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:
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.
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:
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.
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:
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.
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.
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:
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.
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:
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.