News
SCB Hosts Webinar with FDA: CBER's Consensus Standards Recognition Program
On Wednesday, February 21, the Standards Coordinating Body (SCB) held a webinar with speakers from the FDA and SCB to introduce and explain the use of the recently published CBER document, “Guidance for Industry: Voluntary Consensus Standards Recognition's Program for Regenerative Medicine Therapies” as well as the initial list of recognized voluntary consensus standards. After the presentations, FDA speakers, including Judy Arcidiacono, Malcolm Moos, and Archana Siddam answered participant questions.
SCB Co-Hosts Standards Needs Identification Workshop
Washington, DC (January 26, 2024) — SCB, FDA, NIST, USP, and Nexight Group co-hosted a November 2023 workshop centered on the identification of standards needs for gene and cell therapy product assessment. […]
SCB Supports Launch of FDA CBER Standards Recognition Program
Washington, DC (October 5, 2022) — Learn how SCB has taken a leading role in both increasing community understanding of the new FDA CBER standards recognition program and gathering feedback to ensure stakeholder perspectives are considered by the FDA. […]
Working Group Spotlight: Microphysiological Systems
Washington, DC (September 29, 2022) — SCB is coordinating standards development for three interrelated areas within microphysiological systems (MPS), which have the potential to change the paradigm of research in human systems and the development of new medicines and therapies. […]
Ask SCB: All About the FDA Standards Recognition Program
Washington, DC (August 8, 2022) — SCB staff addresses some key questions about FDA’s new guidance around a Center for Biologics Evaluation and Research (CBER) standards recognition program focused on regenerative medicine therapies. […]
Ask SCB: How Does SCB Promote Community Participation in Standards?
Washington, DC (June 28, 2022) — This latest installment of our Ask SCB series addressed some of the strategies SCB uses to make sure that standards have the right input to represent the needs of the stakeholders they will impact. […]
Working Group Spotlight: Treatment Center Data Management Standards
Washington, DC (June 13, 2022) — SCB is coordinating a working group focused on developing a standard on common needs and requirements for interoperability of treatment center data management platforms. […]
Working Group Spotlight: Methods and Processes for Assessing Cell Identity
Washington, DC (May 11, 2022) — SCB is coordinating a working group in the development of a documentary standard on cell identification terminology and product-specific approaches to determining cell identity. […]
Meet the Staff: Justin Barch, Executive Director
Washington, DC (May 4, 2022) —Justin Barch recently joined SCB as its new Executive Director, working with the staff, Executive Committee, and Board of Directors to support SCB’s sustainability and fulfill its mission. Learn more about what brought him to SCB and his goals for SCB’s future. […]
Ask SCB: What Are Some Common Standards Myths?
Washington, DC (May 2, 2022) — In a new installment of our Ask SCB series, SCB staff dispel some common myths and misunderstandings about standards in regenerative medicine. […]
NIST Develops Cell Counting Method EValuation Tool (COMET)
Washington, DC (April 1, 2022) — NIST has developed an open-access, web-based tool to aid the statistical analysis recommended by ISO 20391-2:2019: Biotechnology — Cell counting — Part 2, a regenerative medicine standard that SCB supported. […]
SCB Supports PDA’s New Cryopreservation of Cells Standard
Washington, DC (March 7, 2022) — SCB and the Parenteral Drug Association (PDA) announce the publication of a new cryopreservation of cells standard. The efficiency of its development showcases how community coordination can accelerate the path to publication. […]
SCB and BioPhorum Sign Memorandum of Understanding
Washington, DC (March 1, 2022) — SCB and BioPhorum have signed a memorandum of understanding (MOU) to bring the combined focus of the organizations together to continue to accelerate the rate of progress of the gene, cell, and regenerative medicine community. […]
Ask SCB: Why Participate in Standards Development?
