Precision For Medicine’s Post

Precision's Anshul Mangal weighs in on what to expect in 2024 regarding biopharma manufacturing and supply-related issues in this Scrip Asks Part 3 series. "Cell and gene therapies will continue to dominate the innovative clinical pipeline with the largest number of treatments in clinical trials (589 gene therapies and 568 cell therapies). The recent historic landmark of the first CRISPR technology gaining regulatory approval signals confidence in this approach. Additionally, as the adoption of radioligand therapy increases, it continues to show profound potential. One of the most promising aspects of radioligand therapy lies in the potential to create unique combinations of radioactive atoms and targeting molecules tailored to specific tumor types." Read the article here (subscription required): https://hubs.ly/Q02jhS1j0 #precisionmedicine #biopharma #clinicaltrials

Precision's Anshul Mangal weighs in on what to expect in 2024 regarding biopharma manufacturing and supply-related issues in this Scrip Asks Part 3 series. "Cell and gene therapies will continue to dominate the innovative clinical pipeline with the largest number of treatments in clinical trials (589 gene therapies and 568 cell therapies). The recent historic landmark of the first CRISPR technology gaining regulatory approval signals confidence in this approach. Additionally, as the adoption of radioligand therapy increases, it continues to show profound potential. One of the most promising aspects of radioligand therapy lies in the potential to create unique combinations of radioactive atoms and targeting molecules tailored to specific tumor types." Read the article here (subscription required): https://hubs.ly/Q02jkmfX0 #precisionmedicine #biopharma #clinicaltrials

It may be February, but I am still pondering what 2024 holds 💡 . My colleague, Dr. George Buchman, shares his insights on the future of manufacturing and supply in the cell & gene therapy industry with Scrip: “The impressive steps forward in cell and gene therapy over the past few years give cause for great optimism. We expect several trends to accelerate, including the expansion of these therapies into broader indications. There are thousands of diseases affecting millions of people that could one day have a one-time, even curative, treatment option.  Broad access to these medicines hinges on continued advances in enabling technologies that improve capabilities, expand applicability and lower manufacturing costs. In 2024 and beyond, we expect to see therapeutic viral vectors improve on all three fronts. The field is focused on improving vector capsids, for improved tissue targeting and to modulate immunogenicity, enabling potential re-dosing using the same vector serotype.  At the same time, we expect to see continued benefit from platform approaches for viral vector process development, production and analytics, driving rapid delivery to first-in-human studies, and streamlining the path to commercial.” https://lnkd.in/gXnZmxcu

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

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:

Mark your calendar for an insightful panel discussion with Dr. Rachel Legmann, Sr. Director of Technology, Gene Therapy at Repligen, and a lineup of industry experts. The discussion, titled “Phase-Appropriate Manufacturing: Trial and Error… or Trial and Triumph?”, will take place on September 24th at 4:30 PM during BPI Boston. Don’t miss this opportunity to hear from the experts about the key challenges facing manufacturing in the emerging cell and gene therapy industry Topics: - Navigating the complex grey area of manufacturing for Phase 1 and 2 trials - Keeping efficiency while complying with limited guidance - Need conversation between regulators and developers - Lessons learnt and case studies from companies moving between clinical phases - Therapeutic Developer/CDMO dynamics in the phase 1 and beyond - How to best leverage CDMO expertise and capital efficiency Join the discussion! https://lnkd.in/gt2mFKGN #BPIconf #bioprocessing #genetherapy #processdevelopment #repligen #monoclonalantibodies #vaccines

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 

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." Dive into this valuable guide to see how Alcami can bolster your CGT drug development through our extensive offerings, including: • Quality Control and Analytical Strategy Formulation: Customized approaches to guarantee quality and adherence at each phase. • Methodology Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage Solutions: Reliable storage options that safeguard your substances across the distribution network. • Fill-Finish Services for DNA, RNA, and Additional Raw Materials: Skilled management to preserve the integrity of your essential elements. At Alcami, we're committed to aiding your progress in creating groundbreaking therapies. Get the white paper now and learn how we can collaborate towards your achievement!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

Lyophilization addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes and nanoparticles. This process is advantageous for parenteral drug developers. Learn how to overcome these challenges in our new lyophilization eBook. #lyophilization #formulationdevelopment #qualitybydesign #drugdelivery

Thoughts on this? >> Indian President Droupadi Murmu launches first homegrown gene therapy for cancer - WION >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #biotech #pharma #competitivemarketing