WEBINAR: Replacing serum with dried blood microsampling for pediatric pharmacokinetics of prophylactic RSV monoclonal antibody – September 25, 2024

September 25, 2024; 11:00AM ET; 4:00PM BST; 5:00PM CET

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

Speakers: Joleen T White (Senior Bioassay Development Lead, Bill & Melinda Gates Medical Research Institute) and Micha Levi (Clinical Pharmacology Leader, Bill & Melinda Gates Medical Research Institute). Moderated by Neil Spooner, Founder, PCSIG.

What will you learn?Ideal forSpeakersSponsor information

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

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

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.

Moderator:

Neil Spooner
Founder, Patient Centric Sampling Interest Group

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.

Alturas Analytics: Alturas Analytics provides expert GLP & non-GLP LC-MS/MS and GC-MS/MS bioanalytical and PK/TK analysis services of small and large molecules in any matrix for discovery through Phase IV clinical trials.

Capitainer: Dried blood spots (DBS) is now quantitative with volumetric control through our microfluidic qDBS technology solution. Precision, accuracy, sample protection and ease of use both at sampling and in the lab are key features for us in all product development.

Charles River:Charles River Laboratories are a leading drug discovery and development contract research organization providing a broad spectrum of laboratory and data science support to the clinical development industry. This includes bioanalytical chemistry, immunology, biomarker services, immunoassay, genomics, vaccine development and ADME services. With over 1000 dedicated laboratory colleagues across a global footprint and expertise in traditional and advanced modalities, Charles River Laboratories are well placed to leverage scale and scope to support Clinical programs carried out anywhere in the world.

Genentech: Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit gene.com.

GSK:We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of 2030. Our bold ambitions for patients are reflected in commitments to growth and a step-change in performance. We are a company where outstanding people can thrive.

Inuvi: Through nationwide phlebotomy and sample collection services, flexible health assessments and expert laboratory testing, Inuvi helps to create certainty in the worlds of research and clinical trials, functional and lifestyle medicine, health and wellbeing, occupational health, and primary care. Every year Inuvi’s network of over 300 independent health practitioners and doctors delivers over 100,000 domiciliary health assessments and phlebotomy visits throughout the UK and Ireland. Through our state-of-the art UKAS accredited medical laboratory in Gloucestershire, Inuvi processes over 1 million blood tests annually. In addition to collecting and testing high volumes of venous blood samples, Inuvi is also a pioneer in capillary (finger-prick) blood testing, offering the largest schedule of UKAS accredited tests using capillary blood.

MSD: We use the power of leading-edge science to save and improve lives around the world.

Q² Solutions: Q² Solutions is a leading drug discovery and development laboratory services organization providing innovative solutions that encompass broad central laboratory and specialty biomarker services, including genomics, immunoassays, flow cytometry, anatomic pathology, precision medicine assays, vaccine assays, ADME and bioanalytical along with extensive offerings in antibody drug discovery, biomarker discovery, and decentralized clinical trial lab solutions. Through the Decentralized Clinical Trials group, Q² Solutions is at the forefront of patient-centric sampling, offering a variety of self-collection methodologies and is validating multiple assays using micro-samples that are self-collected by study participants.

RedDrop Dx: Next generation blood sampling solutions.

Roche: Doing now what patients need next.

Takeda: We exist to create better health for people and a brighter future for the world. While the science and technology we advance are constantly evolving, our ambition remains. We move science forward, so we can transform more lives.

Tasso: Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time.

VCTC: The VCTC is a full-service UK clinical trial site providing virtual and decentralized clinical trial services.

Veloxity Labs: Veloxity Labs is a CRO focused on LC-MS bioanalysis. Our company is employee owned and operated, and offers start-up times and turn-around times in days by maintaining 80% capacity.

Waters Corporation: Waters Corporation, a global leader in analytical instruments, consumables, and software, has pioneered innovations in chromatography, mass spectrometry, and thermal analysis serving the life sciences market for more than 60 years. Waters Corporation aligns with PCSIG’s mission, supporting collaboration among diverse stakeholders to advance pharmaceutical medicines development and elevating healthcare outcomes and decision-making through analytical innovation and precision.

YourBio Health: YourBio Health, makers of the TAP^® device, was founded by Flagship Pioneering in 2007. TAP^® is the world’s first push button collection device and features patented Halo™ microsampling technology that a enables a patient blood sample to be collected without the pain of a fingerstick or need for traditional phlebotomy. Our patient-centric device is virtually painless, easy-to-use, and enables the collection of a high quality, high volume blood specimen from any setting – clinical or in-home, allowing a more comfortable and less disruptive experience for the patient. We eliminate barriers to blood collection.

In association with