Michael Libiseller’s Post

🚀 Dig deeper into the world of precision medicine with our upcoming webinar! Join us on April 25th, 2024, for expert discussions on "3 strategies for RWD challenges in clinical research and trials." In this session, industry leaders Eric McDavid, RWD & Technology at Lifebit and Philip Awadalla, PhD, National Scientific Director at Canadian Partnership for Tomorrow's Health | Le partenariat canadien pour la santé de demain , will investigate the critical role of real-world data (RWD) in advancing precision medicine by discussing the current challenges around using RWD and showcasing solutions to enable the use of population level data and diverse studies for R&D. 🧑💻 Uncover actionable strategies for leveraging RWD effectively in clinical research and trials. Secure your spot now: https://bit.ly/3UgIIQc #PrecisionMedicine #RealWorldData #RWD #ClinicalResearch #ClinicalTrials #LifebitWebinars #Lifebit

🌍 Exciting times ahead for digital health in France! I had the honor of speaking at the roundtable on "Digital Medical Devices: Where do we stand in their assessment and what healthtech stakeholders need to know?" organized by the Agence de l'innovation en santé (Lise ALTER, Camille Schurtz 👏 ) at the "Next generation of clinical research" event in Lille. The discussion was rich with insights on the current landscape of research and the future of digital therapeutics in France, especially. Special thanks to our moderator, Line FARAH (Ministère de la Santé), and my fellow speakers: Jérôme Fabiano (EIT Health France), Corinne Collignon (Haute Autorité de Santé), Sarah Zohar (INSERM), Dr. Joris Giai (CHU Grenoble Alpes) and Louisa Stüwe (Ministère de la Santé). 💡 One of the key insights: YES, foreign clinical data can be used to apply for reimbursed of a digital medical device in France! Let's connect and explore opportunities together! 🚀

🚀I'm thrilled to announce that I'll be speaking at the upcoming DIA Global Meeting, taking place in San Diego, US, between 16-20 June, on a topic that's close to my heart: Digital Biomarkers as Clinical Endpoints - The Road to Regulatory Acceptability. 💡In an era where technology and healthcare are increasingly intertwined, digital biomarkers offer groundbreaking potential to revolutionize clinical trials and patient care. This session will explore how we can harness these innovative tools to meet regulatory standards and improve health outcomes worldwide. 🔍In my speech, I'll be diving deep into the current landscape of digital biomarkers, with the focus on Europe, and exploring the path towards wider regulatory acceptance. I'll be sharing real-world examples and @Bayer’s perspective to help us navigate this exciting new frontier in clinical research. 🙏I'm especially grateful to Susan Awad and Lina AlJuburi for inviting me to share the industry insights on this critical topic. Digital biomarkers have the potential to revolutionize clinical trials, offering a more objective and efficient way to measure treatment effects. However, their regulatory acceptance is still evolving. 🌐 If you're interested in the future of clinical trials and the potential of digital biomarkers, then be sure to join the conference! I look forward to a stimulating discussion and the opportunity to connect with fellow leaders in the healthcare industry. hashtag #digitalhealth hashtag #clinicaltrials hashtag #regulatoryaffairs hashtag #globalhealthcare hashtag #digitalbiomarkers hashtag #DIA2024 https://ow.ly/XxFR50QwsWt Steve Berman – BIO, Deputy Vice President, Science and Regulatory Affairs Strategy Gul Erdemli – Novartis, Global Program Regulatory director Anindita (Annie) Saha – FDA Associate Director for Strategic Initiatives, Digital Health Center of Excellence Marwan Fathallah, President and Chief Executive Officer, DIA Global Ania Mitan, DIA Susan Benedetti, MSOL, DES, Senior Project Manager, Global Annual Meeting Maureen Lamplugh, Retired, Former Annual Meeting Program Manager, DIA Christian Rommel, Bayer AG Stefan Oelrich, Bayer AG Elena Popa, Bayer AG Antoine Manson, Bayer AG

Adama Ibrahim, EMBA of Novo Nordisk has been attending Mobile in Clinical Trials for five years! She has noticed the industry’s shift towards a more “human-centric approach of bringing in the user’s perspective, and understanding their journey”, which is a key theme at #MobileClin2024. Learn more about Mobile in Clinical Trials 2024, the leading conference for patient technologies in research: https://lnkd.in/ggv8w76s #conference #clinicaltrials #mobiletechnology

Have you ever considered participating in a clinical trial but are worried about accessibility or understanding the guidelines? Good news! Many research studies now offer virtual engagement options and local testing facilities. Plus, before joining, you’ll receive clear guidelines for informed decision-making. Check out this article debunking myths about clinical trial participation: https://lnkd.in/g5dbfNK9 #WorldBronchiectasisDay2024 #WorldBronchiectasisDay #BronchiectasisResearch #bronchiectasis World Bronchiectasis Day is July 1, you can help spread awareness of bronchiectasis by sharing this post!

