Michelle Kenyon, Pfizer Global Research and Development - Qepler Summits And Conferences

Michelle Kenyon

Associate research fellow in Drug Safety
Pfizer Global Research and Development
USA
Pfizer: One of the world's premier biopharmaceutical companies

Michelle Kenyon is an associate research fellow in Drug Safety at Pfizer Research and Development in Groton, CT where she has worked since 1993. She received her undergraduate degree in Biology from Quinnipiac University in New Haven, CT and her graduate degree in Biology (MA) from Brown University in Providence, RI.

Michelle has more than 25 years of experience in the application of genetic toxicology testing in support of pharmaceutical development, with expertise in screening and regulatory bacterial mutagenicity assays and the use of in silico tools to assess the mutagenic potential of pharmaceutical intermediates and impurities. She represents Drug Safety on a multidisciplinary council that provides advice to teams regarding impurity qualification matters and contributes to the development of risk assessments to address potential safety issues that arise across Pfizer’s global marketed product supplies. She is involved in IQ DruSafe and EFPIA workgroups addressing qualification of pharmaceutical impurities, as well as industry nitrosamine collaborations. Michelle is a long-time member of the Genetic Toxicology Association and is a past chair of the board of directors.

Related Sessions:

2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 15 July 2021
CASE STUDY: Risk Assessment of Nitrosamines in Pharmaceuticals: Not All Nitrosamines are Highly Potent.
  • Commercial product nitrosamine risk assessment using nitrosamine structural groupings
  • Read-across approach developed to minimize compound-specific risk assessments and analytical testing
  • Case example compound-specific risk assessment
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