NIIMBL-facilitated Active Listening Meeting between industry and FDA identifies common challenges for adoption of new biopharmaceutical manufacturing technologies.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) piloted a forum to encourage an exchange of information between the biopharmaceutical industry and the FDA. To facilitate this exchange, NIIMBL conducted a survey of industry representatives around the perceived challenges associated with the adoption of new innovative technologies for biopharmaceutical manufacturing or for continuous improvement and then held an Active Listening session with industry and FDA stakeholders to share common themes. The scope was limited to biotechnology products regulated by the Center for Drug Evaluation and Research (CDER). This manner of exchange has not been tested before and led to meaningful dialog between industry and the Agency and valuable takeaways by all involved. One of the general findings and key points of discussion was around the perceived lack of a business case for adoption of new technology in the manufacture of monoclonal antibodies and therapeutic proteins. Tight timelines were the primary constraints for hesitation around pre-approval implementation and the challenges associated with a global regulatory environment was the primary constraint around post-approval adoption of new technology. Mechanisms that would allow industry and regulatory scientists to develop a shared understanding of new technologies, outside of formal applications, could de-risk adoption of new technologies by the industry. The favorable response to this NIIMBL-facilitated exchange suggests that this format could be useful in establishing a more informal dialog between the FDA and industry on industry-wide challenges.