Growing Industry Interest in Emerging Technologies: CDER
CDER has seen growing drug industry interest in its Emerging Technology Program, Center Office of Testing and Research director Lucinda Buhse told a Drug Information Association session in Chicago 6/20. She said CDER has accepted 32 industry requests to participate in the program over the past two years. She noted that recent approvals in which the emerging technology team played a critical role included the first 3D-printed drug product in 2015, and the first FDA-approved drug product switching to continuous manufacturing in 2016, Janssen’s HIV-1 therapy Prezista (darunavir). The company’s efforts in manufacturing advancement were facilitated by the use of FDA’s recently-released draft guidance on Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.
Buhse told DIA attendees that emerging technologies are key to addressing pharmaceutical manufacturing challenges because they can address the underlying causes of product recalls and drug shortages (two thirds of drug shortages resulted from product-specific quality failures or general manufacturing facility issues). These technologies will facilitate new clinical development (precision medicine), and enable a wider range of novel dosage forms without extensive alterations of the process, she said. Also, they can improve manufacturing efficiency by increasing process robustness, lowering manufacturing costs and increasing supply chain flexibility.
The draft guidance provides recommendations to companies interested in participating in the program or submitting chemistry, manufacturing, and controls submissions containing emerging manufacturing technology. Under the program, companies can submit pre-submission questions and proposals about the use of a specific emerging technology to CDER’s Emerging Technology Team (ETT). “The ETT will work in partnership with relevant pharmaceutical quality offices and assume a leadership or co-leadership role for the cross-functional quality assessment team (including review and on-site agency evaluation) for submissions involving emerging technology,” the document says.
FDA notes that companies may have concerns that using such technologies could result in delays while agency reviewers become familiar with them and determine how they fit within existing regulatory approaches. Through the ETT, CDER intends to leverage existing resources within the agency to facilitate the regulatory review of such submissions, it said.
Last year, stakeholders commenting (see story) on the draft guidance asked for additional information and clarification. Pharmaceutical Research and Manufacturers of America said FDA should clarify the scope and extent of the technologies covered, acceptance criteria for admittance to the program, level of detail required in the application, the anticipated and potential benefits of program participation, and coordination timeframes within the agency to provide program participants with consistent and timely feedback. GlaxoSmithKline said more definition from FDA is needed on what constitutes an “emerging technology” would be helpful, along with a better distinction of whether the agency is proposing a program or a process.