Nick Stefanopoulos MD, MBA
New York, New York, United States
3K followers
500+ connections
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Explore more posts
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Koen Kas
Frameworks for procurement, integration, monitoring, and evaluation of artificial intelligence tools in clinical settings Here is a great resource by Mark Sendak and team just published in PLOS Digital health: https://lnkd.in/eeM743wG The use of artificial intelligence (AI) tools has seen exponential growth in multiple industries, over the past few years. Despite this, the implementation of these tools in healthcare settings is lagging with less than 600 AI tools approved by the United States Food and Drug Administration. In this systematic review, the authors organize and synthesize data and themes from published literature regarding key aspects of AI tool implementation; namely procurement, integration, monitoring and evaluation and map the extracted themes on to the Plan-Do-Study-Act framework. They found that currently the majority of literature on AI implementation in healthcare settings focuses on the “Plan” and “Study” domains with considerably less emphasis on the “Do” and “Act” domains. This is perhaps the reason why experts currently cite the implementation of AI tools in healthcare settings as challenging. Furthermore, the current AI healthcare landscape has poor representation from low and lower-middle-income countries. To ensure, the healthcare industry is able to implement AI tool into clinical workforce, across a variety of settings globally, we call for diverse and inclusive collaborations, coupled with further research targeted on the under-investigated stages of AI implementation. I discuss aspects of this research in my Keynotes Demystifying and Destigmatising AI in healthcare (see https://lnkd.in/eQRVjtKV). #AIinhealthcare #SAMD #ArtificialIntellgence #digitalhealth #healthtech #implementation
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National Health Council
The Center for Innovation & Value Research (the Center) has released the final report in its Health Equity Program series, Fulfilling the Promise of Equity in Value-Based Care: A Focus on Communications and Use in HTA.” This comprehensive report outlines action steps for integrating equity into how healthcare drugs and treatments are valued. Through focused dialogue with diverse stakeholders, we have identified key domains impacting the inclusion of equity in HTA: Power, People, and Processes; Data and Inputs and Methods; and Communications and Use. Discover how we aim to create a more inclusive healthcare system. Read the report: https://lnkd.in/dEXRXTD2 #healthequity #equity #value #patientengagement #patients #healthcare #hta #engagement
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Phil Garner
The Innovation and Value Initiative has rebranded as the Center for Innovation & Value Research, reflecting a renewed commitment to patient-centered #HTA and equitable health care. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata #healthequity #healthpolicy
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Maria Hendricks
FDA finalizes guidance on using EHRs and medical claims data for new uses of FDA-approved drugs or biologics. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. This guidance finalizes the draft guidance of the same title issued on September 30, 2021. Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products- Guidance for Industry https://lnkd.in/dSEQmfvx
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Dr. Ikjot Singh
So you want to switch from clinical medicine I'm listing down the pre-requisites. Save them for future reference. 1) Where to? Consulting? Pharma? Health-tech startups? Public health? Tech ( Yes it's possible!) Data science? Cybersecurity (Yes that too is possible!) Marketing? Finance? Think about it. 2) Reach out to people who are already in the #jobs you wanna be in 4) Read up on the #industry, the major players, deals, pipelines, mergers and acquisitions, future #growth areas. 3) These are the jobs you can apply to. So make a note for current and future openings. 4) Prepare a CV and a cover letter accordingly. The cover letter should mention why you are the right candidate, why that role and why the #company? 5) Apply, apply, apply and be patient. If you can score referrals, nothing like it. More on every pointer in the upcoming posts.
