Michael Philcock

ClinGen Resource's patient registry, GenomeConnect, is at Virginia State Genetics Education Conference #VAAGC. Stop by our booth today to learn more about engaging patients in data sharing. #GCChat #Genetics #DataSharing.

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Accelerating drug discovery & development by improving screening workflows with libraries and structure drawing tools…that is the simple but important objective of this great product release. #naturalcompounds #activecompounds #drugdiscovery #chemicalstructure

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Learn what an advanced #IRT system and the people behind it can deliver, beyond core #Randomization and #TrialSupplyManagement expectations. Read the blog. https://lnkd.in/g8YqrcsR #RTSM #ClinicalTrials #ChooseCalyx

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Have you seen the proposed update to USP <60>? Are you confident in your control of Burkhokderia cepacia Complex? Join us on May 30th to discuss!

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With the challenges facing clinical toxicology laboratories, including POLs, the industry must look beyond the next client acquisition and develop a vision for the future. With an ever-changing market landscape labs must innovate to maintain relevance. No longer is it enough to generate results without context. Providers must quickly grasp essential information and make decisions. SafeDrugs reporting, integrates with existing LIS services to provide additional context related to drug safety. #LCMS #Toxicology #DrugSafety #SafeDrugs #Contraindications #DrugDrugInteractions

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💡 Check out the latest from Doreen Alberts on CCC's Velocity of Content blog: Why Innovation in Drug Development Depends on a Successful Scientific Content Strategy: https://lnkd.in/eixH4-75 #drugdevelopment #lifesciences #infopros #research

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We are hiring a manufacturing lead for HelixNano, a clinical stage startup building next-gen mRNA tech to augment the immune system. You'll be perfecting our manufacturing processes/strategy and removing blockers. Here are some problems you might need to solve in the next year: * R&D develops a therapeutic that involves complex (~1e3) libraries of mRNA, and wants to make large batches for preclinical toxicology and NHP efficacy studies. You are tasked with rapidly adapting the existing manufacturing process to to enable multiplexing, including identifying and fixing methods that generate unacceptable biases, and finding or developing library-compatible QC strategies for DNA, mRNA, and LNP-formulated mRNA. * You have built an internal system for managing reagent inventory both internally and across all partners involved in product manufacturing. However, you notice that a specific team at a CDMO partner instead uses their own internal tool, syncing with the HelixNano tool too rarely to be useful (every ~2 months). You need to address by first figuring out why they are not using the HelixNano system, in case this identifies gaps in our system or processes and we need to tweak them. Similarly, you need to check whether any processes are breaking down at the CDMO, and advise them on how to address this.n * You are deploying a more automated, computer-vision-based robotics process in GMP manufacturing. You end up having to liaise with OSHA to ensure that the system is safe for the technicians working in the clean room. If this sounds exciting, find out more at https://lnkd.in/gQG73AuP.

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What kinds of study changes and amendments need @IRB review? Check out Advarra's most recent #blog to get a refresher on the basics of what to send for review by the IRB.

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Come join me at #SLASEurope2024 as I talk about the Broad Institute's Drug Repurposing Library. https://cdmcd.co/bRYL3m Wednesday May 29, 2024 at 3:00 pm (Barcelona time) Track Name: Shaping the Future of Therapeutics | Lab Automation and Screening Parallel Path Session Title: Precision medicine and drug repositioning Presentation Title: The Broad Institute Repurposing Hub: a Small Molecule Toolbox for Interrogating Biological Pathways in Disease Models

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ELIQUENT Expert - Katie McKay - examines two new FDA guidance documents impacting Cell & Gene Therapy (CGT) products. Read Katie's analysis at https://lnkd.in/e_cqsnDG and learn more about ELIQUENT Life Sciences CGT capabilities at ELIQUENT.com

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https://lnkd.in/e_NzGRwZ The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route. Here are some key advantages and examples of how the 505(b)(2) pathway enables innovation:

