Peter G. Millili, PhD

Johnson & Johnson
Senior Director, Manufacturing Science and Technology
Peter Millili received his Bachelors and Masters degrees in Chemical Engineering from Drexel University, and his Ph.D in Chemical Engineering from the University of Delaware. Previously, he worked at Merck & Co. in Vaccine Manufacturing, supporting technical elements associated with the purification, formulation, and lyophilization of live virus vaccines. Presently, he works at Bristol Myers Squibb, managing a group of scientists and engineers who support the development, technology transfer, and launch of new biologics in the Manufacturing Science and Technology organization. He has been an ISPE member for the past 15 years, and is currently an active member of the process capability sub-team of the PQLI technical team. He has presented at multiple conferences on the topic of formulation design, process development, and technology transfer of large molecules.

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This article is Part 1 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Part 1 introduces key considerations and themes in general terms and...