Pre-Conference Seminar Day

As ADCs become more crowded with Topo1 and MMAE payloads across oncology indications, the need for ADC differentiation across payload and targeting moieties is crucial to overcome patient resistance and provide long-term patient benefit.

Join this seminar day to stay ahead of the ADC design curve across non-cytotoxic payloads, site-specific conjugation technologies, and emerging multi payload ADC design rationale and performance

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• Breaking down the exciting landscape of novel drug conjugate design and mechanism of action
• Exploring emerging trends across drug conjugate design and targets
• Spotlighting novel conjugate innovation across multi payload ADCs, bispecific ADCs, and degrader conjugates

• Contextualizing success from cytotoxic ADC development, headlined by the approval and success of Padcev
• Re-envisioning ADC design through collaboration on dual payload ADC development
• Demonstrating ADC payload innovation through degrader antibody conjugate programs

• Creating and optimizing versatile drug bundles with different drug combinations and ratios
• Sharing CHO-TEM Technology allowing linkage of four drug bundles, each containing 2 or 3 drugs from two categories
• Discussing development of high-efficacy and stable ADCs with high DAR (8 or 12) and dual drugs

• Addressing the clinical challenge of acquired resistance to single-payload ADCs by delivering two different payloads simultaneously to tumors
• Utilizing an innovative cell-free platform to create novel dual payload conjugates
• Showcasing dual-payload ADC approaches with superior preclinical in vitro and in vivo efficacy data

• Showcasing design and assembly of multi-payload conjugates leveraging validated building blocks and innovative conjugation using native amino acids
• Screening payload combinations for enhanced anti-tumor activity and exploring tunable DAR to match potency for multipayload combinations
• Exploring preclinical evaluation of multi-payload conjugates and pathway to the clinic

• Exploring innovation to improve the therapeutic window of ADCs with glycosite-specific design
• Applying glycosite-specific conjugation to develop next-generation ADCs
• Discussing challenges and solutions for manufacturing glycosite-specific ADCs

• Detailing Bright Peak protein engineering and protein conjugation to construct BPT567 and other antibody-protein conjugates
• Showcasing preclinical activity of immunoconjugate BPT567 with IL-18 payload
• Reviewing plans for ongoing Phase 1/2a in-human study and highlighting the need for novel ADC payload innovation

Whilst the path to the clinic is established for cytotoxic ADCs, in-depth knowledge of ADC MoA and tumor targeting behavior remains elusive, especially for ADCs with novel payloads and targeting moieties.

Attend this seminar day to leverage PD and systems pharmacology modeling to investigate ADC tumor targeting behavior, unlock transferable insights into non-cytotoxic ADC MoA, and assess applications of bioconjugates beyond oncology

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• Exploring non-clinical evaluation of the unique characteristics of PDL1V, a PD-L1-targeting vedotin ADC
• Understanding PDL1V impact on immunosuppressive cells in the TME
• Assessing PDL1V impact on immunoresponsive cells needed for natural anti-tumor immunity activity

• Describing pharmacological characterization of SOT106, including LRRC15 expression within different cell populations in the TME with emphasis on pivotal role in tumor biology
• Developing SOT106 diagnostic antibody tailored to optimize patient selection and identify patients who could benefit
• Exploring the prospect of SOT106 combination therapies to elevate therapeutic potential

• Exploring next-generation ADCs delivering innate agonist payloads with precision
• Explaining how targeted delivery ensures location-specific processing by tumor-resident phagocytic immune cells, leading to the strategic release of the payload
• Assessing how resulting robust activation of myeloid cells within the tumor microenvironment sets the stage for a potent adaptive anti-tumor immune response

• Leveraging systems pharmacology modeling to understand ADC behavior and MoA
• Combining knowledge from novel payloads with classical cytotoxic ADCs to impact future ADC constructs
• Utilizing pharmacology characterization to assist with translation and first-in-human dosing strategy

