PCSIG Webinar On Demand

Opportunities and challenges in mobile phlebotomy and self-sampling for precision chemotherapy dosing in clinical trials

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We present a case study demonstrating how chemotherapy exposure measurement via patient-centric sampling can drive personalized, more effective, and safer cancer treatments.

Chemotherapy dosages are often prescribed based on body surface area (BSA), an outdated method that doesn’t consider individual differences in drug metabolism. This can lead to underdosing or overdosing, reducing treatment efficacy or causing toxic side effects. In this presentation, we will introduce True Dose’s patented technology, designed to measure precise drug levels through patient-centric self-sampling. We discuss how this approach personalizes treatment, linking drug exposure to side effects, and leveraging both venous and capillary blood samples via mobile phlebotomy. Our goal is to revolutionize diagnostics in chemotherapy to increase precision and improve patient outcomes.

Ideal for:

Clinical researchers and trial designers seeking to improve precision medicine in cancer treatment.
Oncologists and healthcare providers aiming to offer personalized chemotherapy dosing.
Clinical trial professionals focused on patient recruitment, retention, and improving trial participation rates.
Developers of medical devices and diagnostic tools who are interested in integrating patient-centric sampling methods.
Pharmacologists and geneticists exploring drug metabolism and the role of pharmacogenomics in tailoring treatments.

What you will learn

How True Dose’s at-home sampling technology is transforming precision medicine and improving chemotherapy dosing accuracy.
The limitations of body surface area (BSA) dosing and how personalized drug exposure measurement can solve this challenge.
A case study on linking chemotherapy dose concentrations with patient side effects using patient-centric blood sampling.
The benefits and obstacles of incorporating mobile phlebotomy and self-sampling techniques in clinical trials.
How integrating True Dose technology reduces patient burden, increases participation, and delivers personalized treatment based on metabolic and genetic factors.

Speakers

Elham Hedayati
Senior lecturer & Associate Professor of Oncology | Senior Consultant in Clinical Oncology | Co-founder of TrueDose AB, Karolinsia Institute/Karolinska University Hospital

Elham Hedayati is a clinical researcher, senior lecturer in oncology, and senior oncologist at Karolinska Institutet and Karolinska University Hospital. Her work focuses on breast cancer research, particularly therapeutic drug monitoring to enhance drug efficacy and reduce treatment toxicity. She earned her PhD in 2012 from Karolinska Institutet, and became a docent in oncology in 2022. Elham is head of clinical trials at Karolinska Centre for Clinical Studies and co-founder of True Dose AB, with funding support from the Swedish Cancer Society, Vinnova, and Bröstcancerförbundet.

Sofie Sibia
Head of phase 1 clinical unit, Karolinska University Hospital

I have worked in various strategic roles, focusing on expanding opportunities for clinical studies and improving patient access. My experience spans both the public and private sectors, where I have developed and implemented initiatives to enhance the availability of clinical trials. With a strong background in molecular biology, I bring a deep understanding of the scientific and operational aspects necessary for driving innovation and success in clinical research.

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

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.