8:20 am Registration Opens

9:20 am Chairperson’s Opening Remarks

  • Chris Chumsae Director, Analytical Development, Bristol-Myers Squibb

Overviewing ADC Analytical Development – Challenges & Successes

9:30 am Analytical Challenges Encountered in ADC Development

  • Chris Chumsae Director, Analytical Development, Bristol-Myers Squibb

Synopsis

  • The ADC Landscape: Overview of the different conjugation chemistries and various payloads employed in ADC development
  • Address the analytical challenges associated with ADCs; how the conjugation can complicate the assessment of other inherent molecular attributes
  • Evaluate innovative approaches to navigate the ADC analytical space: How scientists in the industry have been able to use novel approaches to gain increased insight on ADC structure, PTMs and drug-like properties

Showcasing Novel Method Development for More Accurate Analytical Readings

10:00 am Unlocking the Potential of Analytical Ultracentrifugation: Measuring Polymer Content in an Antibody-Polymer-Drug Conjugate

  • Susan Clardy Associate Director, Analytical CMC, Mersana Therapeutics

Synopsis

  • Addressing challenges in the characterization of protein-polymers
  • Reviewing a novel approach to utilizing AUC for the characterization of ADCs
  • Obtaining a deeper understanding of conjugation impurities

10:30 am
Speed Networking

Synopsis

This session is an opportunity to connect with other analytical enthusiasts, hold in-depth conversations with some of the brightest minds working in the ADC analytical space, and establish meaningful business relationships.

Quantifying the Most Important Critical Quality Attributes (CQAs)

11:30 am CQA-Driven Approach to Comparability Studies: An ADC Case Study

  • Simon Letarte Director, Extended Structural Characterization , Gilead

Synopsis

  • Evaluate general CQA scoring and risk assessment
  • Discuss a CQA comparability strategy for an ADC
  • Review a case study of a shoulder peak identification and risk management

12:00 pm Applying LC-MS for Improved ADC Characterization

Synopsis

  • Discussing linker-payload LC-MS method development
  • Improving ADC stability via transformation
  • Outlining free payload and intact mass analysis for ADC stability studies

12:30 pm
Lunch & Networking

Outlining Approaches to Improve DAR Characterization & Distribution

1:30 pm Examining How to Accurately Quantify DAR & DAR Distribution

Synopsis

  • Discussing the challenges in DAR and drug load distribution determination
  • Reviewing analytical approaches in quality control and extended characterization of DAR in ADCs
  • Introducing a novel approach in DAR distribution assessment with multiplexing MS/MS tags

2:00 pm Leveraging Orthogonal Assays to Ensure Accurate Quantification of DAR: An Attribute-to-Assay Approach

Synopsis

  •  Sharing Seagen’s approach to DAR quantification
  • Discussing how using orthogonal assays helps overcome challenges seen with DAR quantification
  • Exploring what this means in an applied setting

2:30 pm
Afternoon Break

Assessing the Regulatory Landscape for Analytical Development of ADCs

3:00 pm Roundtable Discussion

Synopsis

As ADCs become more complex in structure and scientists improve their understanding of the effect of structure on its function, regulatory bodies are demanding an increasing abundance of evidence to show safety, stability, efficacy and consistency of each drug.
Understanding the key pieces of information regarding acceptance criteria, critical quality attributes and methodologies from a regulatory perspective is therefore pivotal to prevent delays in submission and clinical development.
Topics to be discussed include:

  • With more advanced analytics more aspects of molecules can be measured – what are the key aspects which need characterization and should be included on release or control strategy?
  • Are specifications required for all numerical controls for all ADC CQAs?
  • Examining what information you must provide in the regulatory dossier regarding the reference?
  • What are the critical pieces of information to include in a briefing book and what can be left out?

4:00 pm End of Conference Day One