Dan Leonard

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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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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In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/ejWZ7hMa #FDA #Webinar #RareDiseases #ClinicalTrials

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Traverse Health pioneers #ClinicalResearch with Real World Data (RWD) from underrepresented patient populations. By targeting growth markets and prioritizing data diversity 📊, they bridge industry #data gaps. Their strategy includes smart geographic expansion, partnerships, and alliances with leading #hospitals, positioning them as pioneers in blue ocean markets. This exclusive access to diverse patient data fulfills strong customer demand, including #pharma, biotech, and regulators. Learn more about their startup journey and check out their #LiveRound 🚀 on Leapfunder.

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On the next episode of The Pulse, leading experts Ge Bai, PHD, CPA, Jonathan Bonnet, MD, MPH, CAQSM, FAAFP, FACLM, DipABOM, DipACLM and Jennifer Perlitch, RPh., MBA shed light on the role of the PBM in prescription drug access and costs and what employers need to do to redefine expectations and outcomes from PBMs. 📅 Register below https://lnkd.in/grsQkP3w    #dataanalytics #glp-1 #employeebenefits 

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To continue to the discussions from the American Society of Gene & Cell Therapy conference, check out CTI's Podcast "Moving Medicine Forward," highlighting the work we conduct in Cell and Gene Therapy: 1. Bret Marshall discusses CTI's involvement in Cardiac gene therapy trials, exploring our impact, goals, and industry trends 2. Michael Schmidt and Nicole Sparshott discuss Chain of Custody best practices 3. Joana Lancastre discusses feasibility considerations for Cell and Gene Therapy Trials 4. Jaclyn Guillory shares CTI's experience with enrolling patients to trials with targeted therapies #CTIPodcast #MovingMedicineForward #CRO #ASGCT24 #CellTherapy #GeneTherapy

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🎯 thoughts by Anna. If you had time to read the NYT article, take another 1 minute to read Anna’s summary of PBMs below.

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The most consequential piece of health care policy legislation since the Inflation Reduction Act is barreling toward passage. From the lemons of supply-chain shocks and slowed development on new drug development -- to the lemonade of thousands of good, high-paying, clean manufacturing jobs in the US... "Since the bill was first introduced in January 2024, it has had a chilling effect on the industry, pressuring an already strained U.S. supply chain and threatening continued R&D. A recent GlobalData report found the legislation could affect more than 120 U.S. drugs partnered with companies named in the BIOSECURE Act, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery." The BIOSECURE Act -- independent of the national security necessity argued by it supporters, or the industry-styming downsides associated with it over-correction argued by its detractors -- does have the potential to create good jobs all over the US, if Congress is honest about the lemons and amends the legislation with provisions for making the lemonade.\

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Is your city on the list? 🏙️ Our partner, the Asthma and Allergy Foundation of America, has just released the 2024 Asthma Capitals™ report, ranking the 100 largest U.S. cities based on how challenging they are for people living with asthma. With nearly 28 million Americans affected by asthma, this report serves as a vital call to action for creating healthier environments. Factors such as access to healthcare, clean air, and economic stability play a crucial role in managing asthma outcomes. The report ranks cities based on: - Asthma prevalence - Emergency department visits - Asthma-related deaths It also highlights key risk factors like poverty, air quality, and access to medical care, which contribute to asthma disparities. Discover how your city ranks and join us in advocating for better health outcomes for everyone!  #asthmacapitals #asthma #indoorairquality https://lnkd.in/eQxhiTCZ

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The Asthma and Allergy Foundation of America's 2024 Asthma Capitals™ report highlights the critical role that indoor air quality and environmental factors play in asthma outcomes across the U.S.

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Last week, Adam Feuerstein of STAT+ highlighted the complex relationships between patient organizations and pharmaceutical companies. This story emphasizes the need for industry transparency, the independence of advocacy organizations, and the respect for patients contributing to research. Rx4good's Chief Patient Advocate and SVP, Heidi Schultz Adams, shares her insights on our blog. Read more here: https://shorturl.at/9USy7 and sign up for our Good4Patients newsletter to keep up with the latest.

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In this AJMC - The American Journal of Managed Care interview, Crystal S. Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network® (NCCN®), discusses different policy approaches to address the ongoing cancer drug shortage, including market incentives, better infrastructure, and quality management. #NCCN #DrugShortage #Cisplatin #Carboplatin #CancerDrugs #HealthPolicy Watch now!

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Dont miss “Leveraging Patient Advocacy Functions and Organizations to Provide Better Patient Experience” with B.J. Viau, Director Patient Advocacy, Rare Disease, Amgen, Alicia Barron, LGSW, Executive Director, Infusion Access Foundation, & Chrissie Jenkins, LISW-CP, Patient Advocate, Palmetto Infusion at #NICA2024 June 21-22 at the MGM Grand, Las Vegas. Sign up at bit.ly/NICA2024 Join us for a dialogue on how pharmaceutical companies, sites of care, and nonprofit organizations can work together to ensure that patients are receiving the information and resources available and vital to them to best manage their disease and their care. All of these groups have important pieces of information to share, but a more coordinated effort must be made to disseminate information and engage patients and providers. Patients are often unaware of services that they could access that would improve their quality of life, quality of care, and their financial well-being. In this session, the group will discuss ideas on how to better collaborate and will dialogue with the audience on ideas they may have or efforts already underway in their centers or companies. #infusionprovider #medicalprovider #infusion #infusioncenter #infusionnurse #infusiondeliverychannel #medicalinfusionprovider

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