Posts by Dominic Warrino, Ph.D.
Dominic's role is to lead a team of scientific advisors for both clients and internal teams for development, validation, and sample analysis for support of PK, immunogenicity, and biomarker methods for a wide range of therapeutics. Dominic has 30 years of experience developing and validating assays for support of drug development.
Being produced by Xtalks on Friday, June 24, 2022 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min Webinar Description: Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a…
Blogs
The age of cell and gene therapies (CGTs) is upon us! It has been a long road to get to this time. The first gene therapy trial on humans was performed in 1990 by researchers at the National Institutes of Health. The first FDA approved CGT came in 2017. One…
Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…
Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies…
I have been studying Biological Markers (biomarkers) for over 25 years, but last 5 years they have exploded and become a key bioanalytical component to a drug’s success. Biomarkers are used to support drug…
The long-term economic consequences of the COVID-19 virus are yet to be determined. However, short term it is having major impact on research & drug development so companies are adapting in order to survive.
Blogs
Biomarker is a broad term and can mean so many different things depending upon the scientific discipline. For Bioanalytical biomarker analysis – and specifically for CROs equipped with 9 different platforms to measure biomarkers and a cell culture suite with up to 19 color flow cytometry all under one roof…
The bioanalytical landscape for support of biopharmaceuticals (biologics or large molecules) and biomarker testing is an ever changing map. The industry is currently focused on low level sensitivity, data integrity, and compliance with the…
Blogs
Protein characterization is a broad term describing the profile or fingerprint of a large molecule’s (or biologic’s) physical, chemical, and biological properties. Characterization of the protein will test the purity, activity, and the quantity…
Blogs
As the Bioanalytical support for drug development continues to grow, more and more scientists are requiring more complex assays. Two examples are cell based assays and what we refer to as live cell assays.
Immuno-oncology is a growing field. The goal is to augment the patient’s immune system to attack the cancer cells. The current lines of treatment for cancer are radiation, chemotherapy, and surgical resection. If these treatments do not work, physicians can seek alternative treatments, such as immune-oncology therapeutics. Two emerging immune-oncology…
Blogs
KCAS is the first GLP laboratory to qualify all 54 biomarkers offered as a V-Plex (Validated Plex) by MSD. The a la carte style allows for customization of panels that will fit the exact…