ET Phone Home, Then Call the FDA

In FDA’s world, ET does not refer to The Extra-Terrestrial as made famous by the movie, but rather Emerging Technologies, and it set up a special task force to facilitate pharmaceutical innovation

By Katie Weiler, Managing Editor

Although ET may be alien to some, emerging technologies has become a buzzword in the pharma space. But those are not just words to the FDA. The agency put those words into action when it launched its Emerging Technology Team (ETT) - aimed at providing early engagement and additional meeting opportunities for companies interested in implementing emerging manufacturing technologies into their production process. The ETT program helps the FDA address a long-standing concern that the Agency is a roadblock to new technology adoption.

The first question that comes to mind is what exactly constitutes emerging technologies? In a recent presentation at the 2017 PDA annual meeting, Laurie Graham, FDA Acting Director, DIPAP, defined ET as “technology with the potential to modernize the body of knowledge associated with pharma development to support more robust, predictable, and/or cost-effective processes or novel products and with which the FDA has limited review or inspection experiences.”

For example, emerging technologies for small molecules include continuous manufacturing, 3D drug printing and continuous aseptic spray drying. For biological molecules, ETT has been involved with controlled ice nucleation for lyophilization processes, advanced process control and next generation sequencing. On the equipment side, innovations include closed aseptic filling systems, isolator and robotic arms for aseptic filling, and novel container/closure systems for injectables.

The FDA believes emerging technologies have made it possible for drug manufacturers to remedy a variety of problems that have traditionally plagued operations. Advanced automation equipment, for example, has led to less operator error while isolators and other separation technologies have lessened contamination on the processing line.

But the FDA admits that its inability to keep up with emerging technologies has made pharmaceuticals hesitant to use them despite the benefits. “Pharma companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the technologies and determine how they fit within existing regulatory approaches,” FDA says.

Hence, ETT was created - to promote pharmaceutical innovation. Of course, emerging technologies still need to meet regulatory pathway requirements for approval, including manufacturing per cGMPs.

The ETT not only serves as the primary point of contact for companies interested in implementing emerging manufacturing technology and relevant quality assessment team, but also performs other functions:

• Answers an applicant/sponsor’s submission questions;
• Identifies and helps facilitate regulatory review;
• Serves as the lead on the quality assessment team, in partnership with relevant CDER pharma quality offices, to make the final quality recommendation; and
• Identifies and captures resolution to policy issues that may inform FDA approaches and recommendations regarding future submissions with the same technology.

The FDA says it aims to work with participants on a one-to-one basis, including coordination with FDA staff involved in the review of CMC sections of the application and facility evaluation.

Given this rationale, this program could encourage companies to adopt emerging technologies faster than they otherwise would by granting easier access to resources within the FDA that deal directly with submissions involving emerging technologies.

This month’s cover story addresses how recent emerging technologies in aseptic processing, such as advanced isolators, robotics and increased automation, have advanced the industry and markedly reduced contamination risks for sterile products. Aseptic experts agree that as we enter a new era of smaller batch aseptic products, the acceptance of new technologies is critical.

So now when you think of ET, emerging technologies might just replace the cute little alien image in your head.

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