Sharon Reagan

🔍 As the biotech industry evolves, professionals must adapt to changing job trends. Here are strategies to thrive in this shifting landscape: - Embrace Continuous Learning: Stay updated on the latest advancements to remain competitive. - Network Strategically: Build connections within the industry to explore new opportunities. - Leverage Transferable Skills: Highlight versatile skills applicable across various roles. - Seek Mentorship: Learn from experienced professionals to navigate career challenges effectively. - Embrace Flexibility: Be open to diverse roles and career paths within the biotech sector. - Stay Resilient: Develop a growth mindset to overcome setbacks and seize new opportunities. Let's discuss: How do you navigate career changes in the biotech industry? #BiotechCareer #ProfessionalDevelopment #IndustryInsights

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𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐬𝐢𝐭𝐞𝐬 𝐬𝐞𝐞𝐧 𝐚𝐬 𝐡𝐨𝐭 𝐩𝐫𝐨𝐩𝐞𝐫𝐭𝐲 𝐟𝐨𝐫 𝐏𝐄 𝐢𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭 Private equity is increasingly investing in clinical trial sites due to industry demand for larger networks, as shown by PitchBook's analysis of first quarter 2024 deal activity. Contract research organizations (CROs) are acquiring trial sites to enhance their service offerings, exemplified by American Clinical Research Services acquiring Elixia and Alcanza Clinical Research's focus on sites in Hispanic areas. This trend is part of a broader movement towards vertical and horizontal consolidation, aiming to create end-to-end drug development capabilities. #privateequity #clinicalresearchsites

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💊 Industry News Roundup 💊 🧠 Scientists, at Epoch Biotech, have discovered a new genetic clue for delaying Alzheimer's - this has been inspiring drug discovery and could be ground-breaking. 💲 Emergent BioSolutions sold their Baltimore facility for $30M to Bora Pharmaceuticals, which included 350 of Emergent's employees 🔥 Novo Nordisk office building in Denmark, set fire again. This is the third time in the last month - everyone was safe. ➕ Zealand Pharma hits early efficacy goal for amylin weight loss candidate - another movement in the obesity space 👀 😢 Cara Therapeutics have had to cut their workforce after trial failure 😍 iOnctura raises 80M to advance early-stage eye cancer treatment 👁 ❤️ Silence Therapeutics plc siRNA candidate for cardiovascular disease is continuing to deliver in Phase 2 trials!!! 💲 The target is set for new obesity biotech UroGen Pharma, aiming to raise over $107M 🐥 A tweet about a gene led a start-up called Marea raise $190M to develop a drug to lower a type of cholesterol, a new way of maybe attacking cardiovascular disease An exciting time in the biotech space, and if you haven't already - give our podcast The BioHub Podcast a follow.

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Exciting times ahead in gene therapy! 🧬✨ Regeneron has just announced a colossal partnership with Mammoth Biosciences, spotlighting a promising future for CRISPR-based in vivo gene editing treatments. This dynamic duo is bringing together Regeneron's state-of-the-art viral vectors and Mammoth's cutting-edge compact nucleases to forge treatments with precision targeting. The deal includes a whopping $100 million upfront with an additional $370 million for milestones, plus royalties. That's a serious investment in next-gen healthcare. Dr. Christos Kyratsous from Regeneron cites years of groundwork laying the foundation for this collaboration, set to align the delivery systems with specific diseases for optimal outcomes. With equity involved and the option for Mammoth to co-fund and profit-share, the deal embodies a true symbiotic spirit. As the second major gene editing stride for Regeneron, after its ongoing work with Intellia Therapeutics, we're witnessing an exhilarating era where the potential for breakthrough therapies is skyrocketing. This is game-changing science with patient lives ready to be profoundly impacted! #GeneTherapy #CRISPR #Innovation #Healthcare

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One for my Diagnostic network - I'm interested to hear thoughts on the FDA's plan to bring LDTs into its regulatory fold over the next 4 years? What impact is this going to have on the market? 👇 ✏ #FDA #IVD #diagnostics #LDTs #labdevelopedtests #IVDS

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Have you ever wondered about the history of clinical trials? What are they and how did they get started? Check out Fortrea's new podcast -- The Research Realm. In Episode 1, Jamie gives us a better understanding of what clinical trials are. fortreaclinicaltrials.com #fortrea #clinicaltrials #stressawareness #research #clinic #health #healthcarepodcast

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Partnerships start with collaboration and an understanding of client culture. It is important to understand if a potential vendor shares the same values through a comprehensive RFP that also measures problem solving and personality traits. It is not about what you have....It is how you are going to customize an approach that best serves the client.

