ISBT 128 Labeling Standard for Cells Collected for Cellular Therapy Manufacturing: Comments Due October 18th
Thanks to the teamwork of several stakeholders in apheresis cell collection, the field is one step closer toward label standardization. Comments are needed in the most recent draft ISBT 128 label published by ICCBBA by October 18, 2020.
As reported in previous Just the FACTs newsletters, a multi-stakeholder working group led by the Standards Coordinating Body and the Deloitte NextGen Industry Working Group, consisting of industry, registries, accrediting organizations, technology providers, and apheresis and quality subject matter experts, released a draft standard labeling proposal for collected cells.
Public comments following the release of that draft indicated support for ISBT 128 labeling for starting material intended for further manufacturing. After reviewing these comments, ICCBBA has released a draft Standard for Labeling of Collection Products for Cellular Therapy Manufacturing.
This Standard builds on existing ISBT 128 standards, including compatible label dimensions and essential traceability information, but also accommodates sponsor/manufacturer information. As stated by the ICCBBA website, “it is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.” Although the standard was written with apheresis in mind, the label could be used on products collected from other sources and intended for further manufacturing.
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.