The US FDA’s Emerging Technology program was established as a catalyst for new technologies to help modernize pharmaceutical development and manufacturing in areas where the FDA has limited review or inspection experience. Thomos O’Connor from the FDA’s Office of Pharmaceutical Quality explains that “this is technology with the potential to modernize the body of knowledge associated with pharmaceutical development to support more robust, predictable, and cost-effective processes or novel products… our vision is to have a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight ” (in-PharmaTechnologist.com).
O’Connor is a member of the committee formed to facilitate the program and assist the industry with applications. The committee, known as the Emerging Technology Team (ETT), has already received 20 applications this year, doubling the number requested last year. The in-PharmaTechnologist article breaks down the submissions: continuous manufacturing technologies for drug product, substance, and biologics represent 30% of all requests, another 30% consists of the use of robotics and container closure systems for sterile injectable production, biotechnology processes and analysis represent 22%, and the final 17% include other areas of innovation such as new dosage forms and 3D printing.
What implications, if any, do these numbers say about the future of the life sciences industry? One could look at the breakdown as a compass for where future demand (and funding) will be. Though continuous manufacturing and robotic/container closure technologies led the way with a majority share of submissions, the numbers represent a fairly even and robust spread of emerging technologies. If your firm is looking to participate in the Emerging Technology program and need guidance with your IND, NDA, ANDA, or BLA application, our dedicated team of experts at Pearl Pathways is here to help.