Washington, DC (December 20, 2021) — In the latest installment of our recurring “Ask SCB” feature, SCB staff present six key ways that participating in standards development can pay off for both you and your regenerative medicine organization. […]
SCB Seeks New Executive Director
Washington, DC (December 20, 2021) — SCB is seeking a new Executive Director to help us fulfill our mission of connecting the regenerative medicine community to the standards development process. Read the full position description. […]
Two New SCB-Coordinated Standards Published
Washington, DC (December 1, 2021) — Two SCB-coordinated projects have recently resulted in published standards: ISO 23033:2021 and ISO/TS 23565:2021. They join the list of seven other new regenerative medicine standards that have been published with SCB support since its launch in late 2017. […]
SCB SEEKS TO HIRE ADDITIONAL Scientific Program Manager
Washington, DC (September 20, 2021) — SCB is seeking applicants for a Scientific Program Manager position, responsible for coordinating and supporting a variety of SCB projects and activities, contributing to SCB’s management of programs, and carrying out other important operational duties. […]
ASK SCB: What Key Groups Make up the STandards Ecosystem?
Washington, DC (August 31, 2021) — In this new installment of the recurring “Ask SCB” feature, SCB staff discuss the major groups involved in standards development, how SCB fits into the standards ecosystem, and the kinds of challenges that SCB helps to address. […]
SCB Staff Spotlight: Alison Bramhall, MPH
Washington, DC (August 2, 2021) — SCB’s newest staff member is Scientific Program Manager Alison Bramhall. Read our Q&A with Alison, in which she talks about her background and her experience at SCB -- and shares some fun facts about herself. […]
Working Group Spotlight: Characterization of Human Cells for Therapeutic Use
Washington, DC (July 20, 2021) — An SCB working group has helped to accelerate the development of a draft standard to aid in assay selection for characterization of cells for regenerative medicine products. Learn how they contributed and how you can get involved in similar efforts. […]
SCB CURATES STandards Packages with ANSI
Washington, DC (July 12, 2021) — To help the regenerative medicine community more easily find standards relevant to their work processes, SCB has partnered with ANSI to develop standards packages tailored to specific application areas. […]
ASK SCB: How Standards Fit into the U.S. Regulatory Process
Washington, DC (June 21, 2021) — In the first installment of this new recurring feature, SCB staff members Dawn Henke and Katie Zander answer common questions from the regenerative medicine community related to standards and the U.S. regulatory process. […]
SCB Staff Spotlight: Catherine (Katie) Zander, PhD
Washington, DC (June 14, 2021) — Dr. Zander (Katie) joined the SCB team in July 2019. To help you get to know Katie a little better, we asked her some questions about herself, her experience at SCB, and what she has learned from leading standards working groups. […]
Working Group Spotlight: Characterization of Fiber-Based Scaffolds
Washington, DC (June 1, 2021) — The efforts of the Characterization of Fiber-Based Scaffolds project working group recently resulted in the publication of a new ASTM standard. Learn about the working group’s accomplishments and how to get involved in similar efforts. […]
SCB Perspectives: Upcoming SCB Initiatives and Events
Washington, DC (April 7, 2021) — Executive Director Bob Shaw offers at look at what’s coming next in 2021 for SCB, including the annual meeting, quarterly standards development forum, a standards implementation program for industry, and more. […]
Working Group Spotlight: Cell Collection Standards for Apheresis Products
Washington, DC (April 6, 2021) — Learn more about one of SCB standard project working groups, which works to advance standards to address variation in apheresis cell collection requirements. […]
SCB Launches Digital Regenerative Medicine Standards Portal
Washington, DC (March 18, 2021) — SCB has launched the Regenerative Medicine Standards Portal — a unique, interactive database of easily searchable information on published standards, in-development standards, and areas of standards need for the regenerative medicine community. […]
Community-Informed Report Identifies 9 New Areas of Need for Regenerative Medicine Standards
Washington, DC (January 28, 2021) — Based on direct input from the regenerative medicine standards community, SCB has published an updated version of the Community Perspectives: Needed Standards in Regenerative Medicine report. […]