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During my 15+ years in clinical research, I've lived both sides of the divide. The "haves" vs. the "have nots". The "haves" have expert teams, fantastic processes in place, and seemingly unlimited resources (money) to make things happen. The "have nots" have a massive uphill struggle, they are overworked, under-resourced, juggling clinic schedules, and trying to fit research in on the weekends...problem is, some of the most brilliant research ideas come from the "have nots". Why? Because they are intimately involved in the pain points faced by their patients. Frustrated at my experience being a "have not" and working with other brilliant clinicians struggling to get the resources they needed, drove me to create EZDocs- a simple to use online platform that helps researchers go from idea to IRB submission in days, not months! EZDocs is in final beta testing and I couldn't be more thrilled at the feedback. 😀 I'm here to help more brilliant research ideas see the light of day and to save researchers their hairlines. EZDocs is here to level the playing field. Let's get the (research) party started! If you have a burning idea for a clinical trial and want to get your study into the IRB this month, send me a direct message me and I'll do my best to get you Pre-Launch access. Stay-tuned for more updates! #studystartup #investigatorinitiated #digitalprotocol #automation #compliance

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2 updates on a previous post on trial terminations - First, I did look at the data by phase. Maybe not shockingly, phase 3 trials had a clearly lower termination rate (just under 14% - though that's still higher than I would have thought). The "slash" trials, phase 1/2 and phase 2/3, were considerably higher, presumably with a number of those terminating at the phase transition, per plan. Second - I tried parsing the data by trial size (target enrolled), but realized that the data is not reliable: some sponsors retain the original estimated enrollment, but others update to the actual enrolled at termination. This is actually the MORE interesting result to me, as it illustrates how these kinds of analyses can go sideways very easily if you're not looking very skeptically at your data*. (*Obligatory Feynman quote: "The first principle is that you must not fool yourself and you are the easiest person to fool.")

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Big news in lung cancer treatment! A new drug called ivonescimab from China appears to be effective against non-small cell lung cancer (NSCLC) 🇨🇳 This bispecific antibody is the first to outperform Keytruda, the current market leader, in a head-to-head trial #NSCLC #Keytruda Here's the breakdown: -Ivoncimab significantly extended progression-free survival (PFS) in patients compared to Keytruda -Experts are interested to see if this translates to an overall survival benefit, which is crucial for FDA approval #FDA -MSD , maker of Keytruda, acknowledges the potential of ivonescimab but highlights the need for more data #drugdevelopment The challenge? Ivoncimab was only tested in China, and the FDA may require additional trials for US approval #clinicaltrials This is a significant development in lung cancer treatment, and it will be interesting to see how it unfolds. Stay tuned for further updates! #cancerresearch #innovation

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New coding reports we are working on for our SDTM deliveries, instantly available reports. Mini views can be clicked to expand the visualization and also a coding progress widget for at a glance progress. #CDISC #SDTM #Reports

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Clinical Trials Updates: Sanofi shares positive phase III trial results, hoping for a swift FDA approvals Immune Thrombocytopenia (ITP) is a serious autoimmune blood disorder characterized by low platelet counts due to autoantibody-mediated platelet destruction and impaired platelet production. Symptoms include bruising, petechiae, and in severe cases, life-threatening bleeding episodes. ITP affects about 9.5 per 100,000 adults annually and can significantly impact patients' quality of life. Treatment options traditionally include steroids, immunosuppressants, and, in severe cases, splenectomy. The LUNA 3 Phase III study evaluated rilzabrutinib, a novel oral BTK inhibitor, in adult patients with persistent or chronic ITP. Rilzabrutinib aims to address underlying mechanisms of ITP by reducing autoantibody production and platelet destruction. Rilzabrutinib demonstrated significant efficacy in achieving durable platelet response compared to placebo, particularly in patients refractory to prior therapies. Secondary endpoints also showed promising outcomes. These results suggest a potential breakthrough in ITP treatment. Rilzabrutinib's ability to improve platelet counts and potentially alleviate symptoms offers hope for patients with persistent and chronic ITP, potentially enhancing their quality of life and reducing the risk of life-threatening bleeding episodes. This novel therapy represents a significant advancement in addressing the complex challenges of ITP management. https://lnkd.in/efk39S4n #medicalaffairs #clinicaldevelopment #hematology #clinicaltrials #medicaljobs #clinicaljobs

