Dr. Larisa Toulokhonova is a distinguished biochemist with more than twenty years of experience in the pharmaceutical industry, focusing on the commercialization of potency methods for biologics as part of CMC (Chemistry, Manufacturing, and Controls) packages. She is currently a Principal Scientist in Analytical R&D - Cell-Based Sciences, where she is enthusiastic about exploring strategic opportunities related to potency methods and expedited marketing applications. Dr. Toulokhonova is also dedicated to developing and implementing effective regulatory strategies for the life-cycle management of bioassays across various modalities within Merck’s biologics pipeline. To achieve this, she employs her extensive knowledge of quality and regulatory standards, including activities related to IND (Investigational New Drug) and BLA (Biologics License Application) submissions, while establishing phase-appropriate strategies for specifications and critical analytical needs at every stage of development. Throughout this process, she collaborates with both internal and external stakeholders. Dr. Toulokhonova has been instrumental in the successful launch of several commercial products, such as Keytruda®, Zinplava®, Winrevair®, and Opdivo®, and she continues to actively participate in industry cross-functional teams to ensure compliance with regulatory standards from various international agencies.