Mary Margavio

Do you feel like you are managing your 340B program all on your own? What if I told you #SUNRx clients enjoy a complete team of #340B experts who work with you to optimize your program to be as compliantly productive as possible? It's true! #SUNRx doesn't just supply you with data, but actually works your program with you. Reach out to me today to learn more!

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Check out our summary of key data releases and news from ASCO 2024!

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Another great ASCO! We had a wonderful team at ASCO to evaulate the new data presented. They have been hard at work since we left writing up their insights for our ONCrg Conference reports. Reach out if you want more details on our ASCO coverage. #ASCO24 #competitivestrategy #oncology #competitiveintelligence #pharmaCI

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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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Attention Life Science Professionals! 🔥 HOT TOPIC ALERT! 🧪🔬 Curious about the state of hiring in the life sciences? Check out the summary of a quick poll on hiring trends. Share your thoughts in the comments! #hiring2024 #lifesciences #impact #biotech #pharma #medicaldevices #diagnostics The Richmond Group USA

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🌡️ Mandatory reading for #HEOR professionals Stewing on this blog from Scott Ramsey with the Curta team this week and appreciating the candor. At the same time, I played back an investor call for a company releasing pivotal data at #EHA. The first question from investors? It was about patient-reported outcomes. The second question? About EU access strategy. These are two subject areas where HEOR shines! As such, I agree with Scott’s conclusions… “As long as the organizations that pay for these products ask for the information that HEOR provides, pharma will be obliged to supply it.” Additionally, I believe we should dispense with box-checking exercises and focus on the research that: 1️⃣ Matters to patients first 2️⃣ Drives shared decision-making Thoughts are my own. No AI tools used. #biotech #patientreportedoutcomes #marketaccess #healtheconomics #medicalaffairs

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As a site, how has clinical technology changed your operations? What challenges have you faced? What benefits have you experienced? Now's your chance to share candid feedback on clinical trial technology. Take a few minutes to complete the Technology Landscape Survey ⇢ https://lnkd.in/e2G_fmsi

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As a site, how has clinical technology changed your operations? What challenges have you faced? What benefits have you experienced? Now's your chance to share candid feedback on clinical trial technology. Take a few minutes to complete the Technology Landscape Survey ⇢ https://lnkd.in/eFnHKi9d

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GLP-1s continue to be a hot topic. Impressive weight-loss results were seen for both tirzepatide and semaglutide in a recently released real-world study, but comparative analysis shows tirzepatide the clear winner. Tirzepatide demonstrated superior weight reduction while having similar safety & tolerability to semaglutide. These results are surely going to put even more pressure on Lilly to supply market demand fueled by growing evidence of superiority. "Tirzepatide-treated patients were also 76% more likely to achieve at least a 5% weight loss -- the threshold for clinical significance -- than those on semaglutide (HR 1.76, 95% CI 1.68-1.84). They were also over two-fold and three-fold more likely to achieve at least a 10% and 15% total weight loss, respectively (HR 2.54, 95% CI 2.37-2.73, and HR 3.24, 95% CI 2.91-3.61)." https://lnkd.in/g99vHcxT

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Should MRD negativity be accepted as a surrogate endpoint for clinical trials in myeloma - Ben Derman https://lnkd.in/gaYMuZkh #oncodaily #oncology #cancer #MRD #myeloma #clinicaltrials #FDA #surrogateendpoint #OverallSurvival #PFS #mmsm #mmMRD

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10 principais tendências da ISPOR 2024-2025 . The ISPOR 2024-2025 Top 10 HEOR Trends . . Evidência do mundo real - Chegando em primeiro lugar mais uma vez como uma das 10 principais tendências, desempenha um papel muito importante nas tomadas de decisões em saúde. A utilização de RWE em pesquisa oferece múltiplas vantagens que não são alcançáveis ​​apenas apenas com os ensaios clínicos randomizados (ECRs). . Real World Evidence - Coming in at #1 once more as a top 10 trend, it starts to play a very tangible role in healthcare decision making. Utilization of RWE in research offers manifold advantages that are not attainable solely through randomized controlled trials (RCTs). #RWE #RWD #ISPOR #HTA #HEOR

