Lisa Skelton

As #BreastCancerAwareness Month comes to a close, let’s take a look at how far treatment has come—and the promising path ahead. Thanks to continued R&D, we’re seeing breakthroughs in early detection and targeted treatments that have made a real difference in patient outcomes, giving us powerful new tools to improve outcomes. Today, molecular profiling enables treatments tailored to each patient, while non-invasive liquid biopsies provide precise disease monitoring without the need for invasive procedures. It’s all helping to make a genuine difference. Leading researchers and executives are dedicated to making these developments possible. Daniel O'Day and Gilead Sciences, through Immunomedics, have introduced Trodelvy—an antibody-drug conjugate that’s offering new hope for those with metastatic triple-negative breast cancer. Meanwhile, Vas Narasimhan and the team at Novartis are leading research into novel biomarkers, promising earlier diagnosis and more customized therapies. And Eric Lefkofsky at Tempus AI has set a new standard with AI-driven data analysis, which is rapidly expanding our ability to personalize treatments at scale. It’s exciting to think about the future of precision medicine and how these advancements could reshape cancer care, getting us closer to a time when every patient receives the most effective treatment possible. #BreastCancerAwareness #CancerResearch #PrecisionMedicine #Innovation #Biotech

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🌟 Celebrating Achievements in the Rare Disease Space 🌟 Today, we shine a spotlight on the incredible work being done in the Rare Disease space, where innovation and dedication are transforming lives. The UK is home to some remarkable organizations leading the charge in developing therapies and solutions. Kudos to #OrchardTherapeutics, #FreelineTherapeutics, #SilenceTherapeutics, and #MereoBioPharma for their tireless efforts and groundbreaking advancements. These companies exemplify the power of passion and expertise, showcasing how essential it is to hire the right senior talent. Leaders in this space not only drive innovation but also inspire teams to push boundaries and deliver hope to those who need it most. As we celebrate these successes, let us commit to fostering collaboration and investing in talent that will propel this vital work forward. Together, we can continue to make strides in treating rare diseases and improving the quality of life for countless individuals. Here's to the innovators and visionaries who are making a difference. Keep up the extraordinary work! 🌍💡 #RareDiseases #Innovation #Healthcare #Leadership #UKBiotech #Therapeutics #LifeSciences

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NICE plays hardball with Enhertu - a blockbuster ADC drug is blocked from the UK health coverage. Surprising result, that the darling drug that rekindled the ADC field to fevered pitch, failed to win UK government approval for its subsidized health care system. NICE - the agency arm that determines value of drug to be spent for disease treatment in the UK, could not come to terms with Astra Zeneca for reasonable pricing. A very hard-ball, and public decision to recommend the government NOT to cover a breast cancer treatment that could affect 1000 patients in the UK. Biopharma Dive - " The United Kingdom’s drug pricing watchdog has officially declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu for HER2-low breast cancer in the UK, noting that the companies were “unwilling” to offer a fair price. ... ... “NICE and NHS England offered as much flexibility as possible, but the companies did not put forward a new price, so we have no choice but to publish our final decision which is not to recommend the medicine in this group of patients,” NICE’s director of medicines evaluation Helen Knight announced on Monday alongside the final guidance." Needless to say, Pascal Soriot, CEO of AZ was not pleased, suggesting that the process of value judgement at NICE is flawed. The article continues - " “At the end of the day, it is not a question of price. The price we have offered is a very competitive price, so much so that we have reimbursement in many countries around the world,” AstraZeneca CEO Pascal Soriot said last Thursday on the company’s second-quarter call with investors. “It is a question of the methodology that NICE is using, in particular the severity scoring.” " As a reference point, in the US, Enhertu sells for ~$3000 per dose, 21 day cycle, average treatment lasts more than 7 months, roughly $20K - $30K for drug cost over duration of treatment. It was not disclosed in the Biopharma Dive article what price was offered to NICE for Enhertu in the UK. https://lnkd.in/dXJjrU-e

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Following Endpoint's Women in Biopharma 2024 event has been a reminder of just how vital diverse leadership is to this industry’s progress. Although the full event recap isn’t out yet (and I'm looking forward to when it is), what’s already clear is how these women are driving meaningful change. From Marsha Henderson's work advancing women’s health research at the FDA, to Angie You (Architect Thearpeutics) and Katherine Bowdish, PhD (PIC Therapeutics) reshaping the landscape for biotech investors, these leaders are not just breaking barriers — they’re setting new standards for innovation and resilience. Despite the persistent challenges in this field, these women continue to lead with clarity, purpose, and a vision that benefits all of us. Their contributions go far beyond gender; they’re advancing science and improving lives, building a path for the next generation of innovators. Looking forward to seeing what’s next, but for now, let’s celebrate the incredible impact they’ve already made. Register to watch the full panel on demand... #WomenInBiopharma #Leadership #BiotechInnovation #DiversityMatters

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The potential of using Intelligent OMICS for the identification of new targets for current and future diseases is huge. For example, over 200 companies are chasing the same IP trail of Semaglutide targeting GLP1. What if, rather than following the pack and hoping you can Pharmacophore your way out of the IP space, you could identify a new target, implicated in the same mechanism, found by Intelligent OMICS, with similar pharmacology but no IP issues? New target, same disease, new IP. Interested, get in touch...

