Bruce Hart

Independent Consultant at Self-employed | Seattle, Washington, United States

About Bruce Hart

Bruce Hart is a seasoned regulatory affairs professional with over twenty-five years of extensive experience in drug development, particularly within the oncology sector. As an independent consultant, Bruce leverages his deep expertise to provide tailored regulatory affairs consulting services to biotechnology and pharmaceutical companies navigating the complexities of drug development. His notable contributions include pivotal roles in multiple development programs, most prominently with Seattle Genetics, where he was instrumental in guiding ADCETRIS from pre-IND stages through to its successful marketing approval and launch.

Bruce's consulting practice focuses on post-proof of concept (POC) assets, where he excels in managing critical regulatory authority submissions and facilitating strategic interactions with regulatory bodies. His comprehensive understanding of both biologics and small molecules allows him to craft effective regulatory strategies that align with the unique challenges faced by each client. With a keen interest in oncology therapeutics, Bruce is adept at navigating the intricacies of clinical development and regulatory compliance, ensuring that his clients are well-prepared for every phase of the drug development lifecycle.

In addition to his technical skills in IND submissions and clinical trials, Bruce has established a reputation for building strong collaborative relationships with stakeholders across the pharmaceutical industry. His ability to communicate complex regulatory requirements clearly and effectively has made him a trusted advisor to many organizations seeking to advance their drug development programs. Through his independent consultancy, Bruce Hart continues to make significant contributions to the biopharmaceutical landscape, helping to bring innovative therapies to market that can transform patient outcomes.

Bruce Hart Work