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Cell and Gene Therapy (CGT) - Disrupting Biopharma Payment System 📌 2023 was a groundbreaking year for gene therapy, with five regulatory clearances, including the first-ever approval of a CRISPR gene editing therapy. And the momentum continues with five more gene therapies poised to receive approval this year, making 2024 the year of gene therapy 📌 But gene therapy is not the only area making strides. Cell therapy is also making waves, with three potential approvals in 2024, bringing the total number of approved CGT therapies to 18 (product details in the slide pack)   📌 Drugmakers are also exploring the potential of cell therapy to treat autoimmune conditions, with systemic lupus erythematosus (SLE) at the top of the list. Several CAR T cell therapies are currently in early trials 📌 Non-CAR-T based cell therapies are gaining traction in the fight against cancer. Natural killer (NK), T-cell receptor (TCR), and tumor-infiltrating lymphocyte (TIL) therapies all show great promise and are advancing in clinical trials alongside CAR-T therapies. The recent approval of Iovance's AMTAGVI (TIL therapy for advanced melanoma) is a significant step forward, indicating the possibility of more non-CAR-T based therapies reaching the market soon   📌 The market of cell and gene therapies (CGT) is poised to disrupt how we pay for biopharmaceutical care. Payers are faced with high, one-time payments when curative treatments replace chronic treatments. Outcomes-based rebate arrangement, innovative contracting models, and payment flexibility can help win payer coverage and reimbursement   📌 The launch trajectories for CGT will look very different from traditional biopharma drug launches. With population sizes differing across indications in CGT, it is unclear how the high price point and patient adoption will impact the shape of the launch   #genetherapy #celltherapy #medicaladvancements #cellandgenetherapy #advancedtherapies #strategy #marketintelligence #competitiveintelligence #marketaccess #perspectives #management #consulting #pharmaceuticals #marketresearch #marketing #leadership #lifesciences #healthcare #pharmainnovation #marketanalysis #advancedtherapy #atmp ---------------------------------------------------------------------- At EOS Intelligence, we specialize in turning complex challenges into successful outcomes. Our proven primary market research approach has been successful across multiple projects, enabling us to navigate the intricacies of commercialization and regulatory approval to ensure your products achieve their maximum potential and reach those in need.   Are you facing unique challenges and goals in your market access strategy? Our team of specialists is here to help. Let's connect for a no-obligation consultation to explore how we can work together to achieve your objectives. With your vision and our expertise, we can achieve great things. Reach out to us at bhabesh.panigrahi@eos-intelligence.com.

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Join me tomorrow afternoon to discuss the challenges faced by different stakeholders when it comes to #clinicaltrial technology! #clinicalresearch #SiteEnablement #stakeholderengagement

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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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●●● 10 Largest Medtech Companies (2024 Forecast) ●●● For more rankings & standings follow #WtorkowyRankingLifeSciences Demographics aren’t changing. Key drivers in the medical device manufacturing sector consist of the demand from adults aged 65 and older. Additionally, you can add age-related disorders such as diabetes, neurology, hypertension, and osteoarthritis combined with chronic disease and toss in the rising costs of healthcare. Altogether that sets up the global medical devices market size, valued at $597.4 billion in 2023, to grow at a compound annual growth rate (CAGR) of 6.2% through 2032 to reach $ $1.025 trillion by 2032. Read more: https://lnkd.in/dMy9GZ_x

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🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking

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https://lnkd.in/eTwcXg79 "Over the years, melanoma has become a popular testing ground for researchers to explore new immuno-oncology approaches. With prior approvals in the skin cancer, Bristol Myers Squibb and Iovance Biotherapeutics are now showcasing early clinical data for their respective novel combinations. For the first time, investigators have revealed clinical trial performance for a triplet containing BMS’ PD-1/LAG-3 combo Opdualag and the CTLA4 inhibitor Yervoy in advanced melanoma. The three-drug regimen shrank tumors in 27 of 46 first-line melanoma patients. The 59% overall response rate, including a 17% rate of complete responders, came after a 49.4-month median follow-up of a cohort in the phase 1/2 RELATIVITY-048 trial. The results will be presented in detail at the upcoming American Society of Clinical Oncology (ASCO) 2024 annual meeting. Separately, researchers will present updated data showing that the pairing of Iovance’s newly FDA-approved cell therapy Amtagvi and Merck & Co.’s Keytruda delivered a 65.2% response rate in front-line advanced melanoma, including a 30.4% rate of complete responses. The result came from 23 patients after a median follow-up of 21.7 months of cohort 1A in the phase 2 IOV-COM-202 trial. Both research teams called the findings encouraging. And for Iovance, its immunotherapy doublet met a high efficacy bar previously set by Leerink Partners analysts in first-line melanoma." JCR Pharma Jessica Smith Alexander Henderson

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🏥💰 Big News in Healthcare Pricing Transparency Attention #biotech and #pharma professionals! The Biden administration has made a surprising move in the ongoing battle for hospital price transparency. Key points: • No changes to current hospital price transparency regulations • Patient advocacy groups' pleas for stricter enforcement ignored • Concerns over hospitals' compliance and pricing accuracy remain unaddressed What this means for our industry: 1. Continued opacity in healthcare pricing 2. Potential impacts on drug pricing discussions and negotiations 3. Opportunities for innovative solutions in price transparency As leaders in biotech and pharma, we must consider: • How can we contribute to greater transparency in healthcare? • What role can our industry play in empowering patients with pricing information? • How might this decision affect our partnerships with hospitals and insurers? Let's discuss: What are your thoughts on this development? How do you see it impacting our sector? #HealthcareTransparency #Biotech #Pharma #HealthcarePolicy #PatientAdvocacy

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📨 Potential implications exist in regard to #LCM and #strategies regarding market exclusivity, see below, the latest from the FTC, sending warning letters to ten major pharma companies in an attempt to continue challenging and cracking down on #JunkPatents. 📂 The claims are around 'inaccurate or improper' patents in place which essentially block competition and keep drug prices high. Many big-name prescription brands are included in this round of probes. 2️⃣ 0️⃣ : "The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate." 🤔 Are your brands affected? ❓ How might actions against you or your competitors affect your LCM strategy? https://lnkd.in/eVuapvWJ #LifeCycleManagement #RegulatoryAffairs #Policy #FTC #FederalTradeCommission #OrangeBook #PharmaPatents #AntiTrust #Pharma

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