4th-6th March 2019
London

Pre-Conference Workshops
Monday 4th March

Workshop A (Full Day)
Monday 4th March

9.00 - 16.00
Primer Course: Introduction to the Design, Discovery & Development of ADCs (FULL DAY)
Workshop Leader: David Bramhill, President, Bramhill Biological Consulting

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 programs. 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, President, Bramhill Biological Consulting

Dr. Bramhill has over 20 years experience in biologics, both in large biopharma and startup biotech companies. He has experience in isolating and improving antibodies using phage display and is an inventor on library design techniques for small scaffolds. He also has experience in diverse expression systems for producing antibodies, antibody fragments and different scaffolds. He has taught numerous technical courses for over 10 years at international conferences.

Morning Workshops
Monday 4th March

Workshop B
Monday 4th March

09.00 - 12.00
Conjugate Diversity: Past, Present & Future
Workshop Leader: Charles Dumontet, Professor of Hematology & Team Leader , Cancer Research Center Lyon

Driven by payload toxicity and resistance there is a huge drive in the ADC field to discover new payloads with differentiated mechanisms of action. Join this workshop to explore novel payload classes, as well as to discuss the current challenges and how to overcome these.

Attend this workshop to discuss:

  • Diversity of conjugates, one of the struggles with ADCs is finding conjugates with different mechanisms of action
  • Going from classic cytotoxic chemotherapy to bacterial toxins which has raised immunogenicity issues
  • Chemical and functional diversities of conjugates and different developments
  •  How to overcome toxicity and drug resistance

Charles Dumontet, Professor of Hematology & Team Leader , Cancer Research Center Lyon

Charles Dumontet is a Team Leader at the Cancer Research Center Lyon. His group studied the mechanisms of action of monoclonal antibodies that are targeting cancer cells. We also study the mechanism of resistance towards these biomolecules in order to increase the activity of therapies based on monoclonal antibodies in patients with hematological malignancies or solid tumors.

Workshop D
Monday 4th March

09.00 - 12.00
Designing Effective ADCs through Pharmacokinetic Modelling and PK/PD Experiments
Workshop Leader: Greg Thurber, Assistant Professor , University of Michigan

The PK of ADCs are more complex than that of the antibody and cytotoxic drug alone. This two-part, all day workshop focuses on all aspects of pharmacokinetic modelling and PK/PD experiments, the focus of the morning workshop is for the early stages of ADC development.

Attend this workshop to:

  • Cover mechanistic and multi-scale modelling of biologics such as antibodies and contrast these with
    small molecules
  • Outline how computational models can be integrated with experimental data for a more complete picture of
    effector-site PK/PD within a tumour
  • Discussing strategies to tailor the molecular design to a specific target and patient population based on the antibody, linker, payload and target properties

Greg Thurber, Assistant Professor , University of Michigan

Greg Thurber is the Assistant Professor of Chemical and Biomedical Engineering at the University of Michigan. Prior to joining the University of Michigan in 2014 Greg was an Instructure at the Center for Systems Biology and Research Fellow at Harvard Medical School. Greg received his PhD in Chemical Engineering at Massachusetts Institute of Technology.

Workshop F
Monday 4th March

09.00 - 12.00
Scale Up, Outsourcing & Managing Complex Supply Chains
Workshop Leader: Brian Clark, Principal Consultant, GMP Operations Consulting

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

Brian Clark is Principal at GMP Operations Consulting, LLC, and provides interim executive leadership, CMC strategy, manufacturing and quality strategy and operational support to biopharmaceutical companies worldwide.  GMP Operations Consulting focuses on biopharmaceuticals with additional expertise in regenerative medicine, cell therapies and antibody drug conjugates.  Previously, Brian was at ImmunoGen Inc. from 2011 to 2016, most recently serving VP Manufacturing and Norwood Site Head and, prior to that, as Executive Director, Quality.  Prior to joining ImmunoGen, Brian was an individual consultant for several years in his current practice.  Brian previously served in senior Operations and Development leadership roles at Altus Pharmaceutical, Alkermes, Therion Biologics, Antigenics (now Agenus) and Genzyme Tissue Repair.  Brian obtained his MBA in General Management from Boston University and his BS in Biology from the University of Massachusetts.

