Boyds expands US regulatory affairs team with new hire
Leading global drug development consultancy Boyds has strengthened its team with the appointment of senior regulatory affairs professional Kelsey Lenoch.
Kelsey joins Boyds as Associate Director, Regulatory Affairs in the US, bringing with her 15 years of experience in clinical research and drug development.
Previously, Kelsey was Senior Manager, Regulatory Affairs at Usona Institute, a non-profit medical research organization in Madison, Wisconsin, USA, working across both regulatory strategy and CMC development, supporting the clinical development of multiple psychedelic drugs. Prior to this, Kelsey worked as a site start-up specialist at Covance, as well as a production scientist for in vitro diagnostic devices at Promega.
She has a Bachelor of Science in Physics from the University of Minnesota Duluth, and a Master’s Certificate in Project Management from the Wisconsin School of Business. Most recently, Kelsey obtained her Regulatory Affairs Certification (RAC-Drugs) from the Regulatory Affairs Professionals Society (RAPS). She is also a member of the Drug Information Association (DIA).
At Boyds, Kelsey will support clients with FDA strategies and submissions. She will also liaise directly with FDA stakeholders in support of her clients’ Investigational New Drug (IND) applications.
Commenting on joining Boyds, Kelsey says: “I am excited to be joining the talented regulatory affairs team at Boyds. Having previously worked for a small pharma company, I bring experience across CMC, non-clinical, and clinical areas, which has afforded me an in-depth understanding of how all these elements fit together for a successful program. I am looking forward to applying my expertise in US regulatory processes to provide direct support with FDA strategies and submissions, helping to drive forward clients’ drug candidate programs.”
Eric Hardter, Director of Regulatory Affairs at Boyds, comments: “We are thrilled to have Kelsey on board, and I know she will be a valuable addition to both our growing regulatory affairs team and our US staff, bringing with her a strong expertise in investigational product lifecycle development. In working with Kelsey previously, I was able to witness firsthand how she helped bring Usona’s novel investigational product development program from translational science all the way to a pivotal clinical trial, leveraging significant FDA interaction along the way. I look forward to her doing the same for our clients here at Boyds.”
Boyds was established in 2005 by Professor Alan Boyd and provides specialist consultancy services to a global client base, supporting the development of new, cutting-edge medicines for patient benefit.
For more information, please visit: www.boydconsultants.com
