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New #Podcast Alert! 🎙️🚨 Advancing treatment for #BPDCN: current therapies, a deep dive into #tagraxofusp, & emerging novel agents🩸 🎧 Naveen Pemmaraju, MD, The University of Texas MD Anderson Cancer Center discusses: 💡 The challenges in treating this disease and reviews current therapeutic options such as #chemotherapy, #tagraxofusp, and #transplantation 💡The #CD123-targeted agent #tagraxofusp, addressing patient eligibility, the role of #tagraxofusp in bridging to #transplantation, and real-world data on its use 💡Insights into ongoing #clinicaltrials and emerging treatments for #BPDCN, including novel #CD123-#targetedtherapies, combination strategies, #BCL2inhibitors, and #immunotherapeutic approaches Tune in 👉 https://lnkd.in/eV3h_NSw Use the time codes to skip to your favourite part of each episode 👀 SUBSCRIBE so you don't miss any future episodes📱 #VJHemOnc #Hematologynews #MMsm

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#CDER’s Emerging Drug Safety Technology Meeting Program (EDSTM) -- in this conversation, Robert Ball, M.D., M.P.H., ScM, Deputy Director of CDER’s Office of Surveillance and Epidemiology, explains the EDSTM program and the application of #AI in #Pharmacovigilance based on his experience of more than a decade researching and developing AI systems in PV. https://lnkd.in/eRg7K7GB #FDA #DrugSafety #PV

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New research from Technology in Cancer Research & Treatment: Radiomics Harmonization in Ultrasound Images for Cervical Cancer Lymph Node Metastasis Prediction Using Cycle-GAN https://lnkd.in/gfjxbb22 #cancerresearch #cancertechnology #technology #openaccess #SAGEresearch

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📺 Catch our conversation with Roger Li, MD, of Moffitt Cancer Center, on the final results of #CORE001, which investigated #cretostimogene plus #pembrolizumab for #BCG-unresponsive #NMIBC with #CIS. 👉 Find the Full Video Here:

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Breaking barriers in ADC development: What’s next? 🔎 Antibody-drug conjugates are no longer just a concept – they’re revolutionizing cancer therapy with precision-targeted treatments. However, their success hinges on robust development strategies. Allucent explores how improved analytical methods, scalable manufacturing, and compliance with global regulatory standards are key to unlocking the full potential of ADCs. 🚀 By understanding the complex interplay of science, strategy, and regulation, biotech companies can navigate the challenges of bringing ADCs from the lab to the clinic. Dive into Allucent’s roadmap for clinical success and learn how ADCs are evolving to meet the unmet needs in oncology. 🔬 Full article below ⬇️ https://lnkd.in/dmUUXcdB #ADCtherapies #oncologyinnovation #cancerresearch #targetedtherapies #precisionmedicine #bispecificADCs #pharmabreakthroughs #drugdevelopment 

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Join Novotech’s Dr. David Ng (VP. Biometrics & Data Management) and Dr. Yafei Zhang (Director Biostatistics), with special guest Dr. Shan Xiao (Assoc. Director Biostatistics) from Takeda for an informative webinar on Biostatistics in the Development and Evaluation of Advanced Therapies in China. This expert panel will discuss: 🔹 Overview of Statistical Methods in Innovative Drug Development. 🔹 Statistical Analysis of Advanced Therapies for Rare Diseases and Case Studies. 🔹 Considerations of Innovative Statistical Methods in FDA Review. Like to know more? Register now: https://lnkd.in/gS_tg8PG #ClinicalTrials #BioStatistics #Novotech

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Clinical pharmacologists: If you're working on research into pediatric rare diseases using a model-based approach, #PSPjournal has an open #callforpapers. Check out this podcast hosted by yours truly that digs into this 2025 themed issue. A big thanks to Ping Zhao, Rajat Desikan, and Jane Knöchel for stopping by PSPod!

