Preclinical & Translational

Chair: Rakesh Dixit, President & Chief Executive Officer, Bionavigen Oncology

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Exploring Successes & Learnings From ADC Preclinical
Studies to Maximise ADC Translation

11.00 am Leveraging Non-Natural Amino Acid Conjugation Technology to Understand ADC Fundamentals

• Understanding correlations between in vitro properties and in vivo performance of ADCs
• Reviewing key takeaways on ADC construction considerations
• Utilising non-natural amino acid conjugation platform to engineer next-generation ADCs

Megan Rice, Senior Scientist, AstraZeneca

11.30 am Catalent’s SMARTag® Technology: Precision Design Solutions for Best-In-Class ADCs

• Presenting new data highlighting the improved efficacy and tolerability of SMARTag® ADCs as compared to marketed ADCs against the same target
• Exploring platform features including site-specific conjugation with optimized payload placement on the antibody
• Showcasing linker-payload solutions to meet your program needs including options with bystander activity, microtubule inhibitors and topo Inhibitor mechanisms of action

Penelope Drake, Head, R&D Bioconjugates, Catalent Biologics

12.00 pm Development of a Topoisomerase I Inhibitor-Based ADC Platform for the Treatment of Solid Tumours

• Developing a platform of a Topoisomerase I inhibitor containing payloads
• Characterising in vitro and in vivo payload pharmacological properties
• Applying payload platform to multiple ADC targets

Lolke De Haan, Vice President, Toxicology, ADC Therapeutics

12.30 pm Anti-GPCR1 First-in-Class Next Generation ADC: SKM104-MA L2 as a Highly Differentiated Candidate Ready for IND Studies

• Exploring GPCR1 target across strong multi-tumour expression, low healthy tissue expression, rapid internalization, and lysosomal trafficking
• Detailing SKM104 selective antibody high affinity to tumour cells, cross-reactivity in cynos and low or no binding to normal cells
• Demonstrating preclinical safety with no off-target side effects; HNST not reached at the highest tested dose of 145 mg/kg in rats
• Showcasing the Skymab reversible platform with enhanced efficacy in resistant tumours, stability, and pharmacokinetics

Manel Kraiem, Chief Development Officer Skymab Biotherapeutics

1.00 pm Lunch & Learn Session: Manufacturing of Linker-Payload & ADCs Presented By

Invite only session

Addressing the Predictive Value of ADC In Vivo & In Vitro Preclinical Models

2.00 pm Maximising ADC Translational Safety Characterisation from Preclinical Studies

• Characterising ADC safety in short preclinical studies
• Understanding what clinical toxicities can be predicted preclinically
• Understanding how to manage toxicities identified in preclinical studies

Rakesh Dixit, President & Chief Executive Officer, Bionavigen Oncology

2.30 pm Investigating Preclinical & Translational Development of ADCs Across In Vitro & In Vivo Models

• Assessing the predictive value of in vitro models in ADC development
• Transitioning from in vitro to in vivo models in ADC preclinical development
• Progressing towards translational development and future strategy for ADC patient selection

Michael Conner, Investigator & In Vitro Scientist, Extracellular Tumour Cell Targeting Research Unit, GSK

3.00 pm TME-Specific Payload Release: Discovery & Preclinical Validation of a Novel Enzyme-Cleavable Linker

• Addressing challenges of tumor heterogeneity and poor drug penetration of solid tumors with internalisationindependent payload release
• Screening and identifying a unique linker using a specific TME enzyme consistently expressed across cancer models for next-gen ADC development
• Achieving superior efficacy and safety with an internalisation-independent linker-payload system in ductal carcinoma and squamous carcinoma cell lines

Xiaoxiao Wang, Vice President, Antibody Discovery & ADC Platform, Nona Biosciences

Clinical Lessons

Chair: Dhiraj Gambhire, Global Clinical Lead, Enhertu, Executive Medical Director, Daiichi Sankyo

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Spotlighting ADC Development & Success Reshaping Frontline Oncology Treatments

11.00 am The Current State of the ADC Landscape

• Outlining how the total number of ADC programmes has increased massively over the last few years and what the
emerging trends from this recent influx of activity
• From payloads and linkers to targets and bispecifics, which approaches are seeing the most use across development stages?
• Unveiling what were the key highlights and updates for ADC development across 2024

Jake Morris, Senior Account Manager & ADC Insights Lead, Beacon by Hanson Wade

11.30 am ABBV – 400: A c-Met Targeting ADC
With Activity in CRC & MET Amplified Tumours

• Exploring the elusive targeting of c-Met protein
• Reviewing the limitations of small molecule inhibitors and antibodies
• Discussing next generation ADCs that are effective at targeting the c-Met protein: Teliso-V, Temab-A

