Jordan Johnson, MSHA, iMPaCT’s Post

What a great way to start 2024...new study in JAMA Neurology shows that ALZpath Inc. blood test, which is funded through the Diagnostics Accelerator and is powered by Quanterix technology, is 95% accurate and will eventually replace more invasive diagnostic tools. With early diagnosis, we can intervene earlier with new treatments and look to prevent the disease. We are moving closer to the holy grail of Alzheimer's: combination therapy, precision medicine and prevention. There is no progress without partnership and this is proof. Thanks to the vision of Alzheimer's Drug Discovery Foundation Co-Founder Leonard Lauder and Bill Gates, we have the Diagnostics Accelerator, a $100M global research initiative focused on bringing affordable and accessible diagnostics to market. The DxA's success wouldn't be possible without our scientists, like Henrik Zetterberg, Kaj Blennow, Nicholas Ashton, and Dr. Andreas Baumgartner, as well as our visionary founders, #JeffBezos, Dolby Family Ventures, The Association for Frontotemporal Degeneration (AFTD), NFL Players Association, Eli Lilly and Company, Biogen, Niranjan Bose, Kristina Malzbender and more. Here's to more partnerships and progress...

🗓 On International Clinical Trials Day 🩺, we thank the patients, clinicians, researchers and partners helping to advance our pipeline of potentially lifesaving therapeutics addressing rare and life-threatening liver conditions with high unmet medical needs. #ClinicalTrialsDay #CTD2024 #InternationalClinicalTrialsDay #InnovationInHealthcare ACRP - Association of Clinical Research Professionals

Great to see this published today: American Society of Clinical Oncology (ASCO) research statement with four key solutions to address the regulatory and administrative barriers for decentralizing trials to improve patient access: (1) #FDA should engage the research community in a public-private partnership to #modernize standards and enable local #access to #trials (2) #sponsors and #CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency (3) research centers, networks, and #sites should update policies and procedures to implement #decentralized trial elements (4) research community should develop a streamlined, uniform mechanism to simplify #regulatory #data collection and #documentation and use it consistently across trials. Link to the paper here: https://lnkd.in/gSz2CheM

ReD perspective // Why pharma needs to focus on improving – not just extending life. Read ReD's Millie Parekh Arora and Tamara Moellenberg's piece for this month's Pharmaceutical Executive, "Thriving ‘Beyond the Pill’: Closing Key Gap in Patient Support", where they argue that the winning life science companies of tomorrow will be those who dare to rethink the value they can provide “beyond the pill,” putting quality of life front and center. "The future of healthcare should emphasize longevity and quality of life equally," they write, "actively supporting both patients and caregivers through the years of living with chronic diseases. In an increasingly competitive market of 'miracle treatments' that promise to extend lives, we see an increasing need for services that move beyond the realm of surviving, making 'thriving' a key differentiator." Read the full article below. And thanks to Marianna T. for contributing research and writing to the piece. https://lnkd.in/dqJz5e3g #healthcare #strategy

In this regular monthly feature we share articles to keep you informed about the latest findings and insights across the spectrum of #realworldevidence (#RWE) research. This month, we cover: R WE ready for #reimbursement? A round up of developments in real-world evidence relating to #healthtechnologyassessment: part 15 Alejandra Castanon, Ben Bray & Sreeram Ramagopalan (LCP Health Analytics) Journal of Comparative Effectiveness Research Real-world evidence of bariatric surgery and #cardiovascular benefits using #electronichealthrecords data: A lesson in bias Jeremy Rassen (Aetion), William Murk & Sebastian Schneeweiss (Brigham and Women's Hospital) Diabetes, Obesity and Metabolism Mobilizing data during a crisis: Building rapid evidence pipelines using multi-institutional #realworlddata Jayson Marwaha, MD, MSc (Harvard Medical School), Maren Downing, John Halamka, M.D., M.S. (Mayo Clinic Platform), Amy Abernethy (Verily), Joe Franklin, Brian Anderson, Isaac Kohane, Kavishwar Wagholikar, John Brownstein, Melissa Haendel (University of Colorado Anschutz Medical Campus & Gabriel Brat, MD, MPH Healthcare A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in #rarediseases Shailja Vaghela, Kaniz Afroz Tanni, Geetanjoli Banerjee (Moderna) & Vanja Sikirica Orphanet Journal of Rare Diseases Using social media as a source of real-world data for pharmaceutical #drugdevelopment and #regulatory decision making Didrik Wessel (Copenhagen Business School) & Nicolai Pogrebnyakov Drug Safety #Patientlistening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators Philipp Cimiano, Ben Collins, Maria Carmela De Vuono, Thierry Escudier, Jürgen Gottowik, Matthias Hartung, Mathias Leddin, Bikalpa Neupane, Raul Rodriguez-Esteban, Ana Lucia Schmidt, Cornelius Starke-Knäusel, Maarten Voorhaar & Krzysztof Wieckowski Frontiers in Medicine The #DigitalTherapeutics Real-World Evidence Framework: an approach for guiding evidence-based digital therapeutics design, development, testing, and monitoring Meelim Kim, Kevin Patrick, Camille Nebeker, Job Godino, Spencer Stein, Predrag Klasnja, Olga Perski, Clare Viglione, Aaron Coleman & Eric Hekler Journal of Medical Internet Research Cross-sectional analysis of use of real-world data in single technology appraisals of oncological medicine by the National Institute for Health and Care Excellence in 2011–2021 Jiyeon Kang & John Cairns BMJ Open Read at The Evidence Base® #rwd #hta

