March 2020


3rd Analytical & Bioanalytical Day

3rd Analytical & Bioanalytical Day | Monday 4th March

08.30   Chair’s Opening Remarks

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre

08.40 Moving Beyond the Simplistic; Novel Analytical Methods for ADC Characterisation & Assessment

• Discussing evolution of analytical methods for ADC characterisation
• Assessing novel analytical methods for analytical characterisation of next-generation ADCs
• Reviewing application of optimised analytical methods for ADC research

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre

Integrating a Robust Bioanalytical Support Strategy

09.10 Strategies & Challenges for Developing Total Antibody & Antibody Conjugated Drug 2-in-1 Method for Dolaflexin Antibody Drug Conjugates

• High throughput 96-well sample preparation approach
• Total antibody and antibody conjugated drug in one assay
• Non-clinical and clinical assays

Ling Xu, Principal Scientist, Mersana Therapeutics

09.40 Morning Refreshments

What Happens When it Gets Tricky?

10.30 Panel: Predicting Efficacy/Tox Relationships through Modelling of ADC Distribution & Biotransformation

• Quantification and characterisation of intact ADC and intermediates, predicticting toxicities and efficacies
• Process chemistry changes in mAb vs conjugation vs small molecule
• What are the gaps in our analytical capability?

11.00 Preclinical Analytical Strategies

  • PK of ADCs are more complex than that of antibody and cytotoxic drug alone
  • Novel assays are required to truly understand the behaviour of ADCs and drug intermediates in vivo
  • Lessons learned from working with PBD-ADCs

Kathryn Pugh, Analytical Group, Spirogen

11.30 Leveraging Prior Knowledge to Gain Efficiencies During Product Characterisation of Antibody Drug Conjugates

• Seattle Genetics has developed a deep product understanding of Antibody Drug Conjugates
• As we continue to build our pipeline, accommodate an ever increasing need for speed to clinic and market, we continue to explore opportunities to gain efficiencies. Leveraging prior knowledge gained from multiple product characterization efforts can help realize some of these efficiencies
• This presentation will show a comparison of size & charge variant characterization results for multiple ADCs to highlight common modifications and structural variants across ADCs. Based on this data we propose a streamlined and targeted approach to product characterization that takes advantage of prior knowledge

Nomalie Jaya, Principal Scientist, Seattle Genetics

12.00 Lunch & Networking

13.00 Preclinical Strategy to IND & Beyond – With a Focus on Bioanalysis

This workshop will focus on the preclinical bioanalytical methods that need to be developed and put in place to ensure that meaningful preclinical studies can
be undertaken. Safety data from these GLP studies can be translated into relevant information for the selection of starting dose, patient exclusions and clinical Risk Evaluation and Management Strategy (REMS).

Attendees will learn about:
-Evaluating target risks and managing these through preclinical and clinical development
-Understanding the need to develop robust and sensitive bioanalytical methods
-Biomarker selection to support preclinical and clinical development
-Ensuring that the maximum amount of information will be generated to facilitate a robust IND submission with valid patient risk assessment and REMS for first in-human doses
-Interacting with regulatory agencies to facilitate their early input to development programmes

Peter Bach, Director, Nonclinical Development BioPharmaLogic Consulting


15.00 Chair’s Closing Remarks:

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre