2021 Research Conference

Manuel Osorio, PhD, Senior Scientist for Emerging Technologies, US Food and Drug Administration (FDA)

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry and PhD degree in Cellular Immunology from the University of California at Santa Cruz. He was a postdoctoral fellow at the National Institutes of Health before joining the FDA.

CBER Advanced Technologies Program: Promoting the Development and Adoption of Advanced Manufacturing Technologiess

FDA regulates pharmaceutical products to ensure a continuous supply of high-quality products in the
United States. In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a
maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high
quality biologics. To help achieve this vision, the Center for Biologics Evaluation and Research (CBER)
encourages the development and adoption of advanced technologies to modernize biopharmaceutical
manufacturing of complex biologics. In this presentation, I will discuss new initiatives under the CBER
Advanced Technologies Program to promote the development of advanced manufacturing technologies
for CBER-regulated products.