PCSIG Webinar On Demand

Incorporating patient centric sampling into multicenter clinical trials: Summary of a PCSIG workshop

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Challenges and proposed solutions to incorporating patient centric sampling into clinical trials.

This webinar presents materials arising from a PCSIG workshop ‘Incorporating Patient Centric Sampling into Multicenter Clinical Trials’ held in June 2024. The presenters discuss the challenges associated with incorporating PCS into multicentre clinical trials, and outline some of the solutions proposed by the workshop attendees, along with resulting actions and outputs.

The purpose of the workshop was to:

Outline the key stages associated with the implementation of PCS for multicenter clinical trials
Define the challenges to implementation of PCS for multicenter clinical trials
Identify how we can overcome these challenges
In this webinar, we outline the key outcomes from the workshop and discuss next steps on the roadmap to the use of PCS in clinical trials.

Of interest to any stakeholders involved with, or interested in, patient centric sampling, including: patients, healthcare providers, regulators, scientific experts, technology providers and policy makers.

What you will learn:

Challenges of implementing PCS in multicenter clinical trials and potential solutions, focusing on the following key stages along the clinical trial pathway:

Requirements and concerns of patients
Study planning
Logistics
Study conduct
Regulatory interactions

Moderator

Neil Spooner
Founder & Chair, 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 organization 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.

Joined by:

Alex Georgiou (Roche)
Brenda Yanak (CT Partners)
Chi Pakarinen (MediPace)
Daniel Baker (AstraZeneca)
Graeme Clark (Parexel)
Jasbinder Bajwa (Roche)
Jennifer Russell (Roche)
Jenny Royle (MediPace)
Navdeep Kalia (Roche)

IN ASSOCIATION WITH

OUR SPONSORS

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 Laboratories are a leading drug discovery and development contract research organisation providing a broad spectrum of laboratory and data science support to the Clinical development industries. 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 programmes 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.

IQVIA Laboratories 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, IQVIA Laboratories 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.

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

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, 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, 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, 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, makers of the TAP® device, was founded by Flagship Pioneering in 2007. TAP® is the world’s first push button collection device. Our technology allows a patient blood sample to be collected from any location without the pain of a fingerstick or need for traditional phlebotomy. We enable the decentralization of clinical trials and access to companies who offer wellness testing to consumers. Our patient-centric device is virtually painless, easy-to-use, and enables the collection of a blood specimen from any setting – clinical or in-home. We eliminate barriers to blood collection.