World ADC Europe Day One

8:20 am Chairperson’s Opening Remarks

Dario Neri Chief Executive Officer, Philogen

Reviewing Recent Breakthroughs & Thinking Strategically About the ADC Landscape

8:30 am Strategically Developing & Advancing ADCs

Daejin Abidoye SVP Oncology Therapeutics, Gilead Sciences

Synopsis

Providing an historical review of ADCs
Overviewing the current ADC landscape
Discussing the future of ADCs: Combinations and Sequencing

9:00 am ADCs in Breast Cancer: Reflections & The View Forward

Sunil Verma Global Head & Head of Breast Cancer Strategy, AstraZeneca

Synopsis

Discuss the learnings from the development of ADCs in Breast Cancer
Explore opportunities to bring the power of ADCs to the next wave of clinical studies
Imagine the future of ADCs as the foundation of care in Oncology

9:30 am Industry Leaders Panel Discussion – Reviewing the Last Year & Creating Strategies to Further Develop ADCs Through 2022

Sunil Verma Global Head & Head of Breast Cancer Strategy, AstraZeneca
Daejin Abidoye SVP Oncology Therapeutics, Gilead Sciences
Shweta Jain Senior Medical Director, Seagen
Dario Neri Chief Executive Officer, Philogen

Synopsis

Reviewing how breakthroughs in 2021 are shaping the ADC industry
What decision are industry pioneers making to ensure continued progress within the ADC space (technical and business/partnership decisions)?
Outlining the biggest challenges that ADC drug developers are facing in taking drugs from the bench to bedside
Discussing methods to bring ADCs to earlier-line treatment

10:15 am Structured Networking

AM: Discovery Stream Chair: Nadia Luheshi, Senior Director, Global Project Leader, AstraZeneca

Harnessing Novel Linker Technologies to Widen the Therapeutic Index

11.15 Designing & Developing Next- Generation Antibody-Drug Conjugates

Discuss the importance of a design and developability assessment to select the appropriate combination of antibody, linker and payload for a successful ADC
Explore how the involvement of a multidisciplinary team of experts in integrated multiple work streams reduces the overall timeline from bench to bedside

Nicolas Camper, Group Leader – Chemistry, Abzena

11.45 Understand the Effect of Conjugation Site & Technique on the Stability & Pharmacokinetics of Antibody-Drug Conjugates

Review the characterisation of ADCs that were conjugated by different conjugation methods to different conjugation positions by multiple in vitro assays
Evaluate ADCs in vivo for conjugate stability and pharmacokinetic (PK) behavior in transgenic Tg276 mice
Review the ADC variants regarding in vitro assay and in vivo PK properties

Christian Schroeter, Associate Director, ADCs & Targeted NBE Therapeutics, Merck Healthcare Business

12.15 Lonza Bioconjugates Early Development Service to Facilitate ADC Lead Development

Lonza

AM: Translational Stream Chair: Rakesh Dixit, Chief Executive Officer, Bionavigen

Understanding the Optimal PK Property of Your ADC to Reduce Associated Toxicities

11.15 Catalent’s SMARTag® Technology: Differentiated Solutions for Optimal ADC

Demonstrating how SMARTag is a clinicalstage ADC technology featuring sitespecific conjugation with multiple linker and warhead options
6 CRs and 2 PRs among 22 patients were achieved by TRPH-222, a CD22-targeted SMARTag conjugate, in the dose-escalation stage of a Phase I trial for R/R B-cell lymphoma
Highlighting how new linkers are being used to achieve proprietary high DAR ADCs featuring topoisomerase I inhibitor payloads
Showcasing how conjugate stability has been demonstrated —even with cleavable linkers—to deliver efficacy with improved tolerability and a wider therapeutic window

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

11.45 XB002: Model-Based Dose Selection for a Novel Anti-Tissue Factor ADC With a ZLA Payload for the Treatment of Solid Tumours

Review how efficacy data from Pharmacology tumour models in mice and PK data from monkeys were used to predict XB002 human PK and estimate human efficacious dose
Understand how nonclinical safety in cynomolgus monkeys demonstrated adequate safety margins for the range of doses explored in the FTIH study
Assess how the PK model was fitted to the human PK from the FTIH dose escalation phase to refine dose predictions