SCB Updates Regenerative Standards Landscape Report
Washington, DC (January 20, 2021) — SCB has updated its comprehensive Regenerative Medicine Standards Landscape report. This latest updates includes 26 new standards, over 40 expanded standards descriptions, direct access links to standards, and more. […]
SCB Perspectives: Looking Ahead to SCB’s Important Work in 2021
Washington, DC (January 12, 2021) — For the first post of the new year, SCB Executive Director Bob Shaw shares his perspectives on SCB's areas of focus for 2021 and how regenerative medicine stakeholders can get involved.. […]
Meet the SCB Staff: Robert Shaw, Executive Director
Washington, DC (December 16, 2020) — The Standards Coordinating Body welcomed Robert (Bob) Shaw as its new Executive Director in October. Read the new Q&A with Bob to learn more about his background, his vision for SCB’s future, and the major trends he sees in regenerative medicine. […]
SCB-Led Effort Results in New Labeling Standard for Cell Therapy Products
Washington, DC (December 9, 2020) — The Standards Coordinating Body announces ST-018 ISBT-128, Standard Labeling of Collection Products for Cellular Therapy from ICCBBA, the result of an SCB-led project, and outlines the benefits for apheresis centers, manufacturers, patients.. […]
SCB Selects Robert Shaw As New Executive Director
Washington, DC (October 1, 2020) — The Standards Coordinating Body is pleased to welcome Robert (Bob) Shaw as its new Executive Director. With nearly 30 years of experience in the regenerative medicine and biotechnology fields, Bob will help guide SCB in its next phase of growth. […]
Expert Input Needed to Update Tissue ENgineering Lexicon
Washington, DC (August 31, 2020) — SCB and ARMI|BioFabUSA are updating ASTM F2312, Standard Terminology Related to Tissue Engineered Medical Products, which serves as the lexicon for the tissue engineering field. SCB is seeking experts from all regenerative medicine sectors to join a working group and share input on how they use tissue engineering terminology in their work. […]
Cell Transportation Standard Published
Washington, DC (July 30, 2020) — SCB announces that another SCB-coordinated project has culminated in the publication of a standard, ISO 21973: General requirements for transportation of cells for therapeutic use. Published in June 2020, the standard is now available for purchase. […]
Four New High-Priority STandards Initiatives
Washington, DC (June 30, 2020) — SCB is working to advance four new high-priority standards initiatives within the regenerative medicine space involving chain of custody/chain of identity labeling standards, microphysiological systems, tissue engineering lexicon, and base requirements for digital platforms for providers. […]
SCB SEEKS FULL-TIME EXECUTIVE DIRECTOR
Washington, DC (June 25, 2020) — SCB is seeking applicants for a full-time Executive Director to partner with the full committee and Board of Directors to successfully lead and manage SCB so the organization can achieve its strategic direction. […]
SCB Introduces a New Logo
Washington, DC (June 1, 2020) — SCB has adopted a new logo, which better illustrates its mission of accelerating regenerative medicine standards advancement through community engagement, coordination, and education. […]
STANDArds Advancement Continues During the Pandemic
Washington, DC (May 29, 2020) — As the world continues to adapt to new ways of collaborating, SCB highlights some of the ways standards advancement is continuing during the pandemic. […]
SCB Launches Project to update ISBT 128 Labeling Standard
Washington, DC (April 7, 2020) — SCB has launched a new project to update the ISBT 128 labeling standard for apheresis products intended for use in regenerative medicine manufacturing. Learn more about how the project evolved and how you can get involved. […]
SCB Perspectives: The Impact of Collaboration
Washington, DC (April 2, 2020) — The SCB staff discusses how collaboration within the regenerative medicine community is helping to accelerate standards advancement to improve product safety, quality, and manufacturing efficiency. […]
Safety First: SCB Continues Operations Safely During Coronavirus Crisis
Washington, DC (March 27, 2020) — Executive Director Peter Reczek shares an update on precautions the SCB organization is taking regarding the COVID-19 pandemic. […]
Meet the SCB Staff: Dawn Henke
