Specialty: Regulatory Affairs Consulting

Isaiah is a Senior Regulatory Affairs Scientist and Consultant at BioPharma Global, a division of Pace® Life Sciences. His formal education and professional regulatory experience provide a unique perspective of patient advocacy to his role in drug development. He works diligently to ensure high-quality regulatory advice and deliverables are provided to clients. This is evidenced by his impressive track record of successful submissions to both the FDA and EMA, including requests for Orphan Drug Designation (ODD), Rare Pediatric Disease (RPD) Designation, and Fast Track Designation (FTD). He also collaborates with team members on larger-scale projects, such as assessing gaps in clients’ data to determine if they are ready to submit an Investigational New Drug (IND) application. Further, he has experience in authoring and reviewing IND applications to comply with FDA’s requirements, to increase the likelihood of success of clients’ clinical development programs, and to avoid INDs being put on clinical hold. Overall, Isaiah’s early professional career in regulatory affairs has been remarkable and he is excited to gain further experience and knowledge in the constantly evolving world of drug development and the pharmaceutical industry.