic therapies. This presentation explores how capsule, API, excipient and device interactions influence DPI aerosolization and support robust next-generation inhalation development.
Delivery-Driven Innovation: Unlocking The Potential Of Next-Generation Therapeutics
Keynote• When delivery—not the molecule—is the bottleneck
• Overcoming barriers across peptides, CNS therapies & infectious diseases, and emerging modalities
• From AI to clinical use
Start Up Zone Presentations x2
Industry PresentationAutomation & AI: Examples From Recursion
Industry PresentationFoundation Models For Chemistry: A New Paradigm In Hit Discovery And Lead Optimization
Industry PresentationSolving The Right Problems – Finding AI’s Value In Drug Discovery
Panel Discussion• How to use AI/ML to solve drug discovery problems
• Success metrics
• Overcoming validation hurdles
CNS Drug Repurposing Using AI/ML Frameworks
Industry PresentationAI Rewiring The Future Of Drug Discovery
Keynote• Taking a deep dive into generative AI for molecular design to illustrate individual methods that have transformative implications
• Putting it all together – active learning and multi-property optimisation for multiple drug properties
• Using AI to integrate early and late-stage considerations – agentic AI approaches
• How do we collaborate across the industry to develop these frameworks?
Applications Of High-Throughput Data Collection In AI/ML
KeynoteMulticellular Perturbation Models For Drug Discovery
Industry Presentation• AI architecture for virtual clinical trials and phenotypic in silico drug discovery
• Building TRAILBLAZER, the first AI foundation model built specifically for multicellular biology, capable of simulating patient-level treatment outcomes
• Case studies of phenotypic in silico drug discovery and modeling multicellular patient responses to treatments
Accelerating the DMTA cycle through AI adoption and automation
Industry Presentation- Drug discovery follows the design–make–test–analyze cycle.
- AI/ML is transforming data analysis and molecular design.
- Automation can accelerate compound synthesis and testing.
- Together, they can close the DMTA loop and achieve efficiencies at an unprecedented scale.
Solution Provider Presentation
Solution Provider PresentationCell Free Antibody Engineering: Accelerating Discovery And Screening with PUREfrex®
Industry PresentationPUREfrex® is a fully reconstituted, cell free protein expression system enabling rapid, high throughput antibody engineering. It efficiently produces scFv, Fab, and IgG, and supports robust ribosome display (PUREfrexRD) for screening highly diverse libraries. Combined with AI/ML workflows, PUREfrex® accelerates discovery of next generation antibodies and cyclic peptide modalities with enhanced precision, flexibility, and scalability for biologics R&D.
Integrating AI/ML And Automation In Discovery Chemistry
Industry Presentation
Afternoon Break & Refreshments
Lunch Break
Morning Break & Refreshments
Close of Day One & Networking Drinks Reception
Lunch Break
End of Event
Morning Break & Refreshments
Bridging The Translational Gap In Neurodegenerative Drug Development
Roundtable Discussion• Building more predictive preclinical programs using human-relevant models and biomarkers
• Leveraging AI to improve target prioritization, patient stratification, and clinical trial design
• Overcoming the biggest barriers to translating promising discoveries into clinical success
• What recent neuroscience programs have taught us about reducing late-stage attrition
How Early Should Developability And Drug Delivery Considerations Influence Target Selection And Lead Optimization Decisions?
Roundtable Discussion• What risks emerge when delivery and developability are addressed too late in the discovery process?
• Should delivery feasibility be a formal criterion when prioritizing targets?
• How can discovery and development teams collaborate earlier to improve program success rates?
From Discovery to Delivery: Turning Scientific Innovation into Commercial Success
Roundtable Discussion• What separates promising science from commercially viable innovation?
• Common pitfalls in translating research into therapeutics
• Building collaborations between academia, biotech, and pharma
• How startups can position themselves for investment and strategic partnerships