Heather Bristol

Good Morning from New Jersey! It's Day One at the Nexus Conference - 21st BioPharma Clinical Trials! What a fantastic opportunity to connect with leaders and innovators in the world of clinical trials. Today, we are excited to participate in the Panel Discussion on Running Clinical Trials in Different Geographic Regions: Assessing Opportunities and Challenges, featuring Rui Rui Zhang Xiang Business Director. Stay tuned for insights and key takeaways on overcoming the complexities of global trials! #ClinicalTrials #Biopharma #PharmaInnovation

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Check out AscellaHealth’s Q2 Specialty & Rare Pipeline Digest featuring the latest updates on recent specialty drug approvals, upcoming reviews, CGT and biosimilar pipelines. If you haven’t already, make sure to subscribe today: https://lnkd.in/epMupw4w #specialtypharmacy #pharmaceuticals #raredisease #FollowAscellaHealth 

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Discover the latest enhancements to Labcorp Global Trial Connect, designed to streamline site workflows and boost clinical trial efficiency. These updates, driven by insights from collaboration with sponsors and sites, aim to empower investigator sites to focus more on what truly matters, patient care. Your commitment to patient care is why we’re committed to redefining clinical trial delivery. Learn more: https://lnkd.in/eavYncMz #ClinicalTrials #GlobalTrialConnect

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BMS is poised to enter the Eosinophilic Esophagitis (EoE) market. Buried in the BMS Q2 2024 earnings call was news that company's eosinophilic esophagitis (EoE) treatment, cendakimab, successfully met Phase 3 clinical endpoints. Similar to already-approved, Dupixent, cendakimab is a biologic with subcutaneous injections every other week. Specifics on the data have yet to be released, this new agent could pose some competitive pressure for Dupixent in EoE. #gastroenterology #clinicaldata https://lnkd.in/g_2a2MWv

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That’s a wrap on American Society of Clinical Oncology (ASCO) 2024!   Looking for a quick recap? Check out our latest blog “Top News from Biggest Players at ASCO 2024” to see a summary of key data and takeaways.   https://lnkd.in/eFZm_kjy   #ASCO24 #Oncology #AdelphiResearch #MarketResearch

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Innovation starts here. For sponsors looking to make a real impact, #GeneTherapies are promising. Pharmacokinetic analysis can shape dosing strategies and provide input into drug safety & efficacy – learn more: https://bit.ly/3zDqPRs #CGT #GeneTherapy #PKassessments

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🔬 Outcomes4me partners with Labcorp to present a study at the 2024 San Antonio Breast Cancer Symposium, highlighting how digital education boosts HER2-low awareness among metastatic breast cancer patients. 🔄 Labcorp announces CFO Glenn Eisenberg's retirement, with Julia Wang set to take over the role from December 2, 2024. 💰 Labcorp reveals Q3 2024 results and updates full-year guidance. Key figures include $3.28 billion in revenue and $162 million in free cash flow. 🤝 Labcorp & NowDiagnostics team up to provide the only FDA-authorized over-the-counter syphilis test, expanding its accessibility in the U.S. 🩺 Labcorp boosts its STI testing capability with the addition of the First to Know® Syphilis Test, the first OTC blood test with FDA approval. #DataPorium #Labcorp #BreastCancerAwareness #HealthcareInnovation #CFOTransition At DataPorium, we track the financial performance, product sales, market share, and social network analysis. We also track the trends of nearly 1,000 products every quarter. 🚀 Want to see more? Head over to https://lnkd.in/duDAwekv and explore! 🔗 Visit our LinkedIn page https://lnkd.in/gJ2iKqKw today for exclusive updates—completely free!

