Join Mitch Johnson (Lab Director, Veloxity Labs) for this discussion of method development and validation, sample handling, additional experimental considerations for patient-centric sampling.
Microsampling and patient-centric sampling is a relatively new and emerging field that has been introduced with success in both the preclinical and clinical space. Although there have been significant advancements made on the collection side, there remains challenges and considerations on the lab side of things. This talk will touch on additional experimental considerations and tips for processing and handling samples.
Of particular interest to:
Bioanalytical scientists
Sponsors interested in using these collection devices as part of their development
Speakers
Lab Director, Veloxity Labs
Mitch Johnson earned a Bachelor’s Degree in Chemistry from Monmouth College and his PhD in Analytical Chemistry from the University of Missouri. He has spent a majority of his career in the CRO sector, working on bioanalytical method development, validation, and sample analysis using LC-MS/MS. He is a Co-Founder of Veloxity Labs, where he currently serves as the Lab Director. In his free time, he enjoys golfing and spending time with his family.
Moderator
Director Spooner Bioanalytical Solutions & Chair Patient Centric Sampling Interest Group
Neil is 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, Founder of the Patient Centric Sampling Interest Group and Co-Chair of the Reid 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.
MSD/Merck: We use the power of leading-edge science to save and improve lives around the world.
Q Solutions 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, Q Solutions 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.
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.
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.