Scott Gottlieb

The collaboration between Virpax Pharmaceuticals Inc. (Nasdaq:VRPX) Pharmaceuticals and the National Center for Advancing Translational Sciences (NCATS) heralds a significant advancement in pain management research. Focused on the development of NES100, an intranasal peptide targeting acute and chronic non-cancer pain, this partnership utilizes innovative nanotechnology to enhance the delivery of enkephalin to the brain. By leveraging Molecular Envelope Technology (MET) and a specialized device, NES100 aims to provide analgesic effects without the adverse events commonly associated with opioids. This extended collaboration underscores the shift towards non-opioid alternatives for pain management, crucial in addressing the opioid crisis. The research aligns with the NIH’s HEAL initiative, emphasizing the national commitment to combat opioid addiction. The potential of NES100 lies in offering a non-addictive pain treatment, potentially transforming pain therapy and improving outcomes for individuals with chronic pain conditions. NES100's development presents a promising avenue for pain management, offering a safer alternative to traditional opioids. If proven effective in clinical trials, NES100 could emerge as a valuable tool for patients seeking pain relief. The intranasal delivery method not only enhances convenience but also holds the promise of improved patient adherence and treatment efficacy. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dwMpJZf8 Gerald W. Bruce Matt Barnes

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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Digital therapeutics (DTx) are transforming healthcare by offering clinically validated, software-driven interventions that effectively manage and treat a wide range of conditions. With proven results in areas like mentalhealth, diabetes, and chronic pain management, it is clear that DTx can enhance patient outcomes. However, trust and widespread adoption remain key challenges. It is important that patients are fully involved in the development of DTX to ensure their needs and experiences are considered.Let's continue pushing for greater uptake and integration.#DigitalTherapeutics #DTx #HealthcareInnovation #PatientOutcomes #ClinicalCollaboration #HealthTech #FutureOfHealth #MentalHealth #DigitalHealth #DTxRevolution https://lnkd.in/eBNPUiEA

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While cell and gene therapies (#CGT) are undeniably expensive, their financial impact can mean something different for differently sized plans. During episode 19 of Astonishing Healthcare, Casey Stockman, PharmD (VP, PBA Services) broke down what the financial impact could be for a national plan with only a few eligible members and a smaller regional plan with one eligible member. Listen to the full podcast here: https://okt.to/0EhO36

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As the dust settles on election results, #Avalere is helping clients game out scenarios for the future of #IRA negotiations and other drug pricing policies under the new #Congress and #WhiteHouse. If you need materials with robust policy nuance to help your forecasting and internal prioritization, please consider Avalere your partner in sorting through the uncertainty. #Medicare #DrugPricing

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COTA and Guardant Health Partner to Advance Precision Oncology Research and Therapy Development with Real-World Clinicogenomic Data and AI Analytics C. K. Wang, MD Craig Eagle https://lnkd.in/eTHKe7Se #OncoDaily #Oncology #Cancer #Health #Medicine #OncologyResearch

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Thoughtful perspective on the medtech industry..

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🚨 Webinar Announcement: Improving Outcomes and Access to Precision Medicine🚨- https://lnkd.in/eSvkPZPG Despite groundbreaking advances in precision medicine, a critical gap remains: the lack of diverse representation in genomic data, leading to unequal healthcare outcomes—especially for people of color. 🔬 What is the impact? Genomic testing is a cornerstone of modern medicine, yet current databases are largely based on data from individuals of European descent. This leaves underrepresented populations at a disadvantage, with less effective treatments and limited access to life-saving innovations. 💡What you’ll learn: 1️⃣ Understanding the genomic testing gap and the structural barriers in healthcare 2️⃣ How to advance precision medicine for all, ensuring inclusivity 3️⃣ Practical strategies for improving access, including policy changes, community engagement, and innovative healthcare models 📅 Date: Thursday, 21st November, 2024 ⏰ Time: 12:00pm - 1:00pm ET 📍 Location: Zoom (Register Here https://lnkd.in/eSvkPZPG) Let’s work together to create a healthcare system that serves everyone. #PrecisionMedicine #GenomicTesting #HealthEquity

