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Ready to chase your molecule in the body? Check what's new in a bioanalyst's warehouse. Part II

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

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Agenda: 

• Quantitative Biomarker Assays - what’s are the actual differences to other bioanalytical methods? 
  • Are they real or imagined?
  • Fit-For-Purpose and Context Of Use?
  • Biomarkers vs PK assays – Validation requirements?
  • Case Studies – the Good, the Bad and the Ugly!
• Hybrid LBA/LC-MSMS approach - quantitative method for better sensitivity and selectivity 
  • Overview of hybrid LBA/LC-MSMS approach
  • Advantages of utilizing hybrid approach
• Challenges and opportunities - the application of radiolabeling techniques in bioanalysis 
  • Overview of applications of 14C in ADME and IVPK studies
  • Overview of supporting technology (AMS and LSC)
• Toolbox for new modalities - how do we approach bioanalysis in support of cell and gene therapy products? (Benjamin Bronfin, Absorption Systems, a Pharmaron company) (10-15 min)
  • Analytical methodologies, with examples specific to different applications
  • Assay considerations

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Moderated by: Chris Bode, Ph.D. - VP Scientific and Corporate Communications at Absorption Systems, a Pharmaron company

Speakers: 

John L Allinson FIBMS - Vice President, Biomarker Sciences at Immunologix Laboratories.

John Allinson leads Biomarker Sciences at Immunologix in Tampa Bay, Florida. He was previously the Head of Biomarker Strategy of LGC and brings over 45 years of experience in developing and working with biomarkers including their use in drug development across a wide range of therapeutic categories and all phases of development.

John spent 22 years in NHS Clinical Pathology services before moving into the CRO industry in 1994 where he has managed Central, Bioanalytical and Biomarker Laboratories.

He was part of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) Biomarker Committee which published the first consensus white paper on biomarker assay validation requirements for use in Drug Development (Lee et al) and was also co-author of the first white paper on the Validation of Multiplexed Biomarker assays as well as other leading consensus Biomarker white papers on the subject including the latest one from C-Path on assay validation and Biomarker Qualification (2019).

Mitesh Sanghvi – Site Director, Bioanalytical Services at Pharmaron 

Dr. Mitesh Sanghvi is Site Director of bioanalytical site located in Germantown, Maryland. Dr. Sanghvi joined Pharmaron in 2015 (formerly Xceleron). Dr. Sanghvi leads a team with more than 50+ scientists responsible for regulated bioanalysis in supporting GLP toxicology studies and clinical sample analysis studies for small and large molecules using techniques such as LC-MSMS, Immunoassay and Accelerator Mass Spectrometry (AMS).

Dr. Sanghvi obtained his Ph.D. in Pharmacology from Texas Tech University Health Sciences Center (TTUHSC), where his studies focused on structural characterization of affinity-purified 5-HT3ARs. Dr. Sanghvi has published more than 25 research articles in peer-reviewed international journals.

Marie Croft - Scientific Director, Radiolabeled Sciences at Pharmaron

Based in the UK, Marie is responsible for the scientific oversight of the bioanalytical AMS team at Pharmaron ABS, Germantown, MD and collaborates with other key teams within the radiolabeled sciences group.

Marie has 17 years of experience in bioanalytical applications of accelerator mass spectrometry. Following her graduation from De Montfort University with a BSc. in Pharmaceutical Chemistry in 2004, she started her career with Xceleron Ltd, obtaining hands on laboratory experience in AMS and LC+AMS analysis.  During this time, she conducted research into AMS microdosing, specifically cassette dosing in DDI studies, and combined use of AMS and PET after microdose administration.  She received her PhD in ‘Applications of human microdosing with accelerator mass spectrometry’ from the University of York in 2013. 

Marie has a keen interest in the clinical applications of AMS and plays a key role in the design and review of microtracer, macrotracer and microdosing clinical studies utilizing AMS, and the design and execution of the analytical phases.  She has co-authored a number of scientific publications as well as a book chapter focused on current uses and future opportunities for AMS in clinical development.

Benjamin Brofin - Senior Director of Operations at Absorption Systems, a Pharmaron company 

Benjamin Bronfin joined Absorption Systems in August 2018 as Senior Director of Operations. Benjamin has over 25 years of experience in both academia and industry, with the last 15 years working in bioanalytical CROs. He started as a bench scientist and is proficient with multiple methodologies like ELISA, qPCR, MSD, Western Blot, HPLC, Luminex, RIA, cell-based assay, IHC, Flow Cytometry. Over the years Benjamin was involved in multiple assay development and validation projects, including PK, PD, and immunogenicity analysis to support all phases of drug development in the GxP environment. He received his MD from Omsk Medical Academy in 1995.