Although February is the shortest month of the year, it is also a very busy month! The FACT office is preparing for several educational events, committee meetings, and activities at the TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR. The Second Edition FACT Common Standards for Cellular Therapies will be published on March 15, 2019, and the public comment period for the Seventh Edition NetCord-FACT International Standards for Cord Blood Banking, Release, and Administration will end on March 1, 2019. Many new events are scheduled for May and June, including a new workshop opportunity at the Canadian Bone Marrow Transplant Group Annual Meeting. As always, FACT is grateful for our volunteers who help make all of this possible!
This month’s newsletter features educational articles, industry news, and upcoming events and activities. Articles in this volume include:
- FACT Standards Development Activities
- Call for FACT Volunteers
- FACT Announces New Educational Workshop Opportunities
- FACT Inspectors are Invited to Social Hour during TCT Meetings
- Upcoming Educational Events
- Cellular Therapy Community Corner
I hope you find our information interesting and useful. We look forward to working with all of you in 2019!
Dennis A. Gastineau, MD
FACT Common Standards, Second Edition Nearing Publication
The Second Edition FACT Common Standards for Cellular Therapies will be published on March 15, 2019. Once published, the updated Standards, summary of changes, and crosswalks will be available on the FACT website for reference, and printed copies of the Standards will be available for purchase from the FACT store.
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. In early stage product development and early phase clinical trials, these Standards provide the quality management infrastructure to facilitate patient and data accrual to advance the therapy.
NetCord-FACT International Cord Blood Standards, Seventh Edition Available for Public Review and Comment
The NetCord-FACT Standards Committee completed its initial review of the draft Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.
The draft Standards and accompanying Accreditation Manual are published for inspection and public comment for a 90-day period. Comments will be accepted through April 1, 2019.
These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through April 1, 2019.
Standards Committee to Initiate FACT-JACIE International Hematopoietic Cellular Therapy Standards and FACT Immune Effector Standards Development
FACT is creating the Steering Committee and Subcommittees that will develop the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and the Second Edition FACT Immune Effector Cell Standards.
In addition to the existing subcommittees (clinical, collection, processing, and quality management), an immune effector cell subcommittee will be added to the Hematopoietic Cellular Therapy Standards development process to ensure consistency between the two sets of Standards.
Standards development will begin this summer, with the first draft scheduled for public comment in April 2020.
Dear FACT Colleague:
The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
In light of your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the committees with current vacancies and either nominate yourself or a colleague to serve as a committee member.
Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.
– Attend monthly one-hour teleconference
– Develop content for workshop and webinar presentations
– Assess effectiveness of training events and recommend improvements
– Serve as a FACT workshop presenter at various meetings
– Develop content for inspector continuing education
Quality Management Committee
Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.
– Attend monthly one-hour teleconference
– Maintain and update the FACT Quality Management Handbook
– Offer a comprehensive schedule of webinars related to quality management activities
– Develop content for quality “boot camps”
– Develop quality metrics for gauging the performance of the FACT inspection and accreditation process, including effectiveness, efficiency, and customer satisfaction
FACT-CIBMTR Data Audit Committee
Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.
– Attend monthly one-hour teleconference
– Develop mechanisms by which CIBMTR and FACT can coordinate audits and inspections of data management processes within transplant centers
– Develop a collaborative approach to evaluate the results of FACT inspections with CIBMTR’s data audit findings to ensure a coordinated response to the transplant center
– Participate in the joint FACT-CIBMTR data review process by assessing programs’ progress on implementing corrective action plans
– Develop education and provide assistance to programs throughout the accreditation cycle to achieve quality improvement in data management
Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of technology and FACT’s online presence.
– Attend quarterly one-hour teleconference
– Suggest ideas to enhance user’s experience using the Accreditation Portal
– Evaluate and review new portal features
– Evaluate new technologies to improve business processes
– Interface with other committees to identify data needs to develop and publish reports
– Evaluate a mobile app option for FACT’s resources such as Standards, announcements, newsletter, and education
Please submit your interest in serving as a committee member along with a description of your qualifications to Linda Miller at email@example.com by March 1, 2019.
The contributions of our volunteer FACT inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.
Dennis Gastineau, MD
Linda Miller, MPA
Chief Executive Officer
In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.
The Cellular Therapy Community Corner provides a forum for the cell therapy community that includes educational opportunities, recent publications, and upcoming events.
ASGCT Debuts Patient Education Program
The American Society of Gene & Cell Therapy (ASGCT) announced the first release of the Society’s Patient Education program, a new initiative for 2019. Designed by ASGCT committee volunteers in coordination with patient advocacy groups, the new patient-centered portal is designed to educate and inform patients, families, and the public on the status and promise of gene and cell therapies.
The following Sessions are now live on ASGCT.org:
Gene Therapy 101, which includes the following information:
Disease Treatments, which includes the following information:
- Spinal Muscular Atrophy
- X-Linked Myotubular Myopathy
- Leukodystrophy (coming February 15)
- Blood Disorders (coming February 22)
- Inherited Retinal Disorders (coming February 28)
All topics ultimately provide patients and patient advocates with video, text, and infographic resources to share with various stakeholders. ASGCT encourages people to share these resources with their friends and family.
FDA Outlines Planned Policies to Advance Development of Safe and Effective Cell and Gene Therapies
Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research
On January 15, 2019, FDA announced its plans to provide policy guidance and advance its drug development network over the coming year in response to increases in cell and gene therapy investigational new drug (IND) applications. The FDA anticipates receiving more than 200 INDs per year by 2020 and approving 10 to 20 cell and gene products a year by 2025.
The full statement outlines FDA’s policy agenda as it relates to these technologies.
Find a clinical trial through the Jason Carter Clinical Trials Program Offered by The National Marrow Donor Program®/Be The Match®
The National Marrow Donor Program®/Be The Match® is offering a new program, The Jason Carter Clinical Trials Program, designed to help patients with blood cancers or blood disorders and their families find and join clinical trials. Funding was provided by the Carter family, in memory of their son and brother, Jason Carter. This free program offers:
- One-on-one telephone support and information from a clinical trial nurse to help patients and families navigate their clinical trial search.
- Easy-to-use, web-based search tool to find relevant clinical trials: JasonCarterClinicalTrialsProgram.org
- Easy-to-understand educational resources for patients and families to learn about cancer treatment options and clinical trials.
On the JCCTP.org website, there are patient-friendly clinical trial descriptions related to leukemia, lymphoma, MDS, aplastic anemia, and more. Treatments in some of these clinical trials include blood or marrow transplant, but many others trials include the latest cell therapies such as CAR T and immunotherapies.
Patients can also apply for financial assistance from the Drs. Jeffrey and Isabel Chell Clinical Trials Travel Grant. This grant works to offset the cost of travel related to clinical trial participation. Grant eligibility information and application are available on JasonCarterClinicalTrialsProgram.org.