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Congrats to Madrigal Pharmaceuticals on a great initial Rezdiffra launch! I listened to their Q2 earnings call and noted a question from one investment firm about MRE/PDFF availability, and its role in providing access to Rezdiffra for patients. Let me provide some numbers: 🔵 Installation numbers: there are 1.5x as many MRE locations (1,250) as Fibroscan (~800) in the US, which is generally regarded as widely available. So MRE access is certainly not a barrier to Rezdiffra. It is readily available to help tackle this important patient population. 🔵 Prior Authorizations: we're seeing commercial payers who rightly identify MRE as the only MRI tool capable of staging F2/F3 for Rezdiffra qualification. We're also seeing most payer policies identify PDFF for fat quant and monitoring. All of this is consistent with the MAESTRO-NASH trial. 👍 🔵 Cut-offs: PDFF >8% and MRE 3.3kPa to 4.9kPa = Treat with Rezdiffra For combo scores, go to coulditbenash.org 🔵 BMI dependent? No. Unlike ultrasound, elevated BMI does not affect MRE assessment or the cut-offs to achieve 90% specificity 🔵 Monitoring: critically, MRE was the only elastography tool significant for monitoring fibrosis regression in the MAESTRO-NASH trial. A 15%+ response in MRE equates to fibrosis regression. Again, not BMI-dependent. 🔵 Cost: an exam consisting of just MRE & PDFF costs just $205 through Medicare (CPT code 76391). It's very inexpensive compared to a traditional MRI exam. Clinicians should order it as MRE/PDFF only so that the Radiology practice does the rapid (10 minute), low-cost exam. 🔵 In sum, MRE/PDFF are widely available, low-cost, non-invasive & highly accurate. They will be key to delivering this breakthrough new therapy to patients who need it. We're proud to be a part of this new paradigm in liver care.

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🚨 The #FDA's latest draft guidance on accelerated approvals takes aim at "dangling" approvals—products still marketed despite failed confirmatory trials. The agency is now mandating tighter timelines (2-4 years for oncology), more transparency in withdrawal processes, and public involvement. 🕵️‍♂️ This marks a shift from flexibility to rigor, signaling that the accelerated pathway is no longer a free pass. For #biopharma, it's both a challenge and an opportunity to align trial strategies earlier. Is this the FDA tightening the reins—or just evolution in regulatory science? FDA website: https://lnkd.in/gqc-z-5e #pharmanews #breakingnews

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🗞️👓 New on the Catalyst Clinical Research Blog: Highlights from hubXchange Immunotherapies Maryland 2024! 📖 Catalyst Clinical Research was excited to share insights from this year’s hubXchange Immunotherapies Maryland 2024, where their Executive Director, Meredith M., joined industry experts to address the latest advancements and challenges in immunotherapy trials. This exclusive event covered everything from optimizing dosing strategies to leveraging cutting-edge biomarkers for improved patient safety and efficacy. In Meredith's keynote presentation and “Project Optimus” roundtable, Meredith led discussions on the FDA’s dose optimization guidance, emphasizing the shift toward minimally and maximally effective doses for early-phase trials. Catalyst also explored how PK-PD modeling is reshaping dose-response understanding, while advanced biomarkers are offering new ways to monitor immunotherapy impact and safety. Visit the blog to see how Catalyst is helping shape the future of immuno-oncology through tailored solutions that drive safety and efficacy in clinical trials. 👀 Read the full article: https://lnkd.in/eJtQB4jP 🌐 https://lnkd.in/e8pDqkji #Immunotherapy #PatientSafety #ClinicalTrials #CatalystOncology #HubXchange

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Why are Americans paying so much for #prescription medicines? According to the FTC, it’s because the biggest #PBMs -- all owned by health insurers -- are using their market power to drive up costs, pocket #rebate dollars, and force patients to use pharmacies that the PBMs own. At the same time, they’re providing independent pharmacists with “untenably low” reimbursement, undermining the care ecosystem even as costs increase. The scathing new #PBM report from the FTC makes clear that PBMs are often a shell game, using vertical integration and convoluted corporate structures to hide the fact that PBM "benefits" are often just a way to steer dollars to the PBM's other businesses. Patients suffer the most, first paying higher prices than they should be paying at the pharmacy, and later as they will have access to fewer new treatments because #biotech innovation suffers due to PBM greed, unless we call attention to this egregious behavior. #patientsfirst #innovation #biotech Biotechnology Innovation Organization https://lnkd.in/gK2A2zFh

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Nice short article on medtech ups and downs. Don’t need a subscription on this one! Reduced biopharma funding could slow medical device growth—50% of revenue in life sciences comes from biopharma. Physician visits suggest fewer surgeries—impacting demand for surgical devices. FDA LDT rules could raise costs & limit competition in diagnostics. R&D spending & clinical trials remain strong, a high number of device approvals & active clinical trials — 756 as of May 2024 — point to a promising future. Automation & supply chain optimization can improve margins during lower sales periods. Data can optimize inventory management, logistics, and geographic footprint. How can MedTech companies adapt further? #FutureOfWork #MedTech #RandD

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RApport's twice yearly analysis of biotech sector trends published today, with author Peter Kolchinsky noting that the first half of 2024 was a relatively quiet one for the public development-stage biotech universe, which has been gradually recovering from the last downturn. Do you know your Core from your Peripheral? How 2024 stacks up, M&A-wise, to prior years? How many years of free cash flow it would take the industry's strategic buyers to acquire the entire biotech universe for a 100% premium? Jump in to our Semper Maior report to find out. #biotech #M&A #financing #fixinsurance https://lnkd.in/ePywBE9C

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