Replacing serum with dried blood microsampling for pediatric pharmacokinetics of prophylactic RSV monoclonal antibody

This case study illustrates consistency of results obtained from serum versus dried blood along with clinical pharmacology conclusions derived from these two data sets.

RSM01 is an anti-RSV monoclonal antibody being developed for infants in their first RSV season and primarily for low and middle income countries. We aimed to minimize sample volumes as oversampling in infants can lead to iatrogenic anemia. In the normal healthy adult FIH study, we collected fully matched sample sets in serum and dried blood to measure RSM01 concentrations for clinical pharmacology assessment. This presentation will show the consistent conclusions across the two different specimen types.

Of interest to:

Drug developers hesitant to change sample collection methods due to established data available from serum
Pediatric clinical researchers aiming to reduce trial participant burden

Pediatricians interested in quantitative comparisons of antibody concentrations between serum and dried blood

Your details

I agree for my registration data to be transferred to the lead partner organization (PCSIG).

By submitting this form you are agreeing to our Terms & Conditions and Privacy Policy, and agree to receiving relevant emails from The Evidence Base about the latest news and editorial features.

Terms & Conditions

I agree to receive third party emails to keep me informed of relevant products and services relevant to my industry.

Date and time

Wednesday

September

16:00 BST

What you will learn:

Understanding the rationale for using patient-centric sampling methods for pediatric clinical development
Determining the correlation between monoclonal antibody drug concentrations measured from serum versus dried blood specimens
Assessing correction factors for pharmacokinetic parameters between serum and dried blood measurements
Understanding consistency of conclusions on dose linearity and bioavailability between serum and dried blood data sets

Speakers:

Joleen T White
Senior Bioassay Development Lead, Bill & Melinda Gates Medical Research Institute

Joleen White provides bioanalytical oversight across the development programs across global health including small molecules, monoclonal antibodies, and probiotics. The Gates MRI motto “Our bottom line: lives saved” resonates deeply for her, enabling her to pursue her passion of helping under-served patients in a full-time position. Joleen is active in the international bioanalytical and immunogenicity community, including chairing or moderating 10 conferences and sessions, and representing Gates MRI and previous employers on AAPS and the International IQ Consortium working groups. She also supports data science initiatives with PhUSE and CDISC.

Micha Levi
Clinical Pharmacology Leader, Bill & Melinda Gates Medical Research Institute

Micha Levi is a Clinical Pharmacologist and Pharmacometrician at the Gates Medical Research Institute. He specializes in implementing pharmacometrics strategies and Model-Informed Drug Development (MIDD) approaches to develop therapies for TB, Malaria, RSV, and other infectious diseases in resource-limited settings. Micha's research involves using quantitative methods to optimize dosing, evaluate drug efficacy, and inform drug development decisions.

Moderated by:

Neil Spooner
Founder, PCSIG

Neil Spooner (PhD, CChem, FRSC) is the Co-founder, Chair and director of the Patient Centric Sampling Interest Group, CIC, a not-for-profit organisation that brings together a variety of interested parties who wish to develop and promote the use of patient centric sampling technologies for blood, plasma and other human matrices to better facilitate the advancement of human healthcare and well-being. Neil is also the founder and Director of Spooner Bioanalytical Solutions, a consultancy based in Hertford, UK. In addition, Neil is a Senior Visiting Research Fellow at the School of Life and Medical Sciences, University of Hertfordshire (Hertfordshire, UK), the Editor in Chief of Bioanalysis Journal and the Chair of the Reid Bioanalytical Forum. He has published extensively, with over 70 peer reviewed manuscripts and more than 50 podium presentations at international Conferences and Symposia.

Share this webinar