In January 2019, the U.S. Food and Drug Administration’s (FDA) in-baskets were already overflowing with investigational new drug (IND) applications. Much of the workload’s upturn was attributed to a surge of new cell and gene therapy products under development. Scientific discoveries are surfacing more frequently, so the agency anticipates that these types of applications will continue to stack up.
In the words of former FDA Commissioner Dr. Scott Gottlieb, “We anticipate that by 2020 we will be receiving more than 200 INDs per year, building upon our total of more than 800 cell-based or directly administered gene therapy INDs currently on file. And by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.”1
As we roll into 2020, the level of activity involving breakthrough scientific and technology innovation appears to be validating Gottlieb’s predictions. Discoveries that enhance public health are always welcome; however, the rapid pace of progress has forged a sizeable gap between the industry’s progress and the technologies needed to translate them into useful therapies. The FDA recently set out to close that gap by fostering modernization in the life sciences industry — beginning with its own technology infrastructure. A new MasterControl trend brief, “FDA Fronts Pivotal Life Sciences Trend in 2020,” details how the FDA will pursue its modernization plan and explains how the endeavor will have a profound impact on the life sciences industry.
Recently, the agency introduced its Technology Modernization Action Plan (TMAP), a program designed to bring the organization up to speed with the latest technologies in order to facilitate breakthrough health care discoveries faster and more efficiently. The first item on the FDA’s agenda is to migrate its technology infrastructure to a cloud environment. In a nutshell, the TMAP is a road map for the agency to:
The action plan also includes strategies to strengthen the agency’s data security measures and enhance its capabilities of managing, controlling and analyzing data.
Digital technologies are transforming all areas of the life sciences industry. Some of the key developments include:
Historically, as new technology with any health care-related functionality became available, the FDA needed to define a regulatory model comparable to the product’s purpose and capabilities. The TMAP will better prepare the agency to handle new innovations in real time.
Beginning in 2002, the Medical Device User Fee Act (MDUFA) was established to help the FDA increase the efficiency of regulatory processes with the goal of reducing the time it takes to bring safe and effective medical devices to market.3 Continuing in that vein, the agency recently launched a pilot program to accelerate 510(k) submissions, using an interactive, PDF-based template.
“As technology advances, the FDA must keep pace with the increasing complexity of rapidly developing technology and continue to modernize and evaluate our programs and processes, ensuring they continue to be efficient, consistent and scientifically rigorous,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).
The agency’s new optional 510(k) submission template, referred to as the electronic Submission Template And Resource (eSTAR), allows pilot participants to submit applications to the FDA using a more dynamic electronic format capable of organizing the complex information necessary for a robust scientific review. Without changing any statutory or data requirements, the submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to the CDRH’s internal review templates currently used to review 510(k)s. The eSTAR template is designed to give the agency’s review staff more time and resources to evaluate applications for devices that pose the highest potential risks to patients.4
Given the steady progress in health care product innovation, the FDA is highly motivated to help get the resulting products into the hands of medical professionals. In addition to getting on board with the latest technology trends, the technology transformation is designed to encourage the entire life sciences industry to follow the agency’s lead in modernization and matching the pace of innovation. Some of the high-level outcomes of the TMAP will include:
The FDA’s cloud-based infrastructure will empower the agency to be more granular with all data and site reviews. Companies are urged to sufficiently prepare for more in-depth and stringent regulatory processes in order to better meet the rapid pace of innovation and deliver higher quality products. Migrating to a cloud environment and digitizing business units and processes throughout the supply chain are essential steps in the direction the life sciences industry is heading.
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