Nabin Paudel, PhD’s Post

We are excited to report major news this week for the development of ⁹⁹ᵐTc-maraciclatide as an imaging agent for endometriosis: the US Food & Drug Administration (FDA) has granted fast track designation to maraciclatide "for the visualisation and diagnosis of superficial peritoneal endometriosis in women 16 years of age or older". Fast track is a process designed to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need so that patients can benefit sooner. Superficial peritoneal endometriosis (SPE) is the earliest and most common form of endometriosis, comprising approximately 80% of all diagnoses. SPE is not well visualised with current non-invasive imaging tools (ultrasound and MRI) and definitive diagnosis requires laparoscopy. In data previously reported from the DETECT study being run by our colleagues at the Nuffield Dept of Women's & Reproductive Health, University of Oxford, maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy. Please see full details here: https://lnkd.in/eQM3nCKm Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. #FDAFastTrack #endometriosis #womenshealth #molecularimaging #diagnosticimaging #medicalimaging #precisionmedicine #nuclearmedicine EndoCaRe Oxford 🎗️ Spectrum Dynamics Medical Hermes Medical Solutions Krina Zondervan Tatjana Gibbons

A team of PathAI scientists including Hanna Pulaski, Neel Patel, Hypatia Hou, and Andrew Beck have recently published a new study titled “Validation of a whole slide image management system for metabolic-associated steatohepatitis for #clinicaltrials” in the Journal of #Pathology: Clinical Research. 📝 Read the publication: https://lnkd.in/e3J4A3hw Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 25% of the global population, and metabolic-associated steatohepatitis (MASH) is now a leading cause of liver transplants. In clinical trials for MASLD #drugdevelopment, glass slides manually read by a pathologist are the gold standard for assessing of #liver #biopsy specimens. However, the need for shipping physical slides from central laboratories to study pathologists risks physical damage to the slides and can result in a slow process. Slide assessment using #digitalpathology may be an accurate and efficient alternative to manual glass slides for evaluating MASH in clinical trials and further addresses key challenges such as endpoint enrollment. Our study demonstrates that the use of digital images on the AISight® Clinical Trials platform yields results equivalent to the use of glass slides for evaluating disease activity in steatohepatitis, streamlining pathologist evaluations and reducing logistical hurdles, thus making #digitalpathology a promising approach for future #clinicaltrials. Learn more about AISight® for #clinicaltrials: https://lnkd.in/eGHH7iFT AISight® is for research use only. Not for use in diagnostic procedures. #AIPathology #biotech #healthtech

Pharmacogenomics (PGx) constitutes an important part of personalized medicine and has several clinical applications. PGx role in clinical practice is known, however, it has not been widely adopted yet. In our recent study, we aimed to investigate the perspectives of Greek physicians regarding the implementation of PGx testing in clinical practice and the key issues associated with it. By conducting semi-structured interviews, we managed to highlight six main themes and understand the barriers and concerns of Greek physicians towards PGx clinical application. For more details, read below: https://lnkd.in/d7Kenk-M #humangenomics #pharmacogenomics #awareness #clinicalapplication #Greekphysicians

Our answer to hamas and all radical islam terror is scientific medical research 🚀 We're thrilled to announce a groundbreaking milestone in diabetes treatment! As the Director of Medical Affairs at Kadimastem, I'm proud to share our FDA INTERACT submission for Isletrx, an innovative therapy derived from embryonic stem cells, in collaboration with our fantastic partners at iTolerance. 🤝🔬 📣 In an inspiring Zoom meeting with iTolerance, led by the visionary CEO Anthony, we discussed not only our shared scientific goals but also the enduring spirit of collaboration and support. Anthony's heartfelt message of solidarity with Israel and his admiration for our resilience in these challenging times was deeply moving. 💪🇮🇱 👩⚕️ As director of medical affairs, I shared my belief in the power of medical excellence and innovation. Israel, with its rich history of medical breakthroughs, continues to be a global leader in healthcare advancements. At Kadimastem, we're committed to this legacy, by my dad 👨 Michel Revel,MD PHD, contributing to medical progress worldwide and leading the way in life-changing therapies. 🌍✨ 🛡️ Against all odds, our determination remains unshaken. We believe in turning challenges into opportunities for healing. Rooted in Jewish values, tikun olam, תיקוּן עולם we're driven to repair and improve the world, a mission that no adversary can halt. This FDA INTERACT submission is a testament to our unwavering commitment to bettering lives. 🌟 🙌 Together with iTolerance, we're not just pushing the boundaries of medicine; we're creating a future filled with hope and health for diabetes patients across the globe. Join us on this incredible journey! 🌈💖 #DiabetesCure 🚑 #Kadimastem💡 #iTolerance 🤝 #MedicalInnovation 🌟 #IsraelStrong 🇮🇱 #FDA 📜 #Isletrx 🌱 #TogetherWeCan 🌍

