I am excited to be writing my first in a series of blogs at Veloxity Labs. Before inception, I knew as a serial entrepreneur we had to fill a niche for liquid chromatography mass spectrometry (LC-MS) bioanalysis in the contract research organization (CRO) space. Two of those niches are microsampling (MS) and patient centric sampling PCS).
Mircosampling and patient centric sampling are areas that I am passionate about, and I have been involved with since before 2010. In preclinical studies, the 3 R’s, reduce, reuse, recycle and thus microsampling are the focus to minimize the use of animals for PK studies. There are many devices to use including simple capillaries, devices such as Mitra® and dried blood spot (DBS) cards.
In this blog, I will focus on clinical studies where the goal is utilizing PCS. One of the challenges in clinical studies is patient enrollment. Patients prefer not to go to a clinic, hospital or an off-site location to get their blood drawn. Imagine being a cancer patient during chemotherapy, and you are weak, sick and just want to stay home. Why not collect your blood samples at home, send the collection via courier to a lab for bioanalytical testing and the MD receives the results? This is possible with PCS, with the use of DBS cards from manufacturers such as Capitainer or devices from Tasso.
Recent guidance from the FDA strongly encourages that all therapeutics should be tested in pediatrics. A challenge for pediatric clinical trials is parents don’t want to have their child subjected to intensive sampling (many time points) or large blood collections, thus their children aren’t enrolled in the studies. Microsampling is an alternative to large volume collections and has been shown to increase patient enrollment. Additionally, it has been shown that patients prefer devices that don’t require a “finger-stick” or venous draw. Enter devices such as Tasso, which collect blood easily and are minimally invasive.
The gold standard for bioanalysis has been the use of plasma as the matrix. With MS and PCS, new devices (Mitra®, capillaries, DBS cards, Tasso) are now used to collect blood. At Veloxity, we have experience with MS and PCS devices. Unique LC-MS method development and method validations are required. Our SOPs at Veloxity are tailor made to perform such validations and sample analysis. We too have experience “bridging” studies from plasma to whole blood to a specific collection device.
We are excited to be assisting our pharmaceutical and biotech partners and their PATIENTS in developing therapeutics to treat disease! Our experienced scientists continue to validate LC-MS bioanalytical methods from MS and PCS devices for clinical, pediatric and preclinical studies. Contact us to discuss your next project where we continue to “MOVE AT THE SPEED OF BIOANALYSIS” #glp #bioanalysis #microsampling #patientcentric #cro
Shane Needham, Ph.D.
Co-Founder, CEO and President
Veloxity Labs, LLC
