Promoting continuous manufacturing in the pharmaceutical sector
Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.
Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.
Welcome, overview, and meeting objectives
Promoting the adoption of continuous manufacturing in the pharmaceutical industry: The FDA perspective
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Session I: Assessing the current landscape and future direction for continuous manufacturing
Professor of Pharmaceutical Science & Director, EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation - University of Strathclyde
Vice President, Late Stage Process Development - Sanofi
Head of the Continuous Manufacturing Unit - Novartis Pharmaceuticals
Director, Center for Structured Organic Particulate Systems, & Distinguished Professor, Chemical and Biochemical Engineering - Rutgers University
Deputy Director, Office of Pharmaceutical Quality - U.S. Food and Drug Administration
Session II: Improving scientific and technical knowledge to support continuous manufacturing
Edwin R. Gilliland Professor of Chemical Engineering - Massachusetts Institute of Technology
Technical Advisor to the Defense Advanced Research Projects Agency - Strategic Analysis, Inc.
Vice President, Global Manufacturing Sciences - Biogen
Principle Scientist, Center for Process Analysis and Control (CPAC) - University of Washington
Senior Vice President, Global Science, Technology and Commercialization - Pfizer
Session III: Addressing barriers to the adoption of continuous manufacturing
Senior Vice President, Global Pharmaceutical Development - Vertex
Head of the Institute of Process and Particle Engineering, & Scientific Director, Research Center of Pharmaceutical Engineering (RCPE) - Graz University of Technology
Global Head, Regulatory CMC - AstraZeneca
Director, Biomedical Advanced Research and Development Authority, & Deputy Assistant Secretary for Preparedness & Response - U.S. Department of Health and Human Services
Session IV: Building stakeholder collaborations to facilitate the implementation of continuous manufacturing
Head of Pre-Competitive Collaboration - GlaxoSmithKline
Vice President, Manufacturing Science & Technology - AbbVie
Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering - Purdue University
Program Director, Engineering Research Centers - National Science Foundation
Assistant Professor of Chemical Engineering - University of Massachusetts at Lowell
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