Sumiko Okubo, Medical Director, Oncology
Early Development, AbbVie

12.00 pm Evaluating the Breadth & Depth of I-DXd (Anti-B7-H3 ADC) Efficacy in Solid Tumours

• Targeting B7-H3 with I-DXd demonstrates efficacy in an array of solid tumours
• Discussing how I-DXd efficacy correlates with B7-H3 expression in a subset of tumour types with a high prevalence of B7- H3 expression
• Exploring how I-DXd is a promising agent for SCLC

Radha Ramkumar, Vice President, Global Team Leader, Oncology Development, Daiichi Sankyo

12.30 pm Harnessing Spatial Biology & AI to Optimize ADC Clinical Development Strategies
• Leveraging the world’s largest spatial and multi-omics dataset in oncology (MOSAIC) to decipher intra-patient tumour and TME heterogeneity
• Applying advanced AI models to translate biological hypotheses into quantified metrics and potential biomarkers, guiding indication selection, patient stratification, and combination therapy strategies
• Case study: Showcasing the relevance of this data and AI edge for some known ADC targets (e.g., NECTIN4)

Jonas Béal, Director, Solution Strategy, Owkin

1.00 pm Lunch & Learn Session: Manufacturing of Linker-Payload & ADCs Presented By

Invite only session

Diving Into Clinical Pharmacology to Optimise ADC Dose Escalation & Clinical Performance

2.00 pm Delving into Exposure Response Analysis to Inform ADC Dosing & Clinical Activity

• Can a model-based meta-analysis and a clinical utility index approach be used to assess the benefit-risk profiles of ADCs?
• Considering dose optimisation under Project Optimus and the role of quantitative medicine in ADC space
• Highlighting lessons learnt from dose capping in ADC space

Venkatesh Pilla Reddy, Senior Director, Global PKPD & Pharmacometrics, Eli Lilly

Daniel Bending, Postdoctoral Researcher, Eli Lilly

2.30 pm Utilising Mathematical Modelling to Inform ADC Dosing in Clinic

• Enhancing characterisation of doses prior to registration trials to maximize the efficacy and safety of oncology drugs
• Assessing the impact of covariates on ADC exposure and on optimal dose
• PopPK and quantitative medicine-based optimal dose and schedule for ADCs and combinations

Pavan Vajjah, Executive Director, Global Head ADC Clinical Pharmacology & Safety Sciences, AstraZeneca

3.00 pm The Next Generation of Precision Medicine: Developing World-Class Cell Biopsy Capabilities for Biopharma’s Transition to ADCs & Bispecifics

• Explaining the increasingly pivotal role of precision medicine in ADC therapeutic development beyond reliance on difficult to obtain tissue biopsies
• Introducing Cell Biopsy-based multiomic testing integrating CTC and ctDNA analysis for dynamic, real time insights into key predictive biomarkers that inform patient selection and treatment monitoring
• Demonstrating Cell Biopsy capability across diverse cancers in contrast to traditional CTC and ctDNA approaches
• Outlining critical elements in integrating Cell Biopsy capabilities into clinical trials and routine practices
• Business Benefits: Accelerates trials, expedites approvals, differentiates therapies, and enhances patient safety by minimizing invasive procedures

Arshad Ahmed, Vice President, Business Development, OneCell Diagnostics Ajay Pandita, Vice President, Scientific Affairs, OneCell Diagnostics

Process & Analytical Development

Chair: Lisa McDermott, Director, Process & Analytical Development, Merck

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Encompassing the Facets of Analytical Characterisation of Complex ADC Therapeutics

11.00 am Introduction to ADC Analytical Characterisation in Discovery: Challenges & Approaches

• Overview of ADC-specific physicochemical attributes
• Analytical methods that can be employed for their determination
• Our characterisation approach in ADC discovery and common challenges

Elizabeth Love, Scientific Leader, ADC Platform, GSK

11.30 am Risk Evaluation of Nitrosamine Impurities in Drug-Linker Intermediates Used to Generate ADCs

• Providing a science-based, holistic approach to evaluating the risks of nitrosamine presence in drug linker as intermediates towards ADC DS
• Demonstrating that chemically synthesised fragments of ADCs are unlikely to lead to nitrosamine presence in the final drug product
• Proposing a simplified abbreviated workflow for quality risk management of nitrosamines in drug-linkers

Osama Chahrour, Principal Scientist, Chemical Development, AstraZeneca

12.00 pm Investigating Simultaneous Ultra-Sensitive Characterisation & Quantification of Antibodies & ADCs in Biological Matrices

• Explaining bioanalytical approaches to characterise ADCs in biological matrices
• Outlining the development of a hybrid LC-MS/MS method for quantification of ADCs

Marisa Schmitt, Director, Bioanalytics, Heidelberg Pharma

12.30 pm Strategies in Early-Stage ADC Discovery for Design of Successful Lead Candidates for Clinical Development

