Amanda Guisbond

A new #CRISPR-based clinical trial for #SickleCell disease is enrolling at UCSF. This is the first therapy in the U.S. to apply non-viral CRISPR gene editing to directly correct the genetic mutation that causes the disease. Read more: https://ow.ly/Smry50UfZi1

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🌟 Clinical Tips from the 20th Annual California Cancer Consortium Conference 2024 🌟 Reflecting on key takeaways from this year's conference, where experts shared groundbreaking insights in cancer research and treatment: 🔬 Expansion Cohorts in Early Phase Clinical Trials: Valuable or Not? 📝 How to Submit a Clinical Letter of Intent (LOI) to NCI/CTEP 🫁 Advances in Limited and Extensive Stage Small Cell Lung Cancer 💡 New Biomarkers in Breast Cancer ⚡ Novel Targets in Hematologic Malignancies These sessions highlighted cutting-edge advancements and strategies shaping the future of oncology. Excited to see where these innovations will lead! #CaliforniaCancerConsortium #CancerResearch #ClinicalTrials #SmallCellLungCancer #BreastCancer #HematologicMalignancies #Oncology #ClinicalTips #MedicalInnovation #NCI #CancerCare Primo Lara Timothy Synold Jonathan Riess Paul Frankel Percy Ivy Tycel Phillips

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Are you attending the Sept. 25th San Francisco #AdvancedTherapiesXchange? Drawing on his 30+ years of experience leading immune cell operations, Kevin King, Senior Director of #CellandGeneTherapy Strategy and Growth at BioIVT, will be leading the 11:25am session “From Donor to Development: Minimizing Risks in the Cell Starting Materials Supply Chain” discussing strategies to de-risk the utilization of cellular starting and raw materials in the manufacture of #AdvancedTherapies: https://hubs.ly/Q02Qbz6B0 In the absence of industry-wide standardization of human cells, tissues, and cellular and tissue-based products (HCT/Ps), production and manufacturing processes are not equivalent among suppliers. This can create significant efficiency, quality and regulatory obstacles as therapeutic platforms transition from preclinical to clinical application. Kevin will also be joined by Lisa Kretzschmar, Senior Scientific Advisor for CGT at BioIVT, and Adam Ross, Technical Sales Specialist for CGT at BioIVT, for 1:1 meeting requests to discuss: - Why you need a partner that can take you from RUO to GMP - The value of having a geographically expansive, secure supply chain - The importance of donor diversity and its impact on your success - How BioIVT can support your CGT development, from discovery to clinical development Make sure to connect with our expert team if you’d like to schedule a meeting! Learn more about our CGT solutions: https://hubs.ly/Q02QbVwK0 #CellTherapy #GeneTherapy #ATMPs #hubXchange

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🔬 The Power of AI in Oncology Research The landscape of oncology is evolving at an unprecedented pace, propelled by the transformative power of artificial intelligence (AI). In a recent interview with Targeted Therapies in Oncology, Christopher E. Mason, PhD, sheds light on the inevitable expansion of AI in cancer management and treatment. AI is revolutionizing how we process vast amounts of data, offering unprecedented insights and transforming the way healthcare providers access information. From AI-assisted tools like Tempus One to handheld devices like DermaSensor, the integration of AI is reshaping the oncological landscape, enhancing clinical decision-making and patient outcomes. Mason highlights the pivotal role of AI in basic research, particularly in DNA sequencing and spatial transcriptomics, where algorithms play a crucial role in deciphering complex tumor profiles. By harnessing the power of AI, researchers can analyze millions of data points simultaneously, uncovering intricate patterns within tumors and unlocking new frontiers in precision medicine. 🚀 Pioneering AI-Powered Oncological Tools Even now, AI-assisted oncological tools are gaining FDA premarket approval, such as Tempus One, the first generative AI-enabled clinical assistant. This platform, in collaboration with Lens Data Analytics, leverages advancements in generative AI to seamlessly analyze patient data, providing invaluable insights for clinicians worldwide. 🔍 Navigating Challenges and Ensuring Responsible AI Implementation Despite its remarkable potential, the widespread adoption of AI in oncology comes with its own set of challenges and concerns. From bias in algorithms to privacy implications, it's essential to tread carefully and ensure that AI technologies are deployed responsibly. #oncology #AI #ArtificialIntelligence

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'BioRationality—How to Promote Science to Secure Waiver of Comparative Efficacy Testing for #Biosimilars' "A recent Biosimilars Council Position Paper presented arguments that “#Comparative #Efficacy #Studies Are Usually Unnecessary” if analytical, functional, and pharmacokinetic methodologies are sufficient to detect clinically meaningful differences. The paper also suggested that the #FDA require clinical efficacy testing “only when scientifically justified and unique risk-based considerations are identified considering, for example, the mechanism of action, the complexity of the product, or the delivery mechanism.” "The #USFDA has admitted that our current clinical trial system is broken. "The #UKMHRA United Kingdom’s Medicines and Healthcare products Regulatory Agency has already concluded and stated that: “Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.” "The #EMA European Medicines Agency has called for a position paper to adopt a similar policy, calling for comments by April 30. A reflection paper is anticipated soon." Read more on these interesting developments in this article. https://lnkd.in/gXeehuCA Biocon Biologics Sandeep Athalye

