Baim Institute for Clinical Research’s Post

Cereno Scientific’s innovative study design of the Phase II study of CS1 in PAH published in the renowned medical journal Pulmonary Circulation.   The research article describes how the design of clinical trials is important to fully understand the mechanisms and benefits of new treatments. Numerous potential pharmacological treatments for PAH have shown promise in preclinical models but have failed to show clinical benefit in humans or have been associated with poor safety and tolerability. A novel feature of the CS1 Phase II study is that the patients are monitored for pulmonary hemodynamics and right heart ventricle function on a daily basis with the implanted CardioMEMS HF technology. Furthermore, in the study, which has safety and tolerability as primary objective, a wide array of functional, hemodynamic, and structural measures and biomarkers as well as patient-reported outcomes are being collected to provide an insight into not only the treatment effects but the disease progression itself. The research article concludes that CS1 represents a potential novel disease-modifying treatment for PAH.   Read the full press release via link.

👨🔬🔬 Today is Clinical Trials Day! 👩🔬🧪 As an innovative biotech company with a diversified pipeline, we are engaged in twin phase 3 clinical trials and a phase 2 clinical trial in relapsing and progressive multiple sclerosis, respectively, along with gearing up for phase 2 clinical testing in celiac disease. Don't miss our Chief Medical Officer, Dr. Andreas Muehler, as he delves into the challenges we face in our day-to-day work and shares insights on how to overcome them ➡️ https://bit.ly/3QOdjUu. ACRP - Association of Clinical Research Professionals Proactive #ClinicalTrials #ClinicalTrialsDay #Biotech #Biotechnology #MultipleSclerosis #MS #PMS #RMS #RRMS #Vidofludimus #Celiac #CeliacDisease #IMU856 #IMUX #Immunic

We are thrilled to announce another exciting public-private cooperation of #MSD in the field of science and medicine! It is with great joy that we declare the continuation of our strategic partnership with the Medical University of Warsaw - MUW! Since February 2023, we have been shaping the future of healthcare hand in hand. Currently, we proudly follow our commitment by signing another agreement to design future research based on Real-World Evidence (RWE). The official ceremony of signing the agreement took place on January 11, 2024. The Medical University of Warsaw was represented by: Prof. Piotr Pruszczyk, Vice-Rector for Science and Technology Transfer,   Prof. Anna Staniszewska from the Department of Experimental and Clinical Pharmacology,  Prof. Maciej Niewada, representing the Department of Experimental and Clinical Pharmacology, while Justin Gandy, Managing Director of #MSDPoland, was acting on behalf of MSD. Justin Gandy expressed his enthusiasm for the upcoming cooperation, emphasizing that the effective implementation of the public-private partnership is a crucial step in enhancing healthcare standards and therapeutic outcomes. ”We are ready to create innovative solutions and engage in joint research that will improve the quality of healthcare for the benefit of all the society”. Marcin Bodio, PhD, EMBA, Dawid Grzeszczuk, Daniel Szulczyk, Associate Professor To read more: https://www.msd.pl/ #ScientificCooperation #StrategicPartnership #MSDPolska #MedicalResearch #InnovationsInHealth #PublicPrivatePartnership #FutureOfHealth

Tomorrow marks the beginning of an epic 4-day journey at the Convergence of Laboratory Medicine & In Vitro Diagnostics 2024, featuring the #CACLP & #CISCE tradeshows and 100+ activities. 🎉🚀 Dive in and chart your course below 👇🏻 #IVD #diagnostics #laboratorymedicine #China #Chongqing #agenda #schedule #countdown

