Sanjoy Ray

🧬 Big Pharma's Facing a Tidal Shift 🚀 As Humira's monopoly fades into history, it's ushering in an era of biologic competition - and that's just the tip of the iceberg. We're looking at industry titans on the brink of a patent cliff, preparing to dive into uncharted waters with drugs for obesity and Alzheimer's. 🌊 Leaders, consider this: the Inflation Reduction Act might shake up the game, but innovation never sleeps. It's time for strategic pivots - novel therapies, smarter operations, and yes, a marketing revamp. 💡 To my fellow execs in MedTech & HealthTech, we have pivotal roles here. Let's navigate these changing tides together, leveraging expertise & forward-thinking to thrive in this next-gen biopharma landscape. 🚀 #Biotech #Innovation #PharmaceuticalIndustry

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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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Takeda's CEO's annual letter hits on some key themes that many biopharma CEO's are converging on: value-based care, price transparency, breaking up the middlemen, and driving healthcare access and equity. "For several years I have been outlining Takeda’s thinking on health equity—including advocating for a transition to value-based health care that pays for outcomes and care quality, emphasizing the need to prepare for the next pandemic by ensuring global vaccine equity and explaining how the protection of intellectual property rights is essential to incentivize investment in R&D. One area where we would like to see greater progress this year is pharmacy benefit managers reform. We support efforts in Congress to delink rebates from list prices or wholesale acquisition cost. It is a complex system, but the bottom line is that the current system creates misaligned incentives that ultimately result in higher costs for the system and higher out-of-pocket costs for patients. One potential way to address these challenges is through greater transparency. Transparency at the point of purchase for patients would empower them to make decisions knowing exactly what their costs will be. This could lower costs for the entire system by building in greater pricing accountability along the chain so that no stakeholder can benefit from the inefficiencies that result in the prices that patients pay today." At COEUS, we are working with the world's leading biopharma companies to help transition them from a broken FFS model towards value-based care. We have built the world's leading platform that hosts the biggest CGT commercial launches, and rapidly moving into Oncology, Obesity/ Diabetes, and beyond. 1. Enabling Value-Based Healthcare: Our solution facilitates the transition to value-based healthcare by providing a powerful tool for creating and managing contracts that pay for outcomes and care quality. 2. Enhancing Transparency: By aggregating disparate healthcare data from various sources, our platform provides unprecedented transparency into the entire healthcare ecosystem. This empowers payers, providers, and patients to make informed decisions and helps stakeholders across the value-chain to tie price and value to therapeutic outcomes. 3. Driving Innovation: Our platform's ability to evaluate complex rules for value-based contracts, real-world evidence studies, and health equity measurements fosters innovation in the pharmaceutical industry. By providing a tool to measure the impact of new solutions, we help companies drive medical advancements while ensuring equitable access. 4. Improving Access and Affordability: Our solution helps identify areas where access and affordability can be improved without compromising innovation. By providing data-driven insights into the effectiveness of various interventions, we enable stakeholders to make informed decisions that benefit patients and the healthcare system as a whole. Visit https://coebra.ai/.

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The biopharmaceutical sector is undergoing significant transformations, underscored by recent strategic shifts and layoffs among Big Pharma firms. A notable cause of this shift is recent legislation from the IRA affecting direct negotiation, as well as inflated salaries from the spike in need in 2020. It's clear to me these changes reflect a crucial need for adaptive leadership amidst factors like new legislation and shifting market dynamics. Knowing when to use new tech such as AI, as well as being acutely aware of the financial implications of various decisions are key for a leader in the current climate. I'm confident that prioritizing streamlined operations and robust talent development within existing teams will be pivotal in shaping the industry's resilience. #Biotech #Biopharma #Biopharmaceuticals

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As former President Donald Trump returns to office, biopharma leaders are prepped for shifts in policy, but are hoping for a more favorable environment for mergers and acquisition. Under the new administration we may see changes at the FTC that allow for a less restrictive stance on business combinations that could fuel deal activity across the sector. With the expected Republican control in Congress we may see changes to drug pricing legislation, including possible adjustments to the Inflation Reduction Act. New leadership at agencies like HHS and FDA, alongside discussions around pharmacy benefit manager reforms, could also further shape the landscape for biopharma. As we transition to a more business centric administration, the industry can prepare for a potentially transformative period that will impact innovation, regulatory practices, and pricing policies in the coming months.

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Recently, I have done a fair amount of work looking at decentralizing clinical trials regarding whether it is appropriate to a given study and, if so, how to operationalize it. There is so much opportunity for organizations to benefit from considering a decentralized trial - whether in its entirety (less often) or a hybrid model. With the various guidance documents, including the FDA's in September, some of the mystery has been removed, but it still takes careful planning to execute a DCT successfully. Take a look at my latest blog and reach out if you want to discuss DCTs. #clinicaltrials #cliniclresearch #medicaldevices #medtech

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What are the challenges and misconceptions about Value Based Contracts (VBC's)? Why has the adoption of VBC's been historically slow? What can we learn from Cell & Gene Therapy VBC's to scale VBC's into Oncology, Obesity, and beyond? How is modern technology accelerating VBC trends? Find out in his thought piece by my colleague Heidi, and feel free to reach out to either one of us for more insights!