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Rapid, detailed cell analysis technology soon ready to assess the difference it can make to process insights and timelines

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🤑 𝐀𝐍𝐈 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐭𝐨 𝐀𝐜𝐪𝐮𝐢𝐫𝐞 𝐀𝐥𝐢𝐦𝐞𝐫𝐚 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐢𝐧 $381 𝐌𝐢𝐥𝐥𝐢𝐨𝐧 𝐃𝐞𝐚𝐥 👀 🤝 In a major industry move, ANI Pharmaceuticals, Inc. has agreed to acquire Alimera Sciences for approximately $381 million, with approval from both companies’ Board of Directors. ANI sees this acquisition as pivotal for expanding its Rare Disease business, aligning with their mission of enhancing patient care. 💲 The integration is expected to bolster ANI’s presence in ophthalmology, specifically in DME and Uveitis and is aiming to generate around $105 million in revenues in 2024 and promising significant earnings per share growth by 2025. Both entities are now focused on regulatory approvals to finalise the transaction in the late third quarter of 2024, marking a strategic advancement for ANI Pharmaceuticals in the pharmaceutical landscape.

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Have you listened to the latest "BioCentury This Week" podcast? ✅ Topics (1) Why did Europe's CHMP decision on #Leqembi from Eisai Co., Ltd. & Biogen differ from FDA's decision? (2) How will the recent FDA ODAC meeting impact perioperative cancer clinical trials for checkpoint inhibitors? (3) Will the U.S. Pediatric Review Voucher system be renewed before sunset? (4) Plus, the latest on #Biosecure, including new inquiries into pharma clinical trials in China. ✅ Listen 🎧 Apple: https://lnkd.in/d-4Y2FE7 🎧 Spotify: https://lnkd.in/dGKKjD4h 🎧 YouTube: https://lnkd.in/dudjvjnr It's a great discussion from my BioCentury Inc colleagues Simone Fishburn, Selina Koch, PhD, Steve Usdin and Lauren Martz. If you like the podcast, please make sure to leave a review to help others find it! #biotechpodcast #biopharma #drugdevelopment

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🚀 **This Week in Biotech: Breakthroughs and Collaborations** Exciting developments are shaping the biotech landscape this week, particularly for early-stage companies. 🎗️ **Orphan Drug Designation Granted** Immune-Onc Therapeutics’ IMM-1-104 received orphan drug designation for pancreatic cancer from the FDA. This designation could accelerate the drug’s development for this challenging disease, highlighting the potential of smaller biotechs in tackling significant health issues. 🧬 **CRISPR Advancements** Caribou Biosciences has made strides in ex vivo gene editing with their hybrid CRISPR guides. This innovative approach enhances precision in gene editing, positioning Caribou at the forefront of genetic therapies. Their technology could pave the way for more effective treatments, showcasing the importance of research in early-stage biotechs. 🧪 **Cell and Gene Therapy Updates** The latest updates from the cell and gene therapy sector reveal several collaborations. Notably, TCR2 Therapeutics announced a partnership to develop next-generation T cell therapies. Such collaborations between larger companies and nimble startups are crucial for advancing therapeutic options and optimizing development pathways. 📊 **Why It Matters** These stories highlight the dynamic nature of the biotech field, especially the role of smaller companies in driving meaningful change. As a biotech staffing specialist, I’m excited to support these innovators and contribute to their growth. The advances in gene editing and the recognition of orphan drugs solidify the importance of focusing on early-stage biotech. Let's continue to champion these breakthroughs as we move toward a healthier future!