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🗞 Breaking news 🤩 Genezen acquire uniQure's commercial GT manufacturing ops in Lexington!! This strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. Check out full article below👇 #CDMO #Genezen #GeneTherapy

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Clinical Trials Updates: Agios Pharmaceuticals reaches primary endpoints on their phase III thalassemia trial Agios Pharmaceuticals announced that its drug Pyrukynd (mitapivat) met the primary endpoint in a Phase III trial (ENERGIZE-T) for adults with transfusion-dependent alpha- or beta-thalassemia. The trial demonstrated a 50% or greater reduction in red blood cell transfusions for 30.4% of Pyrukynd-treated patients versus 12.6% in the placebo group. Secondary endpoints, including transfusion independence, were also met, and adverse events were similar between the groups. Earlier, Pyrukynd achieved its primary endpoint in a Phase III trial for non-transfusion-dependent thalassemia, with 42.3% of treated patients responding versus 1.6% in the placebo group. Agios plans to submit a U.S. marketing application by year-end, including data from both trials, and aims for approvals in Europe and the Gulf Cooperation Council countries. Pyrukynd was previously approved by the FDA in 2022 for hemolytic anemia in adults with pyruvate kinase deficiency. Agios faces potential competition from Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited cell therapy Casgevy, approved by the FDA in January for beta-thalassemia. #medicalaffairs #clinicaldevelopment #phaseIII #FDA #medicaljobs #clinicaljobs https://lnkd.in/ePzppdUE

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Breaking through in Biotech 🧬💡 Ipsen has joined forces with Skyhawk Therapeutics, leveraging a massive $1.8 billion R&D collaboration to bring forward new candidates targeting RNA with small molecules—a leap towards conquering "undruggable" proteins in neuroscience. Skyhawk, a pioneer in the space, has already turned heads with its impressive partnership roster, including the likes of Genentech and Merck & Co. Now, Ipsen brings its neuroscience acumen, particularly in movement disorders, to the table. The goal? To drive forward solutions for rare neurological diseases, with the French drugmaker's eye on global rights. For Ipsen, it's a strategic play. They're investing in external innovation—and with $2 billion in their coffers for precisely this kind of outward growth, the stakes are clear. The upfront fees remain undisclosed, but the commitment is evident with potential payoffs reaching the billion-dollar mark, plus added tiered royalties. While specifics are buttoned up, one thing is certain: Ipsen's expertise in conditions like Huntington's disease aligns perfectly with Skyhawk's cutting-edge efforts. It's a partnership that speaks to the heart of innovation. 🤝🔬 #BiotechCollaborations #RNArevolution #NeuroscienceInnovation

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Cerevel Therapeutics released promising results from its Phase III TEMPO-3 trial for its investigational Parkinson’s disease treatment, tavapadon. The trial demonstrated that tavapadon, when used alongside levodopa, significantly improved motor symptom control, increasing "on" time without troublesome dyskinesia by 1.7 hours compared to placebo. This effect was clinically meaningful and statistically significant. Tavapadon also reduced "off" time, showing safety and tolerability in the trial. These findings support future regulatory submissions for tavapadon. Tavapadon, a selective partial agonist of D1/D5 receptors, targets motor pathways while minimizing side effects. Further studies are underway, including TEMPO-1, TEMPO-2, and TEMPO-4, evaluating tavapadon's efficacy and safety. Cerevel's recent acquisition by AbbVie is expected to close soon, reflecting growing interest in its neurology and psychiatric pipeline! For more information: https://lnkd.in/eJEcP8qm

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