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Approx 4.5 billion people across the world lack equitable access to essential health services (WHO data) though access to highest quality of healthcare is a fundamental right of every human being. Even U.S. strugggles with this issue and ranks last among 10 comparable nations on health equity measures, despite the fact it spends the most on healthcare (Blumenthal D, et al. The Commonwealth Fund; September 19, 2024). Clearly it's not an issue of resources or funds, it's the strategy that counts. The world is off track to achieve universal health coverage (Sustainable Development Goal 3.8) by 2030. Improvements in health coverage have stagnated since 2015 across all regions and the majority of countries. The COVID-19 pandemic has further disrupted progress on this front (Global Health Observatory - Universal Health Coverage Factsheet, WHO). In the latest episode of Princeton Foundation's "What Matters" series, let's hear from Mr. C. K. Mishra, former Secretary, Ministry of Health & Family Welfare, Govt of India the highlights of India’s recent healthcare advancements, major policy initiatives, and how the nation is navigating strategically through the structural and financial challenges. Mr Mishra is credited with leading some of the world's largest public health programs during his tenure including 'Indian National Health Mission' - to provide universal access to equitable, affordable and quality health care services; and 'Mission Indradhanush’ – world's largest ever focused campaign to immunize children. His proactive policy reforms helped India see a huge reduction in maternal and child mortality, Mr Mishra discusses India's approach to enhance equitable healthcare access, sustainable infrastructure development, innovative public health solutions, resilient policy frameworks, and learnings from these endeavors that other nations can employ. https://lnkd.in/ebswzfJF www.pfplus.org Ministry of Health & Family Welfare Indian Administrative Service (IAS) - Government of India World Health Organization U.S. Department of Health and Human Services (HHS) PrimeMinister India Department of Health & Family Welfare, Government of West Bengal Indian Council of Medical Research (ICMR) Medical Council of India The Commonwealth Fund Ministry of External Affairs, India MyGov India

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Earned coverage remains a critical piece of any integrated comms strategy. To remain relevant and sustainable, media business models have had to lean into other areas more and more. Beyond traditional ads, newer areas include more live events and conferences, webinars, networking spaces, and partnered / paid content. So, on our end, media relations has correspondingly evolved. Biopharma comms and PR folks might still yearn for that top headline placement in an Endpoints newsletter, for example, but maybe there's a chance to score an invite for their JPM conference, instead. If we can better understand media's priorities and preferred ways of working, we're not only serving our orgs and clients better, but as a community, we'll collectively shape our industry's narrative. After all, reporters and editors are communicators, too.

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...or maybe not that much. For one thing, there is a social desirability bias: given that the ICER has successfully positioned itself in the US as the arbiter of "scientific pricing", industry peeps are unlikely to answer that their reports are totally irrelevant - it would sound retrograde. And the other thing: it is possible to find interesting tidbits in an ICER report, while not actually using their calculations to drive (net) prices. I recall an earlier survey (and alas, not so precisely that I can provide a reference) that described exactly that: "useful backgrounder on the disease, patients' views, extant clinical data in the space, etc. - but not interested in their modeled prices". In the survey excerpts presented here, note the soft language: "identify concerns", "get a sense of" and the mushy "inform". Things only come into focus with the last question, pertaining to "changing formulary coverage". Pray tell! I look forward to the full survey. #drugpricing

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Excel hidden tab(s)!!! Hidden data on obesity prospect wipe $12B off Amgen market cap By Nick Paul Taylor Nov 13, 2024 6:35am A hidden tab in an Excel spreadsheet published nine months ago has wiped $12 billion off Amgen’s market cap. The tab contains data on bone density changes in patients who received Amgen’s obesity prospect MariTide in a phase 1 trial. Amgen published data from the study in the journal Nature Metabolism in February. The paper makes no mention of bone density. Amgen also shared the source data in Excel spreadsheets. At first glance, none of the spreadsheets contain bone density data either. However, one of the files contains hidden tabs that can be revealed by right-clicking on one of the visible tabs. The tabs remained hidden until an analyst at Cantor Fitzgerald spotted them and published a note about the bone density data this week. Three of the hidden tabs contain femur, lumbar and hip DEXA bone density scan data. A fourth tab, called “DEXA cohort 9 four,” contains patient-level data for the top MariTide dose. Cantor analyst Olivia Brayer called the data a “big unknown” in a research note, according to CNBC, and suggested bone density is a potential risk of GIPR antagonists such as MariTide. Amgen’s share price fell 7% in the wake of Brayer’s note, wiping $12 billion off the biotech’s market cap.  https://lnkd.in/exuq_c3z

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I sat down with Fierce Pharma to share insights into the recent flurry of #biopharma acquisitions and the strategic considerations behind them. While large-scale deals dominate headlines there are many advantages for smaller, targeted acquisitions for long-term shareholder returns. These strategic moves provide an opportunity to mitigate risks and foster innovation, particularly in cutting-edge areas like #cellandgenetherapy. Smaller acquisitions may have potential to drive innovation that can help expand your market reach into new modalities and put you on the leading edge of science in front of your competition. By prioritizing talent retention and leveraging clinical data, companies can position themselves for sustained growth and leadership in the competitive #biotech sector. 

