Incurred Sample Reanalysis (ISR) has become a process check for a bioanalytical method’s performance and should be a routine step in the process of developing a new method. More importantly, having a low Incurred Sample Reanalysis failure rate from your contract research organization (CRO) is important for several reasons:
- It shows repeatability and robustness of the method
- It supports the quality of the individual and the quality of the CRO lab performing the work
- A low Incurred Sample Reanalysis failure rate supports the quality of the data generated for the study
Marsha Luna, Director, Pharma Services, KCAS Bioanalytical & Biomarker Services
Marsha Luna is the Director of Pharma Regulated GxP Services at KCAS. She received her Bachelor’s of Science from the University of Missouri-Columbia. She has over 31 years of experience working in a laboratory environment involving studies focused on environmental analysis, bioanalysis, pharmaceutical finished product analysis and toxicology study analytical support. For the last 20 years, her focus has been on bioanalytical regulatory studies at KCAS, and previously at Quintiles. Marsha joined KCAS in 2006 as a Principal Bioanalytical Investigator and has managed numerous studies and a group consisting of analysts and scientists. She was recently promoted to her new role as a Director and member of the Senior Leadership Team.
Dominic Warrino, Senior Scientific Advisor, KCAS Bioanalytical & Biomarker Services
Dominic Warrino, PhD, is a Senior Scientific Advisor at KCAS. His role is to serve as a scientific and technical advisor for both clients and internal teams for development, validation and application of bioanalytical, immunogenicity and biomarker methods for large molecule therapeutics. Dominic joined the company in 2013 and brought with him expertise in a full range of bioanalytical techniques including ECL, ELISA, RIA, flow cytometry, ELISpot, cell-based assays and Luminex. He has 20 years of experience developing and validating immunological assays for biotechnology and pharmaceutical companies. He most recently spent several years in the Biopharma Services department at Viracor-IBT (formally IBT), and previously worked for Cytogen (formally Cellcor), Eligix and Streck Laboratories developing novel compounds for the treatment of various cancers. Dominic has worked on over 100 large molecule compounds developing and validating PK, PD, ADA, and biomarker assays in support of preclinical to phase IV testing.
Who Should Attend?
This webinar will appeal to senior-level managers, directors, CEOs and analysts working in the following or related departments:
- Large and small molecule mass spectrometry
- Translational medicine
- PK/PD groups
- Drug Metabolism and Pharmacokinetics (DMPK)
- Clinical groups
What You Will Learn
Attendees will gain insights on:
- A history of Incurred Sample Reanalysis
- Why low Incurred Sample Reanalysis failure rates are important through case studies
KCAS Bioanalytical & Biomarker Services is a contract laboratory with 39+ years of bioanalytical expertise. Centrally located in Kansas City, KCAS provides small- and large-molecule PK, immunogenicity, and biomarker analysis operating a variety of equipment platforms to service a wide range of therapeutic areas. KCAS’ team leverages a highly scientific staff with an average tenure in the field of bioanalysis/biomarker analysis of 22 years to provide clients of all sizes with expertise in robust assay development, validation, and sample analysis under fit-for-purpose Non-GLP, GLP, and GCP conditions for discovery, preclinical and clinical studies. Our teams have developed and validated more than 5,500 bioanalytical assays and have undergone 16 FDA inspections.