ISCT Voluntary Consensus Standard: The Development Process and Your Critical Role
VIRTUAL EVENT
This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.
SCB will be a featured speaker.
Raw Materials in Cell and Gene Therapy Summit
The inaugural Raw Materials for Cell & Gene Therapy Summit will help the industry bridge the knowledge gap within the raw material community by delving into critical issues such as supplier selection, material quality, safety assurance and required good manufacturing practices for materials to develop regulatory compliant and high-quality cell and gene therapies.
6th Gene Therapy Analytical Development & CMC Summit
The 6th Gene Therapy Analytical Development & CMC Summit will unite 250+ analytical development, CMC, QC, and process development experts to showcase innovative analytical and process development methods, assess their readiness, and ultimately guarantee safety, quality, efficacy, and consistency of gene therapies to regulators.
ISO 276 Meeting
At this international ISO conference, SCB will discuss multiple standards efforts.
ISO/TC 276 Biotechnology focuses on standards for biotechnology processes and topics including terms and definitions; biobanks and bioresources; analytical methods; bioprocessing; data processing including annotation, analysis, validation, comparability and integration; and metrology.
Biophorum ATMP18
This event will focus on Extractables & Leachables, followed by a day dedicated to analytical and process platforming. SCB will be speaking at this event.
ISCT 2024
SCB Will be presenting at ISCT's annual meeting at the Contributing to FDA’s Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT) Roundtable, as well as a poster presentation, and available at booth 222 to promote the recently released standards implementation courses.
ARMI/BioFabUSA - 2024 Meeting in the Millyard
After the tremendous success of their previous events, ARMI|BioFabUSA is thrilled to welcome people back for another unforgettable gathering. Get ready to dive deep into the future of biomanufacturing as ARMI/BiofabUSA brings you the latest insights, trends, challenges, and opportunities in this rapidly evolving sector. The 2024 MITM promises to be a three-day extravaganza filled with visionary content that will leave participants inspired and informed.
FDA/SCB Webinar: CBER's Consensus Standards Recognition Program
SCB and FDA will explain the CBER guidance document on recognized voluntary consensus standards and an initial list of recognized standards.
Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies
The Standards Coordinating Body (SCB) for Regenerative Medicine, the U.S. Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST) are holding a workshop, co-organized by the United States Pharmacopeia (USP), on November 16 and 17. The workshop will be held at the USP headquarters in Rockville, MD.
NIST-FDA Workshops on Measurements and Standards for Advanced Therapy
Regenerative medicine, including cell and gene therapy, provides an unprecedented potential to treat or cure previously intractable diseases, such as cancer and rare genetic diseases. Advances in manufacturing technologies, measurements, and standards are needed to ensure the safety, quality, and consistency of this new class of therapies and to reduce cost. NIST in collaboration with FDA has been working with the broader industry and stakeholders to develop global standards underpinned by a robust measurement infrastructure. NIST hosts multiple technical Consortia to jointly develop precompetitive technologies, measurement solutions, and standards to accelerate technology development and translation.
ISSCR 2023 Annual Meeting
The world’s leaders in stem cell research convene once a year for the ISSCR Annual Meeting to help advance stem cell research and regenerative medicine to improve human health.
ASGCT Annual Meeting
The American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting is the premier event for professionals in gene and cell therapy.
Stem Cells and Cancer Conference
This conference will bring together a diverse, interdisciplinary group of researchers with interests in organogenesis, tumorigenesis, stem cell function and therapy to catalyze collaboration and cross-fertilize ideas. The meeting will focus particularly on developmental, metabolic, genomic and epigenomic mechanisms regulating the function of cancer cells and stem cells.
ISBioTech Spring Meeting
The ISBioTech 12th spring meeting will be held in Norfolk, VA.
Bioprocessing Summit Europe
HYBRID EVENT
The Bioprocessing Summit Europe brings together 500+ bioproduction, analytical and formulation professionals to advance the manufacture, quality and control of biological and genetic therapies.
Viral Vector Process Development Summit
The inaugural Viral Vector Process Development Summit is the premier platform for Upstream and Downstream Process Development Scientists, Viral Vector Technology, CMC and Production Leads to share their lessons learned and inspirations to overcome bottlenecks.
TGF-β for Immuno-Oncology Drug Development Summit
This meeting will provide you with the must-know takeaways from the basic biology to biomarkers to clinical trial design to overcome the clinical setbacks and produce a blockbuster TGF-β therapeutic.
Next Generation Ophthalmic Drug Delivery Summit
The inaugural Next Generation Ophthalmic Drug Delivery Summit will help ophthalmic drug developers overcome translational challenges of developing novel long-lasting ophthalmic therapies via novel delivery methods to reduce healthcare burden and increase patient compliance.
Cell & Gene Therapy PepTalk
Two back-to-back conferences and a foundational training seminar on the critical challenges facing the analysis, characterization, quality control, scale-up, and manufacture of cell and gene therapies.
iPSC-Derived Cell Therapies Summit
This dedicated meeting is your one-stop shop to see the key advances and learn from the industry's leaders to solve your differentiation, expansion, quality and engineering challenges.
Oncolytic Virotherapy Summit
This forum is the industry’s only definitive end-to-end meeting, from research and discovery through to clinical development, CMC and manufacturing, partnering and licensing, and route to market.
Annual Gene Therapy for Neurological Disorders
The 4th Annual Gene Therapy for Neurological Disorders meeting is returning to Boston to welcome discovery, preclinical, translational and clinical industry scientists to share, learn and network for the shared goal of successfully and safely delivering gene therapies to the CNS.
Cell Therapy Analytical Development Summit
This event is the leading industry-defining forum made exclusively for analytical, process development, CMC, QC, and regulatory experts.
Cell & Gene Therapy Manufacturing & Commercialization Europe Hybrid Event
HYBRID EVENT
World renowned leaders share the latest analytical techniques & vector technologies to revolutionize your cell, gene & gene edited ex vivo cell therapy programs.
Rare CNS & Neurodevelopmental Drug Development Summit
This event is the definitive industry-dedicated forum for large pharma, biotech, academia, and patient advocacy groups, paving the way towards symptomatic and successful disease modifying treatments.
Gene Therapy Analytical Development
This year’s summit reunites 300+ analytical experts in innovative biotech, pharma and academia to continue to develop resilient, long-lasting and robust analytical tools to enhance the safety, quality and efficacy of gene therapy products.
ISSCR Boston 2022 International Symposium: "Translating Discoveries"
HYBRID EVENT
The meeting will bring together international academic and commercial scientists with expertise in the preclinical, clinical, and regulatory phases to discuss the critical processes and strategies in the successful development of PSC-derived therapies.
6th Aseptic Processing Summit
Experts from the industry will highlight the requirements to robust aseptic processing, targeted implementation strategies, recent experience on establishing aseptic manufacturing processes for ATMPs and vaccines in particularly, and adoption of innovative aseptic processing technologies, including robotics.