It wasn’t supposed to be like this: Eisai US and Biogen’s new Alzheimer’s disease drug Leqembi was supposed to be the chosen one after the flop that was Biogen and Eisai’s Aduhelm, but neurologists are voicing “frustration” at core elements of the therapy’s rollout. That’s according to a stark new report out by life sciences consultants at Spherix Global Insights that delved down into insights from 75 high-prescribing U.S. neurologists that work with Alzheimer’s patients. The picture painted by them is bleak: Now around six months after the launch of Leqembi, “few surveyed neurologists consider Leqembi to be a significant medical advance over other historical AD treatments,” Spherix’s analysis found. via Ben Adams @ Fierce Pharma ********* On the contrary, this was entirely predictable, if your read of the market is right. The problem is the plotline, the “screenplay” commercial teams not just at Biogen/Eisai Co., Ltd., but the 'drug market' as a whole are following in the hope for a happy ending, everyone using the same characters cast in the same roles. It's time for a new strategy story. Link in comments for Quentin Tarantino's approach. #ModelCollapse

We applaud the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) unanimous recommendation (12-0) supporting minimal residual disease (MRD) as a viable endpoint in multiple myeloma clinical trials. This decision marks great news for the multiple myeloma community as it could potentially lead to the accelerated approval of innovative therapies and improved clinical outcomes for patients in the future. I’d like to commend the commitment of Johnson & Johnson Innovative Medicine scientists and clinicians who have worked collaboratively with investigators, academic centers, advocacy groups, across consortia and with the FDA and other Health Authorities to advance the science of multiple myeloma, with determination and focus in recognizing the important role MRD may play in improving outcomes for patients. #MyCompany #JNJOncology #MultipleMyeloma #OncologyResearch #ClinicalTrials #Innovation

Brain disorders cause more disabilities than CV and cancer. Also making the news is the approval of newer AD treatments for early stages of AD, placing the importance on performing an early evaluation to detect signs. Learn more on the roundtable discussion

At our research site, we have helped conduct several clinical trials for Alzheimer’s and dementia with various pharmaceutical sponsors, such as Athira Pharma and T3D Therapeutics. Working with patients with Alzheimer’s has helped us learn more about its prognosis, while also highlighting the challenges of caregivers and loved ones of people diagnosed with Alzheimer’s. Research into Alzheimer’s disease is robust, with significant funding allocated for studying its causes, potential treatments, and prevention strategies. The National Institutes of Health (NIH) funding for Alzheimer’s research has increased significantly over the past decade. With current trends of Alzheimer’s still increasing in the U.S. population, funding on this research is expected to increase even more. While there is no cure for Alzheimer’s, early diagnosis can help manage symptoms and improve quality of life. Various medications and non-drug therapies can help with cognitive and behavioral symptoms. By participating in clinical trials, individuals affected by Alzheimer’s and dementia can help contribute to therapeutic research to help others, while having access to potential treatments that are not yet on the market. Disclaimer: You may want to consider your individual mental health needs with a licensed medical professional. This page is not meant to give you medical advice as it does not replace a provider client relationship. #AlzheimersAndBrainAwarenessMonth #alzheimersawareness #clinicalresearch #clinicaltrials

Success often takes multiple attempts, especially in the challenging field of Alzheimer's research. Throughout my career, I've supported client efforts in market shaping, forecasting, and understanding patient pathways for multiple Alzheimer's compounds in development of which none successfully launched. Pharma had to be resilient in the face of the complexity of treating Alzheimers. However, the recent FDA approval of donanemab exemplifies perseverance. This new treatment isn't a cure, but it marks significant progress. True eureka moments are rare; innovation typically unfolds gradually. We can hope that within the next decade, continued advancements will bring us closer to a future where Alzheimer's is no longer a terrifying diagnosis. The journey is arduous, but each step forward brings renewed optimism and a reminder that persistence is key in the pursuit of scientific breakthroughs. #futureofpharma #Alzheimersdisease #regulatoryapproval https://lnkd.in/eJJzhyfh