• Examining unique delivery challenges encountered for solid tumor ADCs that may result in a binding-site barrier
• Investigating how mechanistic modeling, supported by quantitative experimental parameters, can inform on ideal drug design to overcome these challenges
• Focusing on how intentional protein-drug conjugate design can improve tumor penetration to expose the greatest number of tumor cells to a therapeutic concentration of payload

• Understanding potential applications and what has already been achieved in bioconjugate applications beyond oncology
• Outlining similarities in AOC development versus ADCs across DAR and overall conjugate properties
• Breaking down the non-transferable assumptions when developing bioconjugates in rare and chronic indications

• Exploring mechanism of action of AOCs in treating neuromuscular disease
• Determining the preclinical PK/PD relationships of AOCs
• Assessing translation of the PK/PD of AOCs in neuromuscular disease

Bring your burning questions to this closing panel with all the seminar day’s presenters. With all ADC pharmacology topics up for discussion, hear the speakers delve into in-depth ADC MoA investigation, best utilize systems pharmacology modeling, and understand the transferable and non-transferable assumptions for bioconjugates with novel payloads and formats

Despite blockbuster ADCs moving to earlier-line treatments and challenging oncology standard of care, poor tolerability remains the limiting factor to widen therapeutic index and achieve true success in patients.

Don’t miss this seminar day utilizing in vivo and in vitro models to predict ADC clinical safety profiles, characterizing and mitigating on and off-target ADC toxicities, and spotlighting ADC design with enhanced tolerability profiles

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• Contextualizing concepts from emerging novel conjugates: Dual payload ADCs and bispecific ADCs
• Considering factors for balancing DAR and combining mechanisms for dual payload toxicity profiles
• Evaluating the ongoing development and promise of bispecific ADC programs

• Understanding driving factors of off-target toxicities and widespread impact on ADC clinical efficacy profiles
• Highlighting the need for novel methods of ADC tumor targeting to combat ADC off-target toxicity, including the use of pre-targeting
• Sharing pre-targeting data from CECAM5 program that separates binder from payload and uses click chemistry to reunite them at the tumor, highlighting differentiated efficacy and safety

• Laying out the room for improvement with targeting FGFR2b by mAb by optimizing safety and efficacy profile
• Exploring design rationale for FGFR2b ADC with reduced signal blockade and string bystander killing activity
• Evaluating the preclinical profile of FGFR2b ADC with absence of ocular toxicity in preclinical species and strong efficacy in CDX and PDX models with heterogenous antigen expression

• Understanding state-of-play in NHP studies and implications for ADCs in the clinic
• Investigating top-line Topo1 asset toxicity data and considering impact on the ADC space
• Reviewing FIH trial adverse event data to help visualize the Topo1 toxicity landscape

• Evaluating toxicity of three EGFR-targeting ADCs with different payloads with results showing bystander activity and premature payload release in the brain microenvironment
• Investigating EGFR-targeting ADCs in glioblastoma PDX models to narrow down best performing toxicity and PK profiles
• Exploring changes in ADC design to optimize bystander activity and therapeutic index against glioblastoma

• Exploring how utilizing HUB Organoid Technology allows to develop patient-derived organoids relevant with high fidelity to the original tumor
• Leveraging HUB Organoids to de-risk preclinical development of ADCs, prioritize indications, uncover target independent toxicities, and complement biomarker strategy
• Assessing how the next frontier for ADC organoids will see mode of action studies performed to optimize clinical candidates and prioritize patient selection

• Exploring preclinical toxicity characterization across different ADC payload classes
• Selecting and utilizing optimal in vivo models to best replicate clinical toxicity profiles
• Measuring predictability of different in vivo models from ADC translational data

• Applying advanced in vitro models to complement ADC safety strategy alongside in vivo preclinical models
• Integrating bioanalytical methods with in vitro toxicity to improve early-stage clinical toxicity predictions
• Assessing key toxicities commonly observed in clinical settings to prioritize and select the safest ADC molecules

In an ever-growing clinical landscape and with the threat of patient resistance, the role of combinations is crucial to bring better ADC treatments to oncology patients.

