Pre-Conference Workshops

28 February 2012

09:00 - 12:00 Workshop A: Conducting Definitive Preclinical Pharmacokinetic Analyses of Your Antibody-Drug Conjugate Candidates

The target antigen, linker, cytotoxic drug, and the monoclonal antibody are all important determinants of the safety, pharmacokinetics and pharmacodynamics of the ADC. In addition, ADCs are highly heterogeneous in their active components and their subsequent in vivo catabolism and disposition present unique safety, PK/PD, ADME, manufacturing & translational challenges.

In this short course, we propose to address these translational and clinical development challenges in the development of an ADC, including assay interpretation (what and how to measure), translation of safety, PK and ADME in different species and into the clinic, and analytical chemistry hurdles/challenges, clinical pharmacology and finally the regulatory landscape to ADC development.

This workshop will address:

• Overview of pharmacokintetics of ADCs
• Different assay formats to measure analytes: Interpretation and challenges
• ADME characterisation of ADCs
• Translational challenges in PK, safety and efficacy of ADCs
• Clinical pharmacology and pharmacometric strategies in the development of ADCs
• Regulatory perspectives on the PK/PD of ADCs

Workshop leaders

Kedan Lin, Ph.D, Group Leader, Early Development PKPD, Genentech Inc.

Dr. Lin is a Scientist and Group Leader in Research and Early Development at Genentech.  She received her Ph.D from University of California, San Francisco. Her research focuses on applying pharmacokinetic and pharmacodynamic principles in optimizing antibody drug conjugates and advancing clinical candidates.

12:30 - 15:30 Workshop B: Establishing a Safe Working Environment in Your ADC Manufacturing Facility

As with any operation involving handling a biopharmaceutical compound, the hazard that ADC components present and the workplace measures that need to be taken to develop and maintain safe working environments have to be established. Principles that have been honed over many years in big pharma and now effectively applied in ADC biopharma will be discussed, as applied to both ADC R&D and manufacturing working environments.

The business-focused workshop will include:

• Hazard assessments, laboratory and manufacturing operations risk assessments
• ADC facility design matters
• Workplace testing and other management tools for systematic and effective ADCs occupational health and safety management.

Sub-groups in the workshop will then be invited to form teams and come up with their own conceptual designs for different ADC process steps and present their solutions to the other groups!

Lunch is included in this workshop.

Workshop leader

Justin Mason, Director, SafeBridge Europe

Justin Mason is Managing Director of SafeBridge Europe, part of SafeBridge Consultants. SafeBridge has worked for many years with West Coast US ADC innovators, developing practical tools for ADCs occupational health and safety management, including developing and running validated industrial hygiene air and surface monitoring methods in its US accredited laboratories. This experience has been taken forwards in supporting an increasing number of CMOs and licensees of ADC technologies. Justin Mason has been involved in new ADC facility conceptual and detailed design and on-going ADCs projects health and safety management for over five years.

16:00 - 19:00 Workshop C: Understanding the EU Rules and Regulations for ADC Development

Antibody-drug conjugates are an exciting field that are set to make a big impact on the oncology therapeutic landscape. In order to achieve success in ADC development, it is critical to be up-to-speed with regulatory requirements. This workshop will highlight the issues relating to ADCs, with regard to quality and manufacturing concerns and non-clinical study requirements in the EU.

This workshop will:

• Introduce the current EU legislation and guidelines
• Introduce and give overview of CMC requirements for ADC and key guidelines, such as the CMC and quality requirements for drug/linker molecules, biological component, ADC drug substance and drug product
• Give an insight into the key analytical assays (Antibody drug ratio, potency, specific stability indicating assays)
• Case studies: Clinical delay due to CMC deficiencies in the regulatory dossier
• Preclinical requirements for Phase 1 clinical studies.
• Help you to define your regulatory strategy for ADC development

Workshop leader

Sohail Chohan, Associate Director, CMC Regulatory Affairs and Product Development, ERA Consulting

Sohail is an experienced senior consultant, who has significant industry experience in the CMC development of early and late phase drug development programmes (10 years at GSK R&D, 3 years at Renovo), with particular focus on biopharmaceutical. He has expertise in all aspects of biopharmaceutical CMC, quality, development, scale-up and manufacture processes, including project management of CMC activities at CMOs.