September 20 – 22, 2017 | San Diego, CA

Sheraton San Diego Marina

Analytical & Bioanalytical Day

 

Wednesday September 20

Analytical & Bioanalytical Day Partners
eag and thermo
08.50

Chair’s Opening Remarks

Jian Wang, Senior Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb
09.00

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

Next Generation ADCs: Developing a Robust Bioanalytical Approach

09.30

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

10.00

Partner 15 Minute Spotlight Presentation

  • More details to follow

To be confirmed, EAG Laboratories

10.15

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.
 10.45

Morning Refreshments

Next Generation ADCs: Developing a Robust Bioanalytical Approach

 11.15

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

Lieza Danan-Leon, Scientist, III, AbbVie-Stemcentrx

 11.45

Partner 15 Minute Spotlight Presentation

  • More details to follow

To be confirmed, Thermo Fisher Scientific

 12.00

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

 12.30

Lunch & Networking

Innovations in Analytical Technologies/Approaches for More Robust ADC Characterization

13.30

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

 14.00

Analytical Considerations for ADC Development

  • More details to follow

Eoin Cosgrave, Senior Scientist, Seattle Genetics

14.30

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

15.00

Afternoon Refreshments and Networking

Improve Continuity from Discovery to Clinical Development & Manufacturing

15.30

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

16.00

Chair’s Closing Remarks

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