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

Help Improve 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

RSVP for a Webinar on an Overview of Standards for the Regenerative Medicine Landscape

Please join us for a second webinar on Tuesday, March 13, at noon EDT.  We will share some highlights from a recent study of the regenerative medicine standards landscape and pair that with a case study that illustrates how an effort to advance rapid microbial testing is seeking to advance a potential standard. We will also answer questions and facilitate discussion on your experiences and needs regarding regenerative medicine standards.   

Please register for this webinar at this link. We look forward to speaking with you then!

Webinar on 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 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:

·       Full webinar

·       Standards types section

·       Heidi’s section on Labeling and Standards in Tissue and Cell Therapy

·       Anthony’s section on Labeling and Standards in Articular Cartilage Repair and


·       Webinar slide deck 

We will hold the next webinar on the existing standards landscape in March 2018. 

help identify existing standards and gaps

Thank you to those who provided input to identify existing standards and areas where standards are needed in the field of regenerative medicine. This input has been developed into a landscape analysis report on regenerative medicine therapy standards. Once the report has been reviewed by the FDA, it will be shared on this website.