Experience across the whole drug development pipeline
In my career I gained experience in all phases of drug discovery, from biology/genomics and target identification, through discovery and development to Safety and Regulatory affairs.
In every phase the management needs of the software projects is different; from formal Validation and Waterfall techniques to rapid prototyping and agile methods.
Understanding the domain, the processes involved and any regulatory constraints is essential to selecting and implementing the right techniques for your project.
Discovery
At LION Bioscience I was responsible for development and delivery of both Custom solutions and standard product releases of the SRS Biological Data
Integration platform, Enabling scientists to access the vast number of 'omics data sources that are available for Target Identification.
Working with GGA Software (now part of EPAM) in a medium sized EU BioPharma I was responsible for
the development of data acquisition and management systems to work in harmony with High Throughput Screening
robotics as well as many other systems making data available in a usable manner to the scientists. These developments were undertaken by an off-shore development team based in Russia.
Development
Working for Chemical Design Ltd, I developed parts of their pioneering Molecular modelling software suite Chem-X.
As part of this work I published papers on Molecular Mechanics1 and early 3-D Chemistry Databases2.
Clinical Trials
To complete the pharmaceutical development life-cycle I worked for Medidata Solutions Ltd. (www.mdsol.com) to project manage the implementation of the RAVETM
web-based clinical Electronic Data Capture (EDC) system.
This involved development and implementation within fully GxP regulated, validated environments adhering to GAMP principles.
Post Marketing
My Experience in systems used in Post Marketing centres around Aris Global'sTM (www.arisglobal.com)
Total SafetyTM pharmacovigilance suite encompassing; adverse event capture, regulatory reporting and Signal detection,
the REGISTERTM suite for regulatory tracking and submissions and agInquirerTM for Medical information handling
gives me an solid background in applications.
Again this work involved developments and implementations within fully regulated and validated GxP compliant environments adhering to GAMP principles and utilised off-shore teams.
This experience has enabled me to become a member of the Research Quality Association (RQA).
- E.K.Davies and N.W.Murrall, How accurate does a force field need to be?, Computers Chem 1989, 13, 149-156
- N.W.Murrall and E.K.Davies, Conformational Freedom in 3-D Databases, 1. Techniques J.C.I.C.S, 1990, 30, 312-316