Biofourmis’ Post

🎤 Exciting News Alert! 🎤   Avenna Team is thrilled to announce that our CEO, Nina Skorytchenko, will be taking the stage tomorrow at the 2nd Ace Clinical Trials Summit (ACTS) hosted by ACXPO. 🌟   Nina's presentation titled "How precision medicine technologies can be used as complementary diagnostics to optimise clinical trial efficiency" will delve into the intricacies of improving success rates of clinical trials for anti-inflammatory drugs. She will explore the use of prognostic and predictive biomarkers for chronic inflammatory diseases (cIDs), with a special focus on providing an overview of current and next-generation biomarkers for Inflammatory Bowel Disease (IBD).   Are you interested in learning more about how glycomics can bring the missing piece in the multi-omic approach? Or perhaps you are developing a anti-inflammatory therapeutic and looking for a complementary or companion biomarker? Reach out to us and explore further!   Don't miss out and gain valuable insights into optimising clinical trial efficiency with precision medicine technologies.    #ACEClinicalTrialSummit #ClinicalTrials #PrecisionMedicine #Innovation #Leadership #ACXPO

🌟 More Insights from Regeneron's Digital Biomaker Summit! 🌟 During the panel discussion "Implementing Digital Biomarkers in Clinical Trials", industry experts from Merck, Johnson & Johnson, GSK, and Regeneron shed light on the power of digital biomarkers in shaping the future of healthcare. Here are some key takeaways: 🔍 Bryan J. Hansen, Ph.D. from Johnson & Johnson emphasized the critical need for precision in patient identification, particularly in diseases like Alzheimer's. By leveraging digital biomarkers, Johnson & Johnson is spearheading advancements in precision medicine, enabling early detection and continuous monitoring of patient progress. 💡 Basker G of GSK reminded us of the nuanced nature of clinical trials. Highlighting the importance of patient-centric approaches, Baskar emphasized the need to tailor measurements based on individual patient needs and disease characteristics. After all, no two patients are alike, and understanding their unique QOL needs is paramount in shaping effective interventions. Thank you all for the insightful conversation! Marissa Dockendorf, Bryan J. Hansen, Basker G and Oren Levy 💡 #ClinicalTrial #ClinicalOperations #patientcentric #DigitalBiomakers #precisionmedicine

Understanding the differences between biomarkers, clinical outcome assessments, and endpoints is crucial for successful clinical trials. These elements form the backbone of trial design and directly impact the results. This resource demystifies these concepts, offering clarity for your next research project. Make informed decisions in your clinical trials. Clarify your strategies: https://hubs.la/Q02N5GQ20 #clinicalresearch #clinicaltrials #digitalendpoints #digitalbiomarkers

Looking forward to attending the 7th Annual Digital Biomarkers in Clinical Trials Summit in Basel, Switzerland🇨🇭next week (June 26). As Frank Kumli posted, it “is the first and only global forum of its kind to focus on ways for pharma clinical trials to take advantage of new opportunities to collect better data and improve the patient experience.” 🙋♀️If you will be attending, make sure to introduce yourself. I’ll be the short, jet-lagged woman from Canada, who gets very excited talking about the power of digital biomarkers and how with these innovative endpoints we can accelerate clinical trials, enhance precision, and (most importantly!) improve patient outcomes. Digital biomarkers offer real-time, continuous data, enabling more dynamic and patient-centric approaches. Embracing this technology is not just a leap forward for science, but a giant step towards a healthier future. “Measure what is measurable, and make measurable what is not so.” ~ Galileo #Innovation #DigitalHealth #DigitalBiomarkers #PatientExperience PanAgora Pharma Modus Outcomes THREAD

Effective and meaningful communication between healthcare professionals (HCPs) and patients is at the heart of patient-centered care.  In the realm of personalized healthcare, this has never been more crucial.  As we shift from a paternalistic model of medicine to shared decision-making, we face new challenges in communicating complex genomic test results to patients. The Biomarker Test Report: Data Education & Guidance Project aims to bridge the gap in understanding biomarker test results, empowering HCPs to provide clear, patient-centered guidance. A couple of key highlights from the project include: 🔬 Identifying good practices in patient-centered reporting 🔍 Mapping resources to improve the understanding of biomarker test reports 🗣️ Developing a patient-friendly test report summary template to aid HCPs in results disclosure Read more in-depth about it on our latest blog: https://lnkd.in/e4DtFWDU This blog is the first in a series titled 'Decoding Biomarker Test Reports: Patient-Friendly Reporting for Improved Shared Decision-Making'. So stay tuned for more! #BiomarkerReportDecoded #PersonalizedHealthcare

Announcing our new webinar series! Despite technological and clinical advancements, studies show that biomarker-driven approaches are still widely underutilized. Costs associated with launching a new therapy are rising, placing a significant strain on resources available to pharma and biotechs. Diagnostic testing also remains under-supported, with many healthcare facilities lacking comprehensive genetic testing capabilities. This, combined with a knowledge gap among physicians, can lead to a significant number of eligible patients being lost along the treatment pathway. Our webinar series, led by Diaceutics’ in-house precision medicine experts, is designed to provide valuable insights to overcome these obstacles in the market and drive commercial success for your targeted therapy. Join us for our first webinar on Thursday, September 5, 2024, from 1-2pm EDT, titled 'Driving commercial success for precision medicine: Understand the market to maximize patient identification & therapy adoption.' Discover how to use Diaceutics’ 6A™ Commercial Framework to navigate market challenges, utilize real-world data, and enhance patient identification to drive therapy adoption and improve outcomes. Find out more and register here: https://lnkd.in/ep--Jn6f #BetterTestingBetterTreatment #PrecisionMedicine #Webinar

