Sonya Nickerson

After a deep-dive survey focused on innovation readiness in #biotech, Parexel brought experts together to discuss some of these findings. Watch this on-demand webinar on how adaptive strategies can bring more efficient, patient-friendly trials. https://bit.ly/3NJ2xxE

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Are your #MedicalAffairs teams reaching all the providers who need your support? Learn how to transform your outreach strategies with data-driven insights powered by real-world patient journey data. Read more. ⬇️

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🚀 Who Will the Next “Big Pharma” Players Be? 🚀 🔬 Insights from Nadia Bey's BioSpace article, Biopharma industry experts, take note: 1️⃣ Top Pharma Revenue: Johnson & Johnson led 2023 with over $85B in sales. AstraZeneca targets $80B by 2030, having made nearly $46B last year.    2️⃣ Growing Contenders: Regeneron, Vertex Pharmaceuticals, BioNTech SE, and Moderna are pushing into Big Pharma territory, with many surpassing $10B in annual revenue and joining GlobalData's top 20 by market cap. 3️⃣ Market Cap Milestones: Gilead Sciences, Regeneron, and Vertex Pharmaceuticals each boast market caps nearing or exceeding $100B, competing with GSK, Bristol Myers Squibb, and not far behind Amgen, Sanofi, and Pfizer.    4️⃣ Geographic Reach: Established players like Pfizer and J&J operate in 150+ and 175+ countries, respectively. Pharma expansion strategies vary, with biotech firms often concentrating in wealthier markets. 5️⃣ Strategic Acquisitions: Vertex acquired Alpine for $4.9B in April 2024, highlighting the ongoing trend of growth through acquisitions. 6️⃣ Revenue Surges: BioNTech, Regeneron, and Moderna saw significant revenue spikes in 2021 due to COVID-19 contributions, with Regeneron maintaining over $10B through 2023. 7️⃣ R&D Focus: Vertex's revenue hit nearly $10B in 2023, with a 13% YoY increase in Q1 2024. The company is expanding beyond cystic fibrosis to address acute and neuropathic pain. 8️⃣ Innovative Tech: Moderna is revolutionizing with mRNA and LNP technology, reminiscent of Regeneron's antibody innovations in the late '90s. 9️⃣ Stock Movements: Moderna and BioNTech's stocks rose in late May 2024 amid H5N1 concerns, indicating their continued relevance and investor interest in mRNA. 🔟 Expanding Influence: Gilead surpassed $10B revenue in 2013, doubling it by 2014. The firm’s global footprint spans 35 countries, with ongoing portfolio expansion. Stay updated as these rising stars challenge the incumbents, shaping the future of our industry. 🌍💉 #Biopharma #BigPharma #IndustryInsights #BiotechInnovations #RevenueGrowth #GlobalMarket #StrategicGrowth

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Clinical Trials Updates: The FDA approves ImmunityBio, Inc. immunotherapy therapy treatment for Bladder cancer Bladder cancer, the tenth most diagnosed globally, often manifests as non-muscle invasive bladder cancer (NMIBC), where cancer cells are confined to the bladder lining. Up to 80% of bladder cancer cases fall under this category, which is often treated with Bacillus Calmette-Guérin (BCG). However, some patients do not respond to BCG treatment, necessitating alternative therapies. The FDA has approved ImmunityBio's Anktiva, an IL-15 receptor antagonist, in combination with BCG, to address BCG-unresponsive NMIBC, particularly in cases with carcinoma in situ (CIS) and papillary tumors. Anktiva functions by stimulating the patient's NK cells, CD8+ killer T cells, and CD4+ T helper cells, enhancing the proliferation of memory killer T cells. In simpler words, this therapy aims to activate the body's own immune system to fight the cancer, Approval was based on findings from the QUILT 3.032 trial, showing a 62% complete response rate with Anktiva and BCG combination therapy. Notably, 58% of patients maintained a complete response for at least 12 months, with 40% maintaining it for at least 24 months. Expected to be available in the US by mid-May 2024, Anktiva's approval signifies a shift towards next-generation immunotherapies in bladder cancer treatment. Patrick Soon-Shiong, executive chairman of ImmunityBio, sees this approval as a milestone in advancing treatment options beyond conventional approaches, potentially setting a new standard of care for NMIBC patients. Congrats to ImmunityBio, Inc. for this important milestone! #clinicaltrials #medicalaffairs #clinicaldevelopment #cancer #oncology #clinicaljobs #medicaljobs https://lnkd.in/eDgzmW-K

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🔬 Interested in understanding more about #MRD in #cancertreatment? 🧐 MRD stands for Minimal Residual Disease, a technique to detect cancer cells even when they're not visible under a microscope. Learn how MRD can guide treatment decisions and predict remission length in this insightful discussion. #CancerResearch #TreatmentGuidance #FoamEd #MedEd #CME

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Thoughts on this? >> Northwell debuts gene therapy with $2.8M price tag for patients - Crain's New York Business >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #competitivemarketing #healthcare #biotech

