WEBINAR: Evidence vs adoption in PKU monitoring: Understanding the implementation gap – VIEW ON DEMAND

Simple steps that can be taken to improve the PKU patient pathway.

This webinar explores the monitoring of phenylalanine and tyrosine in patients with phenylketonuria, outlining the pre‑analytical and analytical limitations of the current dried blood spot (DBS) testing. It presents evidence‑based solutions to reduce variability and improve sample quality, including the introduction of modern sample collection devices. The session will touch on the patient's views of the new sample collection devices, before addressing the central conundrum: why this solution remains difficult to implement despite clear scientific and practical benefits.

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.

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 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: 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].