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Alexander Condoleon
When Omar Manejwala, M.D. shares his thoughts, I pay attention. His recent article in STAT is no exception - “The #digital-#health-as-a-#medicine business strategy contained serious flaws … Since many players in the digital health industry insisted on being treated as medicines, it stands to reason that they would also be evaluated as medicines … Put simply, products that influence a range of behaviors, conditions, and outcomes should not be narrowly evaluated on point outcomes in a single condition” #digitalhealth #digitalheathcare #innovation #healthcare https://lnkd.in/eDZa6Pv9
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Jorge Herrera, CCXP
AI Navigators: Healthcare's Next Leap While tech giants tout AI Agents, healthcare demands more: AI Navigators. My vision shared 8 months ago, is now at our doorstep. Beyond simple scheduling, these Navigators will revolutionize patient care. Expect pilots and regulatory submissions within a year, setting new standards through rigorous trials. Pharma leaders, are you ready to navigate this AI-driven future? #AIinHealthcare #PharmaTech #DigitalHealth #PharmaInnovation #HealthTech #ArtificialIntelligence #FuturePharma #HealthcareAI #PharmaLeadership #MedTech
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Aziz Nazha
Our new course from AI4Healthcare is now fully released. Check out how to 10X your productivity using ChatGPT as a physician. 10X your productivity with ChatGPT https://buff.ly/4e2ksuh Great tips and prompts on how to automate annoying, time consuming tasks that drive burnout and decrease your time with your patients. I hope all of you will enjoy it and please give us any feedback. Looking forward to seeing you in the class. #AI, #GenAI, #machinelearing, #chatGPT, #AI4healthcare
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Phil Garner
Target trial emulation in #HTA #RWD submissions: methodological evolution or industry revolution? Sreeram Ramagopalan ( LCP Health Analytics), Alex Castanon (LCP Health Analytics), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) provide a multistakeholder perspective of #targettrialemulation in the context of RWD submissions for HTA, exploring the expectations set by HTA agencies and providing insights into the implementation challenges encountered by #pharma. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata
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William Sarraille
“An Influential Drug Industry Expert”? So 340B Report described me in discussing my remarks at the Association for #ValueBased #Cancer Care on whether the rebate model is “dead”—or just headed to litigation. Bella Czajkowski’s provocative article is in the comments. (And Bella, your check is in the mail for that description of me—ha!) I don’t have any inside info on Johnson & Johnson’s plans, but I just have to imagine, as I read their response to the Health Resources and Services Administration (HRSAgov), HHS that it sounds like a strategic pause to provide enough time to draft and file a compliant. And, even if #JNJ wouldn’t push the button on a litigation salvo, why wouldn’t others? It’s a litigation no brainer given the scope of #340B expansion, the inability of contract #pharmacy policies to stem the tide, the creep of “#patient definition”, the emergence of triple and quadruple “discounts”, and the risk this all gets that much worse as soon as #Medicare “fair price” duplicates get dialed into this already unbalanced equation. Win or lose, how is this a case someone (or many someones) doesn’t file? I want to emphasize 2 points from the article: 1) “Sarraille argued that in the debate around cashflow, the rebate model could potentially be more beneficial to #coveredentities that would not have to use a certain quantity of drugs to submit a chargeback. ‘The covered entity doesn’t have to wait to accumulate a big enough package of drugs in order to submit a chargeback, as they do under the current system. Under a rebate system, they can get their money without accumulation on every individual unit as soon as it’s used,’ he said.” In the right hands, payment can come in just 7 days. We can make this work. 2) I’m willing to put my litigation prediction to the steak dinner test: “‘Anyone who wants to pay for a steak dinner for me sometime next month, you feel free to come up here. I’m going to take your money, and I’ll take your steak,” he said.’” Text me. BTW, my fav is a 10 inch filet mignon, butterfly cut, lots of butter. Association for Value-Based Cancer Care
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Phil Garner
In this Guest Column, Sreeram Ramagopalan (LCP Health Analytics), Alejandra Castañon (LCP Health Analytics), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) provide a multistakeholder perspective of #TargetTrialEmulation in the context of #RWD submissions for #HTA. Based on the session ‘Target Trial Emulation in HTA RWD Submissions: A Best Practice Not Embraced – Methodological Challenge or Manufacturers’ Reluctance?’ presented at ISPOR—The Professional Society for Health Economics and Outcomes Research 2024. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata #ISPORAnnual