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iPSC Market Leaders and their Business Models - https://lnkd.in/e5WM_CSQ Today, induced pluripotent stem cells (iPSCs) are being exploited for uses in drug discovery and development, toxicology screening, disease modelling, personalized medicine, cell-based therapeutics, and beyond. A fascinatingly diverse range of business models have been developed by market competitors to provide iPSC specific products, services, technologies, and therapies across the life science sector. Reprogramming kits, reagents, iPS cell lines, and specific culture media are supplied by companies specializing in iPSCs, including FUJIFILM Cellular Dynamics, Inc, Ncardia, Axol Bioscience Ltd., REPROCELL, and others. Diversified research supply companies such as R&D Systems, Promega Corporation , Miltenyi Biotec, STEMCELL Technologies, Takara Bio Inc., Thermo Fisher Scientific, and numerous others also provide iPSC-related research products to the scientific community. Additionally, iPSC specialists have emerged, such as iXCells Biotechnologies which provides normal and diseased iPS cell lines, iPSC-derived cells, custom iPSC services, and functional bioassay development and execution, among related products and services. Likewise, DefiniGEN, Evotec, Ncardia, Fujifilm Cellular Dynamics and Axol Bioscience Ltd. are leaders in offering iPSC differentiation services. Within the world of industrial scale iPSC manufacturing, FUJIFILM CDI, TreeFrog Therapeutics, and Catalent Pharma Solutions (acquired Rheincell Therapeutics) are three companies who are leading the charge. Cynata Therapeutics also has a unique technology for nearly infinite expansion of iPSC-derived MSCs, but currently it is using this capacity for its own iPSC-derived cell therapy product development. Read more at: https://lnkd.in/e5WM_CSQ #ipsc #cordblood #msc

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How are advancements in analytics and manufacturing processes improving the production of #AAV and #adenovirus for gene therapies? 🔎📊📈 We are excited to be featured in GEN article, "Analytics Key to AV and AAV Manufacturing", by Angelo DePalma, highlighting our efforts in developing more effective and scalable adenovirus production solutions. The article showcases our #iCELLis adherent cell platform, which exemplifies our dedication to ensuring high-density cell cultures and high-quality gene therapy solutions. 👩🏼‍🔬🧪🔬 Check out the article to learn more and let us know what you think! Article link available in comments. 🔗 #3PBIOVIAN #GEN #AAV #Biotech #GeneTherapy #ViralVectors

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In case you missed yesterday's webinar on Visiopharm's #Phenoplex and analyzing multiplex protein images by Fabian Schneider, here is a link to a recording. https://lnkd.in/gzyzVQZ5 An excellent presentation covering the rationale for why we want to do Spatial plus an overview of all the image analysis and data exploration tools to be found in Phenoplex. Well worth watching! #spatialbiology #multiplexpathology

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Terrific work leveraging AbbVie's extensive and high-quality database of Suzuki Cross-Coupling yields to develop predictive models. Kudos to the authors for emphasizing both the quality and breadth of training data, and for ensuring their predictions are confined to a well-defined range relevant to the data. 𝐓𝐡𝐢𝐬 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 (𝐨𝐧𝐜𝐞-𝐚𝐠𝐚𝐢𝐧) 𝐮𝐧𝐝𝐞𝐫𝐬𝐜𝐨𝐫𝐞𝐬 𝐭𝐡𝐞 𝐯𝐚𝐥𝐮𝐞 𝐨𝐟 𝐪𝐮𝐚𝐧𝐭𝐮𝐦 𝐦𝐞𝐜𝐡𝐚𝐧𝐢𝐜𝐚𝐥 𝐝𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐨𝐫𝐬 𝐢𝐧 𝐦𝐚𝐤𝐢𝐧𝐠 𝐚𝐜𝐜𝐮𝐫𝐚𝐭𝐞 𝐩𝐫𝐞𝐝𝐢𝐜𝐭𝐢𝐨𝐧𝐬 😉 #computationalchemistry #machinelearning #quantummechanics #neutralnetworks #organicchemistry

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Curious what I do at Sitero? I lead our group in consulting services, and we function with multiple committees on different aspects of research and their compliance. So biosafety and IBC are among them. We also work with IRBs! We have our own external IRB and a whole bunch of other acronyms. I usually joke and say I'm leading the way if it's an acronym or a committee. It's fascinating to be working with so many clients in many research areas, from pre-clinical research to phase three trials and other ways to bring health to communities. #IRB #Sitero #Biosafety #IBC

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#fda releases new guidance on platform technologies. In addition to the endpoints article linked by Cenk Sumen I’m including the guidance here. https://lnkd.in/ehtygBF7

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