Discovery & Development US 2026
Hilton San Diego Bayfront, CA
The Power Of Partnerships: Aligning Pharma, Biotech, And Academia To Accelerate Development & Innovation
Panel Discussion Conference Room 4• 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 Presentation Conference Room 5HT-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
Design And Formulation Of Long-Acting Entecavir Prodrugs For Improved Hepatitis B Treatment Adherence
Industry Presentation Conference Room 6HBV chronic infection requires lifelong daily therapy, risking non-adherence and relapse. We developed long-acting injectable (LAI) prodrugs of Entecavir (ETV) via our platform, screening >30 candidates. The lead prodrug shows sustained IM release >1 month, lower Cmax, low injection volume (<500 µL), and plasma levels above therapeutic threshold—offering a promising adherence-improving LAI approach for HBV.
Overview Of The Challenges Of CMC
Industry Presentation Conference Room 6Formulating 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 Conference Room 5• 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 Presentation Conference Room 6Drug 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 Discussion Conference Room 6Recognize 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 Presentation Conference Room 6This 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 Presentation Conference Room 6First 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.
From Oral to Inhaled: Lifecycle Delivery Strategies for Pulmonary Disease Therapeutics
Roundtable Discussion Conference Room 6When 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 Conference Room 5• 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 Conference Room 4• 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 Presentation Conference Room 6The Next Frontier In RNA Delivery: Antibody-Oligonucleotide Conjugates, Clinical Validation, CMC Challenges And Future Directions
Industry Presentation Conference Room 4• AOCs are emerging as the next generation of RNA therapeutics, combining antibody targeting with oligonucleotide payloads to enable delivery beyond the liver. Clinical proof-of-concept is growing, with industry momentum.
• CMC remains a key hurdle. AOCs combine the challenges of biologics and oligonucleotides, requiring control of stability, conjugation, heterogeneity, manufacturability, and analytical complexity.
• Future success depends on solving delivery and CMC challenges, particularly extrahepatic targeting, scalable manufacturing, and next-generation RNA payloads.
Advancing Oral Peptide Delivery Through Integrated Peptide Engineering And Formulation Design
Industry Presentation Conference Room 5Oral delivery of peptides remains a significant challenge. Despite extensive research, formulation-based approaches alone have made only incremental progress in overcoming absorption barriers. Emerging evidence suggests that a more integrated strategy, combining formulation development with rational peptide engineering, may provide a more effective path toward improving oral absorption and achieving clinically meaningful bioavailability.
Keeping It Together: Understanding And Mitigating Liquid-Liquid Phase Separation In Biologics Formulations
Industry Presentation Conference Room 6o Liquid-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.
o 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 Emerging Solutions
Industry Presentation Conference Room 6• 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.
Breaking The Bottleneck For Biologics & Small Molecules Drug Delivery
Panel Discussion Conference Room 4• 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 Presentation• Overview of ABI-171 as a novel oral anti-fibrotic therapeutic for IPF with orphan designation & 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 PresentationNext-Gen DNA Medicine And Delivery: The Potential For In Vivo Therapeutic Protein Production In Rare Disease
Industry Presentation Conference Room 5• Promising clinical proof-of-concept of long-term in vivo protein expression via non-viral local gene delivery to the skeletal muscle
• Absence of host immune response against the vector or encoded proteins enabled drug redosing
• Data support potential in the development of durable protein replacement therapies in rare genetic disease, including Fabry, Hypophosphatasia (HPP) and Hemophilia A diseases
Translational Nasal Drug Delivery Platforms for Targeted CNS Therapeutics
Industry PresentationDemystifying Fogging In Lyophilized Products
Industry Presentation Conference Room 5The 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 Presentation Conference Room 4Formulation Strategies to Overcome Peptide Gelation During Lyophilization
Industry Presentation Conference Room 6Peptide 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 Discussion Conference Room 4Durable DNA-Based Leptin Gene Therapy for Treatment of Lipodystrophy
Industry Presentation Conference Room 4Congenital generalized lipodystrophy is driven by severe leptin deficiency, with daily metreleptin injections the only approved therapy. Using the non-viral Fusogenix Proteolipid Vehicle, a single intravenous or intrathecal injection of DNA-encoded leptin restored leptin for over six months in ob/ob and CLA-fed mouse models, normalizing weight, food intake, and metabolic function.
