Phil Carvil’s Post

I'm happy to share with you some highlights from the masterclass I delivered on Feb 27th at Paris Saclay Cancer Cluster (PSCC), where I had the pleasure to speak to a group of onco-entrepreneurs about RWD and RWE in product development. Thank you Nouzha Mohellibi for entrusting me once again with this masterclass; and special thanks to my colleague Lionel Riou França for his valuable contribution! RWD and RWE are becoming increasingly important in the healthcare industry, as they can provide insights into the real-world effectiveness, safety, and value of medical products. In this masterclass, we covered the basics of RWD and RWE and highlighted how they can be applied in various scenarios to support decision-making. We also explored some of the best practices and common pitfalls of generating and using RWD and RWE, and how to overcome them. In our presentation, we emphasized how crucial it is to develop RWD/RWE strategies early on and throughout the entire product lifecycle. To achieve this, companies must establish an RWE team that will collaborate closely with several stackholders such as clinical and health economic teams to define best strategies for each product. I hope this masterclass was useful and informative for the participants, and I look forward to continuing the conversation on this topic. If you are interested in learning more about RWD and RWE, feel free to connect with our AIXIAL GROUP. #aixial #PSCC #rwd #rwe #clinicalinnovation #clinicaldevelopment

Denmark’s New Life Science Strategy🚀 Today, we had the honor of hosting more than a hundred key stakeholders and media representatives for the launch of the Danish Government’s new life science strategy at our premises in Copenhagen.🧬🔬 Ministers Morten Bødskov, Sophie Løhde and Christina Egelund, from the Ministry of Industry, Business and Financial Affairs, Ministry for the Interior and Health of Denmark and Ministry of Higher Education and Science, respectively, presented the life science strategy, which seeks to clearly direct the development of the Danish life science sector to maintain Denmark’s position as a world-leading life science nation. Already, we are happy to see the commitment to establish Innovation District Copenhagen as a world-leading hub for innovation in life science and quantum technology, the intention to increase accessibility and utilization of public health data, and the outlined initiatives to strengthen the framework for clinical research. All these are important steps to ensure that innovators, scientists, and clinicians have the best conditions for drug development, drug discovery and health care. At BII, we are ready to facilitate collaborations and innovation to fulfill the ambitions outlined in the strategy.🤝   Ministry of Industry, Business and Financial Affairs, Indenrigs- og Sundhedsministeriet and Ministry of Higher Education and Science Lars Rasmussen, Lars Fruergaard Jørgensen, Mette Trauelsen, SOLID Therapeutics, Lars Petersen Jens Nielsen, Pui Ling Lau, Marianne Philip.

Check out this exciting series!

What a great day for the Danish Life Science and Startup Communities! Denmark has decided to strengthen it's World-leading position in Life Science. One of the main goals, is to be the country that fosters record in building health, green, and life science startups 👍 I cannot wait to see the strategy being executed. Go. Go. Go.

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

𝐖𝐞'𝐯𝐞 𝐞𝐱𝐩𝐚𝐧𝐝𝐞𝐝 𝐨𝐮𝐫 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩 𝐰𝐢𝐭𝐡 Roche Danmark – 𝐚𝐢𝐦𝐢𝐧𝐠 𝐭𝐨 𝐝𝐫𝐢𝐯𝐞 𝐞𝐯𝐞𝐧 𝐦𝐨𝐫𝐞 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 🚀 🤝 Last week, BETA. HEALTH and Roche shook hands on a shared ambition to pursue more industry-connected corporate partners to join our healthcare innovation efforts. We believe that this path forward will make our impact even greater! Roche has shown us that the industry has unlimited capabilities that can benefit the development, implementation and scaling of innovative clinical solutions – and together, we believe that more BETA. HEALTH-funded projects should benefit from extended partnerships. Our partnership began last summer when we joined forces to create an 'Industry Call' pilot programme aimed at further accelerating clinical innovation. The selected project, cancercare@home, aims to increase care capacity while improving quality of life for cancer patients by enabling them to self-test their blood values at home. The joint programme has connected the cancercare@home team with Roche’s global network of industry experts, who are using their experience and connections to help bring this point-of-care technology to patients. 𝐑𝐞𝐚𝐝 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 ‘𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐂𝐚𝐥𝐥’ 👉 https://lnkd.in/e3TvnU_i Christian Juul-Nielsen, Rasmus Fält, Agnete Halldorsson, Mikkel Møl Dalsgaard, Bodil Christine Reumert, Sarah Maria Rasch, Rasmus Thomsen, Rasmus Bjørn Dahl

Denmark is #1 in Europe for Conducting Clinical Trials🥇   Denmark ranks no.1 in Europe for conducting clinical trials per capita and with world-class research standards. Medical and health science is the most prioritized research area in Denmark accounting for more than a third of all public investments. Denmark is also a world leader for private investments in drug research and development.   With a fully digitalized healthcare system, Denmark offers world-class patient registries, civil registries, and biobanks. Danish patients and healthy subjects for clinical trials are readily identified and monitored.   We invite you to become a part of this unique ecosystem: At Invest in Denmark, we assist companies in connecting with relevant clinicians and hospitals ready to conduct studies. And we do so free of charge and in full confidentiality.   Are you interested in starting a conversation about how Invest in Denmark can help you connect to a clinical researcher? Click to learn more about how to get in touch with our sector experts who are experienced in assisting pharma and biotech companies looking to conduct clinical trials in Denmark: https://lnkd.in/eMz9WeRh #oncology #clinicaltrials #Healtcaredata #ClinicalStudies The Trade Council of Denmark in North America - Denmark in Canada, Denmark In New York, American Society of Clinical Oncology (ASCO), Phase 1 Unit, Rigshospitalet, Trial Nation

I adore Clinical Trials Day! Let's pave the way for innovation in clinical research together. 🌟From improving feasibility to building trust, there's much we can do to accelerate progress. What steps do YOU think we should prioritize? #clinicalresearch #ClinicalTrialsDay #collaboration

🔔 Join DEEP and DiMe today on the last session of the webinar series on Nocturnal Scratch. We will be joined by an exciting panel, including representation from EMA and FDA, to discuss the validation and adoption of the digital measurements of nocturnal scratch. Don't forget to sign-up and join us today at 5pm CEST! FDA European Medicines Agency Digital Medicine Society (DiMe) Takeda GSK Pfizer ActiGraph Genentech #digitalmeasures #collaboration #validation

Registration is now open for our industry symposium 'Accelerating CF Research: Strategies for rapidly progressing your science to clinical impact', organised by Cystic Fibrosis Trust with support from LifeArc. Please register here to secure your place. https://lnkd.in/eDpmnCJH Places are limited and early registration is highly recommended to avoid disappointment. Date: Wednesday 5 June Time: 10.30am-1.30pm, including a networking lunch Location: Glasgow Science Centre, Pacific Quay, G51 1EA At this event you will find out more about: Uncovering funding opportunities: Learn how to secure funding for pre-clinical proof of principle studies. Accelerating your research: Find out how we can deliver research closer to patients and gain access to lived experience insights. Learn how to set up and deliver clinical trials through our Clinical Trials Accelerator Platform (CTAP). Diving into data-driven insights: Explore the power of data within the UK CF Registry to inform clinical trial design and support pharmacovigilance, pharmacoepidemiology and real-world evidence studies. Tapping into support: Discover how Cystic Fibrosis Trust, Medicines Discovery Catapult and LifeArc can work in partnership with you, providing you with resources, funding and support through the CF AMR Syndicate. We look forward to seeing you there! And please do share with anyone who might be interested.