Pre-Conference Workshop Day
Introduction to Discovery & Design of Novel ADCs (FULL DAY)
Monday, 2nd March
This workshop will offer a one day intense learning environment to establish core skills and understanding in the critical areas of ADC research and development. Designed for new entrants to the ADC field it will deliver critical knowledge in a number of the key problem areas that hinder antibody drug conjugate programmes.
Covering essential elements in ADC discovery and early development, this workshop will enable you to:
- Gain an overview of the development process for ADCs
- Improve payload and linker design chemistry • Understand the impact of conjugation site selection on your ADC
- Choose/choice of optimum “antibody” format
- Select the most appropriate ADC target which is easily accessible
- Learn about cellular assays
- Review the advantages and disadvantages of different preclinical animal models
- Develop early stage assays and learn how to effectively interpret the data
David Bramhill, Consultant, Bramhill Consulting
Workshop A: Advanced ADC Target Discovery
Workshop C: Integrated Development of ADCs - from Gene to First in Man
Workshop E: Outsourcing the Safe Development & Manufacture of ADCs: Perspectives from the CMOs & Drug Innovators
This workshop will offer a half-day session detailing the different aspects of ADC target development.
Aimed at those with an interest in targets, targeting it will consider key areas of this intrinsically critical.
Covering essential elements in ADC target discovery and early development, this workshop will delve into four distinct yet interrelated themes:
- Understanding the current pipeline of ADCs, their position in the clinical development pathway, and their selection as clinically relevant targets
- Novel ADC modalities to enhance target specificity (bispecifics/aptemers/nanobodies/peptides)
- Informatics and design, and influences on IP
- Antibody selection and production, and evaluation in trending preclinical patient derived ex vivo and in vitro models
Steve Conlan, Professor, Swansea University
This workshop is an opportunity to learn and discuss the important aspects in the integrated CMC and non-clinical development of ADC’s. It has been designed to match the interests of CEO / CSO’s for new and established ADC developers looking to gain a greater insight into the key elements in delivering a successful IND package and beyond. The workshop will also be of interest to CMC and non-clinical leads new to the ADC field. The workshop is run by two experts in the ADC field with a cumulative experience of over 40 years and expertise in ADC/conjugate development gained over the last 5-10 years.
- Introduction: program integration for ADCs
- Streamlined CMC technical development – planning and needed CMC activities
- CMC control strategy and product characterisation, purity and impurity
- Contract manufacture of ADCs
- IND enabling non-clinical strategy
- Bioanalytical strategy
- What studies do you need to do
- Determining a safe but meaningful starting dose
- Non-clinical strategy post-IND
- What additional studies do you need to do
- Topics for Health Authority Meetings
- CMC and non-clinical aspects of the IMPD/IND dossier
Simon Chivers, Independent Consultant
Gordon Rigg, Independent Consultant
This workshop will discuss how to evaluate the hazards and risks associated with the development and manufacture of ADCs.
Key topics to be covered include:
- Safe handling procedures and appropriate containment and control devices necessary to prevent worker exposure and workplace contamination
- How the risks change as the development process evolves
- Requirements of CMOs and CDMOs drug innovators should look for when selecting facilities capable of safe handling of these hazardous substances
Bob Sussman, Managing Director, SafeBridge Consultants, Inc.
Martin Axon, Principal Occupational Hygienist, Safebridge Consultant, Inc
Workshop B: The Chemistry of Toxins, Conjugations & Linkers for Antibody-drug Conjugates
Workshop D: Lessons Learned from the Successful & Failed ADCs
Workshop F: Occupational Health & Safety in Delivering ADC Projects
The choice of linker and payload for an ADC is essential for the selection of a successful clinical candidate. This workshop will deepen your understanding of the chemistry behind conjugation technologies and be led by highly experienced leaders in the ADC field who have designed successful candidates from discovery all the way to clinical trials.
Attend this workshop to:
- Understand synthetic challenges, structural features, and stability of toxins
- Analyse the chemistry of linkers, linker choice, linker release mechanisms
- Discuss site-specific conjugations vs non-sitespecific conjugations • Asses the stability of ADCs
- Evaluate mitigation of aggregation
Naresh Jain, President & Chief Executive Officer, NJ Biopharmaceuticals LLC
Jagath Reddy Junutula, Senior Vice President Research & Development, ModMab Therapeutics
The past three decades of the ADC development have provided us five approved ADCs and there is new momentum in the ADC cancer therapeutics development. But unfortunately, the vast majority of ADCs have been terminated during and prior to clinical development.
This workshop will be providing a comprehensive review of the ADC landscape, including early and late-stage ADCs and trends in next-generation ADC development. Major learnings from successful as well as failed targets, linkers, site-specific conjugation, cytotoxic warheads, and translational strategies will be discussed.
Gain in-depth insights into:
- Navigation of the ADC World
- Learning from targets for solid and heme tumours
- Linkers and conjugation matter
- Learnings from antibody selection for ADCs
- Translational medicine lessons
Rakesh Dixit, Chief Executive Officer & Founder, BioNavigen
Establishing and maintaining safe working environments when handling ADC components is imperative. Some ADC payloads are some of the most occupationally potent and toxic materials ever handled in the biopharmaceutical sector.
This workshop will explore the practical H&S elements involved in pragmatic roll-out of ADC projects.
Learn about scientific and systematic, businessfocused integration and delivery of H&S in ADC projects, including:
- Strategic business matters, project planning, project elements and costs
- Conceptual and detailed design steps • Deciding on control and containment
- Dealing with A&E firms and containment equipment vendors
- HPAPI H&S management systems
Justin Mason-Home, Director, HPAPI Project Services Limited