Design Considerations For IV In-Use Studies To Support Clinical Administration
Industry Presentation Conference Room 6A 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 Presentation Conference Room 5Oncoloytic peptides as next generation cancer therapies
Abscopal vaccination - amplifying local cell celling through systemic immune engagement
Insights Into Successful Industry Clinical Collaborations
Industry Presentation Conference Room 5• The session will analyze the landscape of clinical collaborations, focusing on how these external partnerships act as a key driver for innovation in combination therapies.
• You will explore the "give-and-receive" drug model, detailing how to bridge internal assets with external innovation to effectively mitigate risk and improve evidence generation.
• Discussions will cover the challenges and successes of managing these partnerships to accelerate development and redefine approaches to complex treatment pathways.
Formulation & Delivery Challenges For Oral Peptides
Industry Presentation Conference Room 5Despite decades of research, peptides and other biologic therapeutics continue to rely on parenteral administration due to insufficient oral bioavailability. This presentation will examine the key formulation and delivery challenges facing oral peptide development, including current limitations and recent advancements in the field, the difficulties of transitioning from liquid to solid dosage forms, and translational insights from porcine models on species-related intestinal absorption and human predictivity.
Reimagining 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 Presentation Conference Room 5High Dose, High Volume Biologics
Industry PresentationHigh concentration protein therapeutics have become more popular as they favor subcutaneous (SC) administration. Successful development of high dose biologics requires adopting certain formulation approaches to overcome technical challenges such as viscosity, solubility, stability, process issues and delivery limitations. There is no one approach fits for all. This talk will outline some key aspects while designing high concentration protein therapeutics from the formulation and process standpoint.
Where Smart Capital Meets Science: Investing In The Next Wave Of Drug Discovery Innovation
Panel Discussion Conference Room 4• How investors evaluate emerging drug discovery technologies
• What drives funding decisions in a shifting biotech market
• Where capital is flowing next
Beyond The Hype: AI, Data & The Industry Shift In Drug Discovery R&D
Panel Discussion Conference Room 4• 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 Presentation Conference Room 5Heat and organic solvents are commonly used in preparing sustained delivery formulations for small molecule drug delivery. The applications of these formulations are not extended to sustained release formulations of proteins because of the protein stability concern. We have performed case study on surrogate protein to study impact of the high temperature stress and organic solvent to understand the stability of the protein. The results of these case study will be shared and guidance for developing sustained release formulations for proteins will be provided.
mRNA Importance
Industry PresentationProgramming Skeletal Muscle As A Bioreactor: A Platform For Durable In Vivo Delivery Of Therapeutic Proteins
Industry Presentation Conference Room 5• 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 Discussion Conference Room 4DNA 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.
Arg.Glu* (Arginine-Glutamate) As Ideal Excipient For High Concentration Monoclonal Antibody And Complex Biologics Formulations
Solution Provider Presentation Conference Room 5High concentration monoclonal antibody (mAb) formulations present major development challenges, including high viscosity, aggregation, reduced solubility, and liquid–liquid phase separation. Arginine Glutamate (Arg·Glu, A 172) has emerged as a multifunctional excipient capable of mitigating these issues by modulating protein–protein interactions. In this session, we highlight literature and data demonstrating Arg·Glu’s effectiveness in solving some of the challenges associated with high concentration and complex biologics formulations
From Innovation to Impact: Market Strategies Driving the Next Wave of Drug Delivery Technologies
Panel Discussion Conference Room 4• 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 Presentation Conference Room 5Submission required
AI-Powered mPredict™ Co-Crystal Prediction Tool: Recent Advances & Experimental Validation
Solution Provider Presentation Conference Room 5Up 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 Presentation Conference Room 6Preformulation And Solid Form Technologies Utilizing MicroED As A Game Changer For API Characterization
Solution Provider Presentation Conference Room 5Preformulation study is a key for the successful IND of drug candidates. API solid form is one of its critical elements for which 3DED/MicroED analysis is often required because only micrograms of powders and submicron crystals are available.
