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This paper proposes a quadrilateral approach to advance biopharmaceutical manufacturing by fostering collaboration among biopharma, lab informatics, healthcare systems, and academia. Through a retrospection based on Gary Pisano's analysis and real-world examples like insitro and Spark Therapeutics, we highlight the imperative of continuous process innovation and regulatory collaboration. We emphasize leveraging technological advancements, particularly in machine learning and artificial intelligence (AI), to catalyze a paradigm shift in drug manufacturing and delivery. The discussion extends to fostering academic and business partnerships, akin to Silicon Valley's ecosystem, and engaging healthcare systems in a more integrated role, exemplified by the advent of point-of-care manufacturing. The paper underscores the unique potential of the State of Delaware to propel forward the biopharma manufacturing space, advocating for a coordinated effort to translate scientific advancements into real healthcare benefits.
Patrick G. Callahan (Wed,) studied this question.