Join this long-standing seminar day for an overview of ADC clinical combination leaders, assess applications of dual payload ADCs to tackle payload resistance, and delve into rationale-driven practices to smartly select and investigate the right ADC combination partners

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• Optimizing strategy for ADC combination trials
• Overviewing exciting ADC combination data generated in 2025
• Looking to the future: what are the next steps for progressing ADC combinations?

• Exploring ongoing combination trails with Trodelvy and standard of care therapies across solid tumor indications
• Evaluating rationale and design of Trodelvy and other ADC-immunotherapy combination therapies
• Breaking down the potential: What is the route forward and potential impact of novel ADC combinations?

• Building on the past success of ADC-immunotherapy combination therapies
• Contextualizing Disitamab Vedotin-immunotherapy success in bladder cancer
• Outlining additional clinical DV-IO combination response in bladder cancer

• Exploring clinical-stage trial design and results for Nectin-4 ADC-PD1 combinations
• Laying out the rationale for selecting combination partners for CDH17 and B7H3 ADCs and finding the right combination partner for the right payload
• Assessing emerging preclinical results from CDH17 and B7H3 ADC combination investigation compared to monotherapies

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.

• Understanding the role of antigen and payload-mediated resistance mechanisms
• Laying out considerations of how cellular heterogeneity can contribute to ADC resistance
• Exploring examples of how mechanistic and orthogonal combinations can be applied towards improving ADC activity

• Exploring targeted delivery of cytotoxins and immune agonists simultaneously
• Explaining how dual mechanisms enable direct tumor cell killing and activation of anti-tumor immunity
• Demonstrating immunostimulatory ADC enhanced efficacy and therapeutic index

Re-join your expert speakers in a closing panel discussion as they debate the impact of ADC combination within oncology treatment landscape, best strategy to smartly select combination partners, and ability to combat ADC patient

resistance. Come with your thoughts and questions prepared!

Properly understanding ADC PK/PD and in vivo stability is crucial to best inform clinical performance and trial design.

Don’t miss this brand-new seminar day exploring bioanalytical strategy across development phases, insights into LC-MS method development, and in vivo biotransformation impacting PK/PD and stability properties to understand how to efficiently leverage bioanalytical technologies to best characterize your ADC clinical material

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• Evaluating ADC stability and bioanalytical measures from early discovery and throughout development
• Explaining strategy to inform ADC bioanalytical platforms, analytes, and PK assays heading into the clinic
• Striving for collaboration and alignment between regulated and non-regulated ADC bioanalytical teams

• Explaining challenges in ADC PK characterization across monoclonal antibody, free payload, and conjugate
• Assessing bioanalytical and regulatory strategy required for ADC bioanalysis in late-stage clinical development
• Tackling immunogenicity assessment of ADCs: What have we learned so far and what is still to come?

• Understanding the individual needs for ADC PK, ADME, and in vivo stability versus other biologic modalities
• Exploring the common pain points and opportunities to improve typically uniform bioanalytical strategies
• How does this fit into bioanalytical regulatory guidance, and how can this be best updated in the future?

• Presenting LBA-based PK methods for ADC bioanalysis in early non-clinical studies
• Discussing transition of ADC PK methods to hybrid-LCMS in following non-clinical studies to align with clinical PK methods
• Demonstrating the use of bioanalytical methods to assess ADC in vitro stability

• Assessing bioanalytical data for intact LC-MS analysis to investigate linker-payload stability for camptothecin-based ADCs
• Utilizing PK data to guide linker-payload optimization
• Exploring tumor payload data correlation with efficacy and recommending bioanalytical workflows for linker-payload screening optimization

• Introducing REGN5093-M114 ADC with M114 linker-payload and bispecific antibody targeting two MET epitopes
• Outlining exploratory objective of first-in-human study to assess DAR changes in patient plasma samples following intravenous administration
• Developing LC-MRM-MS based assays to monitor average DAR changes and an IP-intact MS method to characterize payload distribution in PK samples

• Undergoing bioanalytical investigation to monitor average DAR, DAR distribution and trending plot monitoring
• Completing bioanalysis in preclinical and clinical settings
• Explaining the significance of DAR bioanalytical measurements in reference material preparation and ADC life cycle management

Close out this brand-new seminar day with a panel session of all the day’s speakers. Bring your unanswered questions to explore how to streamline bioanalytical strategy and alignment across ADC development phases, understand the cutting-edge bioanalytical technologies in 2025, and delve into detailed ADC PK/PD investigation to acutely characterize your ADC clinical material

As we welcome the rise of ADCs with new payload and targeting moieties, ensuring your candidates meet CQA standards is paramount to understand and control all the factors influencing ADC efficacy and safety profiles.

