John Richards’ Post

There has been a whole host of trial readouts and new data for pulmonary fibrosis, especially as the ATS congress was just last week, and it feels like the IPF field is really on the edge of bringing new, more efficacious, therapeutics to the market for patients in need. Here's some of the recent news: - Vicore Pharma AB announced data from their Phase IIa trial and will kickstart their Phase IIb trial for buloxibutid - Ahmed Mousa and Professor Bertil E. Lindmark MD, PhD will be presenting at the IPF Summit - Pliant Therapeutics Bexotegrast has shown to reverse the signs of lung scariing, while improving lung function and easing cough - Gregory Cosgrove MD will be presenting at the IPF Summit - Aileron Therapeutics reported data from cohort one of the phase 1b trial - Brian Windsor will be presenting at the IPF Summit - GRI Bio, Inc. presented positive preclinical data demonstrating that the lead program reduces inflammatory and fibrotic drivers of IPF - Vipin Kumar (Chaturvedi) will be presenting at the IPF Summit With all the news in the space, why not join the community at a dedicated forum this August where you can discuss the drug development challenges for pulmonary fibrosis in-depth? The 8th IPF Summit (see full event guide here: https://ter.li/ipf) is the go-to venue for 150+ senior decision makers, academic KOLs, fibrosis experts and innovators to unite to discuss all things pulmonary fibrosis! From harnessing emerging biological understanding, to applying novel and evolving models, to assessing patient populations, this is your comprehensive and dedicated forum to propel innovative and efficacious pulmonary fibrosis therapeutics through phase 2 and beyond. Access the full event guide here: https://ter.li/ipf where you can see the full session details from 40+ expert speakers 2024 Event Partners: Qureight, Nordic Bioscience, FibroFind, Vitalograph, Imbio, Brainomix, MannKind Corporation, Fortrea, IPS Therapeutique (IPST), Strados Labs, Ionis Pharmaceuticals, Inc., Aragen Life Sciences I hope you can join the pulmonary fibrosis community at this year's IPF Summit! #ipf2024 #ipfsummit #pulmonaryfibrosis #fibrosis #lunghealth #respiratory #lung #drugdevelopment #idiopathicpulmonaryfibrosis

Lung Imaging Breakthrough: FDA Clears Brainomix 360 e-Lung System for AI-Driven Respiratory Care The FDA has granted clearance to Brainomix's 360 e-Lung system, an AI-powered software designed to detect idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs) by analyzing CT scans. This clearance follows successful phase II clinical trial results, published in the American Journal of Respiratory and Critical Care Medicine, which demonstrated the system's superior performance in identifying high-risk IPF patients. Conducted in collaboration with AstraZeneca, the trial validated the system's accuracy in quantifying pulmonary fibrosis using proprietary imaging biomarkers. The Brainomix 360 e-Lung system promises to revolutionize lung disease diagnosis and management, offering a non-invasive, efficient alternative to traditional methods and setting a new standard in respiratory care. For more details please click the link! https://lnkd.in/dsgjEcuD #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

🧪 #FIPO: launch of the 3rd cohort in the clinical trial The scientific council has given the green light for the third dose in the ascending phase of our FIPO clinical trial. This Phase I/II trial tests the safety and efficacy of XON7 in patients with solid tumors. Key updates: ✅ Safety validated: after cohorts at 1.5 mg/kg and 3 mg/kg, the safety of XON7 has been confirmed. 👩⚕️ New cohort: 3 patients with solid tumors are now being treated at 6 mg/kg across our Foch, Lyon, and Toulouse centers. 📈 Ascending phase: we are progressively increasing doses to ensure safety and assess the benefit/risk ratio of XON7. 💫 Hope for patients: XON7 represents a new hope for patients who have not responded to current treatments. 🔍 More information in our carousel. #ClinicalTrial #XON7 #Biotech #Innovation #PatientCare

This Friday an FDA advisory committee will meet to discuss the results of a new meta-analysis on the use of minimal residual disease (MRD) as an endpoint to support the accelerated approval of new drugs in multiple myeloma (MM). Currently, drugs in MM are approved based on clinical benefit endpoints, leading to lengthy clinical trials and drug approval timelines and ultimately delays in offering patients potentially beneficial treatments. MRD testing can measure a patients response to treatment by the use of sensitive technologies which measure the level of tumor cells in a patient’s blood. The use of MRD results as an endpoint for drug approval would allow MRD testing to be used to demonstrate drug efficacy instead of clinical response thus shortening clinical trial and drug development times. A recent Diaceutics report on the use and perceptions of MRD found the majority of hematoncologists were comfortable with the use of MRD as a surrogate endpoint in clinical trials. If implemented, this would represent a paradigm shift in the approval of novel therapies. While this discussion is currently limited to MM, the scope for using MRD in drug development and the management of patients is currently being investigated in multiple haematological and solid tumor indications. MRD has the potential to become routine clinical practice in the management of oncology indications and would enable the early detection of disease relapse and allow patient treatments to be adapted accordingly. View the Diaceutics report on MRD at https://lnkd.in/eKu4imxW

Breakthrough approach on MRD which could significantly impact timelines on getting new treatments to patients. If you have not accessed the Diaceutics report on MRD read more at the link below and get in touch. Dr Bob Holt #precisionmedicine #patients #FDA #MRD #cancer

Are you looking to implement CDx into your clinical program? IQVIA's Q2 Solutions Global Central Labs can help support your needs to bring more personalized medicines to your patients. Reach out to me if you want to explore your CDx need with IQVIA's Q2 Solutions!

With the much-anticipated news finally here, it has been confirmed that additional time is being granted for the transition to the In Vitro Diagnostic Regulation (IVDR). In this engaging blog post we delve into the implications of this extended transition period, explore the significant changes brought about by IVDR, and evaluate how this adjustment will impact industry readiness for the upcoming regulatory transformation. ➡ Ready to know more. Click the link below.

📣 We're launching our new product at SOT! 📣 We're excited to announce the launch of our new axoCells™ Atrial Cardiomyocyte kit, an all-in-one bundle to unlock iPSC technology for in vitro arrhythmia and cardiotoxicity research. And where better to launch it than at the Society of Toxicology 63rd Annual Meeting and ToxExpo? Key features of our Atrial Cardiomyocyte kit are: • Tailored culture medium and optimized coating solution for growth of the cells • Demonstrate chamber-specific pharmacological responses (see below) • No evidence of endogenous arrhythmia • Developed for use in advanced in vitro atrial fibrillation and cardiotoxicity models And with everything you need (including matched reagents) in one easy-to-use kit, you can save time and money, freeing you up to focus on the science and build better cardiac models for research and toxicity screening. Watch the video to hear more about this new product, and click here to learn about why we've developed this kit: New product launch: https://hubs.la/Q02nY8fg0 If you're attending SOT then make sure to visit Booth #2032 to find out more. Looking to unlock iPSC technology for your cardiotoxicity models? Get in contact with us at:operations@axolbio.com #iPSCs #SOT #AtrialFibrillation #cardiotoxicity #StemCells

With Elitech moving to Bruker and at a different scale (of instrument, and, possibly, deal size) LumiraDx moving to Roche - it has certainly been an interesting and exciting final week of 2023 in the world of diagnostics.

In this paper, I have described how precision medicine can improve the safety and efficacy of drugs using mirvetuximab soravtansine as a case study. Furthermore, it offers the advantage of including patients who might have been overlooked using conventional methodologies. https://rdcu.be/djSvq