News

Feedback Needed: Community Perspectives: Needed Standards in Regenerative Medicine Report

Washington, DC (May 15, 2019) — SCB has created a new report to help inspire and align community action around advancing the standards that could make the greatest difference to the regenerative medicine field. A draft version of the report is now available and open for comments through May 30, 2019. […]


TWO SCB Workshops Engage Gene Therapy and Tissue Engineering Stakeholders in Prioritizing Standards Needs

Washington, DC (May 10, 2019) — SCB recently hosted two workshops to engage gene therapy and tissue engineering stakeholders in identifying and prioritizing standards needs. The workshops were aligned with the timing of existing regenerative medicine events as a way of gathering valuable community input and feedback on standards from those who had come together to discuss their sector’s challenges and opportunities. […]


MEET Peter Reczek, SCB’s New Executive Director

Washington, DC (April 17, 2019) — On April 8, Peter Reczek joined the SCB team as our new Executive Director, bringing more than 25 years of experience leading technology programs in academia, industry, and government. We sat down with Peter to learn more about his past experience and his plan to execute SCB’s vision. […]


Feedback Needed: Updated Spring 2019 Regenerative Medicine Standards Landscape Report

Washington, DC (April 15, 2019) — A draft version of the updated Spring 2019 Regenerative Medicine Standards Landscape is now available and open for comments through April 30, 2019. Because the report is an evolving document, we are seeking feedback that can help us improve the report’s accuracy and completeness. […]


PARTICIPANTS SHARE THEIR THOUGHTS ON the Realizing the Benefit of 21st Century Cures through Standards Development Workshop

Washington, DC (March 25, 2019) — SCB sat down with a few of the workshop participants — representing regulatory, industry, and academia — to hear their feedback on the workshop and how they believe it will help the regenerative medicine community. […]


SCB Perspectives: Achievements of the Realizing the Benefit of 21st Century Cures through Standards Development Workshop

Washington, DC (March 22, 2019) — SCB President Richard McFarland shares his thoughts on the success of the recent workshop, which brought together representatives from throughout the regenerative medicine community who shared knowledge and engaged in key conversations that will drive the future of regenerative medicine standards. […]


Read the Q&A with SCB’s Newly elected Executive Committee Officers

Washington, DC (March 18, 2019) — SCB’s recently conducted its second Executive Committee officer election, selecting Dr. Richard McFarland as President, Michael Orrico as Treasurer, and April Lynch as Secretary. Read the Q&A about their vision for the work of SCB for the next two years. […]


Get a Preview of the topics for the Realizing the Benefit of 21st Century Cures through Standards Development Workshop

Washington, DC (March 6, 2019) — The 2-day workshop—co-hosted by FDA, NIST, SCB, and Nexight Group—is fast approaching! Get a preview of the key topics that will be covered by presenters and panelists from SDOs, government agencies, and industry representing key players in the regenerative medicine community. […]


RESCHEDULED: REALIZING THE BENEFIT OF 21ST CENTURY CURES THROUGH STANDARDS DEVELOPMENT

Washington, DC (February 8, 2019) — SCB, FDA, NIST, and Nexight Group are hosting a workshop on March 18-19, 2019 at the NIST National Cybersecurity Center of Excellence (NCCoE) in Rockville, Maryland. Targeted stakeholders for the workshop include: RM manufacturers, clinical trial sponsors, contract manufacturers, academic institutions, raw material providers, and logistics delivery providers. […]


PDA Launches Project on Cell Cryopreservation Standards in Partnership with SCB

Washington, DC (February 6, 2019) — This new cryopreservation standardization project was initiated by the Parenteral Drug Association (PDA), which has enlisted the help of SCB to coordinate development of a consensus-based standard that would provide a common framework for selecting cryopreservation methods. […]


SCB Launches New Project on Advancing Bioink Standards

Washington, DC (January 23, 2019) — SCB has launched a new standards advancement project, Specification for Printability of Bioink, that centers on the intersection of regenerative medicine with another emerging field: additive manufacturing. Learn how SCB is helping coordinate the development of standards for bioink, the material used in 3D bioprinted tissues to mimic the extracellular matrix that supports cells. […]


