Michael Burns
Principal Research Scientist
Michael Burns joined Lhasa in 2015 working on 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, he took over leadership of Mirabilis development and has since been working 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.
DAY 1: NOVEMBER 30th, 2023
SESSION: Revisiting the landscape of complex nitrosamines
◆ Examining how the CPCA has changed the regulatory landscape for nitrosamines.
◆ Impact on drug manufacturers.
◆ Areas that require further understanding and evolution.
DAY 1: DECEMBER 1st, 2022
SESSION: 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.
DAY 1: DECEMBER 2nd, 2021
SESSION: TBC
◆ (TBC closer to event).
◆ Development of an in silico purge tool.
◆ Addressing industry challenges with nitrosamines.
