Mike Urquhart, GlaxoSmithKline - Qepler Summits And Conferences

Mike Urquhart

Scientific Director
GlaxoSmithKline
Stevenage, United Kingdom
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist.

Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to Chemistry Manufacturing and Control (CMC) project manager.

During his GSK career, Mike has led the primary development / delivery of 10 products, spanning early through to late phase development.

Mike’s current roles are GSK CMC Due Diligence lead for small molecules and co-chair of the Genotoxic Risk Assessment (GRA) review team, where he is GSK subject matter expert.

Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium.

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 2: Friday, 12 April 2019
CASE STUDY: Retrospective assessment of the process for mutagenic impurities is also discussed using “free data” to verify purging.
  • Development of a synthetic process to the PPAR-alpha receptor antagonist GW641597X
  • Discussion of associated impurities, their control / removal from the process and drug substance
  • Retrospective assessment of the process for mutagenic impurities is also discussed using the Lhasa Mirabilis in silico software
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2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 15 July 2021
CASE STUDY: Development of a Drug Product workflow for Nitrosamine Risk Assessments.
  • Development of a cross industry aligned approach to the nitrosamine risk assessment of drug products
  • GSK experiences of using this workflow to perform drug product risk assessments
  • Shared experiences relating to regulatory submissions
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3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 1: Thursday, 09 March 2023
CASE STUDY: Management of N-Nitrosamines and their risk assessment within GSK R&D
  • Nitrosamine risk factors and how to assess products for their presence
  • Steps to take if an N-nitrosamine is detected
  • Approaches to take for N-nitrosamine remediation within drug products
  • Implementation of a pre-clinical N-nitrosamine risk assessment workflow and associated mitigation activities
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