PCSIG Free Webinar

Paradigm shifts in phlebotomy: providing reasonable adjustment for underserved patient populations

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December 5, 2024; 11:00AM ET; 4:00PM GMT; 5:00PM CET

Adapting routine clinical laboratory procedures to enable capillary sampling in patient groups who require reasonable adjustments for accessing blood tests for clinical assessment.

Attending a phlebotomy appointment can cause high levels of anxiety, especially in patients with learning disabilities. Alternative blood collection methods are now available and offer reasonable adjustments to phlebotomy for many patient groups.

Analytical verification of blood tests from capillary samples vs standard venepuncture samples was done using our Beckman Coulter AU580 and DXI800 automated analyzers. A standard operating procedure has now been established as part of an end-to-end service, including electronic requesting, patient phlebotomy within a primary care setting according to clinical requirements, to provide reasonable adjustments for our local patients with learning disabilities. This service improvement allows patients to provide blood samples for health monitoring, when previously this was unachievable using standard venous phlebotomy and routine testing processes.

Of specific interested for people anyone interested in providing health equity in the area of blood test accessibility.

What you will learn

The importance of patient centric sampling in providing reasonable adjustments for underserved patient populations.
Investigating concordance of venepuncture samples vs capillary samples in a routine clinical laboratory.
The importance of a multidisciplinary approach to providing an effective clinical patient centric blood testing pathway.

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Speakers

Karen Perkins
Principal Clinical Scientist (Biochemistry), Dept Blood Sciences, Pathology, Morecambe Bay Hospitals NHS Trust, UK

My area of speciality lies within clinical biochemistry and analytical techniques used within clinical laboratories, especially building a toolbox of skills within our team to help all humans access blood tests. We love capillary sampling and learning how we can integrate this into our routine automated workflow. I have a wide range of expertise in biomedical research, ranging from basic cell physiology with a variety of in vitro analytical techniques, to managing small groups of research scientists and building collaborative relationships, liaising with key opinion formers. I am registered with the HCPC as a clinical scientist.

Moderator

Neil Spooner
Director Spooner Bioanalytical Solutions & Chair Patient Centric Sampling Interest Group

Neil is the Co-founder and Chair of the PCSIG. He is also 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 and Chair of the Reid International Bioanalytical Forum. He has published over 70 peer reviewed manuscripts and delivered over 50 podium presentations.

IN ASSOCIATION WITH

OUR SPONSORS

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 testing, clinical pharmacology and proof of concept, bioanalysis, 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 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.

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.

Bento Biology Platforms is a leading self-service biosampling company, transforming the decentralized clinical trial (DCT) 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 (P2L) and participate-to-earn (P2E ) 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 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.

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.

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.

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.

Pfizer:

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 (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), 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.

Slope is a global provider of biospecimen lifecycle software, data, and services for clinical trials. With a focus on tech-enabling the full biospecimen lifecycle, Slope offers expertise that empowers sponsors to make informed decisions using high-quality, real-time sample data. Slope has supported thousands of the most complex, sample-intensive trials worldwide and has been adopted by the vast majority of NCI-designated cancer centers. For more information, visit slopeclinical.com.

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.

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.