Kathryn Chapman
Greater London, England, United Kingdom
3K followers
500+ connections
About
Senior executive with experience across diverse leadership and strategic roles in the…
Articles by Kathryn
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New Partnership with Pfizer announced today
New Partnership with Pfizer announced today
By Kathryn Chapman
Activity
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Thanks to everyone who supported the opening of the Deloitte Life Sciences Catalyst Business Lounge in Cambridge last evening. We value collaboration…
Thanks to everyone who supported the opening of the Deloitte Life Sciences Catalyst Business Lounge in Cambridge last evening. We value collaboration…
Liked by Kathryn Chapman
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Been another good week as our growing global footprint drives overall performance
Been another good week as our growing global footprint drives overall performance
Liked by Kathryn Chapman
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We’re very excited to have contributed towards Health Innovation East Midlands new Innovation Academy that they are launching TODAY. The course that…
We’re very excited to have contributed towards Health Innovation East Midlands new Innovation Academy that they are launching TODAY. The course that…
Liked by Kathryn Chapman
Experience
Education
Publications
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Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
mAbs
Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In…
Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In March 2015, the first biosimilar (ZarxioTM, filgrastim-sndz, Sandoz) was approved by the US Food and Drug Administration; however, to date no mAb biosimilars have been approved in the US. There are currently major differences between how biosimilars are regulated in different parts of the world, leading to substantial variability in the amount of in vivo nonclinical toxicity testing required to support clinical development and marketing of biosimilars. There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union’s guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization’s guidance is interpreted globally to mean in vivo toxicity studies are mandatory.
Other authorsSee publication -
Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies
Journal of Pharmacological and Toxicological Methods
The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing.
Other authorsSee publication -
The predictive validity of the rat self-administration model for abuse liability.
Neurosci Biobehav Rev.
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Preclinical safety testing of monoclonal antibodies: the significance of species relevance
Nat Rev Drug Discov. 2007;6(2):120-6.
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The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates.
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The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates.
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More activity by Kathryn
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Watch our CEO Derek Jones talk to BiotechTV about the importance of the Campus community to grow and create world-class life science companies in the…
Watch our CEO Derek Jones talk to BiotechTV about the importance of the Campus community to grow and create world-class life science companies in the…
Liked by Kathryn Chapman
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Prashant Shah and Catherine Stace recently attended the 10th LSX World Congress in London. They had a great time connecting with innovators from the…
Prashant Shah and Catherine Stace recently attended the 10th LSX World Congress in London. They had a great time connecting with innovators from the…
Liked by Kathryn Chapman
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I'll be on a panel, discussing 'The Pharma's View: Are deals with Big Pharma becoming faster, more collaborative, and more creative or just more…
I'll be on a panel, discussing 'The Pharma's View: Are deals with Big Pharma becoming faster, more collaborative, and more creative or just more…
Liked by Kathryn Chapman
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If you’re at #BioEquityEurope this week, don’t miss the chance to connect with Myriam Ouberai, CEO and Founder, and Adam Collier, CBO, of Start Codon…
If you’re at #BioEquityEurope this week, don’t miss the chance to connect with Myriam Ouberai, CEO and Founder, and Adam Collier, CBO, of Start Codon…
Liked by Kathryn Chapman
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Today we welcomed Roland Sinker of Cambridge University Hospitals NHS Foundation Trust Trust at our strategic R&D Centre and Global headquarters in…
Today we welcomed Roland Sinker of Cambridge University Hospitals NHS Foundation Trust Trust at our strategic R&D Centre and Global headquarters in…
Liked by Kathryn Chapman
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Have you secured your spot for next week's talk from Prof Clare Bryant as part of our Babraham Distinguished Lecture Series? Clare is Professor of…
Have you secured your spot for next week's talk from Prof Clare Bryant as part of our Babraham Distinguished Lecture Series? Clare is Professor of…
Liked by Kathryn Chapman
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Come work with the team and I! Looking for a Founder's associate to work with me and the team on the things that don't scale (until they do) at…
Come work with the team and I! Looking for a Founder's associate to work with me and the team on the things that don't scale (until they do) at…
Liked by Kathryn Chapman
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🌟 Join the Founders Growth Community (FGC) Masterclass with Andy Richards! 🌟 🗓️ Date and Time: Wednesday, 22nd May 2024, from 4:00 PM to 6:00 PM…
🌟 Join the Founders Growth Community (FGC) Masterclass with Andy Richards! 🌟 🗓️ Date and Time: Wednesday, 22nd May 2024, from 4:00 PM to 6:00 PM…
Liked by Kathryn Chapman
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A fun part of my job is championing entrepreneurship at the University of Cambridge, as the place is positively buzzing with innovation and…
A fun part of my job is championing entrepreneurship at the University of Cambridge, as the place is positively buzzing with innovation and…
Liked by Kathryn Chapman
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If you're planning to visit us on Campus for Cambridge Wide Open Day next month then you're in for a real treat. Companies who will be providing…
If you're planning to visit us on Campus for Cambridge Wide Open Day next month then you're in for a real treat. Companies who will be providing…
Liked by Kathryn Chapman
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Great start to #BioEquity in San Sebastian. The blue skies might have gone but the food, drink and networking is just getting started. Thanks to…
Great start to #BioEquity in San Sebastian. The blue skies might have gone but the food, drink and networking is just getting started. Thanks to…
Liked by Kathryn Chapman
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🌟 We can't get enough of the Northern Lights over Cambridge! 📸 Engineering PhD student Jamie Clarkson took this beautiful shot on Friday night:…
🌟 We can't get enough of the Northern Lights over Cambridge! 📸 Engineering PhD student Jamie Clarkson took this beautiful shot on Friday night:…
Liked by Kathryn Chapman
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