Fantastic session on: "Innovations in addressing clinical needs" during Life Science Start-up Summit BRIC ILS. The panel constituted academician, practicing physicians, industry and regulatory experts. The brainstorming session had the following take-away messages: point-of-care diagnostics, affordable healthcare both for urban and rural settings, continued clinical collaboration and meticulous experimental documentation for regulatory clearances are key areas to focus when addressing clinical innovations. DBT ILS BioincubatorNivedita JenaBalaravi RavindranXCyton Diagnostics Private LimitedGauri MisraSai Praveen Haranath

I am excited to participate in the 2024 DIA Real World Evidence (RWE) Conference in Philadelphia today and tomorrow. This annual event lets us delve into the latest advancements and innovative applications of RWE. From data standards and new regulatory guidances to advanced approaches for noninterventional studies and the role of real world data in achieving diversity in clinical trial recruitment, this conference provides cutting-edge insights as well as practical solutions. By exploring new methodologies and practical case studies, we gain the knowledge and tools to leverage RWE effectively in our work and drive forward efficient and informed healthcare decision-making.#dia#rwe2024#teamscience#collaboration#data#regulatoryscience

Read the remarkable story of patients, their parents, fundamental researchers, doctors, patient associations, entrepreneurs, funders and policymakers who embark on a quest to find a medicine for Pompe disease. What a heroes! As a case study this is vital info for research & innovation in the field of rare diseases. Also very much the story of translational research at Erasmus MC, aimed at turning the results of basic research into societal impact. The book written by Pompe patient advocate Maryze Schoneveld van der Linde and researcher Erik Van Uden was published on Monday October 28 during a minisymposium at Erasmus MC, including a presentation about the new generation of research into Pompe disease by Pim Pijnappel, who also showed how the new businessmodel of LentiCure B.V. avoids the notorious pitfal of innovation coming to and end before reaching the market. Published in Dutch by Poiesz Uitgevers. https://lnkd.in/eriRE78z Robert AL, MBA RTTP, Carola Remers, Leonore Tuyt, Arnold JJ Reuser, Joke Boonstra, Cor Oosterwijk, Frits Poiesz European Medicines Agency, Rotterdam Square, Prinses Beatrix Spierfonds, Spierziekten Nederland, Sanofi, Pharming Group N.V., Pharming Healthcare, Inc. #ziektevanpompe #pompedisease #rarediseases #zeldzameaandoeningen #tto #technologytransfer

This is specially for those working in the clinical research & development space- an area I was working in for the past 2 decades within Global Clinical Research Organizations & the Healthcare logistics space leading regional and global teams: Come next wed, I’d be moderating a distinguished group of experts working within the Decentralised Clinical Trial (DCT) space to bring you the latest developments in the industry! Along with the development of connecting technology – which has advanced even further since the COVID-19 pandemic – the concept of the DCT has become increasingly popular. Digital technology enables trial sponsors to cast their nets further than ever before, inviting and including participants from more remote areas, as well as those from underrepresented cultural backgrounds. Ethnic minorities account for between 2 and 16 percent of clinical trial participants, according to Medable, Inc ‘s Chief Development Officer, Hady Khoury. But in this age of data, the tools used to generate a cohort of suitable participants have been disrupting conventional practices over the past three or four years. What’s next? This is what we are going to find out at Singapore Clinical Research Institute (SCRI)’s industry symposium coming up next week. Come by for a chat and to interact with the experts! See you soon! #DCT #IndustryNetwork #SCRI #Symposium

Step into the making of the 9th Mid Term PHO CME conference! Be a part of this transformative event that define this transformative event. From keynote sessions to networking breaks, discover how we're advancing onco healthcare together. Dr Pankaj Dwivedi Trupti Dhabale Medha Dixit #PHOCME #NCIEvents #MedicalConference #HealthcareLeaders #CancerReasearch #MedicalEducation