GO Virginia’s Post

Great platform to deepen the impact of modeling and simulation!

The Final Agendas for https://lnkd.in/ev2K3bR are posted! The event is in San Diego April 1-4, 2024. Plenary Keynotes are Daniel Nomura of UC Berkeley and Double Nobel Laureate, Barry Sharpless of Scripps. There will be 5 parallel day-and-a-half conference tracks in each half and 3 parallel symposia the day before the main event. You can attend anything that runs concurrently with the track for which you register (and access most of what you missed On Demand). #drugdiscoverychemistry, #medicinalchemistry

A good strategy helps when it comes to evidence generation in the CNS trials. But in the execution lies the proof of the pudding! Happy to be part of this exciting spotlight session. #mentalhealth #cns #clinicaldevelopment

Here's some news! The Center for Drug Evaluation and Research (CDER) at the FDA has established a new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. These approaches contribute to the totality of understanding of a drug's benefits and risks, helping to advance therapeutic medical product development and inform regulatory decision-making. Check out the posting below for more details!

Join us for a Virtual Symposium & Live Panel Discussion on new Real World Evidence of Mahana IBS recently presented at ACG 2023, Beyond Research: Bridging the Gap with Real World Results for Prescription Digital Therapeutics in IBS. This event will take place on Friday, November 3,2023 | 12:00 PM EST/9:00 AM PST. Click on the link to register https://lnkd.in/dQPmR-tv OBJECTIVES: ➡ Provide a platform for Dr. Staller and Dr. Pathipati to share and discuss insights into Mahana’s inaugural real world evidence study post-ACG to a wide audience on using Prescription Digital Therapeutics in practice. ➡Discuss and enrich study findings with real world experience from community practitioners. ➡Educate on the evolving landscape and evidence of digital therapeutics used to address unmet needs in the treatment and management of IBS. ➡Gain perspective from the real world evidence and a multi-disciplinary panel on selecting appropriate IBS patients for digital behavioral therapy. ➡Learn real world, practical insights on the application and use of FDA cleared behavioral treatments in the management of IBS, successes, and how to address remaining barriers.

This month to celebrate the "Love Drug", we're running a 30% off sale our on our in-depth online course "Foundations in MDMA Safety, Therapeutic Applications & Research". If exploring MDMA is of interest to you, now is the time to jump into the course! If you'd like to explore some topics we cover first, here are the top 10 articles on our site about MDMA: https://lnkd.in/gsvFHZ-q

Check out this exciting series!

Delve into the realm of Contract Research Organizations to identify the industry's major players. Learn how the leading CROs excel as strategic partners in clinical research, yet explore the nuances of size leading to unintended drawbacks and limitations. Read more here: https://lnkd.in/gyhtgRiD

Cereno Scientific reports significant progress and a timeline adjustment in the Phase II study of CS1 in rare disease PAH. We are today sharing significant progress in the study, however, a slower recruitment pace than estimated during the last months and a longer start-up phase for two new clinics have affected the study timeline. The updated study timeline now expects study completion and top-line results during Q2 2024. Björn Dahlöf, CMO, comments: "We are highly encouraged by the remarkable findings in the reported Patient Case as well as the positive findings from the DQCR that our drug candidate CS1 might be able to document substantial clinical benefits in this fatal disease. We are working hard to complete the recruitment of 30 patients to randomize to treatment with CS1 in the study. We have seen significant progress in the last period, however, there are still some patients to recruit. We currently have a number of additional patients identified at our current sites and our two new sites to be activated and are optimistic about the execution of the study based on this updated timeline.” Read more via link https://lnkd.in/gARwGkd5

Thank you, Needham & Company, for the opportunity to share our story with the executives, leaders, and investors who attended the 23rd Annual Needham Virtual Healthcare Conference.    Our CEO, Dave Marver, gave a presentation on progress towards our 2024 strategic objectives. Our highlights so far this year include:   ⭐️ Our recent De Novo medical device application to the US Food & Drug Administration (FDA) for our first-of-its-kind investigational ARC-EX® System designed to restore upper limb function after spinal cord injury (SCI).   ⭐️ Acceptance 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 the second brain-computer interface (BCI) company to be accepted into this prestigious program.   ⭐️ We received our tenth Breakthrough Device Designation (BDD) from the US FDA for our ARC-BCI System based on clinical data from two human feasibility studies. This makes us the FIRST company in the world to receive breakthrough designation for a BCI paired with therapeutic stimulation. ⭐️ Our successful EUR 20M capital raise, led by EQT Life Sciences, Inkef, our CEO Dave Marver, and several members of our Board of Directors and Management Team.    We appreciate the opportunity to collaborate with digital health leaders and investors dedicated to supporting innovative solutions for the SCI Community.   *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 #Innovation