Joshua Bueller

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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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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Thoughtful perspective on the medtech industry..

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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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Thoughtful planning in the establishment of a commercial data strategy prior to brand launch can help to frame the approach to patient-centricity. Data warehouses are a lot of work to rebuild, the tips in this Beghou Consulting article help to provide four keys to inform that planning so that patients stay at the center of focus. #data #pharma #biotech #patient-centered

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Layoffs in BioPharma CDMOs… There’s been a lot of layoffs in the industry this year. Why? Restructuring (driven by new leadership), site closures, financing restrictions, and M&As. Some recent layoffs 👇 Gilead Sciences set to layoff 72 employees at it’s Seattle location set to close. Thermo Fisher Scientific will layoff 160 employees in plans to close the site in Lexington, MA. Charles River Laboratories has laid off more than 1,300 employees through consolidation and 15 small-site closures. Scorpius BioManufacturing, Inc. had layoffs due to financial restrictions. AGC Biologics has laid off talent across the US and EU for cost challenges. KBI Biopharma had layoffs after backing out of it’s Cell & Gene service expansion. A time of uncertainty for employees at Catalent Pharma Solutions with the acquisition taking place. Some have confirmation they will be retained, lot’s of others unsure. Veranova has been relocating it’s executive team to Boston – not something everyone could do. Although these actions are purposefully driven to benefit, it’s never easy to be directly effected by it. If you have been a part of recent layoffs, don’t hesitate to reach out and send me a message. 📩

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Thoughts on this? >> Candel soars on prostate cancer data despite unclear prospects >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #productmarketing #pharmaceutical

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Fabulous to be on the investor panel for Mintz’s Life Sciences Pitch Event today, on yet another glorious fall day in Boston. ☀️🍁 Key feedback shared by our panel: 🔹 Ensure your target market is clear - especially when the population for your relevant indication is highly heterogenous 🔹 Share your current assumptions about how your product may be used (e.g., chronically vs. episodically) and open questions 🔹 If you're exploring a range of commercial use cases, share how you anticipate prioritizing across them over time 🔹 If your GTM strategy requires you to displace heavily entrenched solutions and/or processes, share how you will enable these transitions 🔹 Note the specific set of milestones to be achieved with investment 🔹 Always include target timelines and potential paths to exit Thank you to the incredible lineup of entrepreneurs who pitched today, and please stay in touch! Thank you to Dean Farmer and Charlie C. for facilitating today's event. Thank you to panelists David Fogel, CPA, Ben Littauer (he/him), Molly Hoult, and Richard Wagner for your contributions. Great to meet you, and thank you for all of your help, Emily (Krasowski) Yanachkov and Diana Malkin. #lifesciences #pitchevent #investor #panel #boston

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Marketers today need to improve campaign performance quickly, optimize frequently, and be confident they have the right analysis to drive the right decisions. Too often, though, we hear from marketers they aren’t getting analysis that is actionable or that can even answer their critical business questions. My amazing colleagues, Rachel Cunningham, Kit Burkus, and Sarah Brown, are ready to spill the tea on measurement, sharing the green (and red) flags to look for and helping marketers get the most out of every marketing dollar. Register today: https://lnkd.in/eX8wfXpt

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David H. Crean and John Foley are thrilled to announce the creation of a new CEO Life Science peer-to-peer advisory group for San Diego CEOs with the leadership team at REF(Renaissance Executive Forum) San Diego. The focus of the REF group will be on more mature companies post-Series A funded companies including those nearing IPO’s and publicly traded companies. The new cohort is expected to begin in early 2025.   REF is a global organization that brings together business leaders in peer advisory groups to enhance their leadership skills and business strategies. Founded in the USA over 30 years ago, REF operates by assembling groups of 12 to 15 business leaders. These groups meet monthly, guided by a Forum Leader, to discuss strategic decisions and personal goals in a confidential environment. REF emphasizes the concept of "Collective Intelligence," where the diverse experiences and backgrounds of members are leveraged to foster better decision-making and personal growth. The organization serves as a hub for over 2,500 entrepreneurs, members, forum leaders, partners, ambassadors, and global speakers, providing a platform for sharing best practices and accessing new opportunities. This peer advisory model is considered more effective than traditional one-on-one coaching, as it builds lasting relationships and provides diverse perspectives that are crucial for both personal and professional development.   The partnership with REF is a recognition of the great work achieved by CEO360 with early-stage life sciences companies over the last 2.5 years plus a desire to take this platform to another level with a larger platform that REF offers for later stage companies. REF currently has a growing international footprint with an unmet need in Life Sciences well beyond the San Diego ecosystem. REF is well positioned to address those needs in 2025 and beyond.   CEO360 will stick to its core and not move away from its early-stage focus. The new REF cohort will be held in addition to the three CEO360 cohorts currently underway in San Diego, the Bay area, and via a new virtual group that will likely involve international leadership. The vision is to create a feeder program where qualified, seed-stage Life Sciences companies can benefit from the power of peer-to-peer advisory as they progress through the stages of funding - Seed, Series A, Series B, and all the way through IPO.   From a timing perspective, the new REF Life Sciences group has just started recruiting CEOs and Ambassadors in the sectors of therapeutics, pharmaceuticals, diagnostics, nutraceuticals, medical devices, and health tech.    Please stay tuned for updates as we embark on this new exciting journey and extend our mentoring support to later-stage Life Sciences CEOs. Below is a link to the REF website.    https://lnkd.in/gcgcgsBy   #Leadership #LifeSciences #CEOs #REF

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Thoughts on this? >> Industry groups critique new guidance for Medicare drug price negotiations in 2027 >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #productmarketing #healthcare #pharmaceutical

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