Day One

• Delving into the development of a suite of bone marrow in vitro models to utilise in preclinical ADC haematotoxicity assessment
• Evaluating in vitro model capability to replicate clinical ADC toxicities and support drug development
• Understanding limitations of ADC in vitro models and exploring future directions to overcome them

• 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
• Highlighting the integration of diverse models to accelerate ADC development and guide decision-making in pharmaceutical R&D

• Presenting the development of a novel antifolate linker-drug platform, a toxin class with a clinically validated mechanism of action
• Discussing preclinical development of antifolate-based ADCs across in vitro and in vivo studies
• Outlining antifolate payload mechanism of action and physicochemical properties

• PDOs act as functional ADC patient avatars, preserving tumour heterogeneity and normal tissue biology to reflect clinical efficacy and on-target/off-target toxicity
• PDOs capture variability in ADC response beyond antigen expression, enabling assessment of target engagement, internalisation, payload sensitivity, and tissue penetration
• PDOs enable the development of next generation therapeutic strategies, allowing for testing of combination therapies and comparison with SoC data in patient relevant models

• Overviewing R-DXd design and mechanism of action
• Presenting clinical activity of R-DXd in patients with platinum-resistant ovarian cancer (PROC) from Phase I and Phase II/III REJOICE-Ov01 study
• Exploring the outcome of dose optimisation analysis of R-DXd in patients with PROC

• Laying out the history and progress made developing ADCs and other therapeutics against c-Met
• Detailing the safety and efficacy profile of ABBV-400 across lung, CRC and solid tumour indications
• Exploring lessons learned to optimise ABBV-400 clinical profile and evaluating the concept of ADCs as targeted therapies

• Laying out amanitin-based ADC as promising approach to overcoming drug resistance through differentiated payload mechanism of action
• Showcasing phase I/II dose escalation data of HDP-101: clinical performance and excellent safety and tolerability
• Explaining lessons learned across opportunities and hurdles of bringing a novel ADC payload to the clinic

This is your opportunity to present newly published clinical data in front of our specialised audience of industry experts.

Data must be published and available to be presented ahead of the deadline of Friday, 31st January.

Please email adc@hansonwade.com to register your interest.

• Defining CQAs of antibody and bispecific Drug Substance intermediates and ADC Drug Substances and Drug Products
• Exploring the role of cutting-edge analytical strategies based on the use of LC, CE, and MS, either as standalone techniques or in combination
• Evaluating use of tailored analytical methods for comprehensive ADC characterisation and early developability assessment with relevant benchmarks

• Exploring the differing development approaches of ADCs across the preclinical to commercial spectrum
• Understanding how the bioconjugate landscape now encompasses a wide variety of modalities with differing mechanisms of action and molecular structures
• Exploring relevant examples of how the requirements for process and analytical development can vary between different conjugates

• Examining the analytical assay needs for ADCs from a stability perspective
• Demonstrating how in vitro assay results guide the rational selection of ADC candidates for further development
• Evaluating emerging opportunities to automate biophysical characterisation ADC workflows

• Navigating the nuances of AOC process development and understanding how to leverage physiochemical properties and chemistry aspects between different AOCs
• Comparing AOCs with classical ADCs across payload complexity, impurity profiles, and essential analytical methods
• Assessing the evolving regulatory framework, impurity control, stability, immunogenicity and target product profiles
• Spotlighting real-world customer case studies that demonstrate a risk-managed approach to get to the clinic quicker

• Assessing supply chain and process development strategy to enable ADC discovery innovation to flow through to first-in-human clinical trials
• Navigating the complexities of ADCs: Linker-payload chemistry, mAb, conjugation, sterile fill and finish in the design of future clinical supply chains
• Understanding key elements to ensure successful process scale up and transfer of ADC across the end-to-end supply chain

• Navigating a holistic and risk-based approach for both drug-linker and ADC drug substance process
• Exploring a case study of environmental monitoring of drug linker and ADC drug substance facilities
• Using case study examples to assess drug-linker and ADC microbial methods

• Leveraging resources to sustain early manufacturability assessments
• Promoting communication and stakeholder engagement between manufacturing and discovery teams to uncover golden opportunities
• Shortening ADC manufacturing timelines without increasing associated risk

• Discussing tools used for efficient and scalable manufacturing of the mAb intermediate, a key starting point for ADC conjugation
• Highlighting various chromatography systems and resins used in the process, such as the ÄKTA™ systems and MabSelect PrismA™ resin, designed for robustness and efficient purification
• Presenting the compatibility of materials in single-use systems with solvents used in ADC manufacturing process, detailing the steps involved in analysis