Katherine Shelby Ishimine

We're thrilled to announce our success in executing Phase II oncology studies. Our team's expertise in complex subject recruitment and timely enrollment has been instrumental in these achievements. By providing comprehensive support, including regulatory submissions to EMA and USFDA, we're accelerating drug development and improving patient outcomes. This milestone underscores our unwavering commitment to excellence in oncology research. #OncologyTrials #ClinicalResearch #Pharma #Biotech #RegulatoryAffairs #DrugDevelopment #RaptimResearch

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📢 Entos Pharmaceuticals Opens State-of-the-Art GMP Facility 📢 Entos Pharmaceuticals has opened a GMP facility in Carlsbad, CA to support IND-enabling studies and clinical trials. 🔬 The facility is 20,000 square feet and will help Entos advance its pipeline of 20 programs. 💰 The cost of the facility has not been disclosed, but it has room for expansion. 🌎 Entos also plans to build a commercial manufacturing facility in Alberta, Canada, as part of its global manufacturing strategy. #BioprocessUpdates #EntosPharmaceuticals #GMPfacility #manufacturing #clinicaltrials #INDenablingstudies #pharmaceuticalindustry #CarlsbadCA #pipeline #expansion #globalmanufacturing #AlbertaCanada #commercialmanufacturing #biotech #pharmaceuticals #medicalresearch ▷ Read the full article here: 📎 https://lnkd.in/dE4eRN7n

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What an incredible day at the 22nd San Diego Biopharma Conference in the beautiful San Diego, full of thought leadership conversations. Dr. Qingcong Lin, president of Medicilon USA Corp., gave a wonderful presentation "Challenges of #ADC Preclinical #DMPK and Safety Evaluation" during the conference. #Medicilon specializes in ADC, a revolutionary approach to cancer treatment. Our services encompass the entire ADC development process, including: 🔹 ADC Chemistry: Payload and linker R&D, antibody-drug conjugation 🔹In Vitro Evaluation: Binding assays, internalization, cell cycle & apoptosis analysis, bystander effect studies 🔹In Vivo Evaluation: Pharmacodynamics, pharmacokinetics, toxicology studies Our team has successfully supported 28 #IND approvals for ADC therapies, underscoring our leadership in this field. 🔗Click to see more details: https://lnkd.in/dPc8mGSF #SABPA #Medicilon #Drugdiscovery #Preclinical

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*** FDA’s List of Approved Gene Therapies *** Gene therapy is rapidly advancing, with several new FDA approvals paving the way for treatments that can potentially cure genetic disorders Recent and notable approvals: - Lenmeldy (atidarsagene autotemcel) by Orchard Therapeutics - U.S. Therapeutics for metachromatic leukodystrophy - Zynteglo (betibeglogene autotemcel) by bluebird bio for beta-thalassemia - Carvykti (ciltacabtagene autoleucel) by The Janssen Pharmaceutical Companies of Johnson & Johnson Biotech for multiple myeloma - Hemgenix (etranacogene dezaparvovec) by CSL Behring for hemophilia B - Roctavian (valoctocogene roxaparvovec) by BioMarin Pharmaceutical Inc. for hemophilia A #GeneTherapies #FDA #Healthcare #DataCollection

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All cell and gene therapy roads lead to Rome this week at ESGCT! Come by booth B38 to learn how Stunner and Leprechaun help you battle bottlenecks in your cell and gene therapy workflows by helping you crush characterization!

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As the FDA has finalized its Project Optimus guidance, significant changes are underway in the early-phase oncology development landscape. Check out our white paper by Andrew Zupnick, PhD, and Meredith Manuel to learn more about these important developments. If you’d like to discuss how we can assist you in navigating this new environment, please don’t hesitate to reach out. I’d love to connect you with our team! #ProjectOptimus #OncologyDevelopment #EarlyPhaseOncology #OncologySpecialtyCRO

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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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How secure is your viral vector supply? A successful viral vector tech transfer at any stage of development requires expertise and precision, minimizing program impact and ensuring confidence around continuity of supply.  Register for the October 3 webinar hosted by Cell & Gene Therapy Insights and learn from MSAT subject matter experts to support your program: https://okt.to/qL9TdS #viralvectortechtransfer #viralvectors #cellandgenetherapy #genetherapy #msat Kevin Taylor James Cody

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Dive into our latest drug chemistry product updates, webinars, and publications - synthesized and served fresh to your inbox. Subscribe now! #drugdiscovery

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The biotech industry is undergoing a significant shift as cell therapy companies move beyond oncology into autoimmune diseases. This transition is leading to a growing need for professionals with expertise in autoimmune conditions, presenting both challenges and opportunities in recruitment. Recruiters are now tasked with connecting the dots between these different areas of expertise, seeking candidates who can seamlessly adapt and possess cross-disciplinary skills. This dynamic landscape in talent acquisition is fostering innovation and driving advancements in the industry. Have you noticed the impact of this shift on hiring practices within the biotech sector? Share your insights on how this evolution is influencing recruitment strategies in this changing landscape. #Biotech #Recruitment #CellTherapy #AutoimmuneDiseases

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Just Published: Our new Lab Note on performing Calcium Flux assays with our new iCell Sensory Neurons. Let me know if you want to discuss how our iCell Sensory Neurons can help your pain research

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