Russell Berg, as the Executive Director of Biosimilars Global Study Management at Amgen, plays a pivotal role in advancing the company’s biosimilars pipeline, leveraging over 30 years of extensive experience in the biotechnology and pharmaceutical sectors. His leadership is instrumental in overseeing the strategic execution...
Russell Berg, as the Executive Director of Biosimilars Global Study Management at Amgen, plays a pivotal role in advancing the company’s biosimilars pipeline, leveraging over 30 years of extensive experience in the biotechnology and pharmaceutical sectors. His leadership is instrumental in overseeing the strategic execution of clinical trials aimed at global registration, particularly focusing on pharmacokinetic (PK) similarity studies and comparative clinical studies. Under his guidance, the Biosimilars study management group is committed to excellence in clinical trial execution, ensuring that each project adheres to the highest standards of quality and regulatory compliance.
Russell's expertise in clinical development is complemented by his adept management of Contract Research Organizations (CROs), fostering strong partnerships that drive continuous improvement within the Biosimilars unit. His proactive approach to clinical trial design and execution not only enhances operational efficiency but also accelerates the delivery of critical biosimilar products to market. Notably, his involvement in the development of significant products such as AMGEVITA and MVASI underscores his deep understanding of the complexities involved in bringing biosimilars to fruition.
In addition to his technical skills, Russell is a champion of innovation within the industry, promoting best practices and leveraging data monitoring committees to ensure robust oversight of clinical trials. His commitment to advancing oncology treatments through biosimilars reflects a broader vision of improving patient access to essential therapies. As he continues to navigate the evolving landscape of global drug development, Russell Berg remains a key figure in shaping the future of biosimilars at Amgen and beyond.