The conviction that #serendipity can be, if not systematized, at least harnessed for augmented scientific discovery, has fueled my (obviously nonlinear) professional trajectory. As we saw with Fleming's "accidental" discovery of penicillin, the #AHA moment does not happen in a vacuum: the mind needs to be ready for the discovery (or "pasteurized" for chance to favor you). While researching other examples of serendipitous drug discovery, I came across an article about systematizing serendipity for cardiovascular drug discovery. It does not fully deliver on its promise, but I can't resist sharing that it is published in AHA journals. In case you are wondering, AHA is the American Heart Association. https://lnkd.in/gWhy2fUS
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In the new age of creative AI, as part of drug development efforts to improve the odds of success of clinical trials, the platform work with patient -derived ips cells and organoids indeed offer a shorter path to high throughout screening of diverse set of molecules in the right disease context early. This is the future of successful drug develpment and we must embrace this approach! While I am trained in in vivo cardiovascular biology at large well known institutions as on this article, and trust the animal models with many publications, the reality is, we must adapt and scale up early clinical development using clinical samples, set up clinical models early and whereever possible, including in parallel to preclinical work, in order to ensure we achieve far greater success in later phases of clinical trials! Biobanks of such clinically derived cells for HTS should be a research priority industry wide!
The new issue of #Stanford Medicine Magazine–focusing on #AI in medicine–features a fresh look at Stanford Cardiovascular Institute's quest for better, faster, and more targeted drug development. Author Krista Conger talks to CVI director Joseph C. Wu MD, PhD about the innovative 'clinical trial in a dish.' #cardiovascular #medicine #drugdiscovery #clinicaltrials #health Joseph C. Wu Dan Polcyn Charlene Kell, DNP, EMBA, RN, CCRN, FACHE, NEA-BC Alan Ching Yuen Yeung Sarah Fan Amanda Chase Stanford University School of Medicine Angela Zhang, MD, PhD Stanford Cardiovascular Institute
Advancing drug development with “petri dish” clinical trials
https://stanmed.stanford.edu
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🔬 Dive deep into the world of central nervous system (CNS) therapies with our Chief Scientist, francesca cormack! Join us in partnership with Altasciences as we unravel the critical stages of drug development for CNS-active compounds. Sign up here: https://lnkd.in/eMRuh5Xc 💡 In this exclusive webinar, we'll uncover: - Determining the essential cognitive and pharmacodynamic tests crucial for your new CNS-active drug. - Identifying the most relevant and valid populations for testing, ensuring precision in your research. - Leveraging cognitive and pharmacodynamic data effectively for seamless drug development and regulatory planning. Sign up today to hear from some of the brightest minds in CNS research: https://lnkd.in/eMRuh5Xc #CNS # webinar #digitalbiomarkers #cognitivetesting
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#ACROHighlights [Featured Product] 🚀 Cardiac Organoids: A New Era in Drug Safety 🫀 Ensuring drug safety is crucial, but traditional Thorough QT studies can be costly and complex. Enter cardiac organoids—a solution offering enhanced models for assessing drug effects on the heart. Our ready-to-use cardiac organoids and assay kits provide accurate, cost-effective evaluations of compounds' impact on cardiac electrophysiology. Elevate your preclinical safety data and streamline drug development with these innovative tools. 🔗 https://smpl.is/9ibwx #DrugSafety #CardiacOrganoids #BiotechInnovation #PreclinicalResearch #DrugDevelopment
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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
About the report
lp.diaceutics.com
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#ACROHighlights [Featured Product] 🚀 Harnessing Cardiac Organoids for Enhanced Drug Development 🌟 Drug-induced cardiotoxicity is a significant challenge in new drug development. Due to their physiological relevance and reproducibility, cardiac organoids derived from iPSCs are now a game-changer for high-throughput drug safety screening. At ACROBiosystems, we've developed cardiac organoids that accurately predict drug-induced cardiotoxicity. But we don't stop there! Our ongoing research also covers other organoid models, including brain, liver, and intestines, to offer comprehensive support for future clinical trials. Join us at the forefront of innovation in drug development! 💊✨ 🔗https://lnkd.in/gzPuS_xg #Biotech #DrugDevelopment #CardiacOrganoids #iPSCs #ClinicalTrials
