Post-Conference Workshop Day

10.00-12.00 EDT | 7.00-9.00 PDT

Workshop A
Design, Synthesis & Preclinical Validation of Next Generation Linker & Site-Specific Conjugation

Advanced Design of ADCs – Principles & Applications with Next Generation Linkers and Site Specific Technology

Let’s explore various ways to improve the therapeutic window of ADCs using a rational approach to improve clinical performance by building a better molecule. By incorporating improvements in solubility as well as attachment stability, great strides can be made.

Join this workshop to discuss various methods for obtaining a defined DAR, and the pros and cons of several key approaches. Particular attention will be given to dual and multi-warhead ADCs, and the various ways to achieve controlled multivalency on native and engineered proteins. Lastly, with the emergence of Immunooncology, dual binding bi-specific antibodies will be discussed as a platform for ADC conjugations.

Rick Powers, Independent Consultant
David Newman, Newman Consulting LLC
Ed Ha, Founding Principal Scientist - Antibody Drug Conjugates, AngieX

10.00-12.00 EDT | 7.00-9.00 PDT

Workshop C
Improving the Therapeutic Window of ADCs, by Optimizing their Payload & Linker Designs

In this workshop, we will discuss ways of improving the therapeutic windo of ADCs, mainly against solid tumor indications, via optimizing payload and linker designs. An overview of the
tumor environment and the mechanisms responsible for ADC internalization by cancer cells (to afford efficacy) or by healthy cells (to lower tolerability) will be presented.

Join this workshop to:

Explore how these mechanisms and the biology of different cancer indications can
affect our choice of payload class
Evaluate Linker designs for improving an ADC’s solubility, stability, pharmacokinetics and ability to kill nontargeted cells in a tumor (bystander killing)
Consider and compare the pros and cons of various conjugation methods and
the preclinical therapeutic windows of representative ADCs

Wayne Widdison, Independent Consultant

10.00-12.00 EDT | 7.00-9.00 PDT

Workshop E
Scale Up, Outsourcing & Managing Complex Supply Chains

In an environment of limited capacity for manufacturing, decisions must be made early on in consideration of how to source different components of the ADC supply chain. This workshop will explore the key criteria for successful clinical and commercial manufacturing of ADCs.

It will also touch upon developing reliable cold shipping lanes. This workshop will
cover:

CMO Selection

Criteria for consideration
Integrated manufacturing vs distributed
Logistics considerations

Start Up Phase

Key elements of agreements
Assay and process transfer and scale-up

Operational Phase

Relationship management
Oversight and governance

Brian Clark, Principal Consultant, GMP Operations Consulting

10.00-12.00 EDT | 7.00-9.00 PDT

Workshop G
Integrated Development of ADCs - from Gene to First in Man - Part 1

This full day workshop is an opportunity to learn and discuss the important aspects in the integrated CMC and non-clinical development of ADCs. It has been designed to meet the needs 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.

Gordon Rigg, Independant Consultant
Simon Chivers, Independant Consultant

1.00-3.00 EDT | 10.00-12.00 PDT

Workshop B
Exploring Novel Mechanism of Actions, Optimizing Payload & Linker Chemistry & Deepening Understanding of Payload Driven Toxicities & The “Utility” Of Highly Toxic Marine-Sourced Compounds

Discussions will focus on how payload-linker combinations can affect ADC clinical activity
and toxicities when attached to antibodies, and how the most appropriate payload-linker
combination can be chosen for a particular antibody and/or cancer type.

Attend this workshop to explore the scientific biological rationale for maximizing the synergy of ADC payload- linker combinations.

This workshop will enable you to:

Improve your understanding of the most desirable properties of payloads and
linkers
Review current payload-linker combinations which are enhancing the therapeutic window
Evaluate past strategies to improve and balance: payload potency, impact of
homogeneous conjugations on PK/PD, protein/nucleic acid payloads & synergy
with I/O
Explore payload and linker combinations currently at the discovery or development
stages

Rick Powers, Independent Consultant
David Newman, Newman Consulting LLC
Ed Ha, Founding Principal Scientist - Antibody Drug Conjugates, AngieX

1.00-3.00 EDT | 10.00-12.00 PDT

Workshop D
Lessons Learned from the Successful & Failed ADCs

The past three decades of the ADC development have provided us seven 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:

Navigating of the ADC World
Learning from targets for solid and heme tumors
Linkers and conjugation matter
Learnings from antibody selection for ADCs
Translational medicine lessons

Rakesh Dixit, Chief Executive Officer & Founder, BioNavigen

1.00-3.00 EDT | 10.00-12.00 PDT

Workshop F
Modelling & Simulation of Antibody-Drug Conjugate Pharmacokinetics & Pharmacodynamics (PK/PD) in Drug Development

This workshop is designed to accommodate both attendees new to modelling and simulation as well as researchers more seasoned in ADC development.

