Supporting Standards Development for Regenerative Medicine Therapies


project description

On September 27, 2017, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to Nexight Group and SCB to engage with experts to recommend processes and outline a strategic plan for developing standards in regenerative medicine and advanced therapies. The Nexight-SCB team will develop a landscape report that outlines business needs, gaps in standards, and promising therapy areas for standards application; host three webinars for community stakeholders; and develop processes and criteria for identifying, prioritizing, and assessing the feasibility of standards that will have a high impact on the quality, safety, and cost-benefit of standards’ needs.

This work will create a foundation that allows industry, regulatory authorities, and other stakeholders to reduce barriers to regenerative medicine research and product development and accelerate the market readiness of these life-changing medical treatments.

project duration

September 2017-September 2018

Landscape Report

Compared with more mature medical fields that feature a greater number of marketed products and a fully developed infrastructure (e.g., traditional pharmaceutical drugs, medical devices), the regenerative medicine field currently has few finalized standards. Analyzing the standards that currently exist and identifying areas of additional standards development opportunities is crucial to facilitate coordinated efforts to advance regenerative medicine therapies from the laboratory to widespread use in patient care.

To this end, Nexight Group LLC and SCB co-authored The Regenerative Medicine Standards Landscape report with funding from the U.S. Food and Drug Administration (FDA). This report provides an overview of nearly 200 existing standards relevant to the cell therapy, gene therapy, or tissue engineering sectors of regenerative medicine and assesses the needs and opportunities for standards development in regenerative medicine as identified by key stakeholders.

This report will be regularly updated to provide the most comprehensive list of existing regenerative medicine standards and to identify emerging standards needs in response to the rapidly developing regenerative medicine field.

If you have suggestions for improving the report or information on other standards relevant to regenerative medicine, please send them to Sarah Lichtner at Nexight Group (


the need for standards in regenerative medicine

More than 60 of you joined us for our first webinar on the Need for Standards in Regenerative Medicine held Tuesday, December 12, 2017.  We heard from Allison Getz, SCB Program Manager, who gave an overview of standards types.  We then heard from Heidi Hagen, the Chief Strategy Officer at Vineti, and Anthony Ratcliffe, Chief Executive Officer of Synthasome, about how the development of standards influenced the work in their fields of regenerative medicine.

If you weren’t able to join us, you may view the webinar or slides at the following links:

Overview of Standards for the Regenerative Medicine Landscape

More than 40 of you joined us on Tuesday, March 13 for our second webinar, The Standards Landscape for Regenerative Medicine.  We heard from Dawn Henke, SCB Program Manager, who shared some highlights from a recent study of the regenerative medicine standards landscape.  Jacqueline Wolfrum, Assistant Director at the MIT Center for Biomedical Innovation, then paired that with a case study that illustrated how an effort to advance rapid microbial testing is seeking to advance a potential standard. 

If you weren't able to join us, you may view the webinar or slides at the following links:

Processes and Criteria for Potential Standards Identification, Prioritization, and Feasibility Assessments

We are seeking expert input from the regenerative medicine field to describe and envision standards identification, prioritization, and feasibility assessment processes and criteria. Your input will inform improvements to the ways in which standards needs advance to become standards and ultimately contribute to the quality and safety of regenerative medicine products.

Please share your experience and thoughts in a poll about regenerative medicine standards identification, prioritization, and feasibility assessments at this link before February 25, 2018