Abstract
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) piloted a forum to encourage an exchange of information between the biopharmaceutical industry and the U.S. Food and Drug Administration (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 were 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.
- © PDA, Inc. 2020
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
