Niamh Kinsella is a biotechnological product development specialist, with particular interest in development of biosimilar medicinal products and Advanced Therapy Medicinal Products.
She has experience in pharmaceutical quality (chemistry, manufacturing and control, CMC), strategic development and regulatory processes and requirements accumulated through years within industry and regulatory consulting. During this time, she has worked in the development of biotechnological products, biosimilar products and Advanced Therapy Medicinal Products and this experience includes manufacturing process and formulation development, comparability strategies during process development, stability assessments and overall strategic development from a CMC perspective. She has been involved in the development of regulatory and product development strategies for a wide range of biotechnological products, including originator and biosimilar recombinant proteins, monoclonal antibodies and related substances, prophylactic and therapeutic vaccines, cell therapy products and gene therapy products. She has also been involved in the development of comparability programmes for products during development and following approval.
Niamh joined NDA Regulatory Science Ltd as a Senior Regulatory Consultant and biotechnological product expert in 2010 where she has supported companies throughout all stages of the product lifecycle.