AHEAD Medicine has announced an upgrade to its Cyto-Copilot platform, enhancing its capabilities for diagnosing acute myeloid leukaemia (AML). This advanced AI-driven platform now features a new analysis module that enables diagnostic classification of AML versus non-neoplastic conditions across five flow cytometry test panels and instruments. The Cyto-Copilot platform automates the analysis of cytometry data, independent of the specific panel or instrument used, streamlining workflows and improving diagnostic accuracy. AHEAD Medicine plans to showcase this development at the upcoming European Society of Clinical Cytometry Analysis (ESCCA) 2024 and The ICCS International Clinical Cytometry Society (ICCS) 2024 conferences. The integration of machine learning models and visualization tools allows for efficient sample-level and cell-level classification, significantly reducing the workload for healthcare professionals. This upgrade follows AHEAD Medicine's previous collaborations with institutions like Mayo Clinic and the University of Pittsburgh to enhance AML patient care through improved cytometry platform performance. The company aims to continue advancing its technology to improve patient outcomes and clinical workflows in the field of haematology. https://lnkd.in/eEfDcXc8 Stay informed and ahead of the curve by following Practical Patient Care on LinkedIn for the latest industry news and insights! #PracticalPatientCare #AMLDiagnosis #AIinHealthcare #FlowCytometry #MedicalTechnology

New paper out! Thanks to Prof Ajeet B Singh MD PhD, David Skvarc and others for the tireless effort required to make this a reality. Given recent developments in the USA, pharmacogenomics is looking increasingly relevent in the field of precision medicine. Personalising tretments for the patient provides benefits in terms of better tolerability, faster response / remission. Additionaly, benefits to society at large, payors, health budgets are possible with these approaches. https://lnkd.in/gpauPZGz

Nice article on PGX. Especially important is the MD/PharmD collaboration mentioned. At Tsela Labs, We believe this collaborative effort is the key to a successful and compliant Personalized Medicine program. https://lnkd.in/eRQn4bCb

Thrilled to share our recent review on blood brain barrier pharmacogenetics. We discussed how genetic factors, particularly ABCB1 polymorphisms, influence drug transport across the blood-brain barrier, impacting pharmacodynamics and pharmacokinetics. This has the potential to advance personalised medicine for CNS disorders by optimising treatment effectiveness and tolerability. Big thank to my co-authors for their leading expertise and collaboration on this work—excited to see where this research leads! #Pharmacogenetics #BloodBrainBarrier #PersonalizedMedicine

Check out this impactful #ClinicalStudy that delves into the comparative diagnostic performance of four major #HCC guidelines, enhanced by cutting-edge MRI techniques and a novel automatic algorithm. Conducted across 11 South Korean hospitals, this retrospective study encompasses 2,237 high-risk patients and evaluates 2,445 focal liver lesions with a focus on accuracy, sensitivity, and specificity. Using #MintLesion, researchers concluded that among 4 different international HCC diagnosis guidelines, Eastern guidelines demonstrate higher sensitivity, whereas Western guidelines displayed higher specificity. The article suggests that respective guidelines are aligned with their corresponding clinical practice and intended outcomes. "Eastern guidelines prioritize sensitivity because of the high prevalence of HCC in Asia and preference for all locoregional therapy, leading to high accuracy (13). Conversely, Western guidelines emphasize specificity, reflecting the lower HCC prevalence in Europe and North America (13) and transplant as a first-line treatment option (4,14)." Read more on the topic here: https://bit.ly/4eFNfp5 Get updates on expert insights and the latest studies using #mintLesion™ to transform medical research by following #ResearchWithMint.

Congratulations ! 🏆 🎉 Team QREC Clinical Research LLP (India-UAE) for INITIATING the Multi center, longitudinal, Observational study on Cardiac molecule "Loop Diuretics + Mineralocorticoid Receptor Antagonist" with 150 KOL Cardiologist's and 4000 patients PAN India. #cro #clinicaldatamanagement #medicalwriting  #clinicaloperations #OBSERVATIONALSTUDY  #statisticalanalysis #clinicalresearch #clinicaltrials  #clinicaldata #medicalwriting #statisticalprogramming #contractresearchorganization #publications  #submission #manuscripts #REALWORLDSTUDY  #doctors #regulatoryaffairs #projectmanagement  #qualitycontrol #sitemanagementb #medicaldevices  #pharmaceuticalsindustry #lifesciences