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🌟 Best of #ASMS2024 🌟 Fintiede Solutions is thrilled to share the groundbreaking advancements unveiled by Evosep at the #ASMS2024 conference in Anaheim! Evosep continues to push the boundaries in the field of proteomics, introducing innovations that are set to transform research and clinical diagnostics. 🔬 Key Innovations Announced: Fully Automated Workflows: - Capable of processing over 500 plasma samples per day. - Maximizes efficiency and minimizes manual intervention. - Ideal for accelerating drug discovery and supporting large-scale translational research. - Reduces cost per sample and environmental impact. Whisper™ Zoom Methods: - Enhances scalability and sensitivity for detailed and accurate proteomic analyses. - Unlocks the ability to detect low-abundant proteins and identify novel biomarkers. - Facilitates deeper biological insights into disease pathways. Evosep Biolabs: Center of Excellence for High Throughput Proteomics: - Specializes in high-throughput proteomics with automated sample preparation. - Offers access to state-of-the-art LC-MS/MS workflows and expert assay development. - Provides scalable capacity for outsourcing proteomics research projects. 🏆 Impact and Vision: Evosep's innovations are designed to make clinical proteomics 100x more robust and 10x faster, revolutionizing the landscape of proteomics research. These advancements are particularly aimed at accelerating drug discovery and enhancing proteomics-based diagnostics, ultimately improving patient care. We are proud to be part of this journey and look forward to the incredible breakthroughs these technologies will enable in the near future. #Evosep #Proteomics #ASMS2024 #ScientificInnovation #DrugDiscovery #TranslationalResearch #Biomarkers #ClinicalDiagnostics #automation #whisper

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As we draw to the end of the year, the #lifescience, #biopharma, and #CGT industries are reviewing what happened in #2024, and looking forward to #2025. Here, Erin Harris, Chief Editor at Cell & Gene, the Life Science Connect publication, asks 3 KOLs about the outlook for 2025 in the #cellandgenetherapy sector. Miguel Forte, President, ISCT, International Society for Cell & Gene Therapy, and CEO, Kiji Therapeutics, and Vered Caplan, CEO, Orgenesis Inc. "As technology improves, and is doing so rather quickly, we will be better at accelerating the development and improving conditions of adoption and use, making the field delivering value to patients and stakeholders faster.” Miguel Forte, MD, Ph.D. Incorporating the advancements in automation, closed systems, quality control and IT solutions into a standard platform will make POC accessible for many institutes and enable a more efficient approach for the clinical development stage and will lay the basis for enhancing accessibility and reducing costs for commercial stage products.” Vered Caplan https://lnkd.in/eFWHqkpW

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In this month’s Biocom California newsletter, leaders from BioMarin Pharmaceutical Inc., Takeda and Bayer join our Board of Governors, Gray Matter by Graymark Capital completes Westlake Labs life science building in Los Angeles’ Westlake Village community, MyoGene Bio receives Orphan Drug and Rare Pediatric Disease designations for its gene editing therapy for Duchenne muscular dystrophy, and more. Read the full edition here: https://bit.ly/40XGaLO

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🚀 Exciting News for Biocom California Members! 🚀 Your fellow member, Transition Services, Inc. (TSI), is hosting a game-changing, hour-long webinar on July 16th, 2024, at 11:00 AM PST that you will not want to miss! Discover a little-known separation benefits structure that can drastically cut your company's costs while providing an innovative alternative to traditional severance. 💡 𝐖𝐡𝐲 𝐀𝐭𝐭𝐞𝐧𝐝? 𝟏. 𝐈𝐧-𝐝𝐞𝐩𝐭𝐡 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠: Learn about SUB Plans, an IRS-sanctioned and tax-advantaged alternative to severance. 𝟐. 𝐋𝐞𝐠𝐚𝐥 𝐚𝐧𝐝 𝐓𝐚𝐱 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬: Understand the benefits associated with SUB Plans. 𝟑. 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬: Discover how to implement this flexible and cost-effective severance alternative. 𝟒. 𝐍𝐞𝐭𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬: Expand your professional network. Click the link below for more details and to secure your spot for this must-attend virtual event. Do not miss out on the opportunity to revolutionize your approach to employee separations! #employeeseparations #severancealternative #hrbenefits #supplementalunemploymentbenefits #costsavings #strategicplanning

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While #ASCO24 is at an end, it was great following all of it on social media. If you were at ASCO and interested in potential collaborations with the journal Technology in Cancer Research & Treatment, please feel free to reach out. Thanks for sharing OncoDaily! #cancer #oncology #cancerresearch #oncodaily

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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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Curious about what we’re working on at Cheemia ReSET, industry insights, and my personal musings?😎 Sign up for the Cheemia ReSET monthly e-newsletter to stay in the loop! 📧 You’ll get the latest updates, details about our upcoming Digital Transformation Series LinkedIn Live, and all things HCP engagement that matter to you. Subscribe here: www.cheemiareset.com (scroll to the bottom of the page) #CheemiaReSET #DigitalTransformation #Pharma #Pharmaceuticals

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Pharma! How are you gearing up to attract and recruit the next generation of clinical trial participants? Are you targeting the right places? Let's discuss the strategies that work! #patientrecuitment, #patientengagement, #clinicaltrialenrollment

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