David Asarnow

"San Diago... which of course in German means..." (you can fill in the blank in your head if you know the reference 😂) But I AM in gorgeous San Diego! Please reach out if you've been curious about base editing and would like to have an in person seminar in the So Cal region this month! Why base editing for your therapeutic cell engineering pipelines? ⏲️ SAVE TIME- reduce timelines on multiplex edited cell products by up to 90% 💰 SAVE ON COSTS of manufacturing when less steps are required to reach the end product 💪 HEALTHIER CELL PRODUCTS - gene editing with our platform avoids double strand DNA breaks, reducing the risk of genomic translocations, reducing cytotoxicity, and supporting normal growth rates

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For anyone building diagnostics: Very cool approach to gain valuable insights into FDA decision summaries. Brendan O'Leary scraped the FDA’s decision summaries and provided some simple R code for anyone to get up and running in no time to prod and probe those summaries. Very nice work!

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digiM's recent FDA IDIQ contract award marks a big step in advancing the role of microstructure analysis in regulatory assessment for complex generics. This partnership is set to deepen industry knowledge around product quality attributes and release mechanisms in key drug products, from injectables to implants. This recognition highlights the growing impact of microstructure tools like 3D microscopy and AI-based modeling, demonstrating how essential microstructure science is becoming within the pharmaceutical industry. https://lnkd.in/d5sj5Eds

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Check out the video below showcasing some of our latest and most technological Repligen products.

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So. Very. Exciting. https://lnkd.in/gRwtDsuQ

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https://lnkd.in/etB2Pmqt : a new compound called TRanscriptional Activator of p53 (TRAP-1) is able to engage p53-Y220C and BRD4 in a ternary complex, which potently re-activates mutant p53, resulting in rapid upregulation of p21 and other p53 target genes and inhibits the growth of p53Y220C-expressing cell lines.

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UC Irvine study reveals circadian clock can be leveraged to enhance cancer immunotherapy Optimizing individual time-of-day delivery offers new avenues for prevention and treatment Irvine, Calif., May 28, 2024 — A multidisciplinary research team at the University of California, Irvine has revealed that the circadian clock – the biological pacemaker that governs daily rhythms in physiological processes, including immune functions – can be leveraged to enhance the efficacy of checkpoint inhibitor cancer therapy. Checkpoint inhibitors block different proteins from binding to tumor cells, allowing the immune system’s T cells to kill the tumor. The study, published online today in the journal Nature Immunology, provides deeper insights into the intricate relationship among the circadian clock, immune regulation and tumor development and found that a therapeutic approach optimizing time-of-day delivery based on an individual’s unique circadian patterns offers new avenues for prevention and treatment. “Disruption of the internal biological pacemaker is an inherent aspect of modern society that may contribute to the rising incidence of many cancer types. We found that proper regulation of circadian rhythms is necessary to suppress inflammation and support peak immune function,” said corresponding author Selma Masri, UC Irvine associate professor of biological chemistry. “Understanding precisely how circadian disruption promotes disease progression could lead to behavior modification to reduce cancer risk.” Team members used an advanced single-cell RNA sequencing technique in a genetic model