Post-Conference Workshop Day
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.
Ed Ha, Founding Principal Scientist - Antibody Drug Conjugates, AngieX
The focus of this workshop will be pancreatic adenocarcinomas, which have a dismal survival rate and represent an urgent unmet clinical need.
This workshop will examine novel research that has been undertaken in a unique project with State University of New York/Buffalo and Queen’s University Belfast to enhance delivery of macromolecule drugs such as ADCs into these difficult tumours, which are characterized by a fibroblast-rich, desmoplastic stroma that acts as a barrier to effective drug deposition.
Discover novel ADCs, combination treatment options, and PK/PD modelling approaches that advance the development of strategies for tackling this disease.
This workshop will cover:
- Pancreatic cancer biology - the drug delivery challenge
- Enhancing antibody and ADC penetration of PDAC
- PK/PD modelling of antibody and ADC deposition in pancreatic cancers
Donald E. Mager, Professor & Vice Chair of Pharmaceutical Sciences, University at Buffalo, State University of New York
Chris Scott, Professor of Pharmaceutical Biosciences, Director of the Patrick G Johnston Centre for Cancer Research
Robert M. Straubinger, Professor of Pharmaceutical Sciences, University at Buffalo
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
ADCs are viewed by regulatory agencies as both drug and biological molecules which adds a layer of complexity for characterization, manufacturing process controls, comparability, release, and stability
Attend this workshop to improve your manufacturing quality controls and meet the appropriate regulatory requirements for the entire ADC molecule.
This workshop will give an in-depth review
of the current:
• Quality Control Standards – what are the
• Process Development
• Method transfer and validation
• Raw material testing
• In-process testing
• Cleaning and environmental monitoring
• Stability testing
• Application of next generation bioassays
Ahmed Bassyouni, Independent Consultant
Discussions will focus on how payload-linker combinations can affect ADC clinical activity and toxicities when attached to antibodies, and how the most appropriate payloadlinker 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
David Newman, Newman Consulting LLC
Ed Ha, Founding Principal Scientist - Antibody Drug Conjugates, AngieX
The past three decades of the ADC development have provided us ten 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
Translational science with quantitative modelling and simulation approach plays an important role in moving molecules from discovery to development and eventually to patients. However, translational science is not a miracle tool that will transform junk into gold and the drug developers simply cannot develop the discovered molecules with undesirable properties into drugs for patients. Therefore, in this study, we elucidated a novel concept of reverse translational science by utilizing a model-based approach to transfer the knowledge in reverse direction from development to discovery.
FcRn binding affinity profiles and charges have been shown to play an important role in the distribution and elimination of therapeutic monoclonal IgG antibody (TMAb). Using two case studies, we will demonstrate the utility of using minimal physiologically-based pharmacokinetic (mPBPK) modelling approach to construct detailed quantitative relationships between the FcRn binding affinity/charges and the PK parameters of the TMAb. Such relationships are useful to identify the discovery “sweet spot” in designing future generation of TMAb wth desirable biodistribution and elimination
properties (Reverse Translational Appraoch).
Furthermore, the mPBPK model developed in the preclinical model was useful to predict the PK of the TMAb in adult human subjects (Forward Translational Approach).
Chee Ng, Associate Professor & Research Investigator, University of Kentucky
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.
Key topics 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