• Designing ADCs for successful clinical development

• Using Thiobridge® conjugation and linker technology to build ADCs with payload diversity

• Modelling complex cell environments in vitro to ensure optimal ADC lead selection - a case study

Johanna Midelet, Head, Bioconjugation & Chemistry, Abzena

1.00 pm Lunch & Learn Session: Manufacturing of Linker-Payload & ADCs Presented By

Invite only session

Tackling Characterisation
& Process Control for ADC
Impurities & Structural Variants

2.00 pm Cracking the Code: Novel LC-MS Solutions for ADC Analytics

• Developing a novel native HIC-MS assay for DAR determination and ADC characterisation
• Developing a novel enzymatic LC-UVMS- based achiral method for linker-drug chiral control
• Leveraging the power of LC-MS for deep ADC analytics

Lance Cadang, Scientist III, Genentech

2.30 pm Investigation of High Molecular Weight (HMW) Size Variant Formation in Antibody-Drug Conjugates:
Microbial Transglutaminase-Mediated Crosslinking

• Reviewing extended characterisation of HMW size variants in mTG-mediated ADCs
• Identifying the primary source of an increased level of HMW size variants
• Exploring approaches to minimise HMW size variants formation in in mTGmediated ADCs

Lizzy Zhao, Senior Scientist, Regeneron

3.00 pm Overcoming Challenges in ADC Drug Product Development by Leveraging an Integrated Platform

• Outlining ADC production molecular diversity from recent advances in ADC development
• Exploring how ADC DP development requires an understanding of how DP 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, customised clinical in-use evaluation, etc.

Shujing Wang, Ph.D., Senior Director, Drug Product Development, AsymBio 

Manufacturing & Supply Chain

Chair: Alain Beck, Senior Director, Biologics CMC Developability, Pierre Fabre

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Troubleshooting Manufacturing Challenges & Supply Across ADC Development Phases

11.00 am Examining the Unintended Consequences of R&D Outsourcing in the Biopharmaceutical Industry

• Discussing the mixed results of R&D outsourcing in terms of efficiency and performance
• Examining the economic consequences of R&D outsourcing on the biopharmaceutical industry, highlighting how overreliance on outsourcing can result in reduced R&D investment
• Identifying challenges in establishing effective collaboration between sponsor companies and contract organisations

William Olughu, Senior Principal Scientist, Ipsen Pharma

11.30 am High Purity Payload Linker: Preparative Chromatography… But Not Only

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

Bertrand Cottineau, R&D Group Head, Axplora

Melanie Derde, Head, Bioconjugation Operations, Axplora

12.00 pm Investigating Challenges & Solutions in ADC Manufacturing Across Stochastic & Site-Specific Conjugation

• Outlining ADC manufacturing across site-specific and random conjugation platforms
• Advancing ADC manufacturing through scale up across development phases
• Exploring challenges and solutions to in ADC manufacturing and process control

Sebastian Birkedal Kristensen, Senior Scientist, Byondis

12.30 pm ADC Manufacturing Strategy & Solutions

• Discussing tools used for the efficient and scalable manufacturing of the mAb intermediate, which serves as 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, which are designed for robustness and efficient purification
• Presenting the compatibility of materials in single-use systems with solvents used in the ADC manufacturing process, detailing the steps involved in the analysis

Lena Jonsson, Product Strategy Manager, Cytiva

1.00 pm Lunch & Learn Session: Manufacturing of Linker-Payload & ADCs Presented By

Invite only session

Troubleshooting Manufacturing Challenges & Supply Across ADC Development Phases

2.00 pm Navigating Efficient ADCProcess & Technology Transfer With External Partners

• Carrying out process characterisation and technology transfer to ADC manufacturing sites
• Leading and executing commercial supply from external partners
• Undergoing testing and characterisation to ensure robust process for manufacturing

Alexander Bijman, Director, Large Molecule External Manufacturing
Technical Operations, MSD

2.30 pm Considerations for a Global Supply Chain for ADC Outsourcing

• Planning for life cycle and supply robustness across regional divides

• Discussing challenges in managing vendor quality oversight in a global network

• Exploring the ever changing regulatory landscape and other external influences that can impact manufacturing strategies and approaches

Philip Mpagi Bwogi, Director CMC Program Leadership, BioNTech

3.00 pm Navigating the Path to ADC Commercialisation: What are the Key Questions?

• Outlining considerations across scale up and BLA strategy on the path on ADC commercialization
• Weighing up the use of Single Use or Stainless Steel Equipment
• Assessing when should you secure capacity
• What can go wrong in the progression towards ADC commercialisation?

Michael Trose, Manager, Process Technologist, MSAT Bioconjugates, Lonza

Andre Unglert, Director, Commercial Development, Bioconjugates, Lonza