Thunicia Moodley, PhD’s Post

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🚀 Register Now: Clinical Trials 2024! 🚀 https://lnkd.in/dJfBPYqV 🌍 Unveiling the Potential of Combined Regional Studies in Emerging Locations 🗓 Tuesday, October 8, 2024 🕚 11:00 AM CEST | 🕒 60-minute webinar The clinical trials landscape is shifting towards emerging regions with faster start-up and enrolment times. For critical areas like oncology and infectious diseases, this speed can make all the difference. Join our expert panel to explore how combined regional studies in Georgia, Armenia, Uzbekistan, and Ukraine can transform patient outcomes, enhance study timelines, and strengthen data integrity. 🔑 Key Takeaways: Streamlined clinical study management Accelerated patient enrolment Strategic partnerships in high-potential markets Ensuring high-quality data and balanced CRA workloads Don’t miss out—register today and gain valuable insights into the future of clinical trials! #ClinicalTrials2024 #EmergingMarkets #Oncology #InfectiousDiseases #PatientCare #Webinar

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I had the great opportunity to attend the Advanced Therapies Week conference in Miami, FL this week. There was a lot of energy and enthusiasm all around and opportunities to connect. I was amazed to learn there are now almost 4000 Gene, Cell and RNA therapies in pre-clinical through pre-registrational phases as of the end of 2023. While the majority of this work has occurred in the oncology and rare disease space, many other therapeutic areas have research underway.   From the clinical operations perspective, the ways in which we plan and setup clinical trials, identify and work with a variety of different data sources for site identification and patient recruitment in trials, partner with specialty vendors delivering unique service offerings, and work through complexities in clinical supply chain logistics will all continue to evolve to meet the needs of new and advanced therapies. Very exciting times ahead! https://lnkd.in/eP2dbHvZ Note: The views and opinions expressed in this post are my own.

Don't forget to join today at 5pm CEST to the final webinar of the Nocturnal Scratch series. Today an exciting panel including EMA and FDA will be discussing the validation and adoption of the digital measurements of nocturnal scratch. My collegue John Batchelor will also be sharing how stack model was used during the EMA pilot to facilitate the engagement between the regulators and the applicant team. Sign up if you haven't yet! #webinar #digitalmesures #collaboration DEEP Measures Digital Medicine Society (DiMe)

Topas’ Cristina de Min, MD, Chief Medical Officer, Hugo Fry, Chief Executive Officer, and Alex Marshall, Chief Business Officer, will be attending BIO-Europe 2024 from November 4-6 in Stockholm, Sweden. Following the initial review of the data from our Phase 2a clinical trial announced earlier this week, we look forward to connecting with fellow industry innovators and investors. Cristina, Hugo, and Alex will be available to discuss the programs in our pipeline and our proprietary platform, which targets the underlying causes of a range of autoimmune and immune-mediated diseases, such as celiac disease and type 1 diabetes, with the goal of delivering long-lasting, disease-modifying therapies. If you’re interested in discussing the data in more detail, make sure to set up a meeting with the Topas team through the PartneringONE platform. #BIOEurope24 #BIOEurope2024 #BIOEurope

Very interesting and timely #immunotoxicology #drugsafety #drugdevelopment article!

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

Really enjoyed this event at the Royal Society of Medicine. Such interesting and complex issues we need to tackle, but they are an absolutely must if we are going to close the gap between development and delivery of advanced therapies. Those who know me well know I say all the time the only thing worse than not having a curative treatment, is having one you cannot access. Addressing the barriers to equity of access to advanced therapies is a priority, whether that's ensuring equity in research funding or applying novel clinical trial design to account for inherent limitations which become barriers. Have a read of the blog to understand more and let me know your thoughts! ⬇⬇⬇

Last night, was one of those nights where I did something I rarely do. I watched a "soapy" just to switch off from my work day. Which one? Grey's Anatomy. I don't think I've ever seen a full episode of this before and it was pretty torrid but what I found interesting was that one of patients in this episode had cystic fibrosis. He was very pragmatic and said that he had lived a lot longer than anyone expected him to, so he felt lucky he'd made it to 26 years old. Any my brain went - wait! What??? That's not right..... And then I realised, this episode first aired in 2005 when the median survival for CF patients was less than 30 years. It would be another 7 years before Vertex' first product, Kalydeco, would be approved by the FDA and a few months later, in 2013, I would submit this registration application to the TGA in Australia. The median survival for cystic fibrosis patients has now almost doubled thanks to new treatments for this disease. We are all very focused on finding the next drug target, starting the next clinical trial, submitting the next registration application, and rightly so. But sometimes, it's good to reflect on how far we've come in the orphan drug space in recent years and the impact this has had on patients and their families and friends. Next week I'll be attending the ARCS Conference in Sydney and will be part of the new BioBeacon sessions. Companies will be presenting on their new products in development and panels of experts will provide opinions on some of the pitfalls they may face, questions to ask etc. I very much look forward to being a member of this panel and hearing about what may come to market, from the Australian biotech ecosystem, in another 10-20 years time. #ARCS #biotech #innovation Adjutor Healthcare Group