Community Publications
The following publications from across industry, government, and academia address current challenges, opportunities, and plans for action in the regenerative medicine field. These collected publications provide a broad overview of current thinking in the community to help align efforts around common priorities. Please contact SCB if you know of a publication that should be featured on this list.
2021
The Importance of Feasibility Assessments in the Standards Development Process
Cell & Gene, July 2021
Author: Catherine Zander, Ph.D., Standards Coordinating Body
2020
Innovation in the Time of COVID-19: ARM Global Regenerative & Advanced Therapy Medicine Sector Report (H1 2020)
August 2020
Author: Alliance for Regenerative Medicine
ARM Annual Report & Sector Year in Review: 2019
March 2020
Author: Alliance for Regenerative Medicine
Risk Assessment Approach to Microbiological Controls of Cellular Therapies
PDA Journal of Pharmaceutical Science and Technology, January 2020
Authors: Anthony M. Cundell, Don Singer, Irving Ford, Scott Drummond, and Dona Reber
2019
TOWARDS A COMMON FRAMEWORK FOR DEFINING ANCILLARY MATERIAL QUALITY ACROSS THE DEVELOPMENT SPECTRUM
Cytotherapy, December 2019
Authors: Oliver Ball, Claudia Zylberberg
See also: SCB-coordinated project on ancillary materials used in cellular therapy production
WORKSHOP ON THE CHARACTERIZATION OF FIBER‐BASED SCAFFOLDS: CHALLENGES, PROGRESS, AND FUTURE DIRECTIONS
Journal of Biomedical Materials Research, December 2019
Authors: Lexi Garcia, Sherif Soliman, Michael P. Francis, Michael J. Yaszemski, Jayesh Doshi, Carl G. Simon Jr., Rebecca Robinson‐Zeigler
See also: SCB-coordinated project on fiber-based scaffolds
CELL MANUFACTURING ROADMAP TO 2030
November 2019
Authors: National Cell Manufacturing Consortium; National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT); Georgia Tech, Marcus Center for Therapeutic Cell Characterization and Manufacturing; Prepared by Nexight Group
CELL AND GENE THERAPY GMP MANUFACTURING IN THE UK: CAPABILITY AND CAPACITY ANALYSIS
November 2019
Author: Cell and Gene Therapy Catapult
CLINICAL TRIALS IN EUROPE: RECENT TRENDS IN ATMP DEVELOPMENT
October 2019
Author: The Alliance for Regenerative Medicine
CELL AND GENE THERAPY CATAPULT ANNUAL REVIEW 2019
July 2019
Author: Cell and Gene Therapy Catapult
GETTING READY: RECOMMENDATIONS FOR TIMELY ACCESS TO ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) IN EUROPE
July 2019
Author: The Alliance for Regenerative Medicine
LEADING INNOVATION: THE UK’S ATMP LANDSCAPE
July 2019
Authors: The Alliance for Regenerative Medicine, UK Bioindustry Association
REGENERATIVE MEDICINE & ONCOLOGY REPORT
June 2019
Author: The Alliance for Regenerative Medicine
REGENERATIVE MEDICINE & INHERITED BLOOD DISORDERS REPORT
April 2019
Author: The Alliance for Regenerative Medicine
REGENERATIVE MEDICINE & RARE DISEASES REPORT
February 2019
Author: The Alliance for Regenerative Medicine
2018
CIRCULAR OF INFORMATION FOR THE USE OF CELLULAR THERAPY PRODUCTS
October 2018
Authors: AABB, America’s Blood Centers (ABC), American Red Cross (ARC), American Society for Apheresis (ASFA), American Society for Blood and Marrow Transplantation (ASBMT), College of American Pathologists (CAP), Cord Blood Association (CBA), Foundation for the Accreditation of Cellular Therapy (FACT), ICCBBA, International Society for Cellular Therapy (ISCT), Joint Accreditation Committee of ISCT and EMBT (JACIE) Accreditation Office, National Marrow Donor Program (NMDP), World Marrow Donor Association
FDA AND NIST COLLABORATION ON STANDARDS DEVELOPMENT ACTIVITIES SUPPORTING INNOVATION AND TRANSLATION OF REGENERATIVE MEDICINE PRODUCTS
Cytotherapy, June 2018
Authors: Judith A. Arcidiacono, Steven R. Bauer, David S. Kaplan, Claire M. Allocca, Sumona Sarkar, Sheng Lin-Gibson
SUMMARY OF THE NIST AND U.S. FDA CELL COUNTING WORKSHOP: SHARING PRACTICES IN CELL COUNTING MEASUREMENTS
Cytotherapy, June 2018
Authors: Sheng Lin-Gibson, Sumona Sarkar, John Elliot
ALLIANCE FOR REGENERATIVE MEDICINE 2018 ANNUAL DATA REPORT
February 2018
Author: Alliance for Regenerative Medicine
2017
POINTS TO CONSIDER FOR CELL MANUFACTURING EQUIPMENT AND COMPONENTS
Cell & Gene Therapy Insights, December 2017
Authors: Sheng Lin-Gibson, Brian Hanrahan, Sandro Matosevic, Aletta Schnitzler, Jiwen Zhang, & Claudia Zylberberg
COMMENTARY: NEW BODY FOR REGENERATIVE MEDICINE LAUNCHED
MedNous, a publication of Evernow Publishing Ltd., May 2017
Alexa Machikas and Elena Kfoury
2016
GUIDELINES FOR STEM CELL RESEARCH AND CLINICAL TRANSLATION
May 2016
Author: International Society for Stem Cell Research (ISSCR)
Presentations
From Cell and Gene Therapy Catapult
From NIST