SCB Perspectives: ISO Publishes Three-Part Documentary Standard on Ancillary Materials for Cell Manufacturing Processes

Washington, DC (December 17, 2018) — SCB Board Member Claudia Zylberberg of Akron Biotech discusses how one of the first standards advancement projects SCB was involved in, Ancillary Materials Used in Cellular Therapy Production, has culminated in the publication of a three-part documentary ISO standard. […]


Save the date: Realizing the benefit of 21st Century Cures through Standards Development

Please note: This workshop has been postponed due to the partial U.S. government shutdown.

SCB encourages you to save the date for a workshop that SCB, FDA, NIST, and Nexight Group are hosting on January 14-15, 2019 at the NIST National Cybersecurity Center of Excellence (NCCoE) in Rockville, Maryland. Targeted stakeholders for the workshop include: RM manufacturers, clinical trial sponsors, contract manufacturers, academic institutions, raw material providers, and logistics delivery providers. […]


SCB Perspectives: Successes in Advancing Standards as a Community

Washington, DC (October 8, 2018) — Dr. Sven Kili, SCB Vice President, highlights several recent SCB projects that have advanced regenerative medicine standards to the point where drafts have been submitted to standards development organizations, thanks in large part to engaged community participation. […]


SCB Perspectives: BioFabUSA Fall Summit Preview

Washington, DC (September 18, 2018) — SCB Secretary Richard McFarland discusses the BioFabUSA 2018 Fall Summit, which focuses on leveraging operational strategies for transitioning engineered tissues and organs from research and clinical trials to commercialization and patient adoption learned from the successes and best practices of pioneers in the biofabrication community, and why standards have a prominent place in the agenda as a critical facilitator of tissue engineering product availability. [...]


SCB Perspectives: New Progress in RMTM, Scaffolds, and Cell Transportation Standards

Washington, DC (September 14, 2018) — As part of the new SCB Perspectives series, SCB President Dr. Jiwen Zhang discusses several SCB standards projects she’s excited about and how these projects can ultimately contribute to safer regenerative medicine products for patients. [...]


SCB Co-Convenes Characterization of Fiber-Based Scaffolds Workshop

Washington, DC (August 13, 2018) — On August 10, SCB, the National Institute of Standards and Technology (NIST), BioFabUSA, and ASTM International hosted a workshop to gather input from the regenerative medicine community on standards needs related to the characterization of fiber-based scaffolds. SCB will use input gathered at the workshop to support ASTM International in drafting a standard for fiber-based scaffolds. […]


SCB Engages Cell and Gene Therapy Community at CASSS Inaugural Meeting

Washington, DC (July 13, 2018) — On July 10-12, professional scientific society CASSS held its inaugural Cell & Gene Therapy Products (CGTP): Manufacturing, Quality and Regulatory Considerations meeting in Rockville, Maryland. SCB was not only an exhibitor partner at the event but also engaged with the cell and gene therapy community through an interactive session focused on recommendations for improving processes and criteria for regenerative medicine standards development and effective information sharing. Additionally, SCB President Jiwen Zhang gave a presentation and spoke on a panel where she discussed what SCB is doing to address the need for standards development in the CGTP space. […]


SCB and Nexight Group Host Third Regenerative Medicine Standards Webinar

Washington, DC (June 29, 2018) — On June 26, 2018, SCB and Nexight group hosted an informative webinar, featuring five presenters, focused on Regenerative Medicine Standards Development Processes and how the community can get involved. […]


SCB Engages with Regenerative Medicine Standards Development Stakeholders at BioFab’s 2018 Spring Summit

Washington, DC (June 7, 2018) — On June 5, 2018, as part of BioFab USA’s 2018 Spring Summit, Nexight Group and SCB conducted a workshop with more than 15 experts in product development, research and development, advanced manufacturing, and standards development to gather input on the development of processes and tools needed to improve the identification, prioritization, and feasibility assessment of standards needs for regenerative medicine. […]


SCB Engages with Regenerative Medicine Standards Development Stakeholders at ASGCT

Washington, DC (May 20, 2018) — On May 16, 2018, as part of the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in Chicago, Illinois, Nexight Group and SCB conducted a workshop with stakeholders in the regenerative medicine community to gather input on the development of processes and tools that will be used to improve the identification, prioritization, and feasibility assessment of standards needs for regenerative medicine. [...]


