Keynote Speaker

“Notes from the Badlands: Deployment of Advanced Technologies in Real World Biopharmaceutical Manufacturing”. Jeffrey C. Baker, Ph.D.

The need for flexible, robust, and economically efficient manufacture of biologics, especially those that bridge the molecular life sciences and the digital age, is a topic increasingly front-of-mind among innovators, investors, legislators, and an increasingly aware lay public.  While the technologies supporting target identification, molecular analytics, clinical data analysis, and materials fabrication are increasingly enriched and renewed by new innovations, the technologies, metrics, and philosophies deployed in commercial biopharmaceutical manufacturing are not that different from those in place 10, 20, or even 30 years ago. This talk will compare and contrast the role of advanced manufacturing technology as a differentiating core competency in the biopharmaceutical enterprise of the late 20^th century and its current as a rarely justifiable risk to timelines and budgets.  The talk will reflect upon how this transformation came to our sector and offer suggestions how we can prevent the new technologies that so enable the innovation space from disappearing in the badlands of commercial biopharmaceutical manufacturing. 

Dr. Baker holds a bachelor’s degree in biochemistry and molecular biology from Northwestern University, doctorate in biochemistry from the University of North Texas, and pursued post-doctoral studies at the University of California, Berkeley. He joined Eli Lilly & Co in 1988 and led the development and manufacture of both first in class and legacy biologics. Dr. Baker received the Lilly President’s Award twice, for development and launch of Humalog, the first insulin analog, and for development and launch of drotrecogen alfa, the first recombinant protein therapeutic manufactured from human cells. Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at MedImmune, a subsidiary of AstraZeneca, and, in 2011 was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research (CDER) at FDA. Dr. Baker has received six CDER awards or citations for leadership and program development and in 2018 received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.” In 2019 Dr. Baker was detailed to the Advanced Manufacturing National Program Office at NIST where he worked with NIST and ManufacturingUSA programs on biopharmaceutical elements of the National Strategic Plan for Manufacturing in the United States and to speed the deployment of advanced technologies into biopharmaceutical manufacturing. He was recalled to FDA 2020 where he participated in CDER responses to the global pandemic and interagency advanced manufacturing programs through the Office of the Commissioner. He retired from the Agency in April of 2021. He remains active in the biotech community as a Senior Fellow in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), participating in conferences, and working with several universities as a both a lecturer and advisor on program development.