Robert Storey

#ASH24 GLPG5201 incorporates stem-like early memory T cells, features rapid manufacturing (7-day vein-to-vein time), and requires no cryopreservation. R/R CLL (n=6): Double-refractory to BTKi and BCL2i; median prior therapies: 4. Richter transformation (n=9): Treated with CLL-directed therapy before RT diagnosis and chemo(immuno)therapy after; median prior therapies: 3. Efficacy: - ORR: 86.7% (13/15). - CR: 66.7% (10/15), with 80% (8/10) maintaining remission. Safety: - CRS: 53% (8/15), all Grade 1-2; no Grade ≥3 CRS or ICANS. - Grade ≥3 AEs: Hematological (lymphopenia 100%, leukopenia 88.2%, neutropenia 76.5%, thrombocytopenia 52.9%, anemia 47.1%).

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“We see the potential for a pickup in #medtech M&A in 2025 with a more favorable regulatory environment, lower financing cost, more normalized end market growth rates, and even more time since peak [small-to-midcap] valuations.” That's from a Bank of America analysts' report. Associate Editor Sean Whooley has more details on MassDevice. Boston Scientific Johnson & Johnson MedTech #mergersandacquisitions #meddevice

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Nice short article on medtech ups and downs. Don’t need a subscription on this one! Reduced biopharma funding could slow medical device growth—50% of revenue in life sciences comes from biopharma. Physician visits suggest fewer surgeries—impacting demand for surgical devices. FDA LDT rules could raise costs & limit competition in diagnostics. R&D spending & clinical trials remain strong, a high number of device approvals & active clinical trials — 756 as of May 2024 — point to a promising future. Automation & supply chain optimization can improve margins during lower sales periods. Data can optimize inventory management, logistics, and geographic footprint. How can MedTech companies adapt further? #FutureOfWork #MedTech #RandD

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The health tech industry is entering 2025 with a cautiously optimistic outlook. While funding environments remain selective, the focus is shifting toward technologies and solutions that address critical healthcare needs with clear paths to impact. Investors are increasingly prioritizing scalability, clinical relevance, and robust commercialization strategies over speculative ventures. This trend underscores a maturing of the health tech sector, where the emphasis is on delivering transformative outcomes rather than following short-term market trends. This cautious yet focused funding climate presents both challenges and opportunities. Companies with differentiated platforms and a commitment to addressing unmet medical needs may find themselves well-positioned to secure support, even in a competitive environment. For the broader industry, this shift could lead to more impactful innovations reaching patients faster. Read more in this article in Endpoints News: https://lnkd.in/eTru3AcJ #HealthTech #Biotech #Innovation #FundingTrends #HealthcareSolutions

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I really enjoyed this edition of Consultants Corner, where they delved into an aspect of business operations that's often met with dread: FDA inspections. There are some really helpful medtech pod casts that will also come up if you use the link. While not anyone's idea of a good time, proper planning is crucial. It's not just about meeting compliance standards; it's about fostering an effective corporate culture and building long-term company value. Let's explore how strategic preparation can transform FDA inspections from daunting tasks to opportunities for growth! #MedTech #Medical #MedicalDevice https://lnkd.in/gXXYvE4n

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The pandemic was a challenging period for all. But it also offered us opportunities! The concept of Jupiter is a great example. Jupiter Bioventures, a product of virtual brainstorming with friends (Ned David, Ned Sharpless and Steve Tregay) to enable Mayo Clinic’s insatiable desire to create the next generation of Cures, is now a powerhouse of drug development that has attracted value-aligned investors and academic partners to join forces in the best interest of patients everywhere…. Congratulations Jupiter team! May the patients win….. Norman Sharpless Nathaniel David Steve Tregay Nirdesh K Gupta, PhD Steven VanNurden Peter Noseworthy, MD Vijay Shah Heidi Dieter Andy Danielsen Mayo Clinic Ventures James Rogers Clark Otley Olayemi (Yemi) Sokumbi, M.D. Pankaj Jay Pasricha Waleed Brinjikji Janani Reisenauer Justin Butler Geoff Johnson, MD, PhD Melissa Noel, MBA, MSE, Johannes Fruehauf, Owen Garrick, MD, Jeanette Caban Cheryl Willman, M.D. #venture, #biopharma, #capital, #venturecapital #accelerator, #drug #drugdevelopment, #development, #technology, #commercialization, #technologytransfer, #research, #clinicaltrial, #patient, #cure, #transform, #venturestudio, #disease, #cancer

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The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices.” Although it mostly resembles the draft guidance, the FDA adds detailed examples and analyses of the regulatory requirements and considerations for “remanufacturers.” Read here for the analysis and guiding principles. #FDA

