Identifying Regenerative Medicine Standards and Standard Development Processes

Client: The U.S. Food and Drug Administration
An image of a scientist inserting orange liquid into a series of test tubes suing a pipette. The front cover of The Regenerative Medicine Standards Landscape report. A sample catalog entry for a reference material. A scientist harvesting cells from a Petri dish.

Project Overview

Under a one-year contract awarded by the U.S. Food and Drug Administration (FDA), Nexight Group and the Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) engaged experts to identify standards relevant to regenerative medicine and advanced therapies and determine areas where standards would be beneficial.

Need

As part of the 21st Century Cures Act signed into law in December 2016, the FDA was directed to “coordinate and prioritize the development of standards and consensus definition of terms... [that] support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies.” The FDA tasked Nexight and SCB with developing the landscape of existing standards relevant to regenerative medicine, which had never been done for this field because of its relative newness and the lack of many standards specific to regenerative medicine therapies.

Our Solution

Nexight and SCB conducted desktop research, compiling and analyzing information from more than 40 organizations and 30 expert interviews. We also distributed a survey to hundreds of regenerative medicine stakeholders asking questions about existing standards, standards in development, and areas where standards are needed. We synthesized and presented these inputs into clear and compelling infographics, summary tables, and appendices to develop the final report, which outlines current regenerative medicine standards, identifies the most promising areas for standards development, and describes the challenges faced by the field.

Impact

The Regenerative Medicine Standards Landscape, published in February 2018, details nearly 200 existing standards relevant to the cell therapy, gene therapy, and tissue engineering sectors of regenerative medicine, providing an easy reference for those who may not be aware of the standards available or under development. The report will help support regenerative medicine standards development processes and inform organizational decision-making on promising investments and strategic direction. Going forward, this information will be regularly updated in two separate reports (with one focusing solely on needed standards) to provide the most comprehensive list of existing standards and to identify needed standards in response to the rapidly developing regenerative medicine field.