18 June 2019 14:00-15:00
The in vivo Pig-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).
Speaker Biographies
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.
Registration
This webinar is free to attend, to register please click here.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Whatever your current challenge(s) at work, this workshop will explore what's holding you back, and how barriers can be removed in order to progress and achieve.
A PSI Training Course covering the statistical methods for repeated measures and other clustered data. Course will cover: Conditional models for continuous hierarchical data, Conditional models for continuous longitudinal data, Marginal models (GEE) for continuous longitudinal data & Discrete data.
We’re now searching at all levels for Biostatisticians and Statistical Programmers to join our International BARDS Health Technology Assessment team at our London and Zurich hubs.
The Associate Director of Biostatistics is the key client interface for all statistical issues and discussions.
In this role you will consult in the design of complex and innovative studies and clinical trial programs as well as Leading DMC/DSMB processes.
This is an excellent opportunity for someone that loves working directly with clients, contributing as a high-level project lead and key contributor.
Join our growing team and discover your extraordinary potential by working as a Covance by Labcorp Biostatistician 2 within our early phase biostatistics department.
The opportunity to combine an exciting professional career with excellent quality of life in the Cairngorms National Park area of Scotland.
Join our growing team and discover your extraordinary potential by working as a Covance by Labcorp Principal Biostatistician.
As a seasoned Biostatistician, will work primarily on Immunology: GI and Dermatology trials with a focus on Late Phase studies. Some PK Analysis experience highly desired.
As a seasoned Biostatistician, will work primarily in late phase oncology.
As an experienced pharmaceutical statistician, you will support Cytel and a client of our Functional Service Provider (FSP) division.
As a Sr Bios, you will function independently as Lead Statistician on projects and support/project statistician on others.
The Senior Manager Biostatistics will be responsible for leading biostatistics strategy and activities for a compound and/or for individual clinical studies.
As a Sr Mgr, Biostatistics you will manage a team of Statisticians and Programmers within the FSP department, as well as managing project work.
At its core, the role of a Senior Statistician at Veramed is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas.
As a Senior or Principal Biotatistician, you will hold a combined project leadership and hands-on technical statistics role, working across a range of phases and therapeutic areas.
You will participate in the development of study protocols including participation in study design discussions and sample size calculations, and review CRFs and data review guidelines.
As a Senior or Principal Statistician, you will hold a combined project leadership and hands-on technical statistics role., working across a range of phases and therapeutic areas.
We are looking for passionate and motivated statisticians to work within our Services team to deliver high quality, innovative, analytical services within a clinical setting as our KerusCloud platform moves into the next phase.
Would you like to join a dynamic, growing firm where you can really make an impact, not just on the company but to accelerate drug development and ultimately benefit patients?
Opportunity to join Amgen's centre for design & analysis. We are looking for a talented Statistician to join the Global Biostatistical Science team.