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🚨 Webinar Announcement: Improving Outcomes and Access to Precision Medicine🚨- https://lnkd.in/eSvkPZPG Despite groundbreaking advances in precision medicine, a critical gap remains: the lack of diverse representation in genomic data, leading to unequal healthcare outcomes—especially for people of color. 🔬 What is the impact? Genomic testing is a cornerstone of modern medicine, yet current databases are largely based on data from individuals of European descent. This leaves underrepresented populations at a disadvantage, with less effective treatments and limited access to life-saving innovations. 💡What you’ll learn: 1️⃣ Understanding the genomic testing gap and the structural barriers in healthcare 2️⃣ How to advance precision medicine for all, ensuring inclusivity 3️⃣ Practical strategies for improving access, including policy changes, community engagement, and innovative healthcare models 📅 Date: Thursday, 21st November, 2024 ⏰ Time: 12:00pm - 1:00pm ET 📍 Location: Zoom (Register Here https://lnkd.in/eSvkPZPG) Let’s work together to create a healthcare system that serves everyone. #PrecisionMedicine #GenomicTesting #HealthEquity

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There's a deep personal history for me with this major acquisition today. Incyte (Rich Levy) had the vision at the time (2016) to let me design a very bold #phase2 #clinicaltrial with topical #ruxolitinib which ended up being the first FDA-approved JAK inhibitor in dermatology as OPZELURA® (ruxolitinib) HCP. Incyte acquires John E. Harris, MD, PhD's Villaris Therapeutics backed by Medicxi to go after #vitiligo. John E. Harris, MD, PhD and I are co-founders of Alys Pharmaceuticals which is going after #urticaria #itch #vitiligo and beyond again backed by Medicxi. In parallel in 2019, we publish an early and key paper in the journal Immunity (Meixiong et al. Immunity 2019) with Xinzhong Dong who discovered MRGPRX2 (actually, the entire family). I then start advising Escient Pharmaceuticals with the most bullish optimism about MRGPRX2 as target for #skin #diseases and witness a brilliant execution by Veena Viswanath et al. Incyte makes a bargain acquisition today for $750 million to transform skin disease in #dermatology and #allergy. The key point here is that MRGPRX2 antagonist will NOT be competing IMO with other more moderate-to-severe assets in #CSU like #barzolvolimab. They will mutually grow the market for #CSU across the mild to severe spectrum in a disease that is growing in incidence and poorly penetrated even by great drugs like #omalizumab. Keep in mind, #antihistamines are >$2 billion annual sales for #itch, which it does not even work for that well! This will accelerate new treatments for #urticaria and much beyond. Great for our patients.

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Biocompatibility testing is 🔥 🔥 🔥 right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Seems some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions from the 1990s - and passing it off as fresh data. Yup - they're charging for biocompatibility testing they're not doing, and medical device companies who contracted with these labs are paying the price. So what's a #meddev manufacturer to do? That was the topic of conversation when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTec back in June. The podcast is now available on Soundcloud and Spotify - links in the comments below. ⬇ #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA

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This is an elegant article that once again proves the central role of IFN-g in altering the tumor microenvironment toward Th1 response. Nonetheless, even the best adjuvant is not sufficient to generate an antigen-specific response. #Immuneoncology #Tcell #IFN #STING #Adjuvant #immunotherapy #tumor #TME https://lnkd.in/d2ZuG9px

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HiPatho and Caprico Biotechnologies Announce Strategic Partnership to Revolutionize Flow Cytometry with AI-Driven Solutions October 22, 2024 – HiPatho, a pioneering company in AI-driven pathology solutions, and Caprico Biotechnologies, a global leader in antibody production and assay development for flow cytometry, are excited to announce a strategic partnership aimed at advancing the future of flow cytometry analysis. This collaboration will combine HiPatho’s state-of-the-art AI algorithms designed to analyze complex flow cytometry data with Caprico’s cutting-edge antibody reagents and assay development expertise. Together, the companies seek to streamline hemotopathlogy diagnostics and accelerate research in immunology, cancer research, and immunotherapy. HiPatho, a leader in the AI pathology space, has been at the forefront of leveraging AI to interpret vast data sets, particularly in flow cytometry, allowing researchers to gain deeper insights with greater efficiency. Caprico Biotechnologies, founded in 2013, specializes in producing high-quality fluorescent-conjugated antibodies for clinical and research applications, with a focus on immunophenotyping and biomarker discovery. Dr. Limin Yu, founder and CEO of HiPatho, expressed his excitement about the partnership: "Caprico’s world-class flow cytometry reagents are a natural fit for our AI-driven solutions. By integrating our AI technology, we can empower researchers and clinicians with automated tools that not only analyze large data sets faster but also enhance diagnostic precision. This collaboration is a significant step forward in redefining how data from flow cytometry can be utilized in clinical research and diagnostics." “The fusion of Caprico's robust antibody products with HiPatho’s AI capabilities will enhance the precision and speed of flow cytometry data interpretation,” added a representative from Caprico. “This partnership not only boosts efficiency but also holds the potential to revolutionize diagnostic workflows for both researchers and clinicians.” HiPatho’s AI-driven technology will help eliminate time-consuming manual analysis in flow cytometry, paving the way for more accurate and faster diagnostics. This collaboration marks a critical step toward incorporating AI in clinical and research settings, benefiting both companies' shared vision of advancing medical research and clinical applications. For more information on Caprico Biotechnologies, visit www.capricobio.com, and for details on HiPatho's AI innovations, visit www.hipatho.com. #pathology #hematopathology #flowcytometry #immunotherapy #immunooncology

