Alliance for Regenerative Medicine’s Post

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

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&GT 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&GT 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

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

🧬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

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

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&GT landscape in European Pharmaceutical Review. https://bit.ly/4ekUUc1

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

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

Great Article about challenges in Advanced Therapies.

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