Speaking 🎙️at the ATCC #Excellence in #Research Webinar Series, UC San Diego HUMANOID: Center of Excellence in Human Organoid Research's Director, Courtney Tindle delved into HUMANOID’s #innovative approach to #benchmarking #organoids as next-generation platforms for drug and biomarker discovery. 💊🔬. Her #talk entitled, "Introducing a ‘Phase 0’ in Clinical Trials with Precise Organoid-based Disease Models", highlighted how we are transforming the future of clinical trials by creating more precise, human organoid-based disease models to accelerate drug discovery and improve patient outcomes. 🌍✨ Learn more by checking out the webinar here:: https://lnkd.in/ghHDETvp] Check out our team, capabilities, and the services we provide [Website: https://lnkd.in/g2Bbww8B] Need assistance? Contact Us: Ctindle@health.ucsd.edu #Pictures: Courtesy Kyle C. Dykes, UC San Diego

Endeavor BioMedicines’ ENV-101 is a hedgehog pathway inhibitor for adults with idiopathic pulmonary fibrosis (#IPF). Investigator Toby Maher, M.D., Ph.D. from the Keck School of Medicine of the University of Southern California recently discussed new data from the ENV-101 Phase 2a clinical trial with Isabella Hornick at Healio. "The placebo group acted as a placebo group should in this type of trial, which is to say that they lost lung function over the course of the 12 weeks.” Dr. Maher also commented, “What was exciting is that the treatment arm demonstrated a continuous and statistically significant improvement in lung function. This really distinguishes the data generated in this trial vs. what we’ve seen with other studies in the past, where we might only see a slowing of disease progression." Learn more about ENV-101 and what's next for the Phase 2b clinical trial: https://lnkd.in/eB6ZeqV2 #biotech #clinicaltrial

🌍 𝟭,𝟴𝟬𝟬+ 𝗔𝗧𝗠𝗣 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 are currently underway worldwide, but only about 100 are in Phase III, the last stage before regulatory approval. 𝗪𝗵𝗮𝘁 𝗰𝗮𝗻 𝘄𝗲 𝗹𝗲𝗮𝗿𝗻 𝗳𝗿𝗼𝗺 𝘁𝗵𝗶𝘀? Since the approval of the first ATMP in 2009, only ~30 ATMP treatments have reached the market. This reveals two realities: - 𝗘𝘅𝗰𝗲𝗽𝘁𝗶𝗼𝗻𝗻𝗮𝗹 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻: ATMPs offer groundbreaking potential and life-changing opportunities, pushing the boundaries of modern medicine. - 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀: High failure rates after Phase I and II, complex regulatory pathways, and logistical hurdles make the journey from trial to approval extremely challenging. Want to explore these challenges and uncover the potential of ATMPs? 👉 Join this 𝗳𝗿𝗲𝗲 webinar on Sept 19th at 4.00 pm CET to dive into the complexities and opportunities of ATMP clinical trials! Let’s make this webinar interactive and valuable for everyone! Share your challenges with running ATMP trials in the comments or via DM, and I'll make sure to address them during the webinar. Register now! 🔗 https://lnkd.in/ey-aCGdg

The FDA encouraged scientists and drug developers to use the alpha-synuclein seed amplification assay (αSyn-SAA) biomarker, discovered in 2023, for research and clinical trials in a “Letter of Support” issued late Summer 2024. The Letter of Support follows multi-stakeholder collaboration amongst The Michael J. Fox Foundation for Parkinson's Research and the Critical Path Institute, with both organizations supporting use of the biomarker for clinical trials and advancing new drugs for Parkinson’s disease. Because the tool can objectively detect early biology related to Parkinson’s and related diseases, including Dementia with Lewy Bodies, even before any symptoms emerge, trials using the biomarker are better positioned to test therapies that aim to delay or even prevent the onset of disease. The use of the tool also enables research toward tailored therapies to treat individuals at all stages of these diseases. “This FDA Letter of Support is a transformative moment for the field, promising to speed clinical trial design in Parkinson’s and related disorders,” said Diane Stephenson, PhD, executive director, CPP, C-Path. “The cross-collaboration among patients, researchers, clinicians, regulators and patient advocacy organizations demonstrates the critical role every player holds in moving today’s achievement forward. Now, we’re closer than ever to better treatments, and perhaps one day, preventing people from developing the symptoms of these diseases altogether.” Full details, here: https://lnkd.in/gqhuVqnW #CPath #MJFF #FDA #Parkinsons #PD #Biomarker #drugdevelopment #diseaseprevention #datasharing #globalhealth #collaboration

