Description:

Each year, the Master of Biotechnology Program hosts Biotechnology Day, a one-day life sciences festival designed to inspire and inform curious minds. We aim to reach a broad community of students, scientists, and science enthusiasts. This year's event includes community outreach activities, tours of facilities, career panels (technical and non-technical focuses), a keynote speaker, and an open networking session.

Thank you to our generous co-sponsors: Office of STEM Education Partnerships (OSEP) and Biotechnology Training Program (BTP)!

ABOUT THE KEYNOTE

Speaker: Jeffrey C. Baker, Ph.D. (Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research at the United States FDA)

Title: "The Development, Manufacture, and Regulation of Biopharmaceuticals in the United States"

Abstract: We are in the midst of an explosion of creativity and innovation in the development of biotechnology based pharmaceuticals. New technologies and manufacturing strategies, therapeutic proteins addressing unmet medical needs, curative biotherapeutics, biosimilars, and products rushed to market with breakthrough status are all on the rise. The combination of technological innovation, a rapidly evolving regulatory landscape, and global market requirements can paint a picture of daunting or energizing complexity. This talk will provide an overview of the regulation of biopharmaceuticals in the United States and explore the current regulatory paradigm of patient centered, risk based oversight employing a totality of evidence framework to assure stable supplies of high quality medicines, a totality of evidence based upon data driven studies, first principle understanding, and sound engineering practices in manufacturing.