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X-WR-CALDESC:Events for Global Biodefense
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DTSTART;VALUE=DATE:20240312
DTEND;VALUE=DATE:20240318
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SUMMARY:2024 Fungal Genetics Conference
DESCRIPTION:The 2024 Fungal Genetics Conference\, the premier meeting for fungal genetics researchers\, will be held 12-17 March 2024 in Pacific Grove\, California \nThe Fungal Genetics Conference is the premier meeting for the international community of fungal geneticists. The conference features cutting-edge research spanning a diverse array of topics\, including comparative and functional genomics\, gene regulation\, cell biology\, biochemistry and metabolism\, population and evolutionary genetics\, host-pathogen interactions\, genetics education\, and more. \nThis is considered by many to be the pre-eminent meeting in this area and promotes interaction between researchers interested in medical pathogens\, plant pathogens\, saprobic fungi and symbiotic fungi. \n\nHighlighted topics and sessions include:\nFunctional genomics illuminates foundational biology and evolution\nNew technologies to understand and control antifungal resistance\nMultilevel regulatory circuits to understand fungal metabolism\nUnderneath\, within\, and around: pathogens and symbionts\nGenetic control of primary and secondary metabolism\nFungi at the cutting edge – microfluidics and other new tools\nMachine Learning in Fungal Genetics\nExperimental evolution with fungi\nInteractions of fungi with the biosphere\nMorphogenesis at multiple scales\nHorizontal gene transfer\, meiotic drive\, and related phenomena\nBiofilms\, biocontrol\, and disease prevention by genome engineering\nUnderstanding fungal pathogenesis by genomics\nSignaling in the gas phase\nPhase separation and sequestration\n\nA virtual attendance option is planned in addition to the in-person meeting. Virtual participant registration fees for full-time residents of any country with low- and middle-income economies will be waived. \nPlease visit the Genetics Society of America 2024 Fungal Genetics Conference website for more the latest information and to register.
URL:https://globalbiodefense.com/event/2024-fungal-genetics-conference/
LOCATION:Asilomar Conference Grounds\, 800 Asilomar Ave\, Pacific Grove\, CA\, 93950\, United States
CATEGORIES:Conference
ORGANIZER;CN="Genetics Society of America":MAILTO:society@genetics-gsa.org
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DTSTART;TZID=America/New_York:20241114T093000
DTEND;TZID=America/New_York:20241114T170000
DTSTAMP:20241107T191142Z
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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/
LOCATION:
CATEGORIES:Conference,Government Hosted
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