Block Clinical Inc. has been recommended by Friedreich's Ataxia Research Alliance (FARA) for our patient support and travel concierge services. Providing patients with rare diseases the best possible support and accommodations is necessary to conducting a successful clinical trial. Our patient support and travel services boost patient recruitment and retention by ensuring that every patient receives the necessary support and accommodations while enrolled in a clinical trial. Companies such as Design Therapeutics, PTC Therapeutics, Inc., and Prime Medicine, Inc. are spearheading research into Friedreich's Ataxia treatment. What types of patient support and travel services are being utilized in these trials? And how can we improve upon the standards of patient support within the rare disease market? #PatientSupport #ClinicalTrials #TravelConcierge #FriedreichAtaxia #PatientTravel #RareDisease

🗓 On International Clinical Trials Day 🩺, we thank the patients, clinicians, researchers and partners helping to advance our pipeline of potentially lifesaving therapeutics addressing rare and life-threatening liver conditions with high unmet medical needs. #ClinicalTrialsDay #CTD2024 #InternationalClinicalTrialsDay #InnovationInHealthcare ACRP - Association of Clinical Research Professionals

How do Central Labs ensure reliability across global clinical trials? In our latest Q&A, Pagona Manika, shares insights into the critical role Central Labs play in ensuring consistency, managing biological samples, and advancing specialized testing. Here’s what Pagona covers: 🔹 How Central Labs ensure consistent, reliable data across multiple locations 🔹 Challenges Central Labs help overcome in sample management and storage 🔹 The importance of Central Labs in providing advanced, specialized testing 🔹 How Central Labs adapt to the complexity of biomarker analysis in personalized medicine and oncology trials Have more questions about clinical research? Drop them in the comments below and we’ll answer them in upcoming posts! 💬 #CentralLabs #ClinicalResearch #BiomarkerAnalysis #PersonalizedMedicine #YourQuestionsExpertAnswers #ClinicalTrials #HealthTech

Our #ASCOGU24 and GI24 EPICS conference coverage reports will have the strategic recommendations and latest insights on translational and therapeutic developments in GU and GI malignancies: https://lnkd.in/eGj4rEGF #GastrointestinalCancer #GenitourinaryCancer

Are you in the process of planning a targeted therapy launch or facing challenges in driving commercial success for precision medicine?   In an increasingly competitive market, a data-driven and timely commercialization strategy is critical to enabling successful therapy and biomarker adoption. Costs associated with launching a new therapy are rising, placing a significant strain on the resources available to pharma and biotechs. Diagnostic testing also remains under-supported, with many healthcare facilities lacking comprehensive genetic testing capabilities. This, combined with a knowledge gap among physicians, can lead to a significant number of eligible patients being lost along the treatment pathway. Diaceutics has just announced a new webinar series, ‘The Precision Medicine Series: Strategies for Launch Success’. Led by precision medicine experts, these webinars will provide valuable insights to overcome these obstacles in the market to drive commercial success for targeted therapy launches. I would like to invite you to join us on Thursday, September 5, 2024 @ 1-2pm EDT for our first webinar in the series ‘Driving commercial success for precision medicine: Understand the market to maximize patient identification & therapy adoption’ where we will share exclusive insights to drive commercial success by applying Diaceutics’ 6A™ Commercial Framework. Register today: https://lnkd.in/e46jVZWA #BetterTestingBetterTreatment #PrecisionMedicine #Webinar