Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Sudhakar Agnihothram, BPharm, PhD
Associate Director
Office Regulatory Initiatives Office of Vaccines Research and Review (OVRR)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Sudhakar Agnihothram, BPharm, PhD is the Associate Director of Office Regulatory Initiatives, at the Office of Vaccines Research and Review, CBER, FDA with extensive experience in the product life cycle regulation of vaccines for prevention of infectious diseases. He served as the chair of FDA multidisciplinary review committees responsible for Emergency Use Authorization for Moderna COVID-19 vaccine and Janssen COVID-19 Vaccine, and review committee for Moderna COVID-19 Vaccine for SPIKEVAX Biological License Application (Moderna COVID-19 Vaccine). Dr. Agnihothram is the Office lead in managing several programmatic regulatory initiatives including activities on frontline COVID-19 vaccines and has been involved in advancing stakeholder partnerships in these areas.
Abstract
Sudhakar Agnihothram presents on the FDA’s CBER Advanced Manufacturing Program, which involves integrating novel technologies, using established techniques innovatively, or developing methods in new production domains for regulated products. The program’s goals include improving product quality, strengthening the supply chain, preventing shortages due to quality issues, and expediting development to enhance agility and resilience in public health emergencies. FDA reviews these technologies on a case-by-case basis and supports innovation through internal collaboration across centers like CDER and CBER, and external partnerships, promoting harmonized standards. A key mechanism is the CBER Advanced Technologies (CAT) team, offering sponsors early, non-binding consultations before formal regulatory submission to discuss technical and regulatory challenges of innovative approaches. Examples of technologies discussed or funded include continuous manufacturing, automated systems, and using artificial intelligence and advanced imaging for real-time product quality assessment. The presentation emphasizes the critical importance of early engagement from sponsors with FDA to navigate the development and regulatory pathway for these quickly advancing manufacturing technologies.