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The Evidence Base Webinar

WEBINAR: Introduction to the UK recommendations for the validation and adoption of capillary blood testing within the routine clinical laboratory: Consensus opinion from the LabMed Patient-Centred Testing and Sampling (PaCTS) group – VIEW ON DEMAND

 
The LabMed UK Patient Centred Testing and Sampling group has just published its recommendations for the validation and adoption of capillary blood testing. Here, we introduce this paper and its ramifications.

Venepuncture is widely considered the gold standard for blood collection. Nevertheless, self-collected capillary blood sampling has gained recognition as a practical alternative in various contexts, promoting a more patient-centered, personalized, and cost-effective approach to healthcare. The NHS UK strategic plans for 2023–2025 highlight a move from hospital-based to community-based care and from treating illness to prevention. Self-collected capillary sampling, coupled with laboratory analysis, is already being used within some laboratories to support this transition.

This webinar has been created to guide clinicians, laboratory scientists, and policymakers through the rapidly evolving field of patient-centric sampling and to enable safe working within a routine clinical laboratory.


What you will learn

We will introduce the recommendations from the PaCT's group, the rationale behind some of these, and some practical steps to consider.


Speaker

Timothy Woolley
Chief Scientific Officer, Inuvi Diagnostics
Editor in Chief, Journal of Patient Centricity

A multidisciplinary biomedical scientist by training, Tim began his career at the Institute of Pathology and Tropical Medicine at RAF Halton. Since leaving the forces, Tim has worked primarily in the private sector, co-founding Inuvi Diagnostics in 2018. Inuvi Diagnostics was the first laboratory in the UK to achieve ISO 15189 accreditation, including flexible scope for capillary blood testing. A passionate advocate of capillary blood testing and its role in patient-centric testing, Tim is a Director of the PCSIG, a member of the LabMed UK Patient-Centred Testing and Sampling (PaCTS) group, and the Editor-in-Chief of the Journal of Patient Centricity.


Moderator 

Neil Spooner
Founder, Patient Centric Sampling Interest Group
 

Located in Hertford, UK, Neil is the Chair and co-founder of the PCSIG. He also runs a consultancy company where one of the main drivers is to help Clients understand the benefits of patient centric blood sampling, develop appropriate technologies and workflows and implement them for the benefit of human wellbeing. Neil’s interest in these technologies began in 2007 whilst leading efforts at GlaxoSmithKline to find blood sampling and analysis approaches suitable for the measurement of pharmaceutical concentrations in samples obtained from children.


Sponsor information

 

Altasciences: Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testingclinical pharmacology and proof of conceptbioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

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.

Ambient Biosciences

Artyc: Artyc's battery-powered cold chain packaging is purpose-built for remote microsample collection, featuring precise temperature and location monitoring to safely enable a wider range of tests (e.g., refrigerated) in remote settings.

BD: One of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

Bento Biology Platforms: A leading self-service biosampling company, transforming the decentralized clinical trial and biorepository landscape. Bento’s Biology Boxes deliver best-in-class biosampling and biosensing tools to each patient’s doorstep and guide them every step of the way with 24/7 live support, all backed by a hyper-kitting facility and sophisticated kitting logistics software. Created and vetted with participant input all along the design path, powered by game economies and participate-to-earn wallet technology, our digital symptom diaries (PROMs) and pharmacovigilance tools build trust across all medical communities while also radically reducing costs, accelerating time-to-market, and significantly lowering cost per-patient-visit.

Boehringer Ingelheim: Boehringer Ingelheim is a research-driven group of companies dedicated to the discovery, development, manufacture and marketing of innovative health care products. Every day our scientists are charting new territory and continuing our commitment to innovation that has created exceptional medicines that have changed the lives of millions of patients. We embrace the power of partnership and diversity of minds across the life-science communities to realize even more innovation and incubate new ideas.”

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.

Celerion: A world-class bioanalytical CRO dedicated to advancing drug development through cutting-edge science and patient-focused solutions. With decades of expertise, we are at the forefront of patient-centric sampling, pushing the boundaries of sensitivity to reduce sample size while maximizing the value of every precious drop of patient blood. Our mission is to ensure that each sample contributes meaningfully to the research and development of new therapies, enabling faster and more accurate insights into drug efficacy and safety. Through innovative approaches and a commitment to excellence, we are proud to support research that brings life-changing medicines to patients worldwide.

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.

IQVIA Laboratories: 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.

LabConnect: LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations. 

LetsGetChecked: Healthcare that meets your people where they are. We enable partners to seamlessly utilize at-home healthcare programs to reduce barriers to access for those most in need.

Neoteryx: Neoteryx, a Trajan Scientific and Medical brand, offers remote microsampling devices designed for easy, reliable, cost-effective specimen collection in the clinic or field by healthcare professionals and end-users. Our innovative tools support decentralized research, remote monitoring, and personalized medicine, enabling streamlined sample collection and lab anaysis for pharmaceutical, clinical, and research sectors. Products like the Mitra® with gold-standard VAMS® technology for biological fluid sampling and the Harpera™ Microbiopsy Punch for skin sampling provide convenient, cost-effective solutions for advancing human health.

RDi: Leveraging our expertise in data processing, technology, and automation, we are revolutionising the healthcare supply chain. Through fulfilment and traceable kitting, we’re changing the way pharmaceutical and medical companies operate and deliver as part of the medical supply chain.

RedDrop Dx: Next generation blood sampling solutions.

Resolian: Global bioanalytical and analytical sciences partner supporting drug development and multi-regional clinical trials. Resolian is a leading global Contract Research Organization providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic, and GMP CMC analytical and materials science. Comprised of the former Alliance Pharma, Inc., Drug Development Solutions Ltd, and Denali Medpharma labs and powered by a team of more than 500 experts across the US, UK, Australia, and China, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum. 

Roche: Doing now what patients need next.

SampleFacts: SampleFacts is a company that specializes in providing dried blood spot (DBS) sampling. We offer a solution that enables instant separation of blood cells and plasma from a single drop of blood. With these characteristics the product facilitates the opportunity to provide a reliable and efficient method for collecting and storing blood samples, addressing the growing demand for remote sampling and biobanking.

Streck: Established in 1971, Streck develops quality control and sample stabilization products that give clinical and research laboratories worldwide confidence in the validity of their results and help make the world safer, healthier and more productive. Streck products are manufactured in La Vista, Nebraska, and delivered to thousands of labs across the globe. 

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.

Unilabs York Bioanalytical Solutions is a specialist provider of bioanalytical, metabolism and biomarker services to pharmaceutical and biotech companies, supporting development of small and large molecule therapeutics from discovery through to post-marketing.

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.


In association with

For more info on the PCSIG, please visit www.pcsig.org and follow on LinkedIn here. 

If you are interested in partnering with The Evidence Base for future webinars, please contact [email protected].