Afternoon Workshops
Monday 4th March

Workshop C
Monday 4th March

13.00 - 16.00
Discussing Next Generation ADC Targets
Workshop Leader: Scott Dylla, Independent Biotech Angel Investor, Advisory and Entrepreneur , Independent

With antibody drug conjugates, much attention focuses on the physical properties of the antibody, drug and linker components. However, the characteristics of the target cell and antigen are perhaps the most critical parameters in ADC design. In the context of developing a commercial successful ADC, this workshop will share insights and discuss the considerations for you to choose the right target for your ADC candidate.
Join this workshop to:

  • Deepen your understanding of tumour heterogeneity
  • Discuss the attributes of the target cell and antigen that make for safe and effective ADC targets
  • Explore methods for target discovery and validation
  • Comprehensively review the current ADC target landscape

Scott Dylla, Independent Biotech Angel Investor, Advisory and Entrepreneur , Independent

Scott is the VP of R&D and CSO of AbbVie Stemcentrx LLC, a wholly owned entity of AbbVie (ABBV)  and located in South San Francisco, CA. AbbVie Stemcentrx is pioneering the discovery and development of cancer-stem cell (CSC)-targeted ADCs, with more than 6 programs in clinical development. Prior to founding Stemcentrx in 2008, which was acquired by AbbVie in June 2016, Scott was one of the first scientists at OncoMed Pharmaceuticals, where he spearheaded the identification and characterization of solid tumor CSC, and led seminal work to identify colorectal CSC and demonstrate their resistance to chemotherapy. Scott received his BS in Biochemistry & Molecular Biology from the University of Minnesota-Duluth, a Master’s Degree in Molecular Pathobiology from the University of Alabama-Birmingham, and his doctorate in Immunology & Cancer Biology from the University of Minnesota. Scott moved to California in 2002 to postdoc at Stanford University with stem cell pioneer, Irv Weissman, and in 2005 was recognized by the British Council as one of eight outstanding young US-based researchers in the field of stem cell biology.

Workshop E
Monday $th March

13.00 - 16.00
PK/PD Based Strategies to Improve the Therapeutic Index of ADCs
Workshop Leader: Dhaval Shah, Assistant Professor of Pharmaceutical Sciences, State University of New York at Buffalo

Following the morning workshop with Greg Thurber, the afternoon workshop focuses on aspects of pharmacokinetic modelling and PK/PD experiments for later stage development and maximisation of the therapeutic window of ADCs.

This workshop will:

  • Introduce basic tenets of ADC PK/PD, and how to characterise them using empirical and system based
    mathematical models
  • A strategy to translate preclinical efficacy of ADCs into the clinic using PK/PD modelling and simulation will be explained
  • How the size of ADC (e.g. FDCs), heterogeneity of tumour, ADC bystander effect, and antibody co-administration may affect the efficacy and therapeutic index of ADCs will be highlighted

Dhaval Shah, Assistant Professor of Pharmaceutical Sciences, State University of New York at Buffalo

Prof. Dhaval K. Shah is an Associate Professor of Pharmaceutical Sciences at the State University of New York at Buffalo. Prior to becoming the faculty Prof. Shah served as a Principle Scientist in the ‘Translational Research-Modeling & Simulation’ group at Pfizer Inc. His research focuses on understanding the determinants for the absorption, distribution, metabolism, and elimination (ADME) of protein therapeutics. His lab uses the principles of Pharmacokinetics-Pharmacodynamics (PK-PD) Modeling & Simulation to support the discovery, clinical translation, and late phase development of novel biologics like engineered antibodies, multi-specific proteins, immuno-oncology agents, engineered T cells, and antibody-drug conjugates. He has developed several pioneering systems PK/PD models for ADCs, and continue to develop mechanism models to understand and improve pharmacological behavior of ADCs.

Workshop G
Monday 4th March

13.00 - 16.00
Occupational Health & Safety in Delivering ADC Projects
Workshop Leader: Justin Mason-Home, Director, HPAPI Project Services Limited

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. Attend this workshop to learn about scientific and systematic, business-focussed 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

Justin Mason-Home is an organic chemist with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the pharmaceutical, biochemical, chemical and other industries.  He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home has worked on multiple ADC projects and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.