Regulatory Thinking®’s Post

Demystifying regulatory challenges and opportunities in the implementation of digital health and AI in drug development: thank you for inviting me to share learnings and opportunities on the regulatory pathways to accelerate the development and acceptance of these novel methodologies. Looking forward to the event! #digitalhealth #digitalendpoints

Interested to learn more about data-driven innovation in personalized medicine and care? 📆 Join us on November 23rd for the ATHENA symposium, supported by MEDVIA. Registrations are open, secure your spot now! ➡️ For more about the event: https://lnkd.in/egc_NZZN ➡️ Register here: https://lnkd.in/eZC2kGsb Artificial intelligence allows healthcare professionals to study extensive medical data sets and recognize patterns, leading to novel insights... Insights which enhance patient care by enabling identification of the most suitable personalized treatment, speeding up drug development, and optimizing diagnostics. Project ATHENA (link: https://lnkd.in/e-V6xSwm) has made significant strides in the field of oncology by harnessing groundbreaking privacy-preserving machine learning techniques for predictive analytics. ATHENA is a project supported by VLAIO - Flanders Innovation & Entrepreneurship and consists of top-level contributing members Janssen Belgium, imec, Inovigate, UZ Leuven, UZ Gent, KU Leuven, Ghent University, az groeninge, Ziekenhuis Oost-Limburg (ZOL), OLV Ziekenhuis Aalst-Asse-Ninove, CHU de Liège, AZ Delta, Illumina, and Robovision #artificialintelligence #datascience #realworlddata

Anyone who is working in precision medicine, pathology, biomarker development, or related fields know that #digitalpathology is the single-most promising technological advancement that will revolutionize medicine forever. Yet, to date, not one #industrydedicated meeting has united all leading biopharma to tackle the current bottlenecks preventing this field from taking off. Enter the 'Translational Digital Pathology & AI Summit' - whether you are new to the space, or looking to refine your expertise, this summit is uniting all stakeholders to overcome regulatory hurdles, foster collaborations, and accelerate the adoption of digital pathology and AI in translational research and clinical practice. The last early bird for this summit closes this Friday (15th March). Make sure you complete your registration today to save over $400! You can use this link to find out more: https://ter.li/0cs7wx Erik Hagendorn, Sabya Biswas, Mark Gustavson, Jessica Baumann, MD, FCAP, Jimmy Tran, Meijian Guan, Lauri Diehl, Claudia Dollins, Edwin Roger Parra Cuentas, Chris Garcia, Jennifer Quigley, Sarah Vargas, Iman Tavassoly MD, PhD, Heike Fuhrmann-Stroissnigg, Zoltan Laszik, Lucy Phillips

In honor of Rare Disease Day, we are sharing the latest breakthrough in the quest for new treatments for ALS thanks to AI and human expertise. ◾ Amyotrophic Lateral Sclerosis (ALS) is a fatal motor neuron disease characterized by progressive degeneration of nerve cells in the spinal cord and brain. The average life expectancy following diagnosis is 2-5 years and there is currently no cure or treatment to prevent disease progression. ◾ Now, a repurposed drug discovered using Insilico's AI engine PandaOmics will soon enter an investigator-initiated clinical trial with ALS patients. ◾ Known as FB1006, the drug was fully discovered and developed using AI, from target identification to efficacy assessment, and the company leading the drug’s development, 4B Technologies, Ltd, has successfully completed enrollment of all 64 patients in the investigator-initiated clinical trial. ◾ The program is expected to complete double-blind dosing this summer and one-year clinical observation next year.  ◾ Insilico has been dedicated to finding new treatment options for ALS patients using AI. In June 2022, Insilico collaborated with researchers from 4B, Johns Hopkins Medicine, Harvard Medical School, University of Zurich and the organization ANSWER ALS, among others, to use its AI platform to identify 28 novel targets for ALS. Now, less than 2 years later, 4B has fully enrolled patients in an investigator-initiated clinical trial based on those findings. *Article linked in the comments. #als #raredisease #rarediseaseday #rarediseaseday2024 #ai #drugdiscovery #biotech #techbio #pharma

At Enzolytics we are excited to announce our collaboration with KhalpeyLabAI, dedicated to finding practical solutions for the long-standing problem of how to live longer and better. By 2030, the number of people aged 65 and over will exceed one billion, so we need to shift our traditional approaches to medicine towards a more proactive strategy focusing on prevention and patient participation while firmly rooted in the science of aging. To achieve this, we are incorporating a Software as a Service (SaaS) solution that uses multi-omic testing and AI algorithms to identify early signs of organ distress, allowing for timely interventions and improving therapeutic outcomes. Our precision medicine suite incorporates patient profiling, proteomics, genomics, and AI to enhance the lifespan and, more importantly, health span. The new Enzolytics AI platform offers real-world data analytics capabilities to discover novel biomarkers and targets and to stratify patient cohorts for research purposes. We are excited to be taking bold new steps in exciting directions, expanding our horizons as we work towards achieving our goal.  Zain Khalpey, MD, PhD, FACS #ENZC #LONGEVITY #AI #microbiome #P5Medicine Kirsten Bischof

