Day Two

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• Explaining the journey of ADC development against low-expressed tumor targets: from previously off limits to emerging advantages against modalities like TCEs
• Diving into a case study of ADC development and profiles against DLL3
• Exploring wider context of ADC successes and development in antigen-low populations in solid tumors 

• Harnessing the power of targeted protein degradation to develop novel ADC payloads
• Optimizing degrader payloads to achieve high potency and a favorable safety profile 
• Exploring Anti-CD19 DAC demonstrating deep B-cell depletion in animal models 
• Evaluating how degrader payloads novel mechanisms can potentially overcome resistance to current TOP1i based ADCs in oncology 

• Exploring target characteristics and solid tumor expression rationale for re-exploring Ly6E
• Showcasing design and development of ZW327 across anti-Ly6E antibody generation and novel Topo1 payload
• Exploring preliminary finding sand future development plans for ZW327 across solid tumors

• Overviewing challenges associated with current ADCs 
• Highlighting ADC innovation including multispecific, conditionally active and long-lasting antibodies
• Discussing a high throughput single-cell-based functional discovery platform to enable future ADC development 

• Identifying high confidence novel targets via innovative proteomic platforms 
• Explaining modality-agnostic strategies to validate ADC targets across indications
• Validating the patient  landscape through clinico- genomic and wet lab insights

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• Laying out preclinical and emerging clinical profiles of zelenectide pevedotin and BT5528
• Making comparisons of the safety profiles of these BDCs versus traditional ADCs
• Exploring opportunities for Bicycle® molecules beyond drug conjugates

• Showcasing GlyCLICK® site-specific conjugation that produces homogeneous ADCs with a defined DAR while preserving antibody function
• Exploring how the platform supports controlled ADC generation and applies to a wide range of antibody formats and payloads
• Laying out case studies and preclinical examples demonstrate how GlyCLICK® is used in the development of novel ADCs

• Characterizing EVA1 membrane protein as an unexplored target to eliminate Glioblastoma-Initiating Cells (GICs)
• Generating high affinity anti-EVA1 antibodies to assess antibody dependent cytotoxicity and complement dependent cytotoxicity
• Exploring non-clinical performance of B2E5-ADC in EVA1 expressing cell lines and GICs in culture

• Understanding how to migrate from non-selective ADC payloads
• Debating the right properties for a next generation payload and linker: Can (or should?) any small molecule therapeutic be developed into an ADC?
• Debating the right strategy for dual-payload ADCs
• Understanding ADC toxicity and developability for next-generation conjugates

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• Evaluating learnings from dose selection of approved ADCs and understanding the implication to novel ADCs
• Optimizing study design and dose scheduling to balance benefit-risk profiles of ADCs
• Integrating quantitative modeling to guide ADC dose finding and decision

• Setting up first-in-patient dose escalation study for ADCs (starting dose and dose regimen selection, dose escalation increment, bioanalytical assays)
• Applying modeling and simulation tools in first-inpatient study for ADCs
• Selecting optimal ADC dose for expansion

• Introducing the clinical program for Enhertu in HER2-mutant NSCLC
• Understanding the general principles of ADC dose selection and highlighting lessons learned from Enhertu clinical program
• Breaking down the dose selection and optimization for Enhertu supporting approval in HER2 mutant NSCLC population

• What translational research can be used for ADC dose optimization?
• Evaluating what quantitative methodologies are most effective for optimal dose determination
• Understanding when to conduct ADC dose optimization given a typical narrow therapeutic index?
• What are the pros and cons of undergoing dose optimization at different stages?

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• Reviewing the successes and failures for ADCs in the clinic in categories across target, indication, ADC design and linker payload
• Understanding implications for human biology and how this relates to improvement opportunities for ADCs
• Laying out lessons for mechanism of action of ORR versus CR/DOR

• Reviewing clinical use and benefits of recombinant human hyaluronidase PH20 (rHuPH20) and potential application to ADCs
• Demonstrating safe preclinical subcutaneous administration of an ADC
• Improving preclinical pharmacokinetics of ADCs delivered subcutaneously

• Exploring how to implement successful plan for first-in-class ADC clinical development 
• Outlining differences in saturated target and payload ADC landscapes – how do we demonstrate differentiation? 
• Explaining other late-stage considerations affecting clinical development

•  Overview on GlycoConnect® based ADCs highlighting the rapidly expanding pipeline of GlycoConnect® ADCs
• Clinical development insights from partnered assets 
• Technology innovations

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• Developing decapping methodology to assess linker payload quality and manufacturability for sitespecific conjugation
• Generating risk assessments to identify linker-payload candidate optimized for sitespecific conjugation
• Transferring process knowledge and analytical insights to clinical-stage ADC teams

• Outlining essential CMC control strategies for ADCs, focusing on critical quality attributes and analytical methods throughout the development process
• Discussing the selection, testing, and specification setting for the linker-payload complex, a critical component that defines ADC efficacy and safety
• Presenting innovative case studies that demonstrate practical solutions and advanced approaches to common linker-payload development and manufacturing challenges

• Leveraging multiple analytical tools to understand and define optimal conjugation process

• Using analytical tools to understand and define the end of reduction, conjugation, and TFF purification process operations

• Utilizing purging data of small molecule impurities during development to justify the release/stability specification of final ADC drug substance

• Understanding the challenges in ADC process development encountered prior to and during lyophilization
• Delving into lyophilization cycle development to ensure ADC drug product stability 
• Looking to the future: What are the opportunities to further improve lyophilization for ADC process development?

• Contrasting early versus late-stage ADC process development strategies
• Laying out considerations for early vs. late-stage manufacturing challenges, priorities, and CoGs
• Exploring case studies for process development and manufacturing goldilocks leveraging scale-up/down models

•  Exploring collaborative models  that ensure process robustness,  knowledge continuity, and  accelerated timelines during  ADC scale-up
• Addressing the unique  complexities of scaling  conjugation, purification, and  formulation steps
• Evaluating real-world  approaches to managing  variability, maintaining product  quality, and meeting regulatory  expectations

• Understanding approaches to scale up manufacturing fast and well as ADCs advance quicker into and through the clinic
• Exploring risk mitigation strategies to counter ADC supply chain pressures
• Delving into considerations and challenges with onshoring of ADC manufacturing