Launching SYNTHIA, a pioneering public-private partnership funded by the Innovative Health Initiative (IHI). The SYNTHIA project, a groundbreaking public-private partnership set to revolutionize the field of personalized medicine by harnessing the power of synthetic data. As the first IHI project to tackle the critical need for privacy-preserving data solutions in healthcare, SYNTHIA aims to propel research and innovation to new heights, ensuring that patients receive the best possible care while safeguarding their personal information. SYNTHIA is a multidisciplinary collaboration of 32 consortium partners - SDG developers, FAIR data experts, clinical researchers, developers of therapies and data-based tools, legal experts, socio-economic analysts, regulatory, policy advocacy, and communication experts - that will provide a 360º vision on how to advance healthcare applications through SD use Synthetic data, which are artificially generated to mimic real patient data, present a solution to many of the challenges faced in health research today. These data allow researchers to overcome the limitations of access to high-quality, real-world datasets and address growing concerns about patient privacy. However, questions have lingered about the quality and applicability of synthetic datasets, especially in diverse and complex scenarios. SYNTHIA is addressing these challenges head-on by developing validated tools and methods for synthetic data generation (SDG) across various data types, including laboratory results, clinical notes, genomics and imaging. By focusing on six specific diseases the project will demonstrate the utility of synthetic data in advancing personalized medicine: Lung cancer, Breast cancer, Multiple myeloma, Diffuse large B-cell lymphoma, Alzheimer’s disease and Type 2 diabetes. Stay tuned for our press release! This project is supported by the Innovative Health Initiative (IHI) Joint Undertaking (IHI JU) under grant agreement No 101172872. The JU receives support from the European Commission European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA - European Federation of Pharmaceutical Industries and Associations, EuropaBio - the European Association for Bioindustries, MedTechEurope, and VaccinesEurope and DNV. #SYNTHIA_SyntheticData #DataGeneration #FutureOfMedicine #Datascience #EUInnovation #HealthResearch

That is great news (and somewhat overdue). As an academic clinician, I hope this FDA-Innovation Hub will look beyond the typical FDA/CBER/CDER missions and pay (a lot more) attention to two main bottlenecks in bringing advanced therapeutics to patients with rare diseases:   1] A contracting workforce of (academic) physicians that are, and will be (see ASGCT report), tasked with implementing these rare therapeutics.    https://lnkd.in/ehi8e79b   https://lnkd.in/e-FbPgDu   https://lnkd.in/eUP3Ez3j     2] General lack of implementation strategies by Sponsors (the “what happens now that the product is FDA-approved”). The FDA-Innovation Hub can help with harmonizing implementation strategies, encouraging Sponsors to share implementation plans with the FDA (before approval) and potential treatment centers, related, harmonized certification criteria for QTCs. Last, but not least, this FDA-Innovation Hub should play a greater role in the determination of value (and the payer side of the therapeutic supply chain).  

Are you in the process of planning a targeted therapy launch or facing challenges in driving commercial success for precision medicine?   In an increasingly competitive market, a data-driven and timely commercialization strategy is critical to enabling successful therapy and biomarker adoption. Costs associated with launching a new therapy are rising, placing a significant strain on the resources available to pharma and biotechs. Diagnostic testing also remains under-supported, with many healthcare facilities lacking comprehensive genetic testing capabilities. This, combined with a knowledge gap among physicians, can lead to a significant number of eligible patients being lost along the treatment pathway. Diaceutics has just announced a new webinar series, ‘The Precision Medicine Series: Strategies for Launch Success’. Led by precision medicine experts, these webinars will provide valuable insights to overcome these obstacles in the market to drive commercial success for targeted therapy launches. I would like to invite you to join us on Thursday, September 5, 2024 @ 1-2pm EDT for our first webinar in the series ‘Driving commercial success for precision medicine: Understand the market to maximize patient identification & therapy adoption’ where we will share exclusive insights to drive commercial success by applying Diaceutics’ 6A™ Commercial Framework. Register today: https://lnkd.in/e46jVZWA #BetterTestingBetterTreatment #PrecisionMedicine #Webinar

The FDA has announced the creation of a Rare Disease Innovation Hub led by Patrizia Cavazzoni, MD and Peter Marks, MD, PhD to serve 3 primary purposes: (1) Serve as a single point of connection and engagement with the rare disease community, including patient and caregiver groups, trade organizations, and scientific/academic organizations, for matters that intersect CDER and CBER. (2)Enhance intercenter collaboration to address common scientific, clinical and policy issues related to rare disease product development, including relevant cross-disciplinary approaches related to product review, and promote consistency across offices and Centers.  (3)Advance regulatory science with dedicated workstreams for consideration of novel endpoints, biomarker development and assays, innovative trial design, real world evidence, and statistical methods. Does this excite you or add uncertainty to your programs?