Sharing the Standards Development Mission at ISCT 2018

Washington, DC (May 7, 2018) — On May 2–5, 2018 in Montreal, Nexight Group and SCB participated in the annual meeting of the International Society for Cellular Therapy (ISCT), a global society of more than 1,500 clinicians, researchers, regulators, technologists, and industry partners representing more than 50 countries with a shared vision of translating cellular therapy into safe, effective therapies to improve patients’ lives worldwide. SCB President Jiwen Zhang was invited to speak about SCB and its efforts to advance standards in regenerative medicine in a session entitled “Progress in the World of Standards for Cell and Gene Therapies.” [...]


SCB Co-Convenes Rapid Microbial Testing Methodology (RMTM) Workshop

Washington, DC (April 11, 2018) — On April 10, 2018, SCB, the National Institute of Standards and Technology (NIST), BioFabUSA, and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) hosted a workshop to gather input from the regenerative medicine community on advancing rapid microbial testing methodology (RMTM) technologies and standards for sterility testing. [...]


Nexight Group and SCB Hold Second Webinar on Regenerative Medicine Standards

Washington, DC (March 13, 2018) — Nexight Group and SCB today held their second webinar aimed at increasing the awareness of available and potential standards and the benefits they can bring to the regenerative medicine community. As part of the FDA-funded project to identify process recommendations and criteria to identify and prioritize standards needs and advance standards for regenerative medicine therapies, the Overview Of Standards For The Regenerative Medicine Landscape webinar featured an overview of the landscape of available standards and a case study on sterility testing requirements. [...]


SCB and Nexight Group Publish Landmark Regenerative Medicine Standards Landscape Report

Washington, DC (February 28, 2018) – With input from more than 30 academic institutions, standards development organizations (SDOs), and other industry experts, Nexight Group and The Standards Coordinating Body (SCB) published The Regenerative Medicine Standards Landscape—developed with funding from the U.S. Food and Drug Administration (FDA)—a first-of-its-kind report that outlines nearly 200 standards currently relevant to regenerative medicine therapies and identifies opportunities for future standards development in the field. [...]


Nexight Group and SCB Hold Webinar on Regenerative Medicine Standards

Washington, DC (December 30, 2017) — In December 2017, Nexight Group and SCB held the first in a series of webinars aimed at increasing the awareness of available and potential standards and their benefit to the regenerative medicine community. As part of the FDA-funded project to identify process recommendations and criteria to identify and prioritize standards needs and advance standards for regenerative medicine therapies, the The Need for Standards in Regenerative Medicine webinar featured case studies demonstrating how the development of standards positively influenced work in two different fields of regenerative medicine. [...]


Significant Efforts Underway to Lay the Foundation for Standards Development in Regenerative Medicine Therapies  

Washington, DC (October 25, 2017) – On September 27, 2017, the U.S. Food and Drug Administration awarded a one-year contract to Nexight Group to engage with experts to recommend processes and outline a strategic plan for developing standards in regenerative medicine and advanced therapies. The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-based Drug Discovery (SCB) has partnered with Nexight to provide subject matter technical support for this effort. [...]


Newly Created Standards Coordinating Body Seeks to Advance Development and Establishment of Regenerative Medicine Standards 

Washington, DC (Marketwired - Jan 19, 2017) The international Standards Coordinating Body for regenerative medicines (SCB), in coordination with the Alliance for Regenerative Medicine (ARM), today announced its formal launch as a public-private partnership for coordinating, prioritizing and supporting standards that advances process, measurement and analytical techniques to support the global availability of products across the gene and gene-modified cell therapy, cell therapy, cell-based drug discovery, tissue engineering and biomaterials sectors. [...]


SCB and NIST to Work Together to Advance Development and Establishment of Industry-Wide Standards

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. [...]