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.

​Ideal for:

  • 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
  • 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

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.

​Joleen 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.

Neil Spooner

Director Spooner Bioanalytical Solutions & Chair Patient Centric Sampling Interest Group

Neil is the Founder of Spooner Bioanalytical Solutions, helping companies to integrate biological fluid microsampling, and patient centric sampling and analysis into workflows. He also works with organizations to develop technologies and introduce them to the market. Neil also assists organizations with their understanding of emerging trends in the pharmaceutical industry and bioanalysis. Neil is a Senior Visiting Research Fellow at the University of Hertfordshire, Editor in Chief of the journal, Bioanalysis, Founder of the Patient Centric Sampling Interest Group and Co-Chair of the Reid Bioanalytical Forum. He has published over 70 peer reviewed manuscripts and delivered over 50 podium presentations.​​​​​​​

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