Ensuring that a novel biotherapeutic is specific to its intended target is undoubtedly advantageous when selecting promising lead candidates, however, it becomes vital when assessing potential safety implications prior to clinical studies.
The unique Cell Microarray technology identifies primary receptors and any potential secondary targets with a high degree of specificity and sensitivity, providing valuable data that can inform lead selection, assist with safety assessment and provide IND-enabling data for regulatory submissions. Cell Microarray data confirming target specificity have been included in IND submissions to various regulatory agencies, such as the FDA (US), EMA (Europe), NMPA (China) and PMDA (Japan), either in complement with, or as a replacement for, tissue cross reactivity data.
This webinar provides an overview of the Cell Microarray technology, with a particular focus on specificity/off-target screening of therapeutic antibodies and related molecules. Industry case examples will highlight data generated for a variety of biotherapeutic modalities and show the utility of the platform from early lead candidate selection through to IND-enabling safety, and clinical trial stages.
Key Learning Objectives:
- Understand how the specificity data generated with Cell Microarray screening is used in lead candidate selection and safety assessment
- Learn how IND-enabling specificity data supports submissions to regulators as either an adjunct to, or replacement for, tissue cross reactivity studies
- Learn more about identifying and mitigating the risk of clinical toxicity caused by off-target effects of antibodies and related molecules
Mark Aspinall-O’Dea, PhD
Asia-Pacific Business Development Manager
Mark is responsible for growing Retrogenix’s business portfolio in the Asia Pacific region and is based at our UK headquarters in the Peak District.
Mark’s wide-ranging experience includes 10 years postdoctoral research in oncology, working in both clinical and academic settings. During this period, he established positive long-term relationships with key opinion leaders from a range of disciplines through his involvement in international scientific collaborations and consultancy projects in both the public and private sector. Mark is first author on multiple peer-reviewed publications and has presented his primary research findings at international conferences.
He obtained his PhD in Biochemistry from the University of Sheffield, UK, in 2005.
Nicholas C. L. Wong, PhD
Project Director, Preclinical Development
NanoMab Technology Limited
Nicholas has broad experience in the development of innovative cancer treatments. He successfully oversaw the translation of NanoMab’s first two projects (NM-01: PD-L1 Imaging and NM-02: HER2 Theranostic) into clinical studies in China and Europe. Prior to joining NanoMab, he held the position of project manager in Jiangsu Laitai Medical Biotech Ltd, responsible for the early development of a liver cancer specific peptide pharmaceutical. He also served as application scientist at Roche Diagnostic where he was in charge of implementing cancer molecular diagnostics in Hong Kong. Nicholas received his academic training and PhD in cancer biology from the University of Hong Kong.
Cost: No Cost!