Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL Positions

In her new role as FDA’s Principal Deputy Commissioner, Janet Woodcock will be able to continue her strong contribution to the effort in the US and around the world to make drug and biologic regulatory processes as supportive as possible of manufacturing innovation.

Across the leadership roles she has played at the agency, Woodcock has shown a clear understanding of the importance of FDA’s active support for industry’s technological advancement in serving the agency’s public health mission and of the need to address the constraints in the existing regulatory processes that have an innovation-inhibiting effect.

Woodcock began her career at FDA in 1986 at the Center for Biologics Evaluation and Research (CBER), where she held senior positions before becoming Director of the Center for Drug Evaluation and Research (CDER) in 1994. Her concern with the issues around modernizing drug manufacturing and its regulation was reflected in the early 2000s in the launching of CDER’s formative Pharmaceutical Quality for the 21st Century initiative, which has had several important facets under her center leadership.

One of the significant developments flowing from Woodcock’s 21st Century effort was the Office of Pharmaceutical Quality (OPQ), established as a “super office” within CDER in January 2015.

OPQ brought the CMC review, compliance, and quality-related research functions for new and generic products under one umbrella to foster consistency, communication, and more cohesive and scientifically advanced quality oversight and policy internally within the agency and with regulatory counterparts internationally.

Key quality initiatives launched during OPQ’s first two years included: ● the Emerging Technology Team (ETT) to help drive innovation within the pharmaceutical industry ● the Concept of Operations (ConOps) to define roles and responsibilities across the review and inspection functions ● the New Inspection Protocol Project (NIPP) to support tracking and improvement of performance across pharmaceutical manufacturers and products, and ● Knowledge-aided Assessment and Structured Application (KASA), focused on modernizing the data submission and review process. [See IPQ October 23, 2017 for an overview of OPQ and its various programs, and IPQ August 11, 2019 and  February 17, 2022 for in-depth reviews of the goals and progress of KASA and the related PQ/CMC initiative.]

OPQ’s 2021 annual report, published in February, provides an update on these initiatives, including the expansion of the Emerging Technologies Program (ETP), and on the more recently launched Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) and Quality Management Maturity (QMM) projects. [See IPQ December 12, 2019 for more on the QMM initiative.]

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