Raffaella Faggioni, Vice President, Clinical & Translational Pharmacology, Exelixis

12.15 Identifying the Causes of Toxicities & Harnessing Approaches to Reduce On & Off-Target Toxicities

Discussing what is known about the causes of on and off-target toxicities
Exploring how to modulate the PK property of your ADC to reduce toxicity, and evaluating how this differs with different payloads
Understanding how translatable preclinical toxicities are into the clinic

AM: Clinical Stream

Overviewing the Clinical Landscape & Recent Clinical Developments

11.15 Providing a Clinical Update of an EGFR Targeted ADC MRG003

Review the ADC landscape in China
Investigate potent anti-tumour activity in preclinical studies
Demonstrate manageable safety and promising efficacy in early phase clinical studies

Mary Hu, Chief Executive Officer, Shanghai Miracogen

11.45 Antibody Drug Conjugate Development: Current Clinical Status & Future Directions

Presenting an update on the key movements in the clinic
Gain insight into the rapidly evolving pipeline
Analyse novel clinical ADCs

Jia He, Senior Research Analyst, Beacon Targeted Therapies

12.15 Delving into Disitamab Vedotin: A Novel HER2 ADC

Disitamab vedotin is a HER2 ADC with an antibody designed to maximise drug delivery with higher affinity and internalisation rate as compared to trastuzumab in preclinical models
Highlighting DV’s encouraging monotherapy clinical data across a range of HER2 expressing solid tumours, and combination activity with anti-PD1 in urothelial cancer

Nicholas Choong, VP, Clinical Development, Seagen

AM: CMC Stream Chair: Lisa McDermott, Director, Process & Analytical Development, Merck

Developing a Strong CDMO Relationship for Effective External Manufacturing

11.15 Bioconjugate Process Development & Manufacture Using Scalable & Chemically Compatible Technologies

Erik Johansson, Principal Data Scientist, Data Science, EMEA, Sartorius

11.45 Evaluating Whether to Outsource to One CDMO or Several

Understanding the relative complexity with both options
Discussing planning, legal and sourcing considerations
Ensuring quality and reliability are at the heart of centre of the decision-making process

Christian Lutz, Director, Project Management CMC, Heidelberg Pharma Research

12.15 Looking to Satisfy the Growing Demand of Capacity & Capabilities for ADCs

A quick look to the most recent data to check how the ADCs market is evolving
Discussing drivers and challenges in ADCs’ manufacturing: Outsourcing or In-house?
Assessing the basics of Integration and our model to support ADCs’ needs
Presenting our conjugation and fill/finish capabilities

Giorgio Salciarini, Senior Manager – Technical Business Development, BSP Pharmaceuticals

12:45 pm Lunch & Networking Supported by Proveo

PM: Discovery Stream Chair: Nadia Luheshi, Senior Director, Global Project Leader, AstraZeneca

Advancing the Next Generation of Payloads to Reach Desired Efficacy

13.45 Panel Discussion – Highly or Low Potency – What Payload Should You Choose?

Comparing and contrasting highly potent payloads with low potency payloads
Which provides that largest therapeutic index?
What payloads are likely to have the most clinical success?

14.15 Developing PBDs From Natural Products to Zynlonta

Identifying characteristics of the PBD platform
Outlining the Teserine development story
Beyond Zylonta – what are the next PBD ADCs?

Philip Howard, Chief Scientific Officer, Spirogen

14.45 Roundtable – Exploring the Next Generation of Payloads

Understanding what payloads with novel mode of actions look promising
Outlining the optimal PK strategy for these payloads

PM: Translational Stream Chair: Rakesh Dixit, Chief Executive Officer, Bionavigen

Overcoming Critical In Vivo Challenges to Accelerate Through Preclinical Development

13.45 Panel Discussion - Assessing How to Optimise Your ADCs Pharmacokinetics to Reduce Toxicity?

Does a longer PK reduce toxicity?
Implementing approaches to be able to adjust PK
Beyond PK, what are the other important translational hurdles to overcome?