Revolutionizing Personalized Medicine: The Power of N-of-1 Approach in Customized Precision Drug Discovery In the ever-evolving landscape of healthcare, personalized medicine stands out as a beacon of hope, offering precision treatments that address the unique needs of each individual. With recent advancements in AI technology, particularly the N-of-1 approach, we are witnessing a paradigm shift in drug discovery, especially in areas such as cancer, active diseases, rare diseases, and aging. The N-of-1 approach, rooted in the idea of treating each patient as their own clinical trial, holds immense promise in unlocking customized precision therapies. By leveraging vast datasets, AI algorithms can analyze intricate biological patterns, genetic variations, and treatment responses on a granular level, leading to interventions that optimize efficacy while minimizing adverse effects. In cancer research, where heterogeneity is a hallmark, the N-of-1 approach allows us to decipher the complex interplay between tumor biology and individual patient factors, paving the way for precision therapies that precisely target malignant cells while sparing healthy tissue. Similarly, in the realm of active and rare diseases, where traditional treatment options may fall short, personalized interventions tailored to the unique genetic makeup and disease mechanisms offer newfound hope for patients. Furthermore, as our population ages and the burden of age-related diseases grows, personalized medicine becomes increasingly indispensable. By dissecting the molecular signatures of aging and tailoring interventions to counteract specific age-related pathways, we can potentially delay the onset of age-related diseases and enhance healthspan, improving the quality of life for individuals as they grow older. In essence, the convergence of AI and personalized medicine heralds a new era of healthcare, one where treatments are not only effective but also finely attuned to the individual nuances of each patient. As we continue to harness the power of N-of-1 approaches, we move closer to a future where medicine is truly customized with precision, transforming lives and reshaping the healthcare landscape for the better. N-of-1 epitomizes the fusion of technology, human intelligence, and AI, spearheading personalized innovation while ensuring individuals are treated with dignity and valued beyond statistical metrics, marking a profound shift in paradigm. #PersonalizedMedicine #AI #DrugDiscovery #HealthcareInnovation #Nof1 #PrecisionMedicine #CancerResearch #RareDiseases #Aging #HealthTech Feel free to engage and share your thoughts on this transformative approach to healthcare!

Before you enjoy the holiday break make sure to register for PWMC 2024. Join me at my talk to learn how regulatory compliance can become part of your AI development efforts and how it can help, not hurt your AI development from bench to bedside (and to a viable business). #ai #airegulation #gesund.ai #fda

🔬 Join Us at the NextGen Medicine Conference - MedLab Middle East 2024 🌟 Mark your calendars for the NextGen Medicine Conference, happening on 5th - 6th February 2024, in partnership with MedLab Middle East and Express Med Diagnostics & Research. This event is an exceptional gathering of leading experts, researchers, and healthcare professionals at the forefront of medical innovation and precision medicine. 🔍 This conference is dedicated to the transformative potential of early disease detection and preventive medicine. With a sharp focus on the intersection of medicine and artificial intelligence, we delve into cutting-edge AI applications in diagnostics, treatment development, personalized medicine, and healthcare delivery. Experts in the field like Dr. Karolina Kobus and Prof Mohamed Al Marri, Louiza Chitour (PhD), Dr. Mohammed Uddin, and Dr. Amal Al Rayes will provide you with insights into the latest breakthroughs in genomics, proteomics, and innovative biomarkers empowering early diagnosis of various medical conditions. Key Topics Include: 1️⃣ Early Cancer Detection and Precision Oncology 2️⃣ Preventive Health Screening and Longevity 3️⃣ Digitalization: AI, Bioinformatics, Data Cybersecurity 4️⃣ Developments in Cancer Genetics and Oncogenomics 5️⃣ Updates on Middle East Genome Projects Benefits of Attending: 🔬 Discuss Genetics and Genomics in Personalized Medicine, including DNA sequencing and genetic testing. 🧬 Review Advanced Diagnostic Technologies such as Next-Generation Sequencing, Liquid Biopsies, Biomarker Discovery, and other cutting-edge techniques for disease detection and monitoring. 🏥 Analyze Practical Applications of Precision Medicine in various medical specialties, including Oncology, Surgery, Neurology, and Rare Diseases. 🎯 Identify Potential Drug Targets and the Development of Targeted Therapies. 🌐 Discuss the Regulatory Landscape and Ethical Challenges associated with implementing Precision Medicine. Don't miss this unique opportunity to be part of a conference that's shaping the future of medicine and let's explore the exciting frontier of healthcare together and drive innovation in medical science! 🚀 #NextGenMedicine #PrecisionMedicine #HealthcareInnovation #MedLabMiddleEast #EarlyDiseaseDetection #ArtificialIntelligence #Genomics #Biomarkers #MedicalResearch #Conference2024 #innovation #CentersOfExcellence Johns Hopkins Aramco Healthcare (JHAH)