Join this new seminar day to identify, understand and meet the breadth of ADC CQAs across DAR, charge variance, impurities, novel payload characterization and beyond to maximize ADC quality and process control

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• Overviewing the critical quality attributes specific to ADCs as complex biologic therapies
• Identifying appropriate control points for monitoring ADC critical quality attributes
• Exploring control strategies for ADCs, including setting appropriate control limits

• Detailing control strategies for controlling drug-linker impurities in ADCs, as outlined by the IQ Working Group
• Discussing phase-appropriate strategy for controlling ADC drug-linker impurities
• Understanding considerations for conjugatable versus non-conjugatable impurities

• Explaining the lack of a simple method to quantify antibody-siRNA conjugates to set specifications in GMP testing
• Leveraging Nanoluc technology to evolve ELISA methodology for antibody-siRNA conjugate quantification in manufacturing batches
• Exploring advantages of quantification method and plans for future development

• Outlining analytical methods for determining DAR in ADC CQA evaluation
• Investigating which ADC properties impact hydrophobic interaction chromatography
• Highlighting that linker length of drug linkers significantly impacts peak separation observed with HIC

• Highlighting stability challenges with ADC icIEF analysis caused by cytotoxic payload hydrolysis at specific pH
• Exploring how On-Board Mixing (OBM) enhances ADC sample stability with immediate sample mixing before analysis
• Supporting potential use of Capillary Zone Electrophoresis as a backup method for charge variant analysis, especially where OBM is not feasible, to enhance the analytical toolkit

Bringing this brand-new seminar day to a close, don’t miss the final speaker panel discussion to ask any unanswered questions from the scientific presentations. With your fellow process, analytical, and CMC experts, break down the challenges and understand the unique considerations in ADC CQAs from a small and large molecule perspective

In fast-paced ADC development, optimizing scale-up, tech transfer, and setting specifications are all vital to assure confidence in regulatory submissions.

Attend this late-stage manufacturing seminar day to understand ADC regulatory CMC strategy, review opportunities to streamline CMC under ADC development timelines, and explore insights to improve ADC DS and DP manufacturing and stability in late-stage and post approval stages

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• Understanding the array of factors to consider across ADC transfer and supply chain that could impact product stability
• Developing ADC stability budgets to support product progression through clinical and commercial-stage process
• Contextualizing strategy with case study data demonstrating strong ADC product stability

• Exploring drug substance freeze and thaw rates to mimic at-scale processes and analyzing how these influence potential CQAs
• Assessing evolution of the freeze/thaw process to determine process parameters that impact protein stability
• Quantifying pH drifts during freeze/thaw of ADCs in a scaled down model

• Laying out the simplification of a potency strategy with one cell-based release assay
• Exploring analytical strategies for assessing biological activities of next-generation ADC modalities
• Approaching biological characterization and control of ADC effector function at the process stage

• Exploring preparative chromatography for ADCs, a great tool for phase 1 and late phase programs
• Outlining development and integration of the chromatography step in payload linker manufacturing
• Combining payload and ADC conjugation on the same site, a good way to speed up the development phase

• Laying out experiences in translating parametric control strategy elements into robust on-the-floor operations
• Exploring strategies to ensure consistent conjugation performance and product quality with different equipment and facility design
• Assessing validation approaches to build robust commercial supply capabilities

Join this closing panel session with your expert ADC CMC speakers to break down the key learnings from the seminar day. Listen and engage with your fellow attendees as they discuss and best approaches to maintain DS and DP stability, streamline process scale up and tech transfer, and debate opportunities for science-based justifications be applied to support alternative control strategies