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Cambridge Healthtech Institute’s Inaugural
Characterization of ADCs, Bispecifics and New Biotherapeutics
Improving Prediction, Screening and Characterization of New Biologics
January 19-20, 2015


With the wave of new biotherapeutics formats flooding the discovery and development pipelines, there is an increasing need for better and faster characterization tools and strategies, and improved biomolecular and biophysical assays for the new biotherapeutics. The new Characterization of ADCs, Bispecifics and New Biotherapeutics conference presents high-level case studies and strategies on improving characterization of ADCs, bispecifics and novel protein formats. Cutting-edge tools, research findings and unpublished data will be featured at this forum.


We invite you to join colleagues in this discussion of the key challenges and solutions improving prediction, screening and characterization of new biologics, and see how experts like you are developing scientifically sound formulations of new biotherapeutics.

Preliminary Agenda 


CONSIDERATIONS FOR DEVELOPING A SUCCESSFUL ANALYTICAL STRATEGY

Developability Assessment for Protein Therapeutics

Stanley Krystek, Ph.D., Senior Principal Scientist, Computer Assisted Drug Design, Bristol-Myers Squibb Co.

Regulatory Perspective on Challenges in ADC Development

Wen Jin Wu, M.D., Ph.D., Senior Investigator, Division of Monoclonal Antibodies, Office of Biotechnology Products, OPS-CDER-FDA


CHARACTERIZATION STRATEGY FOR CANDIDATE SELECTION AND OPTIMIZATION

High-Throughput Developability Screening Methods Targeting Antibody Self/Cross Interaction

Eric Krauland, Ph.D., Senior Director, Antibody Discovery and Optimization, Adimab, LLC

Analytical Characterization of Biologics for Candidate Selection and Optimization: Strategies and Case Studies

Guodong Chen, Ph.D., Principal Scientist, Bioanalytical and Discovery Analytical Sciences, Research and Development, Bristol-Myers Squibb Co.


ANTIBODY DRUG CONJUGATES (ADCs): CHARACTERIZATION, DEVELOPABILITY AND CONTROL STRATEGY

Challenges in ADC Characterization

Shrikant Deshpande, Ph.D., Senior Director, Protein Chemistry, Biologics Discovery California, Bristol-Myers Squibb Co.

Analytical Characterization of ADCs in Early Phase Development

Maureen Fitch Bruhns, Ph.D., Senior Scientist, Analytical Development, Process Development, Igenica Biotherapeutics

Physical Characterization of ADC with Different Loadings

Jianxin Guo, Principal Scientist, Pfizer, Inc.

ADCs Based on RNA Polymerase II Inhibiting Toxins

Andreas Pahl, Ph.D., CSO, Heidelberg Pharma

Addressing Product Heterogeneity Challenges in ADC Biotherapeutics

Nomalie Jaya, Ph.D., Senior Scientist, Seattle Genetics, Inc.

 

ANALYTICAL CHALLENGES FOR BISPECIFICS AND NEW PROTEIN THERAPEUTICS


FEATURED PRESENTATION  

Challenges and Strategies for Establishing an Analytical Control Strategy for Novel Complex Recombinant Biotherapeutics

Johnson Varghese, Senior Director, Head of Analytical Development, Shire HGT

Case Study of Grid Selection to Identify Bispecific Antibodies

Haiyan Jiang, Ph.D., Principal Scientist, Biologics Research, Janssen R&D

Analytical Challenges of Next-Generation Biotherapeutics

Hubert Kettenberger, Ph.D., Principal Scientist, Large Molecule Research, Roche Diagnostics GmbH

Analytical Characterization of Protein-Peptide Conjugates to Support Selection and Optimization of Two Therapeutic Vaccine Candidates: Challenges and Case Studies

Qiong (Joan) Guo, Ph.D., Senior Principal Scientist and Analytical Group Leader, Vaccine Immunotherapeutics Research Unit, Pfizer, Inc.