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🔬 Dive into the world of Recombinant DNA research with our latest CE course! Learn about NIH guidelines, oversight organizations, and the approval process for rDNA experiments. Enhance your knowledge today! #AMTContinuingEducation

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American society of clinical oncology (ASCO) welcomes you to attend the Annual meeting and invites to submit abstract for oral or poster presentation Abstract Eligibility: All types of oncology-related research are eligible for submission.  Abstract should address scientific questions, detail clinical observations, or contain primary scientific data. Submission of multiple abstracts on a single study may result in the rejection of one or more abstracts. To ensure the integrity of the review process, corrections to abstracts will not be allowed after the abstract submission deadline. Author & Sponsor Eligibility As you prepare your submission to the Meeting, please make note of the following author and sponsorship eligibility criteria: Individuals may submit up to 2 regular abstracts as the first author. Individuals may submit an unlimited number of Trials in Progress abstracts. ASCO membership is not required to submit an abstract, however, each abstract must be sponsored by an ASCO member1. New in 2025: All ASCO Members in good standing may sponsor their own submissions. Abstract submitters who are not ASCO members must have their abstract sponsored by an ASCO member. There is no limit to the number of abstracts a member can sponsor. Abstract sponsors must verify that the contents of the abstract and support its data and comply with all Abstract Policies, including ASCO's Confidentiality Policy. The sponsor does not need to be an author of the abstract. Abstract Submission Deadline: January 28, 2025, at 11:59 PM (ET) Merit Awards Based on funding availability, a limited number of Merit Awards will be awarded to trainees and students whose research is addressed in high-quality abstracts submitted to the Annual Meeting and recognized for its scientific merit. Merit Award recipients are honored with the opportunity to present their abstract at the Meeting, receive monetary support, complimentary registration for the Meeting, and access to Meeting hotel reservation blocks reserved for ASCO Members. Merit Award candidates must apply for this award at the time of abstract submission. Eligibility Criteria: Applicants must submit a curriculum vitae and meet all of the following requirements to be considered for a Merit Award: Be the First Author on the abstract submission and agree to present the abstract if selected for presentation at the Meeting Be enrolled in a fellowship/residency/advanced degree training program or in a medical or doctoral degree program at the time of abstract submission Provide a letter from their training program director or faculty advisor confirming the candidate is enrolled in the training program at the time of submission Provide a curriculum vitae Conference date: May 30 to June 3, 2025 Venue: McCormick Place, Chicago, IL Submit abstract: https://lnkd.in/eAiKEdE #ASCO2025 #Oncology #medical #healthscience #annualmeeting #grants #awards #USA

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NEW from #EHA2024 | Challenges in utilizing mutation testing in #AML 🎥 🩸 🇪🇸 Sanam Loghavi, MD, The University of Texas MD Anderson Cancer Center, discusses the challenges and feasibility of #mutationtesting in #acutemyeloidleukemia (#AML) 🧬🤔 Some institutions lack resources for these techniques, and even in well-equipped centers, testing can be time-consuming, so surrogates for #genetic profiling can be used. Dr Loghavi notes that treatment with menin or #IDHinhibitors can induce differentiation and #apoptosis in mutated cells Thus, there is a need for methods to distinguish between these differentiated cells destined to die and #leukemicblasts Learn more 👉 https://lnkd.in/dHd9nwxN #VJHemOnc #Hematologynews #Leusm

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In managing chronic kidney disease (CKD), monitoring eGFR fluctuations is paramount, especially when initiating hemodynamically active therapies. - A reduction in eGFR of >30% on subsequent testing among CKD patients initiating hemodynamically active therapies exceeds expected variability and merits evaluation. - Hemodynamically mediated declines in eGFR (typically 10%-20%) may occur within the first 3 months of intensive blood pressure control. These are often transient and do not necessitate changes in therapeutic agents. - Initiating ACEi/ARBs or SGLT2i may lead to acute eGFR dips, reflecting hemodynamic changes. However, these are usually reversible and not indicative of drug toxicity. - Despite initial eGFR declines, therapies like SGLT2i still confer kidney benefits, particularly in patients with >10% initial drop in eGFR. By recognizing the nuances of eGFR changes and the effects of therapy initiation, healthcare providers can make informed decisions, optimize treatment strategies, and ensure the best possible outcomes for CKD patients. Link to the 2024 KDIGO Guidelines: https://lnkd.in/gDVT83EE #KDIGO2024 #ClinicalPracticeGuideline #ESRD #CKD #ESKD #Kidneydisease #RenalFailure #RenalReplacment #dialysis #hemodialysis #ChronicKidneyDisease #eGFR #CKDManagement #Nephrology #Healthcare #MedicalTreatment #KidneyHealth #PatientCare #TherapeuticAgents #HealthcareGuidelines #MedicalInsights

