SYSNAV Healthcare’s Post

Day #13 of TGen's Top 20: Nicholas Schork's bold proposal for faster, personalized drug development 🌟 TGen’s Nicholas Schork is pushing the boundaries of personalized medicine with a proposal to the FDA on aggregated "n-of-1" clinical trials. By combining single-patient data, this approach could speed up drug development and create treatments tailored to each individual’s unique biology. Schork’s vision could revolutionize clinical trials, accelerating progress in rare disease therapies and beyond. 🧬💡 To learn more: https://bit.ly/3VnGmkc #Science #Research #PrecisionMedicine #Impact #Technology #Innovation #Hope #Arizona #foryoupage #fyp

Key impacts on the market access and payer environment are beginning to unfold from policies enacted in 2023 and new policies enacting in 2024. To gather insights into the latest trends, Trinity Life Sciences conducted interviews with key stakeholders across various pricing and market access landscapes. Trinity is closely monitoring the evolving global advanced therapeutics market environment, including the trends in the carousel below, to determine implications for payers and manufacturers and help them prepare for the year ahead. Read the blog to learn more: https://bit.ly/4gwMePZ

I just returned from CytoSummit in Crete. Together with the CytoReason team and an impressive group of industry experts, we focused on one question: "How can we empower our customers to improve the probability of success in phase 2 clinical trials?" Low efficacy remains one of the biggest challenges in drug development today. 90% of drug candidates fail in clinical trials, resulting in hundreds of millions of dollars and years of research being lost. At CytoReason, we use our proprietary disease models to tackle this challenge. We help our customers identify the right indications and the most responsive patients—before trials even begin. While outcomes can never be fully assured, our goal is to provide data-driven insights that give scientists and pharma executives the confidence to make informed decisions and maximize their chances of success. Learn more about our disease models via the link in the comment below 👇

Whether you’re starting to design your ADME screening cascade or if you are looking to predict clinical exposure (or anything in between) our expert team are here to guide you. Learn more in our webinar! #ADME #DMPK #bioanalysis #pharmacokinetics #freewebinar

The validation step of our drug discovery phase in Everlum Bio’s Cure Plan is where we put our promising drug candidates through the wringer, verifying and confirming their potential before they can advance to clinical trials. It's all about ensuring the initial results are reliable, reproducible, and have a real shot at becoming safe and effective treatments for each patient. And when it comes to rare diseases, the proof-of-concept phase is equally essential. This is where we demonstrate the feasibility and potential effectiveness of our novel therapeutic approaches. Want to see if Everlum can do this for you? Contacting us at everlum.bio today! #DrugDevelopment #PreclinicalResearch #RareDiseaseInnovation #Validation #RapidProofof Concept #PersonalizedMedicine #JourneyToACure

✨Join Dr. Katharina Schwarz for a Webinar ✨ We’re thrilled to partner with SCIREQ Scientific Respiratory Equipment Inc. and The 3Rs Collaborative (3RsC) to bring you an insightful session led by Katharina Schwarz from Fraunhofer ITEM. Dive into cutting-edge strategies that are revolutionizing drug development for inhalable therapeutics through predictive #invitro and #exvivo models: 📅October 29th, 10-11am, via Zoom! 💡🔎 What you’ll discover: ▶️Precision-Cut Lung Slices (PCLS): Assess drug efficacy and respiratory toxicity of inhalable treatments ▶️P.R.I.T.® ExpoCube® System: Experience dose-controlled, air-liquid-interface exposure for precise modeling ▶️Therapeutic Window Identification: Determine optimal efficacy with minimized local toxicity risks ▶️Data Integration for Predictive Modeling: Combine in vitro and in vivo insights to refine toxicity thresholds and first dose estimations More information about the webinar including a brief speaker spotlight, is available on our website🔗: https://lnkd.in/e8k6TPBV #drugdevelopment #inhalabletherapeutics #PCLS #PRIT #TTC #toxicityassessment

🌍 Advanced Clinical recently partnered with a U.S.-based biotech company to successfully submit ATMP-specific approvals for a Phase I/II CAR T-cell therapy study targeting lupus. With strategic expertise in global regulations, our team ensured submissions were completed within a two-month timeframe, navigating unique country-specific challenges in Europe. Curious how we can help streamline your global study submissions? Learn more about this success story: https://hubs.la/Q02_XyLy0 #ClinicalTrials #CART #Biotech

With just over a week remaining, there’s still time to register for our upcoming webinar, hosted by Thomas Pesnot (FRSC) and featuring keynote speaker Rob Riley. The focus will be on the ADMET Toolkit for Clinical Pharmacokinetics. We’d love to have you join us! Register here: https://lnkd.in/edkmpNF5 In this webinar, we’ll cover: What is ADMET, and why is it crucial for drug discovery? Why are predicted human PK and exposure essential for success? What are the main ADMET challenges? How to design an effective screening cascade. How to anticipate and address ADMET challenges with tailored solutions.

#CellandGeneTherapy developers can significantly streamline the transition from preclinical to clinical development and commercialization by integrating GMP-compliant #humanABserum early in their process development. This serum offers a robust and consistent growth environment for various cell types, promoting enhanced proliferation and reducing the risk of batch-to-batch variability. By incorporating GMP-compliant human ab serum from the outset, developers can establish a more predictable and scalable manufacturing process, ultimately accelerating the path to clinical trials and market approval. Immune Cells Additionally, the use of GMP-compliant human ab serum can mitigate potential regulatory hurdles associated with the use of animal-derived components, streamlining the approval process and reducing development timelines. Learn more about human AB serum: https://lnkd.in/eVMsf6UD Get a quote or place an order: https://lnkd.in/eD5BmdvU #CellCulture #CellTherapy #ATMPs #AdvancedTherapies #RegulatoryAffairs

Stéphane Thiroloix is at BioEurope 2024 in Stockholm from 4-6 November! Catch the latest updates on our Phase II "ACT" trial for ATX01, targeting Chemotherapy-Induced Peripheral Neuropathy (#CIPN). We recently achieved a key milestone with the completion of the Last Patient Last Visit (LPLV). 🤝 https://lnkd.in/dRGyPtmn As we advance towards pivotal data, we’re focused on delivering the first approved treatment for CIPN – where none currently exists. ATX01 is a high-concentration, non-opioid topical treatment that selectively targets nociceptive sodium channels involved in pain signaling. It offers the potential for effective pain relief from CIPN with minimal systemic exposure and toxicity. 🔗 Join #BioEurope2024: https://lnkd.in/dnuNZ2D 🤝 Schedule a meeting with Stéphane: https://lnkd.in/dRGyPtmn #Biotech #Pharma #Innovation #NeuropathicPain #CancerResearch Informa Connect Life Sciences