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#ACROHighlights [Featured Product] 🚀 Harnessing Cardiac Organoids for Enhanced Drug Development 🌟 Drug-induced cardiotoxicity is a significant challenge in new drug development. Due to their physiological relevance and reproducibility, cardiac organoids derived from iPSCs are now a game-changer for high-throughput drug safety screening. At ACROBiosystems, we've developed cardiac organoids that accurately predict drug-induced cardiotoxicity. But we don't stop there! Our ongoing research also covers other organoid models, including brain, liver, and intestines, to offer comprehensive support for future clinical trials. Join us at the forefront of innovation in drug development! 💊✨ 🔗https://lnkd.in/gzPuS_xg #Biotech #DrugDevelopment #Organoids #iPSCs #AllianzBioinnovation #Research #India #ACROBiosystems
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❗️Announcement❗️ We're thrilled to introduce Mitchell Steiner, MD, FACS, Chief Executive Officer of Veru Inc., as the newest addition to our expert speaker faculty! Unveil the full speaker faculty here - https://ter.li/of61al Attendees are gearing up for a groundbreaking presentation on advancing enobosarm, an oral novel selective androgen receptor modulator, to avoid muscle loss and augment fat loss when combined with a glucagon-like peptide-1 receptor agonist drug for potentially higher quality weight loss. Explore Mitchell's talk in more detail by downloading full agenda - https://ter.li/of61al The 𝗚𝗟𝗣-𝟭-𝗕𝗮𝘀𝗲𝗱 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝗦𝘂𝗺𝗺𝗶𝘁 is a truly unique forum, dedicated to advancing GLP-1s, while combatting muscle deterioration. Mitchell Steiner emphasizes that: “𝘞𝘦 𝘩𝘢𝘷𝘦 𝘳𝘦𝘢𝘤𝘩𝘦𝘥 𝘢 𝘴𝘪𝘨𝘯𝘪𝘧𝘪𝘤𝘢𝘯𝘵 𝘮𝘪𝘭𝘦𝘴𝘵𝘰𝘯𝘦 𝘪𝘯 𝘵𝘩𝘦 𝘣𝘢𝘵𝘵𝘭𝘦 𝘢𝘨𝘢𝘪𝘯𝘴𝘵 𝘰𝘣𝘦𝘴𝘪𝘵𝘺. 𝘎𝘓𝘗-1 𝘢𝘨𝘦𝘯𝘵𝘴 𝘢𝘳𝘦 𝘷𝘦𝘳𝘺 𝘦𝘧𝘧𝘦𝘤𝘵𝘪𝘷𝘦 𝘸𝘦𝘪𝘨𝘩𝘵 𝘭𝘰𝘴𝘴 𝘥𝘳𝘶𝘨𝘴, 𝘣𝘶𝘵 𝘮𝘶𝘴𝘤𝘭𝘦 𝘪𝘴 𝘴𝘢𝘤𝘳𝘪𝘧𝘪𝘤𝘦𝘥. 𝘛𝘩𝘦 𝘵𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘺 𝘰𝘧 𝘵𝘩𝘦 𝘯𝘦𝘹𝘵 𝘨𝘦𝘯𝘦𝘳𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘥𝘳𝘶𝘨𝘴 𝘴𝘩𝘰𝘶𝘭𝘥 𝘧𝘰𝘤𝘶𝘴 𝘰𝘯 𝘵𝘩𝘦 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘰𝘧 𝘵𝘩𝘦 𝘸𝘦𝘪𝘨𝘩𝘵 𝘭𝘰𝘴𝘴, 𝘱𝘳𝘦𝘧𝘦𝘳𝘦𝘯𝘵𝘪𝘢𝘭𝘭𝘺 𝘳𝘦𝘮𝘰𝘷𝘪𝘯𝘨 𝘧𝘢𝘵 𝘸𝘩𝘪𝘭𝘦 𝘱𝘳𝘦𝘴𝘦𝘳𝘷𝘪𝘯𝘨 𝘮𝘶𝘴𝘤𝘭𝘦. 𝘛𝘩𝘦 𝘎𝘓𝘗-1-𝘉𝘢𝘴𝘦𝘥 𝘛𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘚𝘶𝘮𝘮𝘪𝘵 𝘱𝘳𝘰𝘷𝘪𝘥𝘦𝘴 𝘢 𝘧𝘰𝘳𝘶𝘮 𝘵𝘰 𝘢𝘥𝘷𝘢𝘯𝘤𝘦 𝘵𝘩𝘪𝘴 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘺.” Will you be uniting with 𝟲𝟬+ 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗲𝘅𝗽𝗲𝗿𝘁𝘀 this May, all committed to 𝘀𝘁𝗮𝘆𝗶𝗻𝗴 𝗮𝗵𝗲𝗮𝗱 𝗼𝗳 𝘁𝗵𝗲 𝗰𝘂𝗿𝘃𝗲? #GLP1BasedTherapeuticsSummit
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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
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
About the report
lp.diaceutics.com
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🚀 New Compound Could Supercharge Naloxone in Fight Against Opioid Overdoses 🚀 In a groundbreaking study led by Stanford University School of Medicine, researchers have identified a novel compound that enhances naloxone's ability to counteract more potent opioids, with promising results in mice. This discovery could be a game-changer in the ongoing battle against the opioid crisis. 🔬 Key Findings: Enhanced Effectiveness: The new compound, known as compound 368, strengthens naloxone's binding to opioid receptors, making it a more effective life-saving medicine. Milder Withdrawal Symptoms: Adding compound 368 to a minuscule dose of naloxone significantly improved its effects, reducing withdrawal symptoms. Potential Against Fentanyl: The combination of compound 368 with naloxone was strong enough to counteract fentanyl, one of the most potent opioids. 💡 Why It Matters: Opioid overdoses remain a significant public health crisis. With nearly 74,000 Americans dying from synthetic opioid overdoses in 2022, new tools like compound 368 could save countless lives by enhancing the effectiveness of existing treatments. Collaborators from Kurume University, SLAC National Accelerator Laboratory, Princeton University, and University of Copenhagen (Københavns Universitet) https://lnkd.in/eXWswDB5 #MedicalResearch #OpioidCrisis #Naloxone #OpioidOverdose #HealthcareInnovation #PhysicianInsights #MedicalPractice
New compound could supercharge naloxone in fight against opioid overdoses
med.stanford.edu
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On August 22nd, Alkermes announced the initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with narcolepsy type 2 (NT2). "We are pleased to initiate Vibrance-2, a phase 2 clinical study for adults with narcolepsy type 2, based on the data from our phase 1, proof-of-concept study in this patient population. ALKS 2680 is the most advanced investigational orexin 2 receptor agonist currently in development for narcolepsy type 2," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "Across narcolepsy type 1 and narcolepsy type 2, significant unmet need remains, and we look forward to further characterizing the efficacy and safety profile of ALKS 2680 in the Vibrance studies in both of these important patient populations." Read the full article at: https://lnkd.in/eCZBfH_x #narcolepsy #sleepdisorder #phase2 #clinicaltrial #Alkermes
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