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RApport's twice yearly analysis of biotech sector trends published today, with author Peter Kolchinsky noting that the first half of 2024 was a relatively quiet one for the public development-stage biotech universe, which has been gradually recovering from the last downturn. Do you know your Core from your Peripheral? How 2024 stacks up, M&A-wise, to prior years? How many years of free cash flow it would take the industry's strategic buyers to acquire the entire biotech universe for a 100% premium? Jump in to our Semper Maior report to find out. #biotech #M&A #financing #fixinsurance https://lnkd.in/ePywBE9C

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June 10 is #EqualResearchDay. Women weren't required in US clinical research until 1993. The Equal Research Day Collaborative has published a book that features 100 facts about gender disparities in healthcare research, access, and treatment. Check out this site to learn more about the facts, the book, and the gaps that we need to address to better understand and manage women's health: https://lnkd.in/e3aqHwfB

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🚀 Curious about the future of healthcare and medtech? I recently had the opportunity to host the  Shaping Funding in MedTech: Insights from Industry Insiders webinar.  by Keiretsu Forum. This Webinar became this week's Investor Connect Episode. Listen here: https://ow.ly/ujuS50SG96P I had the honor of moderating the discussion. The panelists include Paul Gianneschi, Managing Principal and Founder, CEO of Hatch Medical, Dr. Lishan Aklog - Chairman and CEO of Lucid Diagnostics, Todd Wallach - CEO of SOLUtion Medical and serial entrepreneur, and Brianna McDonald- President of Keiretsu Forum Northwest and Rockies. Our panel of experts breaks down the latest trends, challenges, and opportunities, from AI integration to supply chain issues. Check out our fireside chat!

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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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Anavex Life Sciences (NASDAQ: AVXL) reports an impressive effect size for their Sigma-1 receptor agonist (activating autophagy), slowing Alzheimer's progression in a Ph2/3 study. https://lnkd.in/efc5r4kr https://lnkd.in/eWvWcQXG "Anavex Life Sciences (NASDAQ:AVXL) added ~13% in the premarket on Thursday after the neurology-focused drug developer said its lead asset blarcamesine (ANAVEX 2-73) slowed Alzheimer's disease progression by more than a third in a Phase 2/3 trial. Based on 48-week data from the trial, the New York-based biotech said blarcamesine, a once-daily oral therapy targeted at an Alzheimer's-linked protein called SIGMAR1, slowed clinical progression by 36.3% in terms of the primary endpoint. The effect was even more pronounced in a subgroup of patients identified as SIGMAR1 wild-type group, with blarcamesine slowing Alzheimer's progression by 49.8% at 48 weeks compared to the placebo group. The company remains on track to file regulatory submissions for the drug in Europe this year. Anavex (NASDAQ:AVXL) presented the data readout at a medical conference focused on Alzheimer's Disease in Madrid, Spain." Compared to Lecanimab, an FDA-approved anti-amyloid antibody (27% decline reduction on ADAS-Cog over 18 months vs. 38% (50 mg group), 26% (30 mg group), and 49% (Sigma 1 receptor WT subgroup). Lecanimab has significant side effects and is expensive compared to Anavex's small molecule.

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𝑬𝒙𝒄𝒊𝒕𝒊𝒏𝒈 𝑵𝒆𝒘𝒔 𝒇𝒓𝒐𝒎 𝑾𝒊𝒍𝒔𝒐𝒏 𝑨𝒂𝒓𝒉𝒖𝒔 2024 𝑺𝒚𝒎𝒑𝒐𝒔𝒊𝒖𝒎 Steve Hahn, MD, PhD, our Chief Medical Officer and Co-Founder, presented updates on a large 22,000-sample pilot study for modernized newborn screening using Key Proteo’s Immuno-SRM. 𝑲𝒆𝒚 𝑻𝒂𝒌𝒆𝒂𝒘𝒂𝒚𝒔: ▪ APT7B peptide target quantified with very high sensitivity and specificity. ▪ Exceptionally low false positive rate and invalid rate. No true false negatives. ▪ Peptide concentrations stable across weight, gender, and ethnicity. ▪ LC-MS proteomics proven feasible for newborn screening of Wilson Disease from standard DBS specimens. Early detection and intervention is critical. Key Proteo’s Immuno-SRM technology reveals the previously undetectable using existing LC-MS workflows. Key Proteo is grateful to the Wilson Aarhus Symposium for featuring cutting-edge Wilson Disease research. Kudos to all presenters, attendees and organizers! #WilsonDisease #WilsonDiseaseAssociation #MedicalResearch #Proteomics #NewbornScreening #HealthcareInnovation #WilsonAarhus2024 #KeyProteo #EarlyDetection Get in touch with us at [email protected] www.keyproteo.com

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