uBriGene Biosciences Inc.’s Post

Join us on June 25th in Woburn, MA for an engaging session at the 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐗𝐜𝐡𝐚𝐧𝐠𝐞 with our VP of Commercial, Robert Margolin! He'll be leading a roundtable discussion focusing on the Manufacturing Challenges with Gene-Editing Technologies for iPSC Therapeutics. Don't miss out on this valuable opportunity to: ·       Explore the manufacturing implications of the recent FDA guidelines from January 2024 on “Human Gene Therapy Products Incorporating Human Genome Editing”. ·       Understand the nuances in manufacturing requirements for gene-editing of master cell banks versus drug substances/drug products. ·       Discover strategies to manufacture gene-editing technologies that meet appropriate quality attributes.  See you there!  #CellTherapy #ManufacturingXchange #iPSCTherapeutic

Are currently facing regulatory challenges in your cell or gene therapies❓   Now's your chance to achieve seamless approvals in your first regulatory submissions with support from the 𝗖𝗲𝗹𝗹 & 𝗚𝗲𝗻𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗦𝘂𝗺𝗺𝗶𝘁.   📚𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗙𝘂𝗹𝗹 𝗔𝗴𝗲𝗻𝗱𝗮 - https://ter.li/t7h8j0   Take this opportunity to learn from top regulatory experts at AstraZeneca, Bristol Myers Squibb, CytoImmune Therapeutics, and more as they delve into every aspect of cell and gene therapy regulation; from pre-IND to post-BLA, benchmarking best practices, and preparing for every critical milestone.   🔍𝗙𝗶𝗻𝗱 𝗼𝘂𝘁 𝗠𝗼𝗿𝗲 - https://ter.li/t7h8j0   We hope you'll join us in October, to understand guidance, streamline submissions, and obtain approval first-time.   #CellandGeneTherapyRegulatoryAffairsSummit 

In the dynamic field of therapeutics development, leveraging bioassays that not only elucidate mechanisms of action (MoA) but also use relevant cell lines to provide accurate, quantitative data is essential. These assays should be straightforward yet robust and adaptable to the ever-changing landscape of research. Dr. Michael Tovey highlights the critical importance of cell engineering technology in overcoming these industry challenges in an insightful Editorial Article. Download your copy today and explore the vital role of cell-based assays in pioneering therapeutics, from tri-specific monoclonal antibodies to AAV gene therapy and more. https://hubs.ly/Q02s3Jlh0 #ComplementingLifeScience #ExpertPartner #Cellengineering #answersinlifescience #iLite #antibodies #genetherapy #drugdiscovery #bioassays #cellbasedassay #DrugDiscovery #Pharma #Therapeutics

Check out the regulatory milestones in the CGT drug development process!👇 The journey of translating CRISPR therapies from the bench to clinical trials is not driven solely by technical advancements, but also by a concerted effort that requires both consideration of established regulatory guidance as well as ongoing dialogue with regulatory bodies. Download whitepaper here https://bit.ly/46F710k and we will guide you through the intricate regulatory journey of cell and gene therapies (CGTs), helping you optimize your pathway to success. #drugdevelopment #CRISPR #clinicaltrial #whitepaperdownload #CGT

With 27 FDA-approved cell and #genetherapy products to date, #plasmidDNA (pDNA) continues to play a crucial function within advanced therapies medicinal product (ATMP) development. In this webinar, Andrew Frazer (Associate Director, Scientific Solutions, Gene Therapy CDMO Services, Charles River Laboratories) will explore common manufacturing and quality standards for pDNA and how they align with regulatory guidance. Watch this #webinar to learn about: • Manufacturing strategies and mitigation plans to streamline #ATMP program • The role of #pDNA as a critical starting material • Case studies demonstrating expedited development and manufacture of advanced therapies Watch this webinar at you convenience below:

Marked by two groundbreaking FDA approvals for cell-based gene therapies and high price tags, the recent strides in treating sickle cell disease present a paradoxical challenge. Authoring the article, "Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity" at American Pharmaceutical Review, our Founder & CEO, Dr. Harsha K Rajasimha, Ph.D. emphasizes the indispensable role of global patient registries in enhancing inclusivity and accessibility in gene therapies. Modern advancements in clinical trial technology and the importance of government support are also explored to address vital affordability considerations. For more, visit: https://hubs.la/Q02spg5Z0 #GeneTherapies #SickleCellDisease #InclusiveRegistries #AccessibleHealthcare

Navigating the regulatory pathway from discovery to the clinic for CRISPR-based therapeutics is a complex and multifaceted process. Download our free whitepaper which guides you through the intricate regulatory voyage of CRISPR based cell and gene therapies and expedite your way to success. Our newly released whitepaper discusses: 🌟 Key regulatory milestones in the CGT drug development process 🌟 Vital considerations at each developmental phase, complete with guidelines and resources 🌟 A clear breakdown of the IND filing, FDA review, and approval process Download here: https://ow.ly/pM6b50ReHYy #whitepaper #CRISPR #cellandgenetherapy #clinicresearch #cancertherapy #therapeutics

MORSE Consulting Inc.'s Sang Mi Lee, MBA, BSc Phm, RPh will be attending the upcoming Cell & Gene Therapy Pricing & Reimbursement Summit in Washington, DC, from June 25-27, 2024! This inaugural summit will bring together leaders from biotech, pharma, healthcare providers, payers, and government agencies to discuss enhancing equitable access to future cell and gene therapies and navigating the latest pricing models. Previously, Sang Mi delivered an insightful conference presentation on The Way Ahead for Cell and Gene Therapies: How to Create Healthcare System Infrastructure that Supports New Pathways to Access and Reimbursement (Details here: https://ow.ly/tU7350SkiyE). Additionally, MORSE Consulting previously published a case study on the Canadian Gene Therapy Landscape Assessment (Case study here: https://ow.ly/VqOt50SkiyC) and recently released a white paper titled "CAR T-cell therapies: Lessons Learned about Canadian Potential to Navigate Regulatory & Reimbursement Pathways" (Download here: https://ow.ly/fe1e50SkiyG) With our expertise in this subject area, we are looking forward to gaining more insights and knowledge from this conference. We are excited to learn from leaders in cell and gene therapy from June 25 – 27, 2024. For more information on the event, please visit: https://ow.ly/G4oc50SkiyH #CellandGeneTherapy #GeneTherapy #MarketAccess

New promising option in #HF for the next future

Cell and gene therapies are quickly advancing, and many new products are in clinical development. Bioanalytical testing, such as PCR-based methods, are crucial for ensuring the safety and efficacy of these drugs. However, there's no established regulatory guidance for validating PCR assays in this context. This white paper explores validation criteria, comparing them to assess potential risks in PCR validation parameters. » https://bit.ly/46IyU6V #cellandgenetherapies #CGT #clinicaldevelopment #bioanalytical