Tatjana Alexa Sadyrina’s Post

📝🎓(Bio) Analytics of Cell and Gene Therapies | 20 & 21 May 2024 | Short Online Course |£316 when you register before 24 April (20% saving) This training course will provide you with a deep-dive insight into how cell and gene therapy products are clinically developed and manufactured. Once completed you will be aware of the types of assays needed to assess pharmacokinetics, immunogenicity and potency. You will also examine the regulatory expectations around assay validation. Learn more about the course - https://buff.ly/3UyEKnQ #educolifesciences #cellandgene #CGT #ATMP #bioanalytics #PK #immunogenicity #celltherapy #training

Polymerase chain reaction (PCR)-based bioanalytical testing is the cornerstone of evaluating delivery, safety and efficacy of cell and gene therapies. Learn more about reducing regulatory risks in this evolving field. » https://bit.ly/41bblBt #bioanalyticaltesting #cellandgenetherapies #PCRassays

Polymerase chain reaction (PCR)-based bioanalytical testing is the cornerstone of evaluating delivery, safety and efficacy of cell and gene therapies. Learn more about reducing regulatory risks in this evolving field. » https://bit.ly/41bblBt #bioanalyticaltesting #cellandgenetherapies #PCRassays

Are you working in Cell and Gene Therapy, using CRISPR, AAV vectors, and mRNA Therapeutics? These innovations require rigorous molecular analyses and adherence to regulated guidelines for bioanalysis and safety testing, including biodistribution, pharmacokinetics, transgene expression, and shedding throughout the developmental stages of therapies so a #GLP accredited #CRO is what you need! #research #aav #cellandgenetherapy #medicine #lifesciences

Several different types of source documents, consisting of study reports for IND-enabling studies, are essential for the preparation of module 3 for a cell and gene therapy regulatory submission. Proper planning and execution of these studies is essential for a successful IND submission. Discover the keys to successful CMC source document preparation for cell and gene therapies in Steve Kornher's article published in Cell & Gene. https://hubs.la/Q02RFtMT0 Have more questions? Contact us today. https://hubs.la/Q02RF6-t0 #celltherapy #genetherapy #regulatorycmc #IND #regulatorysubmission

𝑭𝑫𝑨 𝑮𝒓𝒂𝒏𝒕𝒔 𝑭𝒂𝒔𝒕 𝑻𝒓𝒂𝒄𝒌 𝑫𝒆𝒔𝒊𝒈𝒏𝒂𝒕𝒊𝒐𝒏 𝒕𝒐 𝑩𝒂𝒚𝒆𝒓 𝒂𝒏𝒅 𝑨𝒔𝒌𝑩𝒊𝒐'𝒔 𝑮𝒆𝒏𝒆 𝑻𝒉𝒆𝒓𝒂𝒑𝒚 𝒇𝒐𝒓 𝑷𝒂𝒓𝒌𝒊𝒏𝒔𝒐𝒏’𝒔 𝑫𝒊𝒔𝒆𝒂𝒔𝒆  Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio) announceD that the FDA has granted Fast Track Designation for AB-1005, a promising gene therapy for moderate Parkinson’s disease. AB-1005 also received the Innovation Passport from the UK MHRA. 🌍 AB-1005, an investigational AAV2-GDNF neurorestorative gene therapy, is making strides in treating moderate Parkinson’s disease. Earlier this year, AskBio shared positive 18-month Phase Ib clinical trial results, achieving the primary goal of evaluating the safety of a one-time bilateral delivery directly to the putamen.💡 https://lnkd.in/dvya45vz AskBio is hiring for a Clinical Trial Manager (Remote) https://lnkd.in/d74TtC8D #GeneTherapy #ParkinsonsDisease #Innovation

Demand for #advancedtherapies, such as cell and gene therapies, is growing and won’t stop anytime soon. To get these innovative treatments to patients as quickly as possible, it is critical for #CDMOs to evolve to meet the needs of #pharma and #biotech customers as they work to move medicines from #clinicaltrials to commercialization.   I recently had the opportunity to sit down with [@Clinical Trials Arena] to discuss how our newly opened cold and ultra-cold facility in the #Netherlands will enable our partners in the EU to advance medicines.    Read more from our conversation here: https://lnkd.in/e9j3Rs2e

ICH Targets Cell and Gene Therapies, Real-World Data as Topics Ripe for Harmonization Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of pharmacoepidemiological studies that use real-world data (RWD) to assess new medicines at the International Council for Harmonisation (ICH) regional meeting sponsored by the US FDA and Health Canada. Kathleen Francissen, global head of PT cell and gene therapies at Genentech, and Melissa Kampman, manager of the marketed health products directorate for Health Canada, provided an update on these plans as well as timetables for released harmonized documents at the meeting, which was held virtually on February 22. There are 1,400 advanced therapies in clinical trials around the world. Currently, 5,800 patients have been dosed with AAV-based gene therapies while 38,000 patients have been dosed with CAR T-cell treatments. https://lnkd.in/gTf8JW9q #aspenalert #biotech #bioprocess

🧬 New on Pharma's Almanac: Genezen’s Natasha Rivas, Vice President of Quality and Regulatory, explores how regulations governing the evolving cell and gene therapy sector remain complex and have yet to meet maturity, requiring an understanding of both existing regulations and the sensibility of regulators to anticipate expectations where details have not yet been defined. "Even if a CDMO is focused on process development and manufacturing and does not support clinical trial design, implementation, or management, it is still important for regulatory experts to understand regulatory guidance regarding clinical studies. To act as true partners for their clients, particularly younger biopharma companies new to the regulatory approval process, CDMOs that provide preclinical and clinical manufacturing services must be knowledgeable about regulatory expectations for the materials used in those studies." Read the full article online now. #CGT #genetherapy #pharma #regulatory

Thoughts on this? >> Long-term data shows durability of Vertex's gene therapy Casgevy - FiercePharma >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #competitivemarketing #pharma #pharmaceutical #biotech