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July 16, 2020
11 am to 12 pm EDT
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On-target development - Specificity screening of biotherapeutics to avoid off-target liabilities

Webinar Description:

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 support 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. 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 pre-IND safety, and clinical trial stages.

Learning Objectives:

  • Understand how the data generated with Cell Microarray screening is used in lead selection and safety assessment
  • Learn how specificity data supports IND submissions 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 monoclonal antibodies

Speakers:

Jonny Finlay, PhD
CEO
UltraHuman

Jonny Finlay is the CEO of UltraHuman, an antibody drug discovery biotech in the UK that is developing a series of therapeutics for inflammation and oncology. Prior to co-founding UltraHuman, Jonny led research teams in Biologics Discovery at Pfizer and Wyeth, and carried out postdoctoral research in recombinant protein engineering at several institutes, including the Centre for Biologics Evaluation and Research, FDA.

Nick Brown

Nick Brown MSc
North American Business Development Manager
Retrogenix Ltd.


Nick is responsible for growing Retrogenix’s North American business portfolio and is based at the UK headquarters in the Peak District.

Prior to joining the company in early 2019, Nick worked in the Centre for Stem Cell Biology, at the University of Sheffield, culturing and genetically characterising human pluripotent stem cells (including induced PSCs) destined to be differentiated into human cardiomyocytes for heart tissue grafts. He has also spent 4+ years working at an engineering firm specialising in ultra-high-performance mixers for industrial processes.

Nick has a Masters of Science degree in Stem Cell and Regenerative Medicine from the University of Sheffield, UK.

Martin Scott

Martin Scott, PhD
Scientific Leader and GSK Associate Fellow
GSK


Martin is an experienced program leader and matrix team leader specialising in antibody discovery and preclinical development for diverse target classes and primary indications. After completing his undergraduate studies at the University of Edinburgh and a PhD at the MRC Virology Unit Glasgow, Martin joined GlaxoSmithKline in 2002, initially in supporting NCE drug discovery before shifting focus to biopharmaceuticals in 2006. Martin has worked closely with Retrogenix for the last 3 years to embed off-target screening as a key part of the discovery process for all biopharm programs in GSK.


Cost: No Cost!