On this episode of Molecular Moments, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
Comprehensive Bioanalytical Support
for Neurology Disorders
BioAgilytix leverages veteran insights, gained from decades of real-world experience supporting neurology research studies, to help you successfully navigate scientific and regulatory complexities at every step of development.
The incidence of neurologic disorders is increasing in industrialized countries. Alzheimer’s Disease is a chronic neurodegenerative progressive disease with unknown causes. The diagnosis is mainly based on clinical symptoms using medical imaging and biomarkers. Another devastating chronic neurologic disorder is Multiple Sclerosis (MS), which is characterized by a progressive demyelination of the CNS of autoimmune pathogenesis. Although it is known that a chronic autoimmune reaction causative of MS is mainly diagnosed by clinical signs and symptoms, imaging, and the measurement of biomarkers, the differentiation to other diseases is extremely challenging and the need for specific biomarkers to be analyzed in serum and CSF is immense. Examples of CNS-specific biomarkers include αβ42 and total Tau, neurofilaments light chain and osteopontin.
The treatment of neurologic disorders is extremely challenging as their causes are often not yet fully understood. Based on data that there is an autoimmune component involved in the development of MS, monoclonal therapeutic antibodies such as natalizumab (against alpha4 integrin), rituximab/ofatumumab (against CD20), or alemtuzumab (against CD52) are approved as single or combined administration for its treatment. There is also promise in drug candidates that treat a possible viral cause of MS, as published recently with the bioanalytical work from the BioAgilytix team (Curtin F, Vidal V, Bernard C, Kromminga A, Lang AB, Porchet H. MAbs. 2016;8(5):854-60). This scientific publication demonstrates that pharmaceutical and biotechnology companies involved in neurologic disease-related drug development will need a CRO partner prepared for the complexities these neurology biologics pose in any phase of development.
Today’s pharmaceutical and biotechnology organizations need a scientific partner that can help them constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations.
BioAgilytix has a comprehensive understanding of neurologic diseases and the changing landscape impacting the large molecule drugs used to treat them as well as the GLP/GMP requirements imposed on them. Our robust suite of large molecule bioanalytical services span from the discovery phase through Phase I, II, III, and IV to ensure project continuity.
Our scientists are constantly expanding their expertise in all disease states within neurology. However we have specific expertise in Alzheimer’s disease, biomarker analysis, plasma, peptide/antibody drugs, and single/multiplex support.
The following services are regularly used in neurology-related studies at BioAgilytix:
Explore our array of white papers, articles, and videos to gain deeper insight into our small and large molecule expertise, and to stay updated with the latest news and research coming from the field of bioanalysis.
Pharmaceutical and biotechnology companies are fueling the innovation needed to drive this area of study. We understand, that to continue on this path they need of a CRO partner that can help develop superior biotherapeutic solutions for inherently complex neurologic diseases.
Our team of Ph.D. and Masters-level scientists has extensive expertise in supporting neurology-related studies in a variety of matrices including plasma, CSF and brain homogenates. In addition to an extensive menu of Alzheimer’s and other key CNS-related markers, BioAgilytix is certified to run Aß42 and Total Tau using MSD. Decades of experience working in this area of bioanalysis allow us to help navigate scientific and regulatory complexities at every step of development.
Find an expert partner in BioAgilytix. We are prepared to support your neurologic disease studies with a high level of quality and commitment.