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With AbbVie acquisition of Landos Biopharma and its early-stage therapeutic development pipeline now official, I want to congratulate the remarkable teams at NImmune Biopharma, Inc, BioTherapeutics Inc., and The NIMML Institute. These teams were crucial in my founding of Landos Biopharma in 2017 and its growth into a $600 million market capitalization Nasdaq-listed biotech company outperforming XBI by 5,000 points, characterizing the role of NLRX1 in IBD and developing NX-13 for UC, and remain integral to the development of the next wave of best-in-class precision medicines for inflammatory and autoimmune diseases. Notable and exciting developments include omilancor, currently in a global Phase 3 program as a once-daily oral treatment for Ulcerative Colitis and in Phase 2 clinical development for Crohn's disease, and NIM-1324, an oral, once-daily systemically distributed LANCL2 agonist in Phase 2 for the treatment of systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis and other undisclosed indications with unmet clinical needs. At NImmune Biopharma, Inc, Inc., we continue to leverage the transformative potential of the TITAN-X A.I.-powered precision medicine platform. This platform characterized the NLRX1 target for NX-13 and the LANCL2 target for omilancor and NIM-1324, enabling us to create the next wave of precision medicines for autoimmune and inflammatory diseases. We are excited about the strong market signals from recent I&I deals and remain committed to bringing the best and most disruptive novel treatments that we developed to millions of patients worldwide.

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My segment on CNBC today on #GLP-1 drug pricing, today's Senate hearing, and the market for compounded versions of these medicines #GLP1 #DRUGPRICING American Enterprise Institute

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All pharma CEOs need to understand that they have a responsibility beyond that to their shareholders. Maximizing profits for shareholders beyond what is needed to earn a return on R&D investment—at the expense of people who cannot afford their pharmaceuticals—is unethical. Business ethics should be taught not only in MBA school, but in all undergraduate and graduate programs.

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Important work here by the MassBio team led by Kendalle Burlin O'Connell, Esq. on behalf of all MA based life science focused companies The stats support continued investment at the scale proposed… We now have 2x the number of life science employees in the state since the first MA life science investment initiative was authorized in 2008 Which meant $22Bn in wages in 2023 (great for MA revenues) And this base of talent is helping to attract major investment into new promising technologies that will shape the future of medicine and the health of the nation…that’s 30%+ of all biotech VC dollars the last few years (>$7 Bn per year since 2020…and $13.66 Bn in 2021) #biotech #research #medicine #healthcare Nicholas Collins

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I've been spending a lot of time thinking about the productivity problem in life sciences R&D - which, in my opinion, seems to be the single biggest problem to solve in all of life sciences.   Inefficiency takes on an entirely new meaning in biopharma vs. other industries where it simply amounts to sunk cost. In biopharma - particularly for the long tail of smaller biopharmas - it can be the difference between missing and meeting milestones, securing and not securing funding, life and death. Being efficient is increasingly a requirement for survival. Tech certainly isn't a golden bullet, but we see a lot of opportunity for it to help move the needle, especially if it's in combination with behavioral/cultural change.   Over the last month or so I've been sharing our high-level thoughts on this topic through a series of blog posts, the last of which was published today (see comments for links to the prior two posts). This really only begins to scratch the surface on our thinking here and we're eager to chat with folks in greater detail. If you’re working in this space or have insights to share, I'd love to hear from you! https://lnkd.in/g9EsD5b3

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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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The flagship, 4th mRNA-Based Therapeutics Summit, has officially kicked here in Boston with 400+ key industry leaders from pharma, biotech, regulatory bodies, consultants, academics and solution providers all in one room! The highly anticipated CXO Leader's Fireside Discussion this morning brought together the latest innovators including Nicholas Valiante (Innovac Therapeutics), Thaminda Ramanayake (CureVac), Sophia Lugo (Radar Therapeutics), Andrew Allen (Gritstone bio), Nathaniel Wang (Replicate Bioscience, Inc.) and Igor Matushansky (Sail Biomedicines). The panel delved deep into the opportunities of the mRNA field, challenges faced from a C-Level perspective and investor-partnership climate especially for biotechs in the mRNA/RNA arena. What were the takeaways? - $50M for a start-up is a great level of investement to take your pipeline from concept to IND/Clinic but take it easy with your spending - The type of money and type of investor is crucial, especially when it comes to grant funding too - It's important to have a product mindset and to think about the most investable pipeline - Have open conversations and make promises that you can deliver on according to your timelines - Your lead program is the trunk of your tree and remains your highest value asset #mRNA #vaccine #therapy #summit #flagship #biotech #pharma

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