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Upcoming Activities
Bioanalytical Challenges in Complex Biologics
AGENDA OVERVIEW
30 minute panel discussion
This webinar will explore the key bioanalytical challenges associated with complex biologics and advanced therapeutic platforms. The discussion will focus on bioanalysis of complex biologics, translational challenges, analytical and regulatory considerations, and strategies for successfully advancing programs from bench to clinic.
Our expert panel will examine analytical characterization, method development, and regulatory expectations in preclinical studies, providing practical insights into navigating scientific and strategic hurdles across the development pathway.
Key Topics:
- Bioanalysis of complex biologics in preclinical studies
- Characterization and translational challenges
- Analytical and regulatory considerations
- From bench to clinic: bioanalytical strategies and hurdles
- Regulatory considerations in preclinical studies.
Moderator: Kelly Loyet, Distinguished Scientist and Director, Biochemical and Cellular Pharmacology, Research, Genentech
Panellist:
- Thomas Kraft, Subchapter Lead, ADME; Senior Principal Scientist, Roche Diagnostics GmbH
- Alessandro Gori, Lead Researcher, CNR (Consiglio Nazionale delle Ricerche)
- Julia Deuel, Director CMC, Voisin Consulting Life Sciences
Humanized Oncology and Autoimmune Disease Mouse Models for T-Cell Engager Evaluation
Presented by Dr. Jun Wang, Senior Scientific Director
T-cell engagers (TCEs) are antibody-based therapeutics that redirect T cells to recognize and eliminate pathogenic cells. While TCEs have demonstrated strong therapeutic efficacy in clinical trials across oncology and autoimmune indications, traditional preclinical models often lack the relevant human drug targets and struggle to mimic the complexity of human immune responses. This creates a critical gap in the development of safer, more efficacious TCEs.
In this webinar, attendees will learn how GemPharmatech addresses this gap. It will cover:
1. The current landscape of TCE development
2. Human immune system mouse models
3. Genetically humanized mouse models
4. Strategies for using humanized mouse models in TCE efficacy and safety evaluation
Dr. Jun Wang, Senior Scientific Director
Dr. Jun Wang has over 15 years of experience in biomedical research. Prior to joining GemPharmatech, he served as an Associate Director of Research at Explora Biolabs/Charles River. He has extensive experience with genetically engineered mouse models for drug discovery in various therapeutic areas. Dr. Wang holds a Ph.D. in Developmental Neurobiology from the City of Hope and received his postdoctoral training in pediatric brain cancer research from the Sanford Burnham Prebys Medical Discovery Institute.
You can catch up on our past NextGen Biomed webinar recordings on our Resources page.

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