A lot has already been written about the difference between biomarker assays and PK assays. However, in our daily work in a CRO setting, we still find that many potential sponsors are struggling with the challenges specific to biomarker outsourcing. It is not easy to clearly define a biomarker’s Context of Use (CoU) in a study or to get all the stakeholders involved in understanding the biology and use of the study data. It requires mutual understanding and close collaborations.
In this webinar we will explain why biomarker assay outsourcing is different and will describe good practices and how a pharmaceutical company and a CRO can efficiently collaborate in this process. PRA realizes that biomarker assays require special attention in order to provide reliable and useful data. Join this webinar to gain insights from PRA about biomarker assay outsourcing.
Speakers
Radboud van Trigt, PhD, Director of Bioanalytical Science – Biomarkers, PRA Health Sciences
Radboud van Trigt started his career in bioanalysis in the early 2000s as a study director for small molecule LC-MS/MS analysis at a CRO. A couple of years later, he joined Astellas, a large pharmaceutical company, as a bioanalytical scientist. Over the years, he got involved in other types of analytical studies supporting drug development including large molecule PK using LBAs, qPCR, flow cytometry, microbiology and biomarkers. van Trigt gained a lot of experience in validation of assays and sample analysis in clinical trials of all phases. Currently, van Trigt is a science director for biomarkers at PRA Health Sciences and in that role responsible for the global biomarker science and strategy for the bioanalytical laboratories.
Message Presenter
Amanda Hays, PhD, Director of Bioanalytical Science, PRA Health Sciences
Amanda Hays is the Associate Director of Bioanalytical Science at PRA Health Sciences. Amanda joined PRA in 2017 and leads a group of scientists in method development and optimization of large molecule bioanalytical techniques including LBA, immunogenicity, biomarkers, flow cytometry and qPCR. Prior to joining PRA, she held leadership positions at other CROs, including senior scientist and Biopharma R&D manager. Hays received her Ph.D. in pharmacology in 2012 from the University of Kansas Medical Centre, where she studied targeting organic anion transporting polypeptides in cancer to improve diagnostics and therapy.
Message PresenterWho Should Attend?
- Scientists, lab managers and outsourcing specialists involved in biomarker contracting
- Scientists and project managers working on biomarker assays
What You Will Learn
In this webinar, participants will learn about:
- Why outsourcing biomarker assays is different than contracting other bioanalytical work
- Insights into the important aspects to take into consideration
Xtalks Partner
PRA Health Sciences
PRA Health Sciences recognizes that the world of drug development is complex and dynamic, and that’s why PRA has designed two laboratories to meet those challenges. PRA offers the highest quality services for pharmacokinetic, immunogenicity, biomarker analysis and CMC analysis, comprising a wide range of platforms for small molecules, large molecules and cell-based entities.
PRA’s Laboratories for Drug Development are managed, staffed, and supported by industry-leading experts who have the scientific knowledge and experience necessary to successfully deliver the most complex of studies.
The GLP & GMP compliant facilities in the USA and the Netherlands adhere to the latest global regulatory guidelines and expectations. PRAs technology investments and innovative service offerings are key components of goals and strategies for developing solutions for clients.
No one understands the daily pressure of tight deadlines better than the colleagues at PRA laboratories, because PRA realizes that behind every sample we analyze, a patient is waiting to be treated.
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