Cambridge Healthtech Institute’s 10th Annual

Characterization for Novel Biotherapeutics

Exploring the Analytical Challenges of Emerging Modalities

May 4-5, 2020


As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Very new modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation. The PEGS Characterization of Biotherapeutics conference explores the progression of analytical development for an exciting range of emerging modalities and offers a case study forum for those working in the field to share ideas, experiences and solutions that support the preclinical and clinical development of novel biotherapeutics.

Preliminary Agenda

ANTIBODY-DRUG CONJUGATES

Analytical Toolbox for Measuring the Drug-Antibody Ratio of Antibody-Drug Conjugates

Delphine Mathieu, PhD, ADC Analytical Skill Center, Biologics Development Sanofi, France

Next Wave of ADC Characterization, from Top to Down

Cexiong (Winston) Fu, PhD, Principal Scientist, Takeda

Early Phase Characterization and Method Development for Novel ADCs

Sunnie Kim, PhD, Senior Scientist, Seattle Genetics

TRANSITIONING FROM THERAPEUTIC PROTEINS TO CELL AND GENE THERAPIES

The Experience of a Protein Biochemist Moving to Cell and Gene Therapies

George Bou-Assaf, PhD, Scientist, Biogen

Key Assays and Methods for Generation, In-Process Testing and Characterization, towards CMC of AAV Vectors

Stefan Seeber, PhD, Senior Principal Scientist, Cell Technologies, Roche Pharma Research and Early Development, Germany

KEYNOTE PRESENTATION: Developing a Cell and Gene Therapy Analytical Capability

Julia Ding, PhD, Director, Process Development Analytical & Analytical Development, Bristol-Myers Squibb

EMERGING MODALITIES

siRNA-mAb Conjugate Analysis: To Ioinise in Positive or Negative ESI Mode, That Is the Question

Iain D. G. Campuzano, Principal Scientist, Discovery Attribute Sciences, Amgen

Characterization of Conditionally Activating Biologics

Wendy Ritacco, Senior Scientist, AbbVie Bioresearch Center

Analytical Characterization Tools for Rapid Developability Assessment of Recombinant Protein Vaccine Antigens

Kawaljit Kaur, PhD, Associate Researcher, Vaccine Analytics and Formulation Center, Pharmaceutical Chemistry, University of Kansas

DRUG COMBINATIONS

Release and Stability Testing Challenges for Biotherapeutic Combinations

Ming Zeng, PhD, Associate Director, Parenteral Sciences & Technology Bristol-Myers Squibb

Use of 2D Liquid Chromatography to Characterize Aggregates in Co-Formulated Drug Products

Xiaoqing Hua, Senior Scientist, Merck

Overcoming Challenges in Co-Formulation of Therapeutic Proteins with Contradicting Stability Profiles

Dennis Krieg, PhD, Researcher, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University Munich, Germany

BISPECIFIC AND MULTI-SPECIFIC ANTIBODIES

Native Chromatographies to Resolve Mispairs and Determine Optimal Chain Pairing for BsBv Molecules

Wendy Sandoval, Principal Scientist, Genentech

Bispecific Molecules and Characterization for Pharmacokinetics Studies

Mei Han, Senior Scientist, Pharmacokinetics & Drug Metabolism, Amgen

CHARACTERIZATION CHALLENGES

Agonist Antibodies

Yoshiko Akamatsu, PhD, Senior Principal Research Scientist, AbbVie

Developability Retrospective: Differentiating between Red Flags and Red Herrings in Developability Assessments

Christina Palmer, Scientist, Antibody Discovery, Biogen



* The program is subject to change without notice, due to unforeseen reason.

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Update History
2019/11/25
Sponsor updated



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