Solution Provider Presentation
Solution Provider Presentation Conference Room 6Partnerships, Platforms Or Acquisitions: What Is The Winning Model For Brain Health Innovation?
Panel Discussion Conference Room 4collaboration 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
Critical Attributes For Successful mRNA Based Drug Products
Roundtable Discussion Conference Room 4• What are critical elements for drug substance?
• What makes a good delivery system?
• How sustainable can mRNA-based drug products be?
Beyond Characterization: Turning Early Developability Data Into Drug-Product Decisions
Solution Provider Presentation Conference Room 6Early developability assessment can do more than characterize the API - it can help define the formulation strategy before extensive development begins. Drawing on Serán’s practical experience, this presentation introduces a decision-oriented approach to:
• Identify API attributes that may constrain drug-product development
• Translate characterization findings into formulation risks and drug-product consequences
• Use mechanistic understanding to prioritize formulation strategies
• Generate targeted, decision-relevant data to accelerate early formulation development
Making Smart CMC Decisions In Early Drug Development: Strategies To Accelerate IND Readiness
Industry Presentation Conference Room 6Early 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 Presentation Conference Room 6Pulmonary 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 Conference Room 5• 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 Presentation Conference Room 4Why Formulations Fail — Lessons Learned Across Modalities
Panel Discussion Conference Room 4• 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
Start-Up Presentation - QT Sense
Solution Provider Presentation Conference Room 4Start of Track: Nasal & Inhalation Drug Formulation & Delivery
Industry Presentation Conference Room 6Start of Track: Drug Product Development, CMC & Developability
Industry Presentation Conference Room 6BIONDD® Oral Capsule Technology – Delivery Of Biomolecules Achieving Consistent Similar PK Profiles To Subcutaneous Injection In Dogs
Solution Provider Presentation Conference Room 5Oral delivery of biologics remains challenging due to their degradation in the GI tract and poor absorption, thereby being commonly administered by subcutaneous injections. The BIONDD® technology, with a convenient small-size 00 oral capsule, overcomes these challenges by administering the active substance directly into the stomach wall. Pre-clinical in vivo studies with BIONDD® have shown successful oral delivery of various biomolecules in dogs with a bioavailability comparable to SC injection.
Start-Up Presentation - Helical AI
Industry PresentationStart-Up Presentation - Synfini
Industry PresentationStart-Up Presentation - Matterworks
Solution Provider PresentationStart-Up Presentation - Zephyr AI
Solution Provider PresentationStart-Up Presentation - Intel Corporation
Solution Provider PresentationStart-Up Presentation - Forma
Solution Provider PresentationDealing With High Manufacturing And Product Costs In The Gene Therapy Space
Roundtable Discussion Conference Room 4• Scalability challenges in manufacturing
• Supply chain and raw material constraints
• Process optimization and automation opportunities
• Regulatory and quality compliance costs
• Innovative business and partnership models
AI Rewiring The Future Of Drug Discovery
Keynote Conference Room 1• 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?
Afternoon Break & Refreshments
Lunch Break
Morning Break & Refreshments
Close of Day One & Networking Drinks Reception
Lunch Break
End of Event
Morning Break & Refreshments
How Early Should Developability And Drug Delivery Considerations Influence Target Selection And Lead Optimization Decisions?
Roundtable Discussion Conference Room 4• 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 Conference Room 4• 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