Next week, CEO Dominique Demolle and CCO Krinx Kong will be at the ISCTM 2024 Autumn Conference in San Diego, California – participating in Friday's Working Group Session: Diversity in CNS Clinical Trials. In this working group, we're discussing how diversity can be addressed at key stages of CNS preclinical and clinical development, including: 💡Engagement of diverse participants in study design considerations 💡Data-driven methodological considerations for site selection 💡Operational trial conduct 💡Considerations for eligibility criteria and generalizability of endpoints We're excited to be part of this important discussion and offer our unique perspective on how technology can support diverse clinical trials. Specifically, Cognivia's mission is to minimize data variability caused by patient differences. Our tools help trials confidently meet Diversity Action Plan goals while maintaining study power and generalizable endpoints. #ClinicalTrials #ISCTM #CNS #DiverseClinicalTrials #ClinicalTrialDiversity

🎵If you're going to San Francisco - You're gonna meet some innovations there🎵 At least if you go in January, as FGK Clinical Research GmbH always does. The #JPM2024 conference and the Biotech Showcase are a good opportunity to land new business and financing for the biotech sector. Edgar Fenzl and Martin Krauss experienced new optimism in the biotech industry to get increased financing during 2024. And for FGK, this was an excellent opportunity to convince these companies about the benefits of conducting their clinical trials in Europe. #wefeelresponsible #clinicaltrial #clinicalresearch #CRO

Earn #FreeCME with our activity series 'Real World Retina.' This series includes four activities each with unique faculty perspectives. In 'Diabetic Macular Edema Management Challenges,' Drs. Diana Do, Mark Barakat, MD, and Jennifer Lim evaluate the evidence for anti-VEGF treatment outcomes for DME in clinical practice, identify prognostic indicators for predicting anti-VEGF therapy outcomes, and assess the latest evidence regarding safety, efficacy, and durability of new therapies for the management of DME. This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc. Complete the activity using this link: https://ow.ly/3FiN50Qe7xv

🎉 We have just been accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP), which provides us with streamlined US regulatory review for our investigational ARC-BCI™ System.  We are thrilled to be the second brain-computer interface (BCI) company to be accepted into the program alongside Precision Neuroscience.  What does this mean? ⬇️ ⭐️ Access to the fastest FDA review times for new medical technology.  ⭐️ Early and frequent strategic engagement from the FDA, people in the spinal cord injury (SCI) Community, providers, and payors to facilitate more rapid development and widespread patient access to ARC-BCI. ⭐️ More timely premarket interactions, earlier identification and mitigation of device development risk, and a more efficient premarket review process. This acceptance follows our recent announcement that our ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration. The ONWARD ARC-BCI System pairs BCI technology with investigational ARC-IM® Therapy to restore mobility after SCI. To date, two clinical feasibility studies support the potential of ARC-BCI, including one in 2021 and one in 2023 that restored lower and upper limb movement after SCI, respectively. These were the first studies in history in which a human regained thought-driven movement of their limbs after paralysis. We feel privileged to be at the leading edge of this transformative technology and are further encouraged that TAP enables us to reduce the time and cost to deliver the benefits of the ARC-BCI System to people living with paralysis. ✨ *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.  #EmpoweringMovement #SCI #BCI 

🎉 Exciting news from Tavo Biotherapeutics! They have been awarded a generous $1,066,178 grant from the U.S. Department of Health and Human Services (HHS), specifically the National Institutes of Health and the NIH National Eye Institute. This funding will support their groundbreaking work in developing a first-in-class extended-release IOP-lowering formulation for glaucoma, a leading cause of irreversible blindness worldwide. Their innovative approach aims to address major limitations of current treatments, including poor patient compliance and side effects. #SBIR #STTR #Innovation 🔬 This Phase II SBIR grant will enable Tavo Biotherapeutics to perform the necessary IND-enabling studies required by the FDA, paving the way for their first-in-human Phase IIA IND application. The research, which falls under the category of late-stage pre-clinical development, will span 24 months, starting from September 1, 2024, and ending on August 31, 2026. Kudos to Tavo Biotherapeutics for their dedication to improving glaucoma treatment and patient outcomes! #Healthcare #Biotech #Research

FPFV achieved for our Ph1/b clinical trial (GRT-001 monocyte-depleting mAb)