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 

• Explaining the importance of a comprehensive set of criteria for therapeutic candidates to meet for high quality, differentiated ADCs serving unmet need
• Exploring robust discovery and screening capabilities enabling ADC speed to clinic
• Laying out ADC program examples leveraging target biology for differentiated Topo1 ADC development

• Identifying high confidence novel targets via innovative proteomic platforms that uncover masked targets
• Explaining modality-agnostic strategies to validate high-priority ADC and other targets across indications
• Identifying and validating the patient landscape through parallel clinico-genomic and wet lab insights built upon >500K molecularly-profiled and clinical-data-linked tissues

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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 drug-to-antibody ratio 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

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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

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• Understanding the development journey of a bioassay program for ADC functional and procedural applications
• Exploring how to make methods to be robust and repeatable for ADC bioassay validation
• Assessing opportunities to adapt small molecule bioassays for ADC SAR characterization

• 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

• Assessing application of qualified SPR-based FCGR-binding assays
• Exploring characterization of Fc effector activity of inert and active formats
• Evaluating the impact of variation of N-glycosylation structure FCGR-engagement and ADCC

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• 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

• Enacting innovative approaches to implement the Green Chemistry concept to ADC manufacturing
• Developing clinical to commercial phase manufacturing processes to achieve improvement goals for environmental impact, safety, and economic value
• Managing the supply chain for sustainable and reliable complex HPAPI and ADC manufacturing

• 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

• 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