Dr. Michael Burns, Lhasa Limited - Qepler Summits And Conferences

Dr. Michael Burns

Principal Research Scientist
Lhasa Limited
United Kingdom
Lhasa Limited is a not-for-profit organisation and educational charity that facilitates collaborative data sharing projects in the pharmaceutical, cosmetics and chemistry-related industries.

Michael completed his undergraduate studies in 2006 at the University of York, remaining there to complete his PhD, working with Professors Fairlamb and Taylor, on a project utilising organometallic catalysis for total synthesis. Upon completion of his PhD, Michael moved to Kent (UK) to work for Peakdale Molecular (now Concept Life Sciences). A contract research company who synthesise potential APIs (on various scales) for pharmaceutical companies. Following his spell in Kent, Michael returned to York to take up a position at the Centre for Hyperpolarisation in Magnetic Resonance (CHyM), investigating the use of isotopically-labelled, biologically relevant molecules within hyperpolarising MRI and NMR techniques. The ultimate goal being the creation of biologically inert MRI contrast agents with vastly increased resolution compared to gadolinium contrast agents.

Michael joined Lhasa in 2015, initially deciphering metabolism data for Meteor (Metabolic degradation), developing skin sensitisation and mutagenicity alerts for Derek (knowledge-based toxicity prediction) and investigating forced degradation pathways for Zeneth. Michael quickly moved onto the Mirabilis project, aiding the research and curation of knowledge relevant to understanding the potential for purging of mutagenic impurities from drug substance syntheses. In 2017, Michael took over leadership of Mirabilis development and has since worked closely with leading members of the purge calculation community to develop Mirabilis and the purge concept, including more recently their impact on the ongoing nitrosamine challenges.

Related Sessions:

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 2: Friday, 16 July 2021
CASE STUDY: Continuing development of applied chemical knowledge for an in silico purge tool - Incorporating lessons from nitrosamines.

The impact of nitrosamines within drug substances has been felt widely across the regulatory landscape in the last few years. The application of chemistry knowledge within the risk assessment process for nitrosamines has been one of the subjects that has drawn interest from both industry and regulators. The in silico purge tool, Mirabilis, has therefore been adapting to reflect the lessons which have been learnt from the nitrosamine crisis, incorporating an understanding of both the risk of carry-over, and the risk of formation.

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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: Exploring the scale of potential nitrosamine risk associated with existing approved APIs
  • Assessing the true scale of potential impact on pharmaceutical supply using existing drug databases
  • Identifying trends of nitrosamines that may theoretically form
  • Provide some context for ongoing activities relating to nitrosamines
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