Sally Susman

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 conversation around consolidation in healthcare is overwhelmingly focused on providers, while payors have been gobbling up entities under the guise of vertical integration for years. PBMs are just one example -- and probably the most egregious -- of how payors are profiteering off the backs of sick Americans. The FTC's latest report shows PBMs have significant power over prescription drug prices and control over access, too. And as the FTC says in its report, all for the explicit purpose of boosting their profits. Meanwhile, providers continue to catch most of the blame for rising healthcare costs. Providers facing challenging contract negotiations would do well to start unpacking these types of inequities for their stakeholders and winning back the narrative on cost. And doing so well in advance of a contract negotiation. Shifting this narrative will take years. Providers must play the long game. https://lnkd.in/eGfDxNXw

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Interesting read on what to expect with the passage of Bill C-64.

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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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Another day, another ADC deal. This time, it's for a target that AbbVie and partner Pfizer once liked, and that Genmab snagged by way of its $1.8 billion Profound Bio acquisition. With Tuesday's deal, Day One Biopharmaceutical joins a growing trend of smaller and mid-size biotechs hopping aboard the ADC train after most large pharmaceutical companies have either bought their way into the space or created homegrown programs. The move follows similar deals from Genmab, Ipsen, Endeavor BioMedicines, ArriVent, BioNTech and other biotechs. #antibodydrugconjugates #adc #oncology #drugdevelopment #licensingdeal #biotech

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Delve into the Cutting-Edge of Cell and Gene Therapy (CGT) Drug Development Processes In case you missed it: Our detailed whitepaper unravels the intricate journey of introducing CGT treatments to the market, spanning from crafting analytical strategies to implementing cGMP-compliant cryogenic storage options. Learn how Alcami lends its comprehensive support for your complete CGT requirements with over four decades of proficiency in analytical testing and regulatory insights. Whether addressing QC hurdles, forging new methods, or conducting extensive stability assessments, our team is poised to assist at each juncture. 🔬 To gain further insights, download the whitepaper here➡️ https://gag.gl/DVC7t6 #CellAndGeneTherapy #CGT #PharmaInnovation #Biotech #DrugDevelopment #AnalyticalTesting #cGMP

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How do you solve the widening gap in access to new, effective #cancer medications? Harlan Levine from City of Hope and Emma Charles from Bristol Myers Squibb weigh in on the efforts their organizations are making to bring important treatments to the people who need them. Read it at PharmaVoice.

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Thanks, Tim Sandle, Ph.D., CBiol, FIScT, for publishing this informative Q&A with Qin Rao of Manhattan Gastroenterology in Digital Journal, offering important insights about how #Colorectalcancer patients are getting younger and how early screening with #Colonoscopy can help reduce more serious disease. An important read, even if you're #under40 https://lnkd.in/eHGtB5MC #Coloncancer #cancerscreening American Cancer Society #NYGastroenterologist Percepture

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In 2023, generic sterile injectables accounted for 53% of new U.S. #DrugShortages. According to data and analysis from the #USPMedicineSupplyMap, these medicines are at a heightened risk for shortage because they are simultaneously impacted by three converging risks that make a drug more prone to shortages: increased manufacturing complexity, unsustainable low cost and geographic over-concentration of supply. Find more about what’s driving our national drug shortage crisis.and collective actions needed to solve it via US Pharmacopeia's new report: https://lnkd.in/ekCNq5cx

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With #JPM25 just a month away, I am anticipating how this year’s agenda will be shaped and what new trends will emerge for the industry. In past years, we’ve seen: - Deals that enhance innovation and technology integration - Optimism around evolution in cancer treatments with ADCs and radiotherapies - The ever-growing potential of GLP-1s and their ability to impact healthcare - How AI is moving from nascent uses to measurable successes for healthcare companies....and a more measured understanding of the timeline for AI's true impact on drug development In the aftermath of an election year, I am especially interested in seeing how sweeping administration changes on the horizon for HHS, FDA and more will influence conversations around looming regulatory provisions, including IRA, 340B and Medicare Advantage. I will be keeping my ear squarely to the ground next month in San Francisco and look forward to sharing emerging trends from these conversations. And maybe sneak in a Double Double at In-N-Out Burger as well. #JPM #healthcare #pharma #pr #publicrelations #mediarelations #healthcaremedia

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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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FDA expedited designation trends are a marker of innovation, promise, and momentum in the R&D pipeline, particularly for cutting-edge therapies. Earlier this year, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) declared that “accelerated approvals will be the norm”, especially for initial approvals of gene therapies. Six months later, this trend is indeed accelerating. What’s more, regenerative medicine advanced therapy RMAT requests and designations are emerging as a clear preference to other expedited pathways. Read our quarterly discussion on designation trends for advanced therapies to learn more about the basis for each individual therapy designation as well as commentary and analysis from recognized Parexel experts that offer additional context on data and findings. https://lnkd.in/gxKsPgNC #CBER #Regulatory #RMAT #FDA

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❔ How do we position regional and community sites for success and mitigate risks for sponsors? ❔ In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. 🚧 That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/g7Tzd3t2 #ResearchSites #Oncology #NovelInsights

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How do we position regional and community sites for success and mitigate risks for sponsors? In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/gfibr9S4 #ParexelBiotech #ResearchSites #Oncology #NovelInsights

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma -KEYTRUDA is now the first and only anti-PD-1 therapy FDA-approved in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status -Approval marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40th indication for KEYTRUDA in the US #merck #keytruda #FDAapproval

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Another example where #PBM are way ahead of federal and state regulators. PBMs create opportunities in Medicare Part D to increase profits at the expense of the most vulnerable. This is also occurring in state health benefits plans, Medicaid plans and commercial plans. #PBMReform #drugprices

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Excited to kick off preparations for #JPM2025! Don't miss this free webinar with top industry leaders sharing actionable insights to help you navigate the networking and partnering buzz during #JPMWeek. Whether you're a first-timer or a seasoned attendee, you'll walk away with strategies to make the most of your experience. Save your spot today! 📅✨ #Biotech #Networking #BIOatJPM25

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“The Pipeline”, our new podcast from Mission North, examines the opportunities and challenges top of mind for communicators in #LifeSciences #Biotech #Biopharma and #Health. As brands continue to navigate the market dynamics of 2024, Nick Maschari and I explore:  ⚖ How comms leaders can own and drive performance narratives while balancing hype with reality ❓The importance of clear and cohesive messaging that focuses on the “why” behind the “what” companies do 🗣 What’s resonating today in patient-centered storytelling We hope you’ll give it a listen and share your thoughts on what else Life Sciences communicators should be considering as we continue to ride the wave that is 2024.

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