This session will introduce basic tenets of antibody drug conjugate PK/PD and how to characterize these aspects using empirical and systems-based mathematical models.

These models include systemic PK (plasma clearance, payload deconjugation, target
mediated drug distribution, etc.), tissue distribution (e.g. heterogeneous tumor
concentrations), and cellular targeting (internalization, payload release, bystander effects, etc.).

Several hands-on modelling examples will be conducted along with strengths and
limitations of these approaches.

Greg Thurber, Associate Professor, University of Michigan

1.00-3.00 EDT | 10.00-12.00 PDT

Workshop G
Integrated Development of ADCs - from Gene to First in Man - Part 2

This two part workshop will cover:

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 undertake
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

Gordon Rigg, Independant Consultant
Simon Chivers, Independant Consultant

1st ADCs Outside of Oncology Day

10:30 am Chair’s Opening Remarks

10:40 am Sharing how an Antibody-Drug Conjugate Cures a Stage 1 Model of African Trypanosomiasis (Sleeping Sickness)

Andrea Gonzalez-Munoz Scientist & Research Associate, AstraZeneca

Synopsis

Understanding the emerging role of ADCs in non-oncological therapeutic areas
Gain insight on a generation of an ADC against a Trypanosoma brucei HpHb receptor
Examine how a single dose of this ADC cures the first stage of African Trypanosomiasis in a mouse model

11:10 am Panel Discussion: Developing ADCs for use in Non-Oncological Indications

Synopsis

Evaluating developing ADCs for diseases beyond oncology – where shall we go next?
Sharing lessons learned from R&D efforts to date
Understanding unique development issues with non-oncological indications

11:10 am An Automated Quantitative Mass Spectrometry Assay to Help Select Nextgeneration Anti-Staphylococcus Aureus AAC by Evaluating Intra-cellular Retention

Hilda Hernandez-Barry Senior Researcher - Scientific, Genentech

Synopsis

Staphylococcus aureus – Medical Need
Antibody – Antibiotic Conjugate, AAC – What is it?
AAC Automated Quantitative MS Assay – For what?
Future Directions

11:40 am Morning Refreshments

Exploring ADCs for Different Modes of Diseases

12:10 pm Antibody-Antibiotic Conjugate for the Treatment of Melioidosis

Adam Taylor Senior Scientist, DIST

Synopsis

Antibodies have been assessed and demonstrated ability to opsonise Burkholderia pseudomallei in vitro as well as demonstrating anti-virulence effects
Two antibiotics have been successfully incorporated into a cathepsin cleavable linker, the cleaved products are functional against bacteria in vitro
A down-selected antibody and antibiotic-linker have recently been incorporated into a full antibody-antibiotic conjugate and is currently being investigated in macrophage cell infection assays

September 15-18, 2020

September 15-18, 2020

Post-Conference Workshop Day

1st ADCs Outside of Oncology Day

10:30 am Chair’s Opening Remarks

10:40 am Sharing how an Antibody-Drug Conjugate Cures a Stage 1 Model of African Trypanosomiasis (Sleeping Sickness)

Synopsis

11:10 am Panel Discussion: Developing ADCs for use in Non-Oncological Indications

Synopsis

11:10 am An Automated Quantitative Mass Spectrometry Assay to Help Select Nextgeneration Anti-Staphylococcus Aureus AAC by Evaluating Intra-cellular Retention

Synopsis

11:40 am Morning Refreshments

Exploring ADCs for Different Modes of Diseases

12:10 pm Antibody-Antibiotic Conjugate for the Treatment of Melioidosis

Synopsis

Analyzing the Components of the ADC that Impact a Non-Oncology ADC

12:40 pm Antibody Tether Drug Conjugate Targeting GLP1R for Treatment of TIID & Obesity

Synopsis

1:10 pm Panel Discussion: Considerations for a Non-Oncology ADC Clinical Trial

Synopsis

Looking at the First in Human Studies & Clinical Developments

1:30 pm Chair’s Closing Remarks

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