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In a recent article by Cytel, the indispensable role of key opinion leaders in the realm of rare disease clinical trials is illuminated. Rare diseases present unique challenges in drug development, from limited patient populations to complex regulatory pathways. Here are some key takeaways: 1. Expert guidance: KOLs, with their deep expertise and insights, play a pivotal role in guiding clinical trial design and execution in the context of rare diseases. Their involvement ensures that trials are tailored to address the specific needs and challenges of these conditions. 2. Patient advocacy: Beyond their scientific acumen, KOLs often serve as advocates for patients with rare diseases. Their advocacy can influence trial protocols, ensure patient-centric approaches, and ultimately improve the chances of success in clinical development. 3. Navigating regulatory hurdles: Regulatory bodies have unique considerations for rare disease therapies. KOLs, well-versed in both scientific advancements and regulatory landscapes, can help navigate these complexities, accelerating the path to regulatory approval. 4. Collaborative networks: Establishing collaborative networks involving KOLs, researchers, industry stakeholders, and patient communities fosters a synergistic approach to tackling rare diseases. Such partnerships facilitate knowledge exchange, resource sharing, and innovative solutions. The collaboration between pharmaceutical companies and Key Opinion Leaders is paramount in advancing rare disease therapies. Their expertise, advocacy, and collaborative efforts are instrumental in overcoming the challenges inherent in rare disease clinical trials. Read the full insightful article here: https://bit.ly/44Y1jWi #RareDisease #ClinicalTrials #KeyOpinionLeaders #PatientAdvocacy

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https://lnkd.in/gBRxXrhx

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Here’s an interesting publication detailing how trial efficiency can reshape early-stage development in #biotech... In Phase I studies, every decision affects the development pathway, making trial design and timing critical. By introducing flexibility into these early phases, clinical teams can meet complex study demands without compromising on speed or quality—a balance essential in today’s fast-paced therapeutic field. With streamlined processes, from recruitment through data collection, biotech R&D professionals can better allocate resources, achieve reliable results, and move confidently toward later stages of development. #BiotechR&D #BioTech #BioPharm #EarlyStageDevelopment #ClinicalTrials #TrialEfficiency #DrugDevelopment

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𝐁𝐨𝐞𝐡𝐫𝐢𝐧𝐠𝐞𝐫 𝐈𝐧𝐠𝐞𝐥𝐡𝐞𝐢𝐦 𝐀𝐜𝐪𝐮𝐢𝐫𝐞𝐬 𝐍𝐞𝐫𝐢𝐨 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬: 𝐀 𝐓𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐯𝐞 $𝟏.𝟑 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐃𝐞𝐚𝐥 In a significant move, Boehringer Ingelheim has acquired Nerio Therapeutics for up to $1.3 billion. This acquisition will significantly bolster Boehringer’s immuno-oncology portfolio, particularly through Nerio’s innovative checkpoint inhibitors targeting protein tyrosine phosphatases N1 and N2 (PTPN1 and PTPN2)​. 𝐖𝐡𝐚𝐭 𝐒𝐞𝐭𝐬 𝐍𝐞𝐫𝐢𝐨 𝐀𝐩𝐚𝐫𝐭: Nerio Therapeutics stands out with its small molecule checkpoint inhibitors that enhance the immune system’s response by reshaping the tumor microenvironment. This approach promises more targeted and durable treatments compared to conventional therapies. 𝐊𝐞𝐲 𝐀𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞𝐬: - 𝐼𝑛𝑛𝑜𝑣𝑎𝑡𝑖𝑣𝑒 𝐴𝑝𝑝𝑟𝑜𝑎𝑐ℎ: By focusing on the tumor microenvironment, Nerio’s inhibitors lead to more effective and sustained immune responses. - 𝐴𝑑𝑣𝑎𝑛𝑐𝑒𝑑 𝑃𝑟𝑒𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑃𝑖𝑝𝑒𝑙𝑖𝑛𝑒: Nerio’s preclinical assets show significant promise in early studies, setting them apart from traditional therapies that often lack long-term benefits. - 𝐶𝑜𝑚𝑏𝑖𝑛𝑎𝑡𝑖𝑜𝑛 𝑃𝑜𝑡𝑒𝑛𝑡𝑖𝑎𝑙: These inhibitors can be combined with other therapies to enhance efficacy, adding versatility to Boehringer’s oncology treatments. 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞: Nerio’s small molecule inhibitors will be an important addition to Boehringer’s portfolio with the potential to act as a single agent therapy and in combination with many cancer therapies already being developed in-house​.

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We, the team at CellCentric, are pioneering a new approach to treat multiple myeloma, with an oral p300/CBP inhibitor drug, inobrodib. Huge progress has been made in treating the disease, particularly with recent antibody-based therapies (BCMA targeting agents, TCEs). But 75% of people diagnosed still die of the condition. Beyond and alongside existing approaches, there is a need for oral agents with novel modes of action. Community based delivery also helps address health inequities, meeting the needs of people who are not suitable or able to access more complex treatments in specialist centres. New financing maintains full momentum to registration studies. RA Capital Management and Pfizer Ventures now join Morningside as shareholders. Further additional contribution too from the American Cancer Society’s impact fund, BrightEdge. Total funding: $60.7m. Great to have Laura Stoppel of RA Capital joining the Board, as well as Irena Melnikova from Pfizer Ventures. Press release: https://lnkd.in/d9QpfvFz Endpoints coverage: https://lnkd.in/dg4geESK. Many thanks Lei Lei Wu Business Weekly: https://lnkd.in/e4ZsaJkA Many thanks Tony Quested #multiplemyeloma Debbie Haynes Tomasz Knurowski Karen Clegg Kris Frese Thea Stanway