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FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development The U.S. Food and Drug Administration (FDA) released a new draft guidance on September 16th titled "Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs”.1 Recognizing that most drug development is global, the guidance explains how drug developers should address requirements for ensuring that oncology MRCTs include populations that enable interpretability and relevance of the results to U.S. patients. The guidance also clarifies the FDA’s position on the use of foreign data to support marketing applications for cancer therapies in the U.S. The FDA will no longer accept data from clinical trials conducted in only one country or single geographical region as sufficient to support a marketing application, since these data will not enable understanding of any differences in treatment effect for the diverse U.S. population. While FDA regulations allow for the use of foreign data to support a marketing application2,3, the regulations, along with the guidances4,5,6 focused on ensuring diversity in clinical trials, state that foreign data are acceptable only if the patient population is representative in terms of criteria such as demographics and disease characteristics. Consequently, companies developing therapies for oncology indications who have already conducted their clinical trials in a single country or geographical region may have to conduct additional trials to ensure their clinical program is representative of the target U.S. patient population. The guidance also means that companies must begin their Diversity Action Plan as early as Phase 1 and well before their Phase 3 pivotal studies. In many instances, companies rely upon their Phase 2 oncology study(ies) to support their marketing application, with the Phase 3 trial(s) serving as confirmatory and completed post-approval. The guidance's overall goal is to ensure that data from oncology MRCTs are applicable to the U.S. population and medical practice while maintaining the efficiencies of global trials. https://lnkd.in/ea86t7YQ

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Are you interested in learning more about #QPS #bioanalysis capabilities? Get an inside look at the QPS laboratories in this short video. To learn more, visit https://shorturl.at/asPrS or email [email protected]. 

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🎉 Prepare for an exciting month filled with events!🎉 This month is packed with incredible events you won’t want to miss! From inspiring industry conferences and networking opportunities, there’s something for everyone. Here’s a glimpse of what’s coming up: ✨ Gene Therapy Analytical Development & CMC Summit, 30 October - November 1 | Boston, MA, USA ✨ Bio-Europe Fall 2024, 4 - 6 November | Stockholm, Sweden ✨ PEGS Europe 2024, 5 - 7 November | Barcelona, Spain ✨ Extractables & Leachables Europe 2024, 4 - 6 November | Vienna, Austria Don’t miss out—mark your calendar, register, and join us to connect, learn, and make the most of these fantastic industry events! 📅 #healthscience

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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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Advarra can simplify your next clinical trial's review needs. We have everything you need under one roof: IRB, DMC, endpoint adjudication/CEC, and IBC. #clinicaltrials #clinicalresearch

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Each year the ASCO Annual Meeting reveals cutting-edge clinical trial results, new drug approvals, innovative treatments, and emerging trends in oncology. The insights shared are essential for anyone seeking market intelligence to shape strategic decisions and investments. Join us for a live webinar June 12, where Citeline's team of expert analysts will dissect major announcements from the event and explore their implications for you and your business. Don’t miss out. Register for the webinar today: https://ow.ly/uAT050S8A6q. #ASCOAnnualMeeting #MarketIntelligence #ClinicalTrials #OncologyTrends #WebinarAlert #OncologyInsights

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Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) is a rare high-risk subset of ALL with a gene expression profile that shares significant overlap with that of Ph-positive (Ph+) ALL. Early recognition of Ph-like ALL may lead to more impactful therapeutic strategies and better outcomes. Learn how Labcorp Oncology’s portfolio of tests and consultative services can support the diagnostic process for hematologic malignancies such as Ph-like ALL and myeloproliferative neoplasms (MPN) with eosinophilia. Learn more: https://lnkd.in/gN92bjwx

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📢 Introducing one of our many #PanelDiscussions during the 2 day #PDDPSUMMIT at the Hilton Boston Park Plaza Email us at [email protected] to learn more! #DrugDiscovery #Preclinical #Antibodies #DrugDevelopment #AI #ML #MedTech #Biopharma #Pharma #Biotech #SmallMolecules #Biologics #LifeScienes #Medicine #Scientists #LifeScience #LargeMolecules

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