8:30 am Registration Opens

9:25 am Chairperson’s Opening Remarks

Advancing Bioassay Development for Improved Developability

9:30 am From AlphaPlexing to Cell Culture on the Z-plane: Applying Non-Traditional Methodologies for Biological Characterization of ADCs Within the CMC Space

Synopsis

  • Demonstrating how the use of high-content imaging expedites development of in vitro biological assays that enable ADC manufacturing, control and characterization
  • Highlighting how culturing cells as 3D spheroids can increase their sensitivity to ADC-induced cytotoxicity, how spheroid culture are amenable to GMP potency assays
  • Understanding how binding assays that support bispecific ADCs requires innovative techniques and strategies to simplify lot-release and stability specifications

10:00 am Implementing Novel Methods & Strategies for Characterizing Fc Effector Functions of Antibody Drug Conjugates

Synopsis

  • ADCs with Fc effector functions pose challenges to CMC, including requirements for in-depth characterization and control which can be difficult to navigate in early development phases due to lack of in vivo and/or clinical data
  • Traditional methods of assessing Fc effector functions, such as reporter gene bioassays, can be over-sensitive to small changes in early process development due to Fcy receptor over overexpression in the model
  • Explore how more functionally-relevant assays using PBMCs and live cell imaging of target cells can help determine perceived level of contribution of Fc effector function towards MoA, and can lessen perceived safety risks over concerns with data generated with traditional assays

10:30 am
Networking Break

Developing a Platform for Analytical Development

11:00 am One Size Fits All? Compiling a Panel of Platform Analytical Methods For Antibodies & Antibody-Drug Conjugates

Synopsis

  • Based on prior knowledge, a set of platform physiochemical methods was assembled, consistent with the principles of AQbD
  • Understand how the methods are suited for release and stability testing, in addition to aiding process development of monoclonal antibodies and antibody-drug conjugates
  • The platform methods are intended to support the accelerated early development (up to and including Ph1) of these new biological entities
  • Discover how all methods can be qualified and transferred to QC easily and can be further optimized and validated for each molecule specifically, during late stage development

11:30 am Panel Discussion – Can Analytical Development be Platformed?

  • Mark Eggink Principal Scientist, Byondis
  • Annika Yau Senior Scientist, Discovery Analytical Chemistry , Mersana Therapeutics
  • Keith Canada Senior Principal Scientist, High Throughput Materials & Biophysical Characterization , Merck & Co. Inc

Synopsis

  • Discussing the feasibility of platforming analytical methods across a range of ADCs
  • Is platforming analytical methods applicable to novel-payload ADCs?
  • How can clinical and CMC stability data feed into early development, and alter the platform for improved therapeutic outcomes?

12:10 pm
Lunch & Networking

Ensuring Product Quality Through the Use of Analytical Methodologies

1:10 pm ADC Candidate Screening Via Forced Degradation & Mass Spectrometry

  • Sean McCarthy Senior Scientist II, Analytical Research & Development, AbbVie

Synopsis

  • mAb and ADC candidates can be screened via forced degradation
  • Platform methods for mAbs can be easily extended to ADCs
  • Full understanding of observed ADC degradation products often requires in-depth drug linker analysis, collaboration with chemistry colleagues

1:40 pm Discussion Session – Evaluating the Role of CDMOs in the ADC Analytical Development Process?

  • Chris Chumsae Director, Analytical Development, Bristol-Myers Squibb
  • Susan Clardy Associate Director, Analytical CMC, Mersana Therapeutics
  • Shuwen Sun Principal Scientist, Merck & Co. Inc

Synopsis

  • Discussing the pros and cons of working with CDMOs at the different stages of development?
  • Exploring how to bring analytical work in-house?
  • Moving forward, what are the challenges people are expecting to see as the ADC field continues to grow?
  • When working with CDMOs, how are the responsibilities for a dossier split between the CMO and the sponsor?

2:40 pm Chairperson’s Closing Remarks

2:45 pm End of Conference

Harnessing Tools for Developability Assessment & Screening in Early Candidate Space