Scott Riccio

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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COTA and the FDA will advance #cancerresearch using #realworlddata, focusing on #regulatory decision-making and improving treatment evaluation and availability. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #healthdata

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While the FDA’s plan for improving diversity in clinical trials is well-intentioned, it fails to address some of the most critical barriers underrepresented communities face. In our latest podcast episode, we dive deep into the gaps in the FDA’s strategy and discuss what needs to change for true inclusivity in clinical research. Key points: • Trust Issues: Decades of mistrust between underserved communities and the healthcare system remain challenging. • Logistics and Access: The plan does little to account for transportation, childcare, and other logistical barriers many participants face. • Cultural Competency: Researchers must adopt a more culturally sensitive approach to effectively engage and retain diverse participants. Tune in to the full episode to hear more on how we can break down these barriers. #ClinicalTrials #Diversity #FDA #Inclusion #ClinicalResearch

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In this edition of the New Medicines, Novel Insights newsletter, Paul Bridges chats with clinical experts from Parexel and Health Advances about the critical decision points in the pre-clinical phase that can ultimately determine the success of your product. Learn how these experts are helping biotech companies reduce risk by advocating for better coordination among departments, with a clear patient focus, at the earliest stages. Create success by planning for it ✅ Read the full article below and subscribe for our latest #NovelInsights #ParexelBiotech #ClinicalDevelopment #EarlyPhase #DrugDevelopment

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It is time for #communityoncology to continue the momentum for #PBM reform by sharing stories with the The New York Times' Rebecca Robbins and Reed Abelson. These smart reporters are writing blockbuster pieces exposing the middlemen pharmacy benefit managers that impact patient #cancer care every day (be sure to read this weekend's front page story at: https://lnkd.in/d3Nv6iik). We are at an inflection point for PBM reform in Congress and in states. Coverage like this helps tell the story and keep the attention focused on PBMs who would much rather operate in the shadows. With that in mind, the New York Times published a questionnaire designed to collect personal stories and challenges related to PBMs. This an excellent opportunity for our voices to be heard. You can find the simple questionnaire at: https://lnkd.in/dqAfee-h At Community Oncology Alliance we are encouraging the community to help keep the pressure and attention on PBMs by: 1. Informing patients about the New York Times story, the accompanying questionnaire, and encouraging them to participate. 2. Sharing this initiative with staff and asking them to assist patients in sharing their experiences. 3. Considering a direct response from the practice about professional encounters with PBMs. This initiative is more than just sharing grievances—it's about sustaining the drive for substantial PBM reform at both the national and state levels. With Congress nearing significant legislative actions on PBMs, your contributions are crucial now more than ever. We MUST keep the pressure on PBMs so that we can achieve meaningful change. 

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Everyone is talking about the new FDA Guidance on diversity in #clinicaltrials. Here, Denise N. Bronner, Ph.D., breaks down what's good AND bad about the new guidance. https://lnkd.in/gTcTpg9T #diversityinclinicaltrials #clinicaltrialdiversity

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