14.15 Predicting Successful ADC Candidates Using Combined In Vivo Data & Computational Approaches

Discussing how Antibody Drug Conjugates (ADCs) are complex drugs requiring a combination of small molecule, linker, and antibody optimisation for adequate safety and efficacy
Highlighting how animal data and in vitro experiments provide insight into isolated pieces of ADC design, which can be misleading without integrating the results for optimal clinical efficacy
Demonstrating how combined animal data and computational approaches can predict ADC design for a maximum therapeutic window including why currently approved ADCs are successful and others failed

Greg Thurber, Associate Chair & Associate Professor of Chemical Engineering, University of Michigan

14.45 Advancing Nonclinical Development of PBD-Based ADCs

Reviewing Pyrrolobenzadiazepines as warheads for ADCs
Addressing challenges in preclinical development of PBD-based payloads when compared to other payloads
Assessing the clinical dose setting based on nonclinical data

Lolke de Haan, Head, Toxicology, ADC Therapeutics

PM: Clinical Stream

Optimising Dosing Schedules & Regimens in Human Trials for a Greater Clinical Efficacy

13.45 Sharing Clinical Pharmacology Strategies to Accelerate ADC Clinical Development, a Polivy Case Study

Overview of ADCs and DLBCL
Examining a population pharmacokinetics model based approach to characterise multiple analytes
Discussing the application of integrated quantitative clinical pharmacology strategies to accelerate POLIVY development

Mike Liao, Global Clinical Pharmacology Lead, Oncology & Immunology, Genentech

14.15 Showcasing the Development of DS-7300, a B7-H3-Directed DXd Antibody-Drug Conjugate

Evaluating the pre-clinical profile and mechanism of action of DS-7300
Sharing the clinical development status of DS-7300
Discussing future developments of DS-7300

Gilles Gallant, SVP Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo

14.45 Targeting Folate Receptor-α in Gynecologic Cancers & other Solid Tumours with the Novel Antibody-Drug Conjugate, STRO-002

Review STRO-002 preclinical data (in vitro cytotoxicty and xenograft models) in ovarian, endometrial and other cancers
Evaluate clinical outcomes data from the STRO-002-GM1 dose escalation and expansion cohorts
Investigate ongoing clinical trials testing STRO-002 as a monotherapy and in combination with other agents

Arturo Molina, Chief Medical Officer, Sutro Biopharma

PM: CMC Stream Chair: Lisa McDermott, Director, Process & Analytical Development, Merck

Streamlining Process Development to Confidently Scale-Up Your Manufacturing Capabilities

13.45 High Containment Strategies for ADC Toxin Handling & Downstream Process

Reviewing validated 1.0 nanogram/m3 Single Use Isolator for handling ADC toxins
Discussing isolation for ADC liquid processing to contain leakage and aerosolization risks
Examining aseptic containment for lyophilization process and final fill / finish

Scott Patterson, VP – Technical Support, ILC Dover

14.15 Integration & Acceleration of an ADC Within MSD

Introducing a new modality to an established organisation
Working with external partners to accelerate an accelerated programme
Building knowledge and capabilities across the organisation with a nascent technology

Christopher Gillespie, Director, Biologics R&D, MSD

14.45 Use of Design of Experiments to Define Manufacturing Process Conditions for an ADC

Explore the use of design of experiments (DOE) to understand the impact of process parameters at the reactive stages on an ADC product quality attributes
A 2^4 full factorial design was performed and the results were analysed via the MODDE® software, with Drug to Antibody ratio (DAR) results shown
Review how the software enabled identification of safe manufacturing set points for the process parameters

Conor Barry, Head of Development, Piramal Pharma Solutions

3:15 pm Afternoon Break & Networking

Exploring Best-in-Class CMC Analytical Methods, & Understanding the Key Regulatory Considerations

3:45 pm Integrated Approach to Provide Actionable Data to Support Programmes From Concept to Clinical Material

Jeff Caroll Group Leader Process & Analytical Development, Merck
Omar Lamm Global Director & Head of Analytical Development Business, Merck

