4th Analytical & Bioanalytical Day
Wednesday October, 9

8.30 Chair’s Opening Remarks

Leo Kirkovsky, Director, Clinical Assay Group, Pfizer

8.40 Keynote: 1 Year on – Were the Goals Achieved?

• Introduction to the Analytical and Bioanalytical day
• Lessons learned from previous years
• How the analytical and bioanalytical field has progressed over the last year?

Leo Kirkovsky, Director, Clinical Assay Group, Pfizer

9.10 The Evolution & Current Status of Antibody-Drug Conjugate Bioanalysis

• Overcome technical challenges in ADC bioanalysis with advancing technologies and strategies
• Learn how to select and correlate various analytes, technologies and platforms
• Stage specific and continuity of bioanalytical approaches, platforms and strategies at different phrases of ADC development
• Regulatory perspectives along with challenges and strategies of bioanalysis for new conjugate modalities

Jian Wang, Senior Principal Scientist/LC-MS Technical Integration Lead, Bristol Myers Squibb

9.40 Analytical Strategies for Accelerated Approval of ADCs

Hillary Schuessler, Investigator, GSK

10.10 From Deep Characterization to Sub-Ppb Payload Metabolite ID: HighResolution MS Applications in ADC Analysis

• High-resolution MS-based techniques are widely employed to address a number of complex analytical problems related to the structural
characterization of ADCs, their components, formulation excipients and biotransformation products
• Here we present our current approach, in which the information obtained from the MS fragmentation behavior of the molecule under study is used to design highly specific and sensitive characterization methods
• Explore real life examples in different application fields

Antonio Triolo, Head of the Laboratory of Analytical Chemistry for Development & Research & Development, Menarini

10.40 Speed Networking

11.10 Morning Break

Adaptations to Characterization Techniques as the Field Evolves

12.00 Quantitative DAR Assessment with Intact Native Size-Exclusion Chromatography Mass Spectrometry (SEC-MS)

John Valliere-Douglass, Associate Director, Seattle Genetics

12.30 Single Molecule 3D Image: An Approach to Reveal Antibody Structural Dynamics & Conformational Changes

• Determination of 3D structure of a single protein by individual particle electron tomography (IPET)
• 3D structural dynamics and fluctuation of IgG1 antibody
• Conformational changes and aggregation of antibody by peptide conjugation

Gary Ren, Scientist, Lawrence Berkeley National Laboratory

1.00 Strategies for Analytical Characterization of CQAs for Antibody-Drug Conjugates

• Evaluate ADC specific physico-chemical properties and critical quality
attributes
• Assess tools and techniques for analytical characterization
• Review case studies on analytical characterization of CQAs

Karan Shah, Scientist Analytical & Pharmaceutical Development, ImmunoGen

1.30 Lunch & Networking

2.30 Explore Advances in 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 behavior of ADCs and drug intermediates in vivo
• Lessons learned from working with PBD-ADCs

Kathryn Pugh, Analytical Chemist, Spirogen

Bioanalytical Support Strategies

3.00 ADME Considerations & Bioanalytical Strategies for Pharmacokinetic Assessments of Antibody-Drug Conjugates

• Overview of structural complexity of ADCs
• Current bioanalytical approaches commonly employed to assess pharmacokinetics of ADCs
• Emerging bioanalytical tools for the assessment of ADC biotransformations

Anton Rosenbaum, Translational Sciences Group Leader, AstraZeneca

3.30 Afternoon Break & Networking

Bioanalytical Support Strategies

4.30 A View from the Top: Integrated LC-MS Strategy for Intact ADC/Antibody Analysis

• Novel development of chromatographic column for native ADC separation and online LC-MS analysis
• Top down analysis of antibody/ADC variants
• Establish characterization of conjugation site heterogeneity by LC-MS

Ceixong Fu, Principle Scientist, Shire

5.00 Alternative Assays – Immunogenicity & Metabolite ID

• Importance of ADC Immunogenicity risk assessment including specific risk factors and potential clinical consequence of adaptive immune response to ADCs
• Current industry standards for the characterization of ADC immunogenicity response
• Learn tiered testing approach and bioanalytical strategies to help understand the immunogenic behaviour of ADC candidates
• Key considerations and mitigation strategies to overcome bioanalytical challenges in developing and validating immunogenicity assays for ADCs

Seema Kumar, Associate Director, EMD Sereno

5.30 Chair’s Closing Remarks
Leo Kirkovsky, Director, Clinical Assay Group, Pfizer