Sanofi’s Post

Glowing COVID-19 diagnostic test prototype produces results in one minute

This is AI.

One of the key themes that i have been following ..Do we see this as a major inflection point? The approval of gene editing treatments presents enormous potential for medical advancement and improved human health, it also raises complex ethical, social, and regulatory challenges that need careful consideration to ensure responsible and equitable use while balancing scientific progress with ethical concerns. Here comes Bodyparts-as-a-Service (BaaS)...What an unknown world we are getting into ? Immortality possible? https://lnkd.in/e37Fy_QW

Accelerated approval not only can streamline access to potentially life-saving therapies for rare diseases but also afford the FDA much more stringent post-market tools to monitor the long term safety and effectiveness of drugs in real-world settings, by enabling the FDA to demand rigorous post-market studies. This could make it an optimal pathway for therapies where there is significant unmet need, compelling the need for efficient access, and where regulators seek long term follow up to fully ascertain the durability of the treatment effect, and discharge risk of rare off target effects — both of which might not be fully evaluable in any reasonably sized pre-market study.

These are real cures so speed equals life! It will also be a big benefit for CGT CDMOs with capacity and experience. #genetherapy #cdmo

"Empowering innovation within regulatory frameworks not only ignites creativity across our diverse teams of scientists, biologists, engineers, and CMC experts but also translates into tangible benefits for patients. Together, we're shaping a future where progress and patient well-being go hand in hand. #InnovationInHealthcare #TeamCollaboration"

Moving through the regulatory space can be a challenge when pushing your #CRISPR therapies from bench to clinic. Synthego’s regulatory expert, Lina Jamis, provides answers to several questions including what regulatory experts do, why the clinical development of #CRISPRtherapy products is so time-consuming, issues with preparing regulatory documentation, and the ways Synthego Corporation can accelerate your path from bench to clinic. You will also learn more about regulatory documentation for #cellandgenetherapy sponsors and regulatory trends and the future of CRISPR therapies.

First CRISPR-created therapeutic approved! 28/29 and 39/42 response rates... The cells are modified and infused back so no direct delivery of editing agent...which also makes it expensive and lengthy. But it could be a permanent fix so definitely worth it! Great achievement; well done Vertex! https://lnkd.in/g6p88UP4

Let's discuss. If you are doing.? 1- Cell culture, primarily cod cells, 2- Viral Culture 3- Live attenuated vaccine production 4- viral vector modification what is your media of choice? (company manufacturing?) and how do you maintain sterility?

𝗗𝗜𝗔𝗚𝗡𝗢𝗦𝗧𝗜𝗖 𝗣𝗥𝗘𝗣𝗔𝗥𝗘𝗗𝗡𝗘𝗦𝗦 means: - preparing for next pathogen - viral, bacterial, parasitic or fungal - developing most relevant diagnostic assays to suit the medical need - getting diagnostics where needed: high-income countries, remote low-income areas & everyone in-between - placing diagnostics near patients where they have maximal clinical impact During the early months of Zika, Ebola, H1N1, SARS-CoV2, Mpox..... patients were begging (and needing) reliable available DIAGNOSTICS. Can we do better next time?? Because there WILL be a next time. And already many people and organizations have "forgotten" the need to be prepared.