SCB and FDA will explain the CBER guidance document on recognized voluntary consensus standards and an initial list of recognized standards.
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.
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.
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.
The American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting is the premier event for professionals in gene and cell therapy.
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.
The ISBioTech 12th spring meeting will be held in Norfolk, VA.
The Bioprocessing Summit Europe brings together 500+ bioproduction, analytical and formulation professionals to advance the manufacture, quality and control of biological and genetic therapies.
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.
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.
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.
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.
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.
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.
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.
This event is the leading industry-defining forum made exclusively for analytical, process development, CMC, QC, and regulatory experts.
World renowned leaders share the latest analytical techniques & vector technologies to revolutionize your cell, gene & gene edited ex vivo cell therapy programs.
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.
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.
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.
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.
The From Stem Cells and Genes to Therapies conference will highlight how stem cells can be used to understand development, create disease models and discover new treatments.
The leading gene and cell therapies practitioners and consultants will share insights, technical and regulatory requirements, and expectations on successfully achieving and scaling-up robust, cost- and quality-efficient products, process developments, and manufacturing, as well as explore recent developments, emerging technologies, methods, and tools.
The World Orphan Drug Congress is an award-winning event with an exhibition that has grown to become the largest and most established orphan drugs & rare diseases meeting of its kind across the globe.
Built with world-class biopharmaceutical industry insights, this industry-, therapeutic- and translational-focused meeting will set the scene for non-coding RNAs, such as lncRNAs and microRNAs, for their successful development into the clinic.
With knowledge-sharing & innovation in the manufacturing, regulation and commercialization of advanced therapies more critical than ever, hear from cell & gene therapy leaders targeting increasingly difficult disease areas.
This event brings together the global cell therapy community, highlighting the latest innovations in cellular therapy and providing a forum for health care professionals to discuss practical strategies and best practices in delivering cell therapies for patients with blood cancers and diseases.
SCB will speak about standards from a treatment center perspective.
Onco Cell Therapy Summit Europe 2022 will offer multiple perspectives on how to attract investment from C-suite executives and investors whilst exploring European regulatory and reimbursement challenges for the cell therapy field.
This year’s summit is dedicated to gaining European regulatory clarity to progress efficient and robust gene therapies for rare diseases.
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