Speakers
Kieron McIntyre – Associate Director, Analytical Sciences at Pharmaron Gene Therapy
Kieron is the subject matter expert responsible for managing analytical method validation and tech transfers at Pharmaron Biologics UK. Experienced in developing analytical control strategies from early-stage clinical development through to submission. Experienced in regulatory submissions within EMA, FDA, and PMDA. With 15+ years of experience in the pharmaceutical industry, Kieron has a strong quality control and CMC development background.
John Allen – Senior Manager, Analytical Sciences at Pharmaron Gene Therapy
John is a senior manager of Analytical Sciences at Pharmaron, responsible for developing and validating analytical methods to support early-stage clinical development through submissions. He has a PhD and post-doctoral experience at the University of Liverpool and over eight years of experience in the pharmaceutical industry. This has culminated in a strong background in Analytical Development and platform validation.
Dr. Lee Smith – Principle Consultant and Director at GreyRigge Associates
Dr. Lee Smith’s experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical, and clinical assay development, as well as experience in product characterization and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on using DoE and data analysis for processes, formulation, and assays, with expertise in bioassays. This includes developing, optimizing, and validating both biopharmaceutical processes and methods.
Moderated by:
Rebecca Hobson – Director, Analytical Sciences at Pharmaron Gene Therapy