Synopsis

Display impact of raw material characterisation on conjugation chemistry
Discuss examples where incomplete characterisation delayed timelines
Showcase the importance of an integrated offering from early development through to manufacturing

4:15 pm High-Precision Ambrx ADC Conjugation Process, & Analytical Characterisation to Ensure High Homogeneity & Purity

Mysore Ramprasad Executive Director, Analytical Development & Formulation, Ambrx

Synopsis

Understanding the Ambrx expanded genetic code, protein expression and site-specific ADC conjugation platform
Investigate the development of platform analytical methods and extended characterisation to demonstrate homogeneity and high product quality
Assess the validation of technology with 3 ADCs

4:45 pm Establishing the Most Important QC Parameters for Drug-Linker & Drub Substance for Early Development Candidates

Geoffrey Winters Associate Director - ADC Process & Analytical Development, Zymeworks

Synopsis

Review considerations of critical quality attributes for drug-linker and ADC DS on a phase-appropriate basis
Analyse purity vs. API related impurities
Discuss characterisation vs. quality control

5:15 pm End of Scientific Programme Day One

Scientific Poster Session

Synopsis

After the formal presentations have finished, the learning and networking carries on. The Scientific Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session over 25 scientific posters will be presented from novel linker designs to validation of site specific conjugation technologies and more informative in vivo models.

29th March – 1st April 2022
London, UK

29th March – 1st April 2022
London, UK

Day One

Day Two

8:20 am Chairperson’s Opening Remarks

Reviewing Recent Breakthroughs & Thinking Strategically About the ADC Landscape

8:30 am Strategically Developing & Advancing ADCs

Synopsis

9:00 am ADCs in Breast Cancer: Reflections & The View Forward

Synopsis

9:30 am Industry Leaders Panel Discussion – Reviewing the Last Year & Creating Strategies to Further Develop ADCs Through 2022

Synopsis

10:15 am Structured Networking

12:45 pm Lunch & Networking Supported by Proveo

3:15 pm Afternoon Break & Networking

Exploring Best-in-Class CMC Analytical Methods, & Understanding the Key Regulatory Considerations

3:45 pm Integrated Approach to Provide Actionable Data to Support Programmes From Concept to Clinical Material

Synopsis

4:15 pm High-Precision Ambrx ADC Conjugation Process, & Analytical Characterisation to Ensure High Homogeneity & Purity

Synopsis

4:45 pm Establishing the Most Important QC Parameters for Drug-Linker & Drub Substance for Early Development Candidates

Synopsis

5:15 pm End of Scientific Programme Day One

Scientific Poster Session

Synopsis

OUR CONTACT DETAILS

VENUE DETAILS

ABOUT US

LOCATION

SEARCH

29th March – 1st April 2022 London, UK

29th March – 1st April 2022 London, UK

Day One

Day Two

8:20 am Chairperson’s Opening Remarks

Reviewing Recent Breakthroughs & Thinking Strategically About the ADC Landscape

8:30 am Strategically Developing & Advancing ADCs

Synopsis

9:00 am ADCs in Breast Cancer: Reflections & The View Forward

Synopsis

9:30 am Industry Leaders Panel Discussion – Reviewing the Last Year & Creating Strategies to Further Develop ADCs Through 2022

Synopsis

10:15 am Structured Networking

12:45 pm Lunch & Networking Supported by Proveo

3:15 pm Afternoon Break & Networking

Exploring Best-in-Class CMC Analytical Methods, & Understanding the Key Regulatory Considerations

3:45 pm Integrated Approach to Provide Actionable Data to Support Programmes From Concept to Clinical Material

Synopsis

4:15 pm High-Precision Ambrx ADC Conjugation Process, & Analytical Characterisation to Ensure High Homogeneity & Purity

Synopsis

4:45 pm Establishing the Most Important QC Parameters for Drug-Linker & Drub Substance for Early Development Candidates

Synopsis

5:15 pm End of Scientific Programme Day One

Scientific Poster Session

Synopsis

OUR CONTACT DETAILS

VENUE DETAILS

ABOUT US

LOCATION

SEARCH

29th March – 1st April 2022
London, UK

29th March – 1st April 2022
London, UK