Immunai’s Post

The human immune system is a network made up of trillions of cells that are constantly circulating throughout the body. The cellular network orchestrates interactions with every organ and tissue to carry out an impossibly long list of functions that scientists are still working to understand. All that complexity limits our ability to predict which patients will respond to treatments and which ones might suffer debilitating side effects. The issue often leads pharmaceutical companies to stop developing drugs that could help certain patients, halting clinical trials even when drugs show promising results for some people. Now, Immunai is helping to predict how patients will respond to ...

The human immune system is a network made up of trillions of cells that are constantly circulating throughout the body. The cellular network orchestrates interactions with every organ and tissue to carry out an impossibly long list of functions that scientists are still working to understand. All that complexity limits our ability to predict which patients will respond to treatments and which ones might suffer debilitating side effects. The issue often leads pharmaceutical companies to stop developing drugs that could help certain patients, halting clinical trials even when drugs show promising results for some people. Now, Immunai is helping to predict how patients will respond to ...

📣Last day to register for our webinar on #AI #drugdiscovery Hear from a list of #experts on strategies that de-risk the AI drug discovery process. Click to see panel list and register! #free #webinar #learning #pharmaceuticals #technology #innovation #clinical #newdrug #speakers https://lnkd.in/gKwXYEdu

Thoughts on this? >> Will Today's Clinical Trial Trends Become Tomorrow's Routine - Clinical Leader >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #pharma #biotech #competitivemarketing

Thoughts on this? >> Will Today's Clinical Trial Trends Become Tomorrow's Routine - Clinical Leader >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #pharma #biotech #competitivemarketing

Our latest portfolio company, GNQ Insilico, has announced a collaboration with a #Fortune100 Company to develop a Next-Generation Clinical Trial Platform. #GNQInsilico is developing a generative #artificialintelligence and #quantumcomputing platform to assist #lifesciences companies in conducting in silico #clinicaltrials for #drug discovery and drug development. In silico trials provide a new and revolutionary way of conducting clinicals trials by using a wide range of digital twins to mimic human study participants. Read more: 👉 https://bit.ly/4doAa2J #lifesciences #biotech #healthtech #medtech #tech #technology #AI #quantum #ClinicalTrials #pharma #pharmaceuticals #drugdiscovery #drugdevelopment #therapeutic #diagnostic #insilico #drugs #pharmaceuticalindustry #medicine #science #scientific #scientificdiscovery #research #researchanddevelopment #lifescience #medicaltech #medical #medicaltechnology #privateequity #venturecapital #investing #investment #acquisition #pe #healthcare #capital #portfolio #investmentportfolio #portfoliocompany #capitalmarkets #TrenchantCapital #trenchant #tcc

Thoughts on this? >> Eli Lilly jumps deeper into AI with $409M Genetic Leap deal >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #competitivemarketing #healthcare #pharma #biotech

Thoughts on this? >> Eli Lilly jumps deeper into AI with $409M Genetic Leap deal >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #competitivemarketing #biotech #pharmaceutical

What if you could unlock a greater potential for #AI in your #DrugDiscovery? Read our blog post to learn how applying AI and high-quality biomedical data can help you identify novel #DrugTargets and disease mechanisms. Idorsia Pharmaceuticals Ltd Neo4j

🇪🇺Comparison of Regulatory Pathways for Advanced Therapies: EU vs. US🇺🇸 I would like to share this insightful journal to show similarity and differences. Navigating the regulatory landscape for advanced therapies (gene therapies, cell therapies, and tissue-engineered products) can be complex, especially when comparing the European Union (EU) and the United States (US). 🔹 Regulatory Bodies - EU: The European Medicines Agency (EMA), through the Committee for Advanced Therapies (CAT), oversees approvals of Advanced Therapy Medicinal Products (ATMPs). - US: The U.S. FDA, particularly its Center for Biologics Evaluation and Research (CBER), is responsible for evaluating advanced therapies. 🔹 Regulatory Framework - EU: ATMPs are regulated under Regulation (EC) No. 1394/2007, with classification into gene therapy, somatic cell therapy, and tissue-engineered products. - US: Advanced therapies are regulated under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, requiring a Biologics License Application (BLA). 🔹 Approval Timelines and Expedited Programs - EU: The standard review timeline is 210 days. Expedited pathways like PRIME and Conditional Marketing Authorization offer accelerated approval for therapies addressing unmet needs. -US: The FDA’s standard review is 10 months, but expedited programs like Regenerative Medicine Advanced Therapy (RMAT) and Priority Review can reduce this to 6 months. 🔹 Post-Market Obligations - EU: ATMPs often require post-authorization safety and efficacy studies. Conditional approvals require annual data submission to confirm safety and efficacy. - US: Post-marketing surveillance and Risk Evaluation and Mitigation Strategies (REMS) are often required for advanced therapies with accelerated approval. 🔹 Support for Small and Innovative Companies - EU: EMA’s SME Program offers reduced fees and regulatory support for smaller companies. - US: FDA’s Orphan Drug Program and RMAT designation provide incentives like tax credits and market exclusivity for therapies targeting rare diseases. Both the EU and US provide pathways and support for bringing innovative therapies to market, but each has its own set of requirements and incentives. Early dialogue with regulators can help streamline the approval process and ensure successful market entry. #AdvancedTherapies #Biotech #GeneTherapy #RegulatoryAffairs #ClinicalResearch #Pharma #EU #FDA #Innovation #Healthcare #CNRResearch https://lnkd.in/gvDmn8JZ