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Nathalie Horowicz-Mehler, PhD
The Food and Drug Administration has indicated that achieving health equity is a priority. Please join me and my colleague Marta Villarraga of Exponent, and Blake Wilson, J.D., M.S. of Hogan Lovells today, April 30 at 2 PM ET as we present five questions for life sciences firms to consider when evaluating the role of digital health technologies (DHTs) in meeting health equity goals in clinical trials. #healthequity #DigitalHealth #MedicalDevices #Exponent
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John O'Brien
New research from the National Pharmaceutical Council published in Therapeutic Innovation & Regulatory Science provides drug-level insights about development pathways for #CancerTreatments and the potential impact of the #IRA's #Medicare Drug Price Negotiation Program. This cross-sectional study evaluated 86 #oncology drugs first approved by the FDA from 2008 to 2018 — 56 (65.1%) of which were later approved for one or more additional indications. The research is unique because it captures drug-level trajectories toward subsequent indications. Here’s what we found. 1. Overall, a quarter of these 56 drugs were approved for their most recent subsequent indication after the time at which the drug would be eligible for the price-setting process through the DPNP. 2. Subsequent indications are not simply “me-too” indications. Among the drugs studied: — 61% of these drugs had at least one subsequent indication for an additional cancer type; — Half of these drugs had at least one subsequent indication for a new line of treatment – nearly all moved from later lines to earlier lines; — 41% had at least one subsequent indication for a new combination; 32% for a new mutation, and over 28% for a new stage. 3. The heterogeneity of those development pathways for oncology drugs will be impacted in different ways by the IRA DPNP. — Drugs with the most rapid pace of development often received their first subsequent indication approval within 9 months of initial approval, placing them at the most risk of delayed launches given the changing incentives of the law. — Drugs with more measured development timelines, disproportionately small molecule drugs, often received FDA approvals for later subsequent indications more than 7 years after initial approval, suggesting this group of cancer drugs may be most at risk of changing incentives surrounding subsequent indications under the IRA. You can read the full paper "Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act" here: https://lnkd.in/egasXTzU Julie Patterson, James Motyka, Rayan Salih, PharmD, Bob Nordyke, Jon Campbell #biopharma #innovation #PatientCare #CancerResearch #InflationReductionAct
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Husseini Manji, M.D., F.R.C.P.C.
Last week’s bipartisan action by 15 senators in support of Medicare beneficiary access to Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) scans could have a potentially positive impact for accessibility of therapies for neurodegenerative disease, including Alzheimer’s. These technologies are critical for precision diagnosis, preventing patients who don’t qualify based on biology from being exposed to treatment unnecessarily, and ensuring patients who do qualify have access to treatment. This is a very encouraging development an estimated 6.9 million Americans 65+ were living with Alzheimer's in 2024, which is about 1 in 9 in that age group, according to Alzheimer's Association®. https://lnkd.in/e3tQb6es
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JAMA Oncology
Climate change impacts cancer control and many climate mitigation and adaptation strategies already align with the CDC Comprehensive Cancer Control Program priorities, presenting an opportunity to capitalize on shared solutions. https://ja.ma/4aM2f1c
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Amy Abernethy
Our paper on "Modernizing the Data Infrastructure for Clinical Research" was just published in JAMA. The modernized infrastructure envisioned centers around 2 related concepts: (1) allowing the collection and rigorous evaluation of multiple data sources and types and (2) enabling the possibility to reuse health data for multiple purposes if/when appropriate (eg traditional and pragmatic clinical trials, payer-oriented analyses). A huge thank you to the JAMA editors and all authors: Joe Franklin, Caroline Marra, Kaleab Abebe, Atul Butte, Deborah Cook, Laura Esserman, Lee Fleisher, Cynthia Grossman, Nancy Kass, Harlan Krumholz, & Kathy Rowan. https://lnkd.in/eucWyFGu
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JMIR Publications
Inside Peer Review: A Special 5 Part Series – Part 4: Ethical Considerations in eHealth & Informatics Research Our Inside Peer Review series continues with a spotlight on ethics for #PeerReviewWeek. Tiffany I. Leung, MD, MPH, Scientific Editorial Director at JMIR Publications and Amaryllis Mavragani, PhD, Scientific Editor at JMIR Publications reflect on how peer reviewers uphold ethical standards, particularly in eHealth and informatics. Read the blog: https://lnkd.in/e-iBNT7y #EthicsInResearch #PeerReview #FutureOfPublishing #InsidePeerReview
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