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Achieving diversity in clinical trials is essential in today’s rapidly evolving clinical research landscape, and having a diverse clinical trial team is central to this goal. Download our white paper to explore how our FSP strategies can help build diverse, effective teams: https://lnkd.in/gZr5jxt2 #SyneosHealth

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🚀 Takeda joins the molecular glue market with a $1.2B Deal! 🚀 🔬 Takeda Pharmaceuticals has signed an exclusive licensing deal with China-based Degron Therapeutics to develop groundbreaking molecular glue degraders for oncology, neuroscience, and inflammatory diseases. This partnership could reach up to $1.2 billion, marking a significant investment in the future of innovative therapies. 💼 Key Highlights: Upfront Payment: Takeda to make an initial payment and commit to milestone-based funding. Equity Investment: Takeda will also invest in Degron, solidifying their collaboration. GlueXplorer Platform: Access to Degron’s proprietary discovery platform, leveraging a unique library of molecular glue degraders and AI-driven algorithms. 🧪 Innovative Approach: Molecular glue degraders are revolutionizing drug development by enabling the targeting of previously undruggable proteins for destruction, opening new therapeutic avenues. 🌍 Global Collaboration: This deal exemplifies the growing trend of international partnerships in biopharma, driving advancements in treatment modalities and expanding the horizons of drug discovery. 💬 Quote: Takeda CSO Christopher A. highlights that this collaboration adds “an innovative new platform to our drug discovery toolbox,” potentially accessing targets “previously inaccessible or inadequately modulated by other treatment modalities.” 📈 Market Momentum: Takeda joins other pharma giants like Novo Nordisk, Roche, and Merck in the hot molecular glue space, showcasing a collective commitment to advancing this promising therapeutic class. #Biopharma #MolecularGlue #DrugDiscovery #Innovation #Takeda #DegronTherapeutics #Oncology #Neuroscience #InflammatoryDiseases #Biotech #Pharmaceuticals #HealthcareInnovation #GlobalPartnerships 🌐💊🔬

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Biotechs face funding, inflation, and milestone pressures that necessitate prudent cash flow management, especially during clinical manufacturing. CDMOs need to be willing to take a strategic approach that helps sponsors extend their cash runway. 👉 Learn more about lean clinical manufacturing in our new blog post: https://lnkd.in/g78XfvRM

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Recruiter tip: For biotech job applications, do not put graphics in your resume. We sometimes see a resume with graphs or colorful elements to describe the candidate's experience. While the candidate understands what they meant, the recruiter has no clue! What exactly is 4 out of 5 stars for cell culture experience? It leads the recruiter or manager to question a resume more than to consider it. Keep your resume format simple and clean. Boring and black-and-white is best!

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🌟 Partner with Miami Clinical Research for Cutting-Edge Trials! 🌟 Ready to take your research to the next level? Look no further than Miami Clinical Research – where collaboration leads to breakthroughs! 🚀 🔬 Expertise You Can Trust: With years of experience and a stellar track record, our dedicated team brings unparalleled expertise to every trial. From protocol design to patient recruitment, we've got you covered. 🌴 Gateway to Innovation: Welcome to the gateway of medical innovation! Partnering with us means gaining access to a diverse and engaged patient population in the vibrant city of Miami. 💼 Tailored Solutions: We understand that every trial is unique. That's why we offer flexible, tailored solutions to meet your specific needs and goals. From Phase I to Phase IV, we're committed to your success. 🔍 Efficiency at Its Best: Time is of the essence in research. With streamlined processes and a proactive approach, we ensure efficient trial conduct and timely results – because we know every moment counts. 📊 Data-Driven Insights: Make informed decisions with confidence! Our robust data management and analytics capabilities provide you with actionable insights to drive your research forward. 🤝 Let's Collaborate: Ready to embark on a journey of innovation together? Reach out today to explore partnership opportunities with Miami Clinical Research. Let's make a difference in healthcare, one trial at a time! 📞 Contact Us: Have questions or eager to get started? Reach out to me at trusso@miamiclinicalresearch.com. I'm here to support you every step of the way. Don't settle for ordinary – choose Miami Clinical Research for extraordinary results. Partner with us and let's pave the way for a healthier future, together! #ClinicalResearch #MedicalResearch #ClinicalResearchSite #ClinicalTrials #ClinicalStudies #DrugDevelopment #Pharma #Biotech #CRO #Innovation

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Clinical Trials Updated: The FDA grants priority review to Tagrisso for specific subtype of NSCLC Straight after ASCO, AstraZeneca's lung cancer drug Tagrisso has received priority review from the FDA for treating unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy. If approved, it would be the first targeted treatment for this condition. Tagrisso showed promising results in a clinical trial, reducing the risk of disease progression or death by 84% compared to placebo. Patients taking Tagrisso had a median progression-free survival of 39.1 months compared to 5.6 months for those on placebo. Safety data was consistent with Tagrisso's known profile. AstraZeneca is seeking a fast-track approval and hopes to establish Tagrisso as a new standard treatment for this type of NSCLC. https://lnkd.in/ewtsc7Xz #oncology #medicalaffairs #clinicaldevelopment #clinicaljobs #medicaljobs

