Day One

• Showcasing preclinical development of JSKN021, a bispecific dual payload ADC in IND-enabling studies
• Assessing development and design of other early stage bispecific ADC and dual payload conjugates
• Looking to the future: Evaluating the potential of dual payload ADCs with enhanced tumor targeting properties

• Introducing a proprietary dual-payload conjugation design to overcome drug resistance and tumor heterogeneity
• Displaying preclinical evidence of proprietary dual-payload conjugates against cancer

• Highlighting design and preclinical development of IBI3005 bispecific ADC targeting EGFR & HER3
• Assessing rationale and performance of ADCs with dual targeting and dual payload design versus classical design
• Leveraging novel TOP1i payloads in bispecific and dual-payload ADCs

• Applying RWD to identify novel therapeutic targets and provide insights into ADC development with responder populations
• Examining how patient-derived organoids can enhance biomarker validation and help guide therapeutic decisions
• Highlighting a “lab-in-theloop” approach to incorporate screening panels of PDOs, optimized for ADC evaluation, and RWD to enhance biomarker validation and guide pipeline prioritization

• Exploring degrader modality and opportunities for degrading undruggable targets
• Explaining how ADCs leverage target-mediated cellular uptake to improve therapeutic index and ADME advantages of degrader ADCs
• Discussing PK/PD modeling strategies for degraders and degrader ADCs that enable clinical translation

• Exploring the assessment of ADC efficacy through single-mouse in vitro PDXO, MiniPDX, PDX, and clinical MiniPDX models
• Demonstrating how models bridge preclinical findings to clinical indications, offering insights into drug efficacy and resistance mechanisms
• Highlighting the integration of diverse models to accelerate ADC development and guide decision-making in pharmaceutical R&D

• Exploring the pattern of preclinical dosing in mouse models to clinical profiles from approved ADCs
• Explaining how to best approach dosing and efficacy in mouse models to avoid overdosing and set up translation for success
• Utilizing PDX and computational models to understand patient responses in situations with multiple approved ADC options

• Summarizing results from biomarker results associated with clinical efficacy and adverse events
• Addressing the current gaps in biomarker technologies and capabilities to inform ADC treatment response and patient selection strategy
• Suggesting future directions for ADC biomarker technologies

• Sharing how dysregulated ECM remodeling in cancer leads to the release of specific ECM turnover fragments into the bloodstream
• Discussing the doubling ADC response rates with PRO-C3: Harnessing non-invasive ECM biomarkers for enhanced tumor drug delivery
• Outlining how specific ECM-derived cleavage products have the potential to predict ADC linker cleavage, and drug release within tumors

• Exploring applications of liquid biopsies and ctDNA in the development and characterization of ADCs
• Understanding how liquid biopsies can be used in early clinical development, such as informing dose selection
• Applying lessons learned to ongoing and future ADCs

• Introducing design and development of DB-1311 targeting B7-H3 immune checkpoint protein
• Exploring ongoing clinical development in Phase1/2 studies in patients with advanced solid tumors
• Highlighting future development plans and advantages from collaboration for global ADC clinical trials

• Discussing how the MoA of ADCs and bispecifics warrant an AI-powered spatial biomarker approach for accurate patient selection
• Outlining how novel, AI-powered spatial biomarkers are being deployed for clinical trial enrollment
• Exploring how the exponential rise in ADC and bispecific trials and approvals will result in a new generation of diagnostics to aid physicians in treatment selection and what it means for drug developers

• Covering the rationale for using ADC constructs targeting cadherin-3 (CDH3) which are overexpressed in a wide range of solid cancers
• Reviewing the preclinical performance of BC3195 and the importance of non-clinical studies in developing, a first- in-class CDH3-targeting ADC
• Reviewing the preliminary results of clinical studies of BC3195

This is your opportunity to present newly published clinical data in front of our specialized audience of industry experts. Data must be published and available to be presented ahead of the deadline of Friday, October 3. Please email adc@hansonwade.com to register your interest.

• Developing an alternative purification method to streamline removal of free drug related impurities
• Laying out validation methodology for a novel purification technology
• Assessing risk mitigation strategies for naturally variable raw materials

• Introducing the techniques used during development to achieve deep process understanding and right first-time transfer to manufacturing
• Exploring the established roadmap to scale up ADC manufacturing
• Learning through case studies: seamless transfers from process and analytical development to GMP production

• Carrying out HIC of low DAR ADCs and identifying multiple peaks indicative of potential positional isomers
• Fractioning HIC peaks and conducting further analysis to identify root causes
• Explaining characterization to identify ADC payload hydrolysis and understanding impact on product quality

• Discussing Samsung Biologics’ strategic service expansion into ADCs, leveraging mAb development and manufacturing expertise
• Optimizing ADC facility design and readiness to ensure operational excellence
• Streamlining ADC process development through fundamental principles and effective technology transfer methodologies
• Maximizing program potential through technical expertise in conjugation, analytical methods, form

• Weighing up internal versus external manufacturing: Assessing selection criteria to inform external manufacturing partner selection
• Delving into design considerations, feasibility, and concept studies for greenfield ADC manufacturing facility development in Singapore
• Outlining requirements for meeting process requirements for conjugation in single-use ADC manufacturing facility

• Outlining ADC production molecular diversity from recent advances in ADC development
• Exploring how ADC DP development requires an understanding of how elements can be influenced by each other and ADC molecular design
• Sharing case studies with practical solutions built upon our platform technologies to counter challenges in formulation developability evaluation, light/oxidation protection, lyophilized DP optimization, customized clinical in-use evaluation and beyond

• Discussing when and when not to outsource development and manufacturing
• Examining strategy to identify and build the right types of partnerships with contract organizations, personalized to the type of ADC project
• Identifying challenges in establishing effective collaboration between sponsor companies and contract organizations

• Exploring supply chain integration for the manufacturing of ADCs
• Accelerating development of ADCs
• Discussing how to minimize risks from a CDMO perspective