Announcing a new publication! 🧬📄 The development of cell and gene therapies has resulted in many bespoke and proprietary solutions, each requiring its own development program and regulatory review. Our latest whitepaper highlights the key discussion points of our November 2023 FDA Scientific Exchange, co-sponsored by NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals, which focused on identifying reusable elements of CGT technologies that could be leveraged to improve the time and resource efficiency of development and review. The paper outlines the viability of specific building block proposals in LNP, iPSC, and AAV and explores potential regulatory paths toward establishing reusable technologies. https://lnkd.in/efbJdv3H
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Cell and gene therapies are much more complex to develop, manufacture, and review than other biologics and small-molecule drugs, posing distinct and often unique challenges for getting potentially life-saving therapies to patients. The development of these therapies has resulted in many bespoke solutions that each require their own development program and regulatory review. ARM's latest whitepaper uses our November 2023 FDA Scientific Exchange takeaways to explore the viability of specific building block proposals in 3 technology areas and the potential regulatory paths toward establishing reusable technologies. Read it here: https://lnkd.in/efbJdv3H
Unlocking the potential of building blocks to expedite cell and gene therapy development - Alliance for Regenerative Medicine
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Recruiter: Leadership for CMO, Clinical, RA/QA & Engineering Top Talent in the Medical Device, IVD, Pharma and C> Industry
I was excited to welcome Rajiv Gangurde, Ph.D., the Vice President of Technical Operations, Cell & Gene Therapy at Parexel to the Shurig Solutions, Inc. SSI Executive Conversations Podcast. In Part 1 of our conversation Rajiv and I discuss some important topics relevant to the C> industry. With over 1500 clinical trials in progress last February and the recent announcement of the first CRISPR FDA approval, we discuss the current state of C> FDA approvals, the challenges around CMC, and the specifics of AAV-based gene therapy. https://lnkd.in/ePmHsRk8 #cellandgenetherapy #innovation #clinicaltrials #cmc #regulatorypathway #biotechnology #pharmaceutical
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There are just over 2 weeks until we open our doors at the 4th Gene Therapy Comparability Summit in Boston (February 13-15). Comparability can turn into a significant bottleneck in filing for approval with regulators if drug developers aren’t prepared for it. If your company is at any stage from filing for IND through to running a pivotal clinical trial, this program needs to be a priority. So far industry leaders from the likes of Spark Therapeutics, CSL, Bayer, Genethon, AbbVie and Regeneron have secured their place to join 60+ experts dedicated to implementing an effective comparability study, significantly de-risk costly delays to clinical programs and ultimately increase the chances of approval. With only 8 tickets remaining and limited time, secure your place today: https://ter.li/bgu6et
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🧬What are the 5 key differences between developing Cell & Gene Therapies in the United States vs European Union? While 'traditional' drug categories like small molecules have long-standing similarities, for cell and gene therapies (CGTs) and other complex biologics, the regulatory processes in the United States and European Union vary considerably. This ebook from Thermo Fisher Scientific (summarised in the video below by PharmaSource) explains the 5 key differences to be aware of: 1️⃣ Terminology: Biologics in the US vs Advanced Therapy Medicinal Products (ATMPs) in the EU 2️⃣ Guidance documents and governing regulations 3️⃣ Regulatory interaction and approval Pathways 4️⃣ Manufacturing expectations, inspection processes + documentation 5️⃣ Commercialisation requirements with shorter approval timelines Over time, we hope regulators may converge on harmonised expectations. But for now, download this ebook! https://lnkd.in/eNGRNfPQ #cellandgenetherapy #atmp
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Scaling cell and gene therapies (CGTs) from lab to market has many challenges. Discover how platform technologies, like CellPort, help to address these challenges in our latest blog, featuring insights from European Pharmaceutical Manufacturer. https://lnkd.in/eYNtNBAy
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In 2023, a record number of cell and gene therapy (CGT) products received regulatory approval in the US, and a still greater number of approvals is anticipated in 2024. Andrew Frazer and James Cody discuss the evolving C> landscape in European Pharmaceutical Review. https://bit.ly/4ekUUc1
Pharma Horizons: Cell and Gene Therapy
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Thoughts on this? >> Exegenesis Bio to Present 9-Patient Data from a Phase 1/2 Clinical Trial of EXG001-037, a Novel rAAV Gene Therapy ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #healthcare #competitivemarketing #biotech
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Exegenesis Bio to Present 9-Patient Data from a Phase 1/2 Clinical Trial of EXG001-037, a Novel rAAV Gene Therapy ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #pharmaceutical #biotech #pharma #healthcare
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Great Article about challenges in Advanced Therapies.
Cell & Gene Therapy | Technical Development & Operations | CMC Leadership | Commercialization | Stem Cells | Drug Discovery | Rare Diseases | Start-up
If you've been in the business of drug discovery, for some length of time, then you may join me in appreciating what an incredible journey that we've been on. From the days of screening hundreds of thousands of chemicals for small molecule modulators of disease, to developing advanced biologics, to unleashing the truly remarkable powers of Cell and Gene Therapy. Hope you enjoy this article.
A New Generation of Drug Therapies Requires New Business Strategies
hbr.org
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Thoughts on this? >> Asgard Therapeutics raises €30M Series A to develop off-the-shelf gene therapy for solid tumors >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #pharma #biotech #healthcare
Swedish biotech raises €30M Series A to develop off-the-shelf gene therapy for solid tumors
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