The Power List 2021 – Advanced Medicine
Director at the FDA Center for Biologics Evaluation and Research
Over the past 12 months, Marks has played a pivotal role at the FDA in ensuring that COVID-19 vaccines are both safe and effective. Weighing in on how the pandemic may impact cell and gene therapy, he says, “The holistic approach to product development, simultaneously focusing on manufacturing challenges and clinical development combined with increased sponsor-agency interactions could potentially propel cell and gene therapy product development forward more rapidly.”
For the future, he is most excited about the application of genome editing with base editors or similar technologies to the treatment of human disease, which he thinks could be a “game-changer,” as well as the application of advanced manufacturing technologies to cell and gene therapy production.