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Sure, #AI offers a lot of opportunity for drug development and clinical research, but in this short video from the Innovation Network Gathering, Tala Fakhouri of the #FDA also addresses the myths and challenges that regulatory bodies like the FDA must navigate. https://lnkd.in/gfAp64pC

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https://lnkd.in/gC8QDtpw This issue’s cover is taken from the original research report “Mice hepatic organoids for modeling nonalcoholic fatty liver disease and drug response” submitted by Ruixi Li and Xianjie Shi of the Department of Hepatobiliary Pancreatic Surgery, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, China. Using their model, the authors revealed a significant role of the NOD-like receptor (NLR) signaling pathway and the peroxisome proliferator-activated receptor (PPAR) pathway in free fatty acid (FFA) induced hepatic steatosis. The effect of pretreatment with the NOD pathway inhibitor JC2-11 and the PPAR agonist lanifibranor was assessed using (A) Oil red O staining and Nile red staining of lipid droplets; (B) Liver function indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL);  (C) Triglyceride (TG) levels; (D) inflammatory cytokines IL-6 and TNF-α and (F) Nitric oxide (NO); and finally, (E) fibrosis indicators COL1A1 and LAMA1.

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A new #CRISPR-based clinical trial for #SickleCell disease is enrolling at UCSF. This is the first therapy in the U.S. to apply non-viral CRISPR gene editing to directly correct the genetic mutation that causes the disease. Read more: https://ow.ly/Smry50UfZi1

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Don't forget to check out the latest ASHI Quarterly Newsletter! This edition features our highlighted article "Impact of Laboratory Staffing Levels on Workload and Turnaround Time" Page 77 https://lnkd.in/gJ8ANMep

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📢New article alert from the Journal of Comparative Effectiveness Research:   Title: Comparing the efficacy of cipaglucosidase alfa plus miglustat with other enzyme replacement therapies for late-onset Pompe disease: a network meta-analysis utilizing patient-level and aggregate data   New research highlights the potential benefits of cipaglucosidase alfa plus miglustat over other therapies in improving key clinical outcomes, such as 6-minute walk distance and forced vital capacity, in late-onset Pompe disease, an area where head-to-head trials are currently lacking.   Authors: Simon S., Noemi Hummel, Shuai Fu, Ian Keyzor, Alasdair MacCulloch, Neil Johnson, Jeff Castelli, Ilona Czarny-Ozga, Tahseen Mozaffar & Howard Thom Amicus Therapeutics   #PompeDisease #OpenAccess   Link in the comments!

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Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence   📅 DATE: April 25, 2024 | 9:00 AM - 1:00 PM ET ▶ LOCATION: Zoom   The FDA's new Center for Drug Evaluation and Research (#CDER) Quantitative Medicine Center of Excellence (CoE) is hosting a virtual #workshop to introduce the #CDER QM CoE, providing an overview of the scope, goals, and current state.   #QuantitativeMedicine (QM) uses exposure-based, #biological, and quantitative #models from various data sources to enhance #drugdevelopment #regulatory decisions, and #patientcare.    Workshop objectives: 📌 Provide an overview of the newly formed #QM CoE, including discussion of the current goals, initiatives, and priority areas 📌 Engage with stakeholders to inform future QM CoE initiatives in education, outreach, and #policy development   ✍ Register here: https://lnkd.in/g4YWZEDg

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