September 20 – 22, 2017 | San Diego, CA
Sheraton San Diego Marina


Analytical & Bioanalytical Day


Wednesday September 20

Analytical & Bioanalytical Day Partners
eag and thermo

Chair’s Opening Remarks

Jian Wang, Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb

Current Status & Future Perspective of ADC Analytical Characterization &  Bioanalysis

  •  Current landscape of theoretical and technical challenges in ADC analytical characterization and bioanalysis
  • Recent advancement in strategies and technologies as well as an update of regulatory perspectives
  • The trend and future: When and what will be the steady-state?

Jian Wang, Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb


Speed Networking

This session is a great opportunity to introduce yourself to fellow attendees of the Analytical
and Bioanalytical Day that you would like to have more in depth conversations with. This is the ideal opportunity to get face-to-face time with many of the brightest minds working in ADC analysis and bioanalysis and establish meaningful business relationships.

Morning Refreshments

Next Generation ADCs: Developing a Robust Bioanalytical Approach


Bioassay Development & Validation Strategies for Antibody-Drug Conjugates

  • Overcome the complexity of heterogeneous mixtures of multiple in vivo drug species
  • Explore the unique challenges that ADCs present in bioassay development
  • Gain experience in the development of bioassays for the measurement of a new class of payloads from biological matrices

Michelle Palmer, Director, Bioanalytical Science, ImmunoGen


Partner 15 Minute Spotlight Presentation

  • More details to follow

To be confirmed, EAG Laboratories

Next Generation ADCs: Developing a Robust Bioanalytical Approach


Antibody-Drug Conjugate Characterization & Payload Quantification in Biological  Matrices Using HRMS

  • Many challenges exist in the regulated quantitative bioanalysis of ADC payloads
  • Leveraging HRMS during ADC payload method development yields valuable information from a few key experiments
  • Use of HRMS facilitates comprehensive ADC characterization and robust and reliable ADC payload drug quantitation data
  • Reducing the complexity of ADC payload biospecimen sample preparation and extraction approaches may result in improved quality data
  • Automated workflows via robotic liquid handling is achievable during the regulated
    bioanalysis of ADC payloads

Joseph Tweed, Scientist, Bioanalytical, Pfizer


Analysis of ADCs in a Biological Matrix: Overcoming Payload’s Steric Hindrance that Impedes ADC Immunocapture

  • Understanding sites for payload attachment in ADC and how steric hindrance can arise.
  • Explore different approaches to ADC immunocapture from biological matrices.
  • Discover how to overcome the steric hindrance effect that a payload can introduce into an ADC, which impedes its capture.
  • Demonstrate the dynamic range achieved via the use of hybrid LC-MS and different capture reagents for ADC bioanalysis.

To be confirmed, Thermo Fisher Scientific


Immunogenicity of Antibody Drug Conjugates

  • Importance of ADC Immunogenicity risk assessment including specific risk factors and potential clinical consequence of adaptive immune response to ADC’s
  • 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 Serono


Reserved for Agensys

  • More details to follow

Josh Snyder, Scientist & Senior Principle Associate, Agensys


Reserved for Agensys

  • More details to follow

Maria-Christina Malinmao, Senior Principle Associate, Agensys


Lunch & Networking

Innovations in Analytical Technologies/Approaches for More Robust ADC Characterization


Streamlining Drug Development: Native LC-MS as Platform Method for Drug Load  Distribution of Non-Site Specific ADCs from Rapid Screening, to QC Release Testing, & Bioanalysis

  • Understanding the complexity to develop reliable Native LC-MS methods
  • Harness technological advances to improve understanding of drug-antibody-ratio distribution on non-site specific ADCs
  • Explore a case study of detailed analysis of drug distribution
  • Hear lessons learned on effectively capturing ADC stability in vivo

Omar Hamdy,  Senior Scientist I, AbbVie-Stemcentrx


Sites Matter: Engineered Cysteine Mutagenesis & the Potential Impact on Product Quality of ADCs

  • Discover if an engineered cysteine technology for two-loaded ADCs can be expanded to produce ADCs with an average drug load of 4
  • Improve understanding of how the sites of additional engineered cysteines can affect antibody product quality
  • Explore how these changes to product quality ultimately impact development of site-specific ADCs

Eoin Cosgrave, Senior Scientist, Seattle Genetics


Case Study: Comparison of Two Parallel Conjugation Approaches

  • Explore the comparison of two different conjugation approaches
  • Review results from multiple analytical techniques including Mass Spec, DSC, ITC, SECMALLS etc.
  • Learn advantages and disadvantages of plethora of techniques used

Shawn Owen, Assistant Professor, University of Utah


Afternoon Refreshments and Networking

Improve Continuity from Discovery to Clinical Development & Manufacturing


Emerging Strategies for Computational ADC Target Selection & Prioritization

  • Integrative analysis of heterogeneous data
  • Advanced methods for cancer subtype discovery and patient classification
  • Alternative/aberrant splice variants as ADC targets
  • Neoantigen discovery from RNA-seq and whole exome sequencing data

Francois Fauteux, Research Officer, National Research Council Canada


Development of Control Strategies for Next-Generation Site-Specific ADCs

  • Linking criticality of ADC quality attributes to clinical safety and efficacy
  • Choosing between release methods and characterization methods
  • Challenges and lessons-learned for charge distribution, drug load distribution and free drug methods

Brian Hosken, Principal Scientist, AbbVie-Stemcentrx


Panel Discussion: ADC Analysis & Bioanalysis

This session will be a chaired panel interview in which experts from leading ADC analytical and bioanalytical companies will give their perspectives on how we are to overcome the challenges to robustly characterize your ADC programme and then tailor for bioanalytical purposes.

Chair’s Closing Remarks followed by Poster Session & Drinks Reception

Jian Wang, Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb