RRPV | Rapid Response Partnership Vehicle’s Post

Today is the day! Please join us at 12PM EST for Dr. Jonathan Meyer's live webinar on "Essential Antipsychotic Drug Level Monitoring". Registration details are provided in the link below. We hope to see you there! #AAPP #mentalhealth #psychphamracy #TDM #antipsychotics

Very insightful with lots of important practical regulatory tips for developing and launching a biomedical product!

𝗗𝗮𝗶𝗹𝘆 𝗡𝗲𝘂𝗿𝗼-𝗯𝗶𝘁𝗲𝘀 🧠: 🩸ONWARD Medical receives grant to study BCI in restoring movement after stroke They received a grant from The European Innovation Council and SMEs Executive Agency (EISMEA) to study its ARC-BCI therapy to restore upper limb movement after 𝘀𝘂𝗯𝗰𝗼𝗿𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗿𝗼𝗸𝗲. ONWARD will now work closely alongside partners at CEA, EPFL, and Karolinska Institutet to investigate stroke sufferers regaining use of their arms This falls on the back of an excellent year for the team. Since reporting the first human implant of the BCI offering nearly a year ago they have... 💫Won FDA breakthrough device designation for the technology in February 💫In March, the FDA accepted the BCI into its new Total Product Lifecycle Advisory Program (TAP) 💫Received a grant from the Christopher & Dana Reeve Foundation to support an ongoing BCI study 💫Reported the third implant in September https://lnkd.in/eRTRy6AE

👀 Get an insider’s perspective on FORCE REPAIR Wounds from our partner Histocell. Regenerative Medicine! In our latest FORCE REPAIR video, Begoña Castro shares how Histocell. Regenerative Medicine is driving innovation in chronic wound management - supporting the development and manufacturing of advanced medical devices for hard-to-heal wounds. 📍 The video was filmed at last year’s #EWMA conference, presented as we prepare for EWMA 2025 in Barcelona (26–28 March , 2025). 📽️ Watch the full video here: https://lnkd.in/d9tHk4SQ #EWMA2024 #EWMA2025 #FORCEREPAIR #Innovation #HorizonEU

This week, our CSO, Amin Rostami-Hodjegan, participated in the “Executive Roundtable” at Avicenna Day 2024, hosted by the Avicenna Alliance. This prestigious annual event brings together industry and academic leaders to drive innovation in in silico medicine. Amin shared his insights alongside experts like Mark Palmer, M.D., Ph.D. (Ansys), Jan Hertwig (Simq GmbH), Jean Colombel (Dassault Systèmes), and Martha De Cunha Maluf-Burgman (Edwards Lifesciences), with moderation by Thierry Marchal (Avicenna Alliance/Ansys). He discussed the counter-intuitive philosophies related to transitioning modeling and simulation from academic endeavors to industrial tools and regulatory assessments. Key topics included the challenges of using open-source codes for regulatory purposes and the acceptance of models when no alternatives exist. The panel explored the transformative impact of digital simulations on medicine and technology, and how in silico medicine can bridge the gap between the scientific community, industry, and policymakers. For more on the Avicenna Alliance and the importance of integrating modeling and simulation into broader scientific practice, check out this article: https://ow.ly/XcLo50TfOtu, and visit: https://ow.ly/MnPS50TfOtt. #Innovation #InSilicoMedicine #AvicennaDay2024 #DigitalHealth #ModelingAndSimulation #PharmaTech

We recently completed a collaborative study with Terumo Blood and Cell Technologies on MSC expansion using the Quantum Flex Cell Expansion System. The study paves the way for MSC-based therapy developers to leverage automation to reliably scale from research to clinical manufacturing. We’re proud to continue fulfilling our mission to power the future of medicine.  Read the full press release here: https://lnkd.in/eG73RmD2

Our very own, Austin Collins, will be presenting at the SOCRA 17th Annual Device Research & Regulatory conference this week! He gave us a sneak peek into his presentation, "Introduction to Statistics in Medical Device Research 🎯" earlier this week. We are excited to see him share his expertise and passion with the industry. If you're attending the conference, make sure to say hi to Austin and ask him about his bird shirt! 🐦 Good luck, Austin - we're so proud to have you representing the Biomedical Statistical Consulting LLC team! #socra #clinicaltrials #regulatory #statistics #pigeonshirt #biomedicalstatisticalconsulting #medicaldevice #professionaldevelopment #conferences

🕠 One patent every 30 minutes: this is the level of research and innovation brought by the medical technology sector in Europe    Medical technology is the second highest among all industrial sectors in Europe for the number of patent applications.    Read the new MedTech Europe’s Facts & Figures 2024 to discover the sector's impact in Europe 👉 https://bit.ly/3U8Q3AE 

💡 𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗶𝗻 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝘄𝗶𝘁𝗵 𝗩𝗖𝗠 Struggling with inconsistent sample prep? VCM Technology changes the game. A recent study from University of Copenhagen (Københavns Universitet) showcased its ability to prepare reliable, bubble-free samples for real-time analysis of subcutaneous drug delivery systems. The benefits? Enhanced imaging quality, accurate results, and faster research timelines. Curious how VCM can support your next project? Let’s chat! 👉 Learn more: https://lnkd.in/dPGm6D2e #FormulationScreening #PharmaceuticalManufacturing #SamplePreparation #DrugDelivery

Webinar > Navigating the Regulatory Landscape for Innovative Biomedical Applications > NXTGEN Hightech Biomedical and High Tech NL and  invite you to join us for an insightful webinar on September 4, 2024, from 16:00 to 17:00 CET. This engaging and practical webinar will feature hands-on advice drawn from the extensive experience of Qserve Group, a leading consultancy in #regulatory affairs. Attendees will gain valuable insights into: - The importance of early regulatory involvement - Essential milestones necessary for preparing the launch of your biomedical innovations Registration > https://lnkd.in/eFcz7cqe More information > https://lnkd.in/eCEUdy87 NXTGEN Hightech #lifescience, #biomedical, #innovation, #healthcare, #biotechnology, #engineering, #biosensing, #organonchip, #labonchip, #cellproduction #artificialorgans