SYSNAV Healthcare

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Today is Global ALS/MND Awareness Day. ALS (Amyotrophic Lateral Sclerosis) is a neurodegenerative disease.   The statistics are dreadful: 💔 200,000 people worldwide are living with ALS 🧑 Every 90 minutes, someone is diagnosed with ALS, and someone passes away from it. But if you know someone living with ALS or have heard their testimony, you know how ruthless the disease is. Talking about ALS raises awareness... but there is still no cure and the clock is ticking. What can we do?  At Sysnav, we are committed to providing the right tools to accelerate drug development for ALS. Do you know someone who is living with ALS and wants to share their experience? Do you have good ideas on how we can accelerate ALS drug discovery? Let us know in the comment below 👇 #ALSAwarenessDay

We are grateful to Roche & Genentech for advancing the case for digital endpoints in clinical trials. SPITFIRE Trial post hoc analyses have revealed: 1️⃣ SV95C can detect changes in motor function faster than gold standards (6MWD, 4SC velocity, and NSAA). 2️⃣  SV95C is robust, reliable, and applicable to a broader population. 3️⃣ Syde is widely accepted by patients and is compatible with their lifestyles. Do you want to read the paper? The link to the paper in the comments below 👇

❓ Would you like to know how to communicate the value of digital endpoints to clinical development and trial planning partners? ❓ Do you want to make a compelling business case for developing and implementing digital measures? ❓ Do you want to determine the Return on Investment (ROI) for digital endpoints? The business project "Building the Business Case for Digital Endpoints" by Digital Medicine Society (DiMe) will answer these questions for you! Sysnav Healthcare is excited to partner with the Digital Medicine Society (DiMe) on this project. In this project, along with industry partners, we will: 📉 Develop a framework to evaluate the ROI of digital endpoints 📑 Create templates and resources to support the adoption of digital endpoints in clinical research 💸 Build a compelling case for continued investment in digital strategies aligned with business goals. The project will highlight the potential of digital endpoints in clinical trials to decision-makers and the need for sustained investment in them. Keep updated with the project and access the project resources through the link in the comments below 👇

We are back with 'Lessons from the SV95C qualification Series'. In 2023, Sysnav and its partners qualified SV95C, the first digital primary endpoint to the European Medicines Agency (EMA). In the next few months, we'll share our biggest takeaways from the qualification. 🤝 Lesson 2: It takes a village Creating meaningful endpoints requires interaction between physicians, engineers, patient associations, and regulators.  Digital endpoints should be: 👉 Meaningful for patients 👉 Used by clinicians 👉 Trusted by regulators The SV95C EMA qualification is the result of collaboration with University of Oxford, Roche, Parent Project Muscular Dystrophy, Muscular Dystrophy UK, World Duchenne Organization, and many others.

The pharma industry needs better drug development tools now more than ever ⏳ 🔬 👉 Between 2007-2021, the FDA granted accelerated approval (the conditional approval pathway) to 146 drug indications. 👉 By December 2021, only 48 out of 146 (32.9%) accelerated approvals had been converted to regular approval by the FDA. The success rate of new drug development from conception to new drug registration is only 7.9%. The process faces many hurdles: ❓ Generating meaningful efficacy data faster to enable accelerated approvals ❓ Helping drug developers make better-informed decisions to prioritize their portfolio better? ❓ Ensuring low burden and ease of participation for patients 💡 Digital Endpoints are the solution. Read the article below to learn more about the potential of digital endpoints in clinical trials! If you want to learn more about how you can partner with us to advance the qualification and implementation of digital endpoints, feel free to reach out to us.

Did you know that in 2023, Sysnav and its partners qualified the first digital primary endpoint: SV95C? 🧐 Over the next few months, we will share our main takeaways from the qualification in a series of posts dedicated to it. 💡  Lesson 1: Sensor is key The sensor technology must be analytically validated in the right context of use. SV95C is measured at the ankle from a suitable ankle-worn wearable sensor (Actimyo or Syde). About #SV95C 👉 SV95C is the first regulatory-qualified real-world digital outcome measure for use as a primary endpoint for Duchenne Muscular Dystrophy clinical trials. 👉 It represents the top 5% fastest strides a patient spontaneously takes in their normal daily environment over a predefined time period. 👉 This validation offers a valuable alternative to the 6-Minute Walking Test for evaluating ambulant DMD patients.

🔬 In 2023, the European Medicines Agency qualified SV95C (Stride Velocity 95th Centile) as a primary endpoint for superiority studies for Duchenne Muscular Dystrophy (DMD). #SV95C is the only digital endpoint qualified as a primary endpoint by the EMA. So, what is SV95C? And why is it important? SV95C represents the top 5% fastest strides a patient spontaneously takes in their normal daily environment over a pre-defined time period. It is measured at the ankle using the Syde® or ActiMyo wearable. 👉SV95C objectively reflects disease progression as it is not dependent on external factors and short-term variations like fatigue, motivation, or context. 👉SV95C transforms drug development by enabling shorter trials with smaller patient numbers. It is possible due to the continuous and objective collection of accurate and meaningful patient data in real life. 👉SV95C marks a milestone in the adoption of digital endpoints in the industry and paves the way for broader use in clinical research. Nature Medicine covered the primary qualification of SV95C. Check out the article link in the comments below! Springer Nature Group

👶 Why damien eggenspieler, our Healthcare Program Director tested our wearable Syde on his son? 🔄 How digital endpoints compare against the traditional gold standard for patient ease, convenience, and experience? 🌐 What are the updates on digital endpoint from regulatory bodies like EMA and FDA? Join Jeffrey Statland, Michelle Rohrer, Paul Strijbos, and damien eggenspieler in the LinkedIn event "The Promise of Digital Endpoints in Healthcare" to know the answers! The link to the video is in the comments below! 📺🔗 #digitalendpoints

🗼We are back in Paris for the Myology 2024! We are presenting data highlighting the validity of SV95C on young #DMD patients! We'll be at poster P380! Feel free to reach out if you'd like to learn more about the results or if you want to understand how these data could support decision-making in your clinical program. The link to the poster is in the comments below!