The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-based Drug Discovery

Note: The official website will be launched later this year.
​Please be patient as we continue to update the contents on this page.

Mission

   
The SCB’s long-term mission is to efficiently and effectively support sector regulatory submission review to improve the cost, time, and resources for sector product development and approval by supporting standards development for standards that can be utilized in the regulatory submission process. Creating standards creates a more uniform compliance environment and addresses and assists in future efforts for harmonization internationally of the regulatory framework for submissions across the globe.  These standards are intended to support both industry and other stakeholders as well as the regulatory authorities.  In cases where specific potential standards are not ready for finalization due to technology or other limitations, the SCB will support the relevant pre-standards work via, for example, interlab studies, technical reports/publications, and workshops.  SCB will work closely with NIST, additional federal agencies, and other public and private sector entities throughout this process. 
    
The SCB
   
The international Standards Coordinating Body (SCB) was established to advance process, measurement, and analytical techniques to support the global availability of cell, gene, tissue-engineered, and regenerative medicine products, and cell-based drug discovery products.   The SCB will help to improve product quality, enhance health and safety, help strengthen market access and trade, and help build consumer confidence in the field of regenerative medicine through support of the development of standards, including providing expertise to SSOs and SDOs, industry and other stakeholder coordination and prioritization, technology development in the pre-standards phase and education.
     
About Us
   
The SCB is a Public-Private Partnership (currently with NIST) for supporting standards development in the gene, cell, and other regenerative medicines, and cell-based drug-discovery.  The SCB brings together product developers, tools and service providers, professional societies, government entities, and academic centers with the intent to support standards development via coordination, prioritization, resource compilation, inter-laboratory data generation, participation in consensus Standards Development Organization (SDO) activities, and education, and implementation for standards. 


The SCB consists of stakeholders from the cell/gene and regenerative medicine field, representing industry, academia, and government agencies. It has received broad support from dozens of companies and organizations, within the US and abroad. Together, these charter members develop and direct the projects and standards most needed within the regenerative medicine field. It is directly benefit the scientists and engineers who have day-to-day responsibility for creating and managing scalable and reproducible processes, as well as the assays needed to ensure indisputable quality. Through publicly available resources, networking events, and workshops, professionals can access and share the techniques and best practices needed for safe, effective, and consistent products.

Steering Committee Members​​
    
Editas
EMD Millipore
FACT
GE Healthcare
GSK
Harvard SEAS and Wyss Institute
ISCT
ISSCR
Johns Hopkins University
Johnson & Johnson
Lonza
Lentigen
MaxCyte
NCATS
NIBSC


NIST
Northwestern University
Novartis
Orig3n
Pfizer / Bamboo
Shire/Baxalta
TERMIS
ThermoFisher
USP
WFIRM
Wyss Translational Center, University of Zurich    
AABB
Abbvie
Akron
ARM
ASGCT
Axiogenesis
Binghamton University
Biogen
Brammer Bio
BTI
CCRM
CDI
Celgene
Cell Therapy Catapult
Cell Therapy Manufacturing Consortium


Organization
   
The SCB is currently divided into 4 working groups, which will be replaced by a Board of Directors, and various committees after the official SCB launch in late 2016.
Governance
Economic Model
Chair: Jessica Carmen, MaxCyte
Chair: Morrie Ruffin, Alliance for Regenerative Medicine
Co-Chair: Claudia Zylberberg, Akron Biotech
Work Plan
Government Liaison
Chair: Michael Mendicino, Hybrid Concepts International
Co-Chair: Krish Roy, National Cell ManufacturingConsortium

Subsectors:
  • Cell Therapy
  • Gene Therapy
  • Tissue Engineering
  • Drug Discovery
Chair: Jiwen Zhang, GE Healthcare
Co-Chair: Wen Bo Wang, CDI
News
WASHINGTON, DC, September 19, 2016 – The Standards Coordinating Body for Gene, Cell and Regenerative Medicines and Cell-based Drug Discovery (SCB) announced today it has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology’s (NIST) Material Measurement Laboratory (MML) to advance the development of industry-wide standards for cell therapy, gene therapy, regenerative medicine and cell-based drug discovery.

This MOU signifies the first step toward establishing an SCB-NIST public-private partnership. The SCB aims to build a coalition that will include other partnerships with federal agencies and international organizations. The initiative to establish the SCB originated from the Alliance for Regenerative Medicine’s (ARM) Science and Technology Committee.

Signed by Laurie Locascio, MML director, and Morrie Ruffin, ARM’s managing director and a founding director of the SCB, the MOU describes the first formal collaboration between SCB and NIST.

“The SCB and NIST are united in our dual missions to enable more efficient and successful clinical and commercial development for cell and gene therapies, regenerative medicine and cell-based drug discovery,” said Morrie Ruffin, ARM’s managing director. “Widespread coordination, establishment and implementation of standards for these products is essential to driving our field forward and speeding patient access to these potentially transformative therapies.”   

According to the terms of the MOU, the SCB and NIST will work together to advance the field by collaborating on and contributing to the development of relevant consensus standards and among other activities, improving confidence in measurements of gene-based and cellular systems and their manufacturing processes by engaging key stakeholders to better understand and address industry priorities.

NIST is a non-regulatory federal agency within the U.S. Department of Commerce whose mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology. The SCB will work with NIST’s MML, which serves as the national reference laboratory for measurements in the chemical, biological and material sciences. NIST engages in ongoing activities of standards development organization leadership and developing capabilities in measurement science.

The SCB, a multi-stakeholder consortium representing varied interests across this sector, is a non-profit organization working to support the development, dissemination, education and implementation of relevant standards and related deliverables via public-private partnerships and ongoing work with national and international consensus standards organizations. The SCB will serve as a source of information, knowledge, experience and data collection related to process, material and reference standards to enable more efficient and successful development, manufacture and testing of advanced therapies and cell-based drug discovery. 

For more information about ARM, please visit  www.alliancerm.org . For more information about NIST, please visit  www.nist.gov. For more information about the SCB, please visit www.regenmedscb.org

Upcoming Events

   
Charter Member Meeting
            October 4, 2016 
4-6 pm
Estancia La Jolla Hotel,
La Jolla, CA
    
 
Cell Therapy Liaison Meeting
October 19, 2016
12:30pm-5pm
Bethesda, MD
    
   Drug Discovery Liaison Meeting
October 24 - 26, 2016
Washington, DC
    
 Multi-Agency Tissue Engineering Science (MATES) Meeting
            September 20, 2016
3-5 pm
Food and Drug Administration,
Silver Spring, MD
    
Resources