The Bioanalyst's Warehouse, Part I

Pharmaron DMPK Webinar Series Episode 6 cover on new bioanalytical tools and methods, four expert speakers

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Recorded: May 2022

This webinar will show the importance and complexity of bioanalysis and demonstrate how different methodologies can be implemented in drug R&D.This webinar discussed the importance and complexity of bioanalysis and demonstrate how different methodologies can be implemented in drug R&D.

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Agenda:

The evolving world of the bioanalyst
- Increased involvement in aspects beyond the bioanalytical lab
- Diverse bioanalytical challenges, requiring alternative solutions
- Requiring different approaches
Ever changing regulatory environment
- The world is bright for bioanalytical scientists who grasp the challenge
- Disposable DBS collection device, reproducibility and other considerations Assessment of reproducibility of Kungliga Royal institute of technology (KLH) single use sampling device
- Impact of haematocrit and lipid content of sample on DBS analysis
- Comparison of KTH device and positive displacement pipettes in DBS sample preparation
Follow the rules in ever changing regulatory environment
- Different challenges in conducting regulatory bioanalysis for NDA vs BE studies
- Challenges in conducting global multi-center regulatory bioanalysis
- How to apply new technologies in supporting regulatory bioanalysis

Meet our Speakers

Moderated by:

Ray Cooke, Ph.D., MBA – Principal Scientist, Metabolism at Pharmaron

Speakers:

Neil Spooner – Director and Founder at Spooner Bioanalytical Solutions Ltd

Neil Spooner (Ph.D, C.Chem., FRSC) is the Founder of Spooner Bioanalytical Solutions Ltd., a consultancy based in Hertford, UK. In this role, Neil helps companies to integrate microsampling of biological fluids into non-clinical, clinical and bioanalytical workflows and works with innovator companies to help them develop novel technologies and introduce them to the market. Neil also assists organisations with their understanding of emerging trends in the pharmaceutical industry and bioanalysis. Neil is a Senior Visiting Research Fellow at the University of Hertfordshire, the Senior Editor of Bioanalysis Journal, the Chair of CPSA Europe, the founder of the Patient Centric Sampling Interest Group and the Deputy-Chair and Secretary of the Reid Bioanalytical Forum. He has published over 70 peer reviewed manuscripts and more than 50 podium presentations at International Conferences and Symposia.

Neil has wide-ranging experience in the clinical and non-clinical quantitative bioanalysis of drugs, metabolites and biomarkers for discovery and regulated areas of the pharmaceutical industry and contract research organisations in the UK and USA. He has extensive experience of successfully leading cross functional initiatives, including implementation of new technologies and workflows, outsourcing quantitative bioanalysis, development and implementation of automation approaches and design of new scientific facilities.

Neil Adcock – Analytical Services Manager at Pharmaron

Neil has worked at Pharmaron for 4 years as head of the LCMS bioanalysis group based in Rushden. He was part of the European Bioanalysis Forum working group that provided recommendations to industry on assessment of internal standard variability and over the last 25 years he has worked in chromatography based bioanalysis for a number of organisations including LGC, MDS Pharma Services and Quintiles developing methods and managing projects for GLP and GCP compliant programmes.

Xinping Fang, Ph.D. – SVP, Clinical Analytical Testing at Pharmaron Clinical

With nearly 30 years of extensive research and management experience in regulatory bioanalytical and drug metabolism, Xinping has lead departments of many US and China Pharma and CRO companies, including WuXi AppTec BAS (Bioanalytical Service), XenoBiotic Laboratories, XBL-China Inc., Novartis Pharmaceuticals, Purdue Pharma L.P., and FMC Corporation. He has participated and managed several hundreds of bioanalytical method developments, validations and sample analysis projects.