Leadership of NIH Support Laboratory:
Dr. Frazer-Abel brings a decade of experience in clinical and pre-clinical complement and immunoinflammatory testing to the leadership of this laboratory. To prevent conflict of interest, Dr. Holers is not part of the leadership of the laboratory within Exsera and does not have any responsibility for the work pursued in our pharmaceutical and biotechnology support area.
Ashley Frazer-Abel, PhD, D(ABMLI)
Director, Exsera BioLabs
Dr. Frazer-Abel is the Director of the Exsera BioLabs and Assistant Professor. She brings a strong background in complement and autoimmune testing for both patient diagnostics and clinical trials, having served as Principal Investigator or Contributing Scientist for the complement and cytokine analysis for more than a hundred non-clinical and clinical trials.
In addition she has a strong interest in the development and validation of novel assays to fill diagnostics gaps. Dr. Frazer-Abel brings with her experience of the regulatory landscape and requirements for diagnostics testing, as well as the requirements for compliance with the US FDA GLP and GCP regulations.
Vijayalaksmi (Viji) Nandakumar, PhD, DABCC
Associate Director, Exsera BioLabs
Dr. Vijayalaksmi (Viji) Nandakumar, comes to Exsera with a background in regulated complement and autoimmunity testing, with particular expertise in implementation, validation and clinical interpretation of immunology testing. This experience includes the testing for the monitoring on patients on complement therapeutics, a key prospective to bring to Exsera.
V. Michael Holers, MD
Clinical Research Consultant
Dr. Holers is currently Professor of Medicine and Immunology and the Scoville Professor of Rheumatology. The focus of the Holers’ laboratory research efforts has been on the structure-function relationships and biologic roles of the complement system in autoimmune and inflammatory diseases, using both human disease and murine model studies. More recently his research group has moved a major focus of research activities to studying the natural history and pathogenesis of human rheumatoid arthritis (RA) prior to and immediately after the onset of clinically apparent arthritis. Dr. Holers has also directed for 15 years the Rheumatology Clinical Laboratory wherein human autoantibody testing is performed.
The Exsera BioLabs Team
Exsera is part of a growing movement in the US of having laboratories within academic institutions with different kinds of scientific models that don’t depend on federal research grants. For our group that means we have the privilege of working at the cross-roads of diagnostics for patient care, while supporting basic and translational research as we as supporting the drug development industry. We use our well characterized complement and autoimmunity tests across these areas and find surprisingly often the different needs cross pollinate and benefit each other.
Being part of the University of Colorado, we have the opportunity to support research in areas as diverse as diabetic retinopathy and AMD, to Downs Syndrome and Type 1 Diabetes: from rheumatoid arthritis to the role of adverse drug reactions and loss of efficacy. This research work in turn helps us keep informed on what new testing in complement is needed. This in turn informs what tests we should develop and validate next to help our physicians properly treat patients, particularly those on complement therapeutics. We currently support both our adult and pediatric hospitals on the campus, and for a growing number of outlying hospitals and practices. Our work to help gauge complement inhibition for acutely ill pediatric patients requiring complement inhibition has proven particularly rewarding for the team.
This work with physicians using complement therapeutics and biologics also adds a useful perspective and knowledge base when we work with pharmaceutical and biotech companies working to bring new drugs to market. While working in this area brings with it quite a bit of regulations and paper work, we still find it to be quite interesting and rewarding.
Exsera was started in 2016 when Ashley came to the CU campus. Adding Exsera only built on the complement presence on the campus, which continues to grow. Since that time, we have built out our menu of complement testing validated to the US FDA requirements to a list of over 3 dozen. While we have focused on human testing, we also have an extensive list for non-human primates and a few tests for canines and mice. In addition to multiple species, we have also been successful in measuring a number sample types beyond the standard EDTA and serum. Specifically, we have successfully measured (and validated) vitreous and aqueous humor; we are also working with cerebral spinal fluid, urine and sputum.
Exsera is delighted in having the honor of answering the call for complement testing during this renaissance of interest in this important part of the innate immune and inflammatory systems.