The in vivoPig-a gene mutation assay is based on the endogenous X-linked Pig-a gene (phosphatidylinositol N-acetylglucosaminyltransferase, subunit A).
The Pig-a gene codes for an N-acetyl glucosamine transferase that is involved in the biosynthesis of Glycosyl phosphatidyl inositol (GPI) anchor for tethering a variety of mammalian cell surface protein markers. A single mutation in the Pig-a gene results in loss of the GPI anchor and the GPI-tethered protein markers and can be detected by fluorescent antibodies against the surface markers and flow cytometric analysis to quantify marker deficient cells.
The Pig-a assay has been evaluated internationally and the data generated to date indicate that it is sensitive, robust and has high reproducibility and transferability. With this in mind, Working Groups of the International Workshop on Genotoxicity Testing (IWGT) and HESI Genetic Toxicology Technical Committee (GTTC) have been working towards the development of an OECD testing guideline for performing the Pig-a assay in rodents, which will allow the Pig-a assay to be used for regulatory assessments in drug development.
Current guidance for the assessment of DNA reactive (mutagenic) impurities in pharmaceuticals (ICH M7(R1)) has already suggested the use of the Pig-a assay to investigate the in vivo relevance of in vitro mutagens (Ames positive).
Jim Whitwell Jim has a BSc (Hons) degree in Applied Biological Sciences from the University of Bristol. He has more than 25 years of experience in genetic toxicology and related fields and currently serves as Scientific Specialist and Subject Matter Expert for in vitro micronucleus assays within Genetic Toxicology.
His areas of expertise include in vitro and in vivo chromosome aberration and micronucleus assays, peripheral blood and flow in vivo micronucleus studies and non-standard assay designs (e.g. sister chromatid exchange and mechanistic mode of action investigations).
He is a member of several industry groups and has presented at industry conferences, as well authoring and co-authoring multiple publications in journals such as Mutation Research and Mutagenesis.
Darren Kidd Darren has a BSc (Hons) degree in Biological Sciences from the University of Plymouth and a PhD entitled “In Vitro Gene Mutation and Apoptosis” from the University of York. He has more than 20 years of experience as scientist, toxicologist and study director in laboratory research and currently serves as Lead Scientist for in vitro toxicology assays within Genetic Toxicology.
His areas of expertise include in vitro micronucleus, skin, ocular, phototoxicity and cytotoxicity assays, flow cytometric applications and mechanistic investigations.
He is member of several industry groups and has authored or co-authored dozens of posters, presentations and publications in journals such as Mutation Research, Toxicology in vitro, Genetic Toxicology and Environmental Mutagenesis, Methods in Molecular Biology and Mutagenesis.
Robert Smith Robert has a MSc in Biology from the University of York. He has over 15 years of experience within genetic toxicology at Covance from working in the laboratory on standard and non-standard genotoxicity assays and currently serves as a Study Director within Genetic Toxicology with emphasis on screening as well as investigative work and method development.
His areas of expertise include Ames, in vitro and in vivo chromosome aberration and micronucleus assays, in vivo Comet and MutaMouse, 3D skin micronucleus and fluorescence in situ hybridisation (FISH) assays.
He is member of several industry groups and is the current secretary of UKEMS. He has authored or co-authored publications in Mutation Research and Mutagenesis.
This webinar is free to attend, to register please click here.
PSI Webinar: Wearable Technologies - Challenges and Opportunities
Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.