BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Global Biodefense - ECPv6.18.0//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://globalbiodefense.com
X-WR-CALDESC:Events for Global Biodefense
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20230312T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20231105T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20240310T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20241103T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20250309T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20251102T060000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20241114T093000
DTEND;TZID=America/New_York:20241114T170000
DTSTAMP:20241107T191142Z
CREATED:20241107T191142Z
LAST-MODIFIED:20241107T191142Z
UID:61954-1731576600-1731603600@globalbiodefense.com
SUMMARY:Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral Vectors
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on the clinical use of integration site analysis (ISA) during long term follow-up following administration of gene therapies with integrating viral vectors. \nIn this workshop\, FDA will convene a panel of external experts to discuss the risk of insertional mutagenesis and best practices for ISA method design\, data analysis\, and clinical interpretation. The workshop participants will include research scientists with experience in vector design and ISA\, as well as clinician-scientists with expertise in clinical interpretation of ISA data. \nFocus for this Workshop\nAs of 2024\, twelve approved and hundreds of investigational cell-based gene therapies use integrating viral vectors. While stable integration may have considerable therapeutic benefits\, integration into genomic DNA can alter host gene expression and may contribute to secondary malignancies via insertional mutagenesis. Additionally\, the choice of vector (e.g.\, lentivirus versus gammaretrovirus) and cell substrate (e.g.\, T cells versus CD34+ cells) may also contribute to this risk. \nISA is the established approach to identify vector insertion sites. However\, ISA method design and data interpretation are highly complex and product-specific. Moreover\, ISA methods may be costly and challenging to perform. There is a critical need to understand the best practices for product design and ISA method design\, execution\, and interpretation to facilitate efficient evaluation of complex gene therapy products and protect the public from potential serious adverse events. \nThis workshop will include discussions on the following topics: \n\nEffects of Cell Substrate and Vector Design on the Risk of Vector Insertion-Related Adverse Events\nISA Methodology\, Assay Design\, and Analytical Capabilities\nISA Analysis\, Quality Control\, and Data Reporting\nClinical Follow-Up for Integrating Viral Vectors\nUsing ISA to Inform Clinical Decisions\n\nFor current guidance on the role of ISA in clinical follow-up\, please refer to section V.F “Special Considerations Regarding Integrating Vectors” of the FDA Guidance for Industry “Long Term Follow-Up After Administration of Human Gene Therapy Products” dated January 2020 (https://www.fda.gov/media/113768/download). \n Registration is required.
URL:https://globalbiodefense.com/event/integration-site-analysis-during-long-term-follow-up-for-gene-therapies-with-integrating-viral-vectors/
CATEGORIES:Conference,Government Hosted
LOCATION:
END:VEVENT
END:VCALENDAR