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This excellent article from Pharmaphorum discusses the emerging field of longevity and anti-aging drugs, which aim to extend human lifespan and healthspan. It highlights recent advancements in research, focusing on interventions like senolytics, which target aging cells, and other therapeutic strategies that address aging at the molecular level. The article also emphasizes the growing interest from both biotech companies and investors in developing these treatments, suggesting that anti-aging drugs may soon become a mainstream part of healthcare, potentially revolutionizing how we approach aging and disease. A highligh is the commentary from Alex Zhavoronkov, who believes "the repurposing of FDA-approved drugs with demonstrated anti-ageing potential represents a highly promising and cost-effective approach to addressing the growing burden of age-related diseases....Over the next decade, we can expect the pharmaceutical industry to make significant strides in addressing age-related chronic diseases, which are not inevitably untreatable."

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ONO PHARMACEUTICAL CO., LTD. is set to make its largest acquisition yet, purchasing Deciphera Pharmaceuticals, an American cancer drug maker, for $2.4 billion. 💼 The move comes as Ono seeks to fuel #growth with new drug candidates, especially as key patents on its Opdivo #cancer immunotherapy are set to expire in 2028. 🌱 Established in 2003, Deciphera is the maker of the Qinlock cancer drug available in the U.S. and Europe. 🩺 Qinlock boasts a unique mechanism that inhibits enzymes critical for cancer cell proliferation. 🛑 Additionally, Deciphera holds promising new drug candidates. 🌟 One such candidate, a treatment for benign tumors in joints, is in the final stages of clinical trials in #Europe and the #US, with approval slated for 2024. 💉 Deciphera is also developing a drug to address complications in blood cancer treatment. 🩸 #Japan #Pharma #Pharmaceutical https://lnkd.in/dppfbjsy

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🎉 Major win for Illumina! The Court of Justice of the European Union (CJEU) has ruled in favor of Illumina, overturning the European Commission's attempt to review its $7.1 billion acquisition of Grail. This ruling limits the EU's power to scrutinise mergers below its revenue threshold and removes the basis for a hefty €432 million fine. This decision sets a significant precedent for companies facing EU merger investigations. ⚖️💼 #Illumina #LegalVictory #Merger #EURegulation #Innovation #Biotech #Healthcare

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📰 Sanofi’s Consumer Arm Reportedly Draws Bids From Advent International, PAI Partners, Clayton Dubilier & Rice 💰 🔍 Key Insight: PAI, the only French bidder, believes its local status could give it an edge in acquiring Sanofi’s consumer arm. 🌟 Why This Matters: 🏆 Competitive Bidding: The involvement of major firms like Advent, PAI, and CD&R signals high stakes and potential strategic shifts in the consumer healthcare market. 📥 Read the full article for more details 👉 https://lnkd.in/ecNp_NDq __________________________________________________________________________________ 🏦 Warburg Pincus LLC Names Jeffrey Perlman CEO, Succeeding Chip Kaye 🔍 Key Insight: This marks only the third leadership transition in Warburg Pincus’s 58-year history, highlighting its stability and strategic foresight. 🌟 Why This Matters: 🚀 Leadership Evolution: Jeffrey Perlman’s appointment as CEO reflects the firm’s commitment to continuity and growth. His vision will shape Warburg Pincus’s future endeavors. 📥 Read the full article for more details: 👉https://lnkd.in/ehCBVvGj __________________________________________________________________________________ 💼 Minority-Led PE Firm Targets $350M Fintech Fund 💰 🔍 Key Insight: Estancia Capital Management, LLC is raising a $350M fintech fund amid a cautious LP environment regarding DEI investments. 🌟 Why This Matters: 🌐 Diversity in Investment: This move underscores the importance of diversity, equity, and inclusion in private equity, especially in the fintech sector. 📥 Read the full article for more details: 👉 https://lnkd.in/e4sHETYK __________________________________________________________________________________ 🧪 The Reasons Why #SpecialtyChemicals M&A Remains Robust 🔍 Key Insight: The first half of this year has seen a steady flow of deals in specialty chemicals and materials, driven by both public companies and private equity firms. 🌟 Why This Matters: 📈 M&A Momentum: The continuous dealmaking in specialty chemicals highlights the sector's resilience and attractiveness, with strategic buyers looking to grow volume and integrate supply chains. 📥 Read the full article for more details: 👉 https://lnkd.in/e3DeeBUK #PrivateEquity #MergersAndAcquisitions #InvestmentStrategy #LeadershipTransition #FintechInvestment #DiversityEquityInclusion #PETrends #StrategicInvestment #IndustryInsights #CapitalRaising

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