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.
Blogs
Measuring new biotherapeutic modalities such as cellular therapies are not well defined in the regulatory landscape. Currently no white papers or guidelines are available to help navigate the murky waters of quantifying new modalities, which is why the AAPS PK focus group has set a course toward providing the field…
Blogs
Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and…
Blogs
The challenges and obstacles to including flow cytometry in multi-center clinical trials are well-known. The solutions the KCAS team offers can eliminate risks commonly associated with lost or delayed shipments and allow for batching, which reduces the overall cost of conducting flow cytometric testing. As a result, our customers can…