Washington, DC (February 24, 2020) — Dawn Henke, PhD, was one of SCB’s first full-time staff members, joining as a technical program manager in late December 2017. Dawn has extensive experience in the advanced biological sciences and has played an active role in the regenerative medicine community throughout her career. Learn more about her past experience and her perspective on SCB’s role in the regenerative medicine community. […]
Executive Director’s Corner
Washington, DC (January 21, 2020) — To welcome the new year, Executive Director Peter Reczek reflects on SCB’s accomplishments from 2019 as well as its plans and future outlook for 2020. […]
UPDATED WINTER 2020 NEEDED Standards REPORT Now Available
Washington, DC (January 14, 2020) — An updated, winter 2020 version of the Community Perspectives: Needed Standards in Regenerative Medicine report is now available. This update incorporates feedback received from industry, academia, subject matter experts, and standards developing organizations, as well as some key modifications and improvements. […]
SCB Launches Two New Bioprinting Standards Efforts
Washington, DC (December 2, 2019) — Bioprinting presents a great opportunity to speed testing timelines for new therapies and help treat various health conditions through 3D printing of synthetic human tissues. Learn more about SCB’s newly launched standards projects related to bioprinter software and data governance and bioprinting equipment. […]
Meet the SCB Staff: Sakeenah Muwwakkil
Washington, DC (November 7, 2019) — In August 2019, Sakeenah Muwwakkil joined the SCB team as Program Administrative Assistant, a role in which she leverages her broad-ranging experience providing operational support in the health and medicine field. Learn more about her past experience and her perspective on SCB’s role in the regenerative medicine community. […]
Part 2 of SCB-Coordinated Standard on Cell Counting PUBLISHED
Washington, DC (October 23, 2019) — ISO recently published Part 2 of an SCB-coordinated standard on cell counting. New standards in this area will help improve the precision of cell counting methods, allowing more accurate assessments of product quality and an improved ability to compare different data sets to support product innovation. […]
Meet the SCB Staff: Katie Zander, PhD
Washington, DC (September 25, 2019) — In July, Catherine (Katie) Zander, PhD, joined the SCB team as a technical program manager, bringing with her a combination of leadership and technical skills. We sat down with Katie to learn more about her past experience and her perspective on SCB’s role in the regenerative medicine community. […]
Read the Q&A with SCB’s New Vice President
Washington, DC (August 20, 2019) — Jessica Carmen, Ph.D., was elected to serve as SCB’s Vice President in June, joining the new Executive Committee officers who took office in March for the 2019–2021 term. We sat down with Dr. Carmen to learn more about her experience and her vision for the role of SCB over the next two years. […]
Updates on Regenerative Medicine Standards in Development: ISO
Washington, DC (August 6, 2019) — SCB Senior Technical Program Manager Dawn Henke attended the June 2019 ISO / TC 276 Biotechnology meeting in Tokyo and developed a list of highlights and updates on both SCB-coordinated ISO standard projects and other in-development ISO standards. […]
Updates on Regenerative Medicine Standards in Development: ASTM
Washington, DC (August 6, 2019) — Technical Program Manager Kelly Sauerwein recently attended the ASTM Committee F04 meeting in Denver, where she discussed the status of SCB-coordinated projects and gathered valuable community input and updates on regenerative medicine standards. […]
SCB Conducts Global Outreach at World Advanced Therapies and Regenerative Medicine Congress
Washington, DC (July 8, 2019) — As part of its mission to engage and educate on a global scale, SCB presented at the 2019 World Advanced Therapies and Regenerative Medicine Congress in London on May 15–17. The conference provided an extraordinary opportunity for SCB to educate the community about standards and invite their participation in standards development. […]
SCB HiGHLIGHTED ON FDA Resource Page for Regenerative Medicine Standards Development
Washington, DC (June 13, 2019) — FDA recently published an online resource page summarizing its efforts to coordinate the development of regenerative medicine standards. In particular, this resource page highlights the FDA-funded work that SCB and Nexight Group have undertaken to support FDA’s efforts. […]
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 June 19, 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. [...]