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🌟 Exciting News from Diasorin! 🌟 DiaSorin has just received FDA 510(k) clearance for its updated NxTag Respiratory Pathogen Panel v2, now including SARS-CoV-2 detection! 🎉 This advanced multiplex PCR assay can detect 19 viral and 2 bacterial targets, offering comprehensive insights into respiratory infections. With improvements in test accuracy and ease of use, this panel ensures top-notch performance on the high-throughput Luminex Magpix instrument, which can process 96 specimens per run. 💪🔬 Thanks to support from the U.S. Department of Health and Human Services (HHS) and Human Services' BARDA, DiaSorin has enhanced its capabilities to meet the ongoing challenges of respiratory pathogens. 🤝 Key Highlights: ✅ Includes SARS-CoV-2 along with other coronaviruses, flu A/B, RSV, and more. ✅ Enhanced accuracy and user-friendly design. ✅ Ready-to-use lyophilized reagent wells for convenience. This advancement represents a significant step forward in diagnostic precision and support for public health. 🌍💙 #DiaSorin #FDAApproval #PCR #Diagnostics #SARSCoV2 #HealthcareInnovation #RespiratoryHealth #PublicHealth #BARDA #MedicalResearch #LaboratoryScience #HighThroughputTesting

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🦠 Bristol Myers Squibb (BMS) and Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M. Cellares will optimize, automate, and tech-transfer select BMS CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for BMS’ exclusive use. This strengthens BMS’ existing global network of cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets 🦠 Legend Biotech announced that the European Commission has granted approval of CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, have demonstrated disease progression on the last therapy and are refractory to lenalidomide. 🦠 Vertex Pharmaceuticals and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes (T1D). C-Stem™, is designed to mimic the natural microenvironment, allowing cells to grow exponentially in 3D. The technology will enhance Vertex's ability to generate large amounts of fully differentiated cells for its portfolio of T1D cell therapies 🦠 TScan Therapeutics announced closing of upsized public offering. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan. The company intends to use the net proceeds from the offering for general corporate purposes. TScan expects its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. 🦠 SCG Cell Therapy and the A*STAR - Agency for Science, Technology and Research in Singapore launched joint laboratories to advance the development of iPSC technology to produce novel cell therapies that meet GMP standards. The collaboration is supported by $22 million under Singapore’s Research, Innovation and Enterprise 2025 Plan. The joint laboratories leverage SCG’s and A*STAR’s proprietary technologies to develop scalable GMP-grade iPSC and therapeutic products

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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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🚀 Exciting News from Illumina! 🚀 Illumina is set to spin off its multi-cancer early detection firm, GRAIL, by issuing shares to existing stockholders later this month. 📅 Effective June 24, Illumina will issue one share of Grail for every six shares of Illumina stock, retaining a 14.5% stake in Grail. 🧬💹 Grail will become an independent, publicly traded company, listing on Nasdaq under the ticker symbol "GRAL." With around 31.1 million shares of common stock and an estimated capitalization of $3.99 billion, Grail is poised for a remarkable journey in advancing genomics and improving human health. 🌍🔬 CEO Jacob Thaysen emphasises this milestone as a pivotal step for Illumina: "As we prepare to lead the next era of genomics innovation, we believe Grail will play an important role in advancing the industry and improving human health." This move follows the divestiture orders from the US FTC and European Commission and is aligned with activist investor Carl Icahn's campaign, which led to significant leadership changes within Illumina. 🚀📊 Transaction costs are estimated at $20M for Grail and $60-75M for Illumina, with Grail's cash position post-spinoff bolstered by Illumina’s funding. 💰💼 In after-hours trading, Illumina's shares saw a 2% increase, reflecting positive investor sentiment. 📈💹 #Genomics #HealthcareInnovation #BiotechNews #Investing #NASDAQ #Grail #Illumina #GenomicsRevolution #HealthTech 🚀🔬💼

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As the Regulatory landscape becomes more and more complex to navigate, the importance of making the right Regulatory hire becomes even more important. Are you seeing candidates with a Right-First-Time approach? How do you know that you have access to the candidates that have the expertise needed to get your drug product to the shelves with little or no costly FDA mistakes? Reach out today to discuss how we can help bring you the right talent that you may not be seeing. Lee@IngenuityTalentSolutions.com #regulatoryaffairs #regulatorystrategy

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With all of the recent biopharma layoffs, many industry professionals are looking to land their next gig. But if its been a while since your last job interview, you’re probably worried about being rusty. Thankfully, a little preparation can go a long way. One area that’s often overlooked? The opportunity at the end of a job interview to ask questions. A recent article from Harvard Business Review provides some excellent question recommendations so you can learn more about your potential boss and the company’s culture. Check it out! Source: https://hubs.li/Q02mXpk50 #layoffs #careeradvancement #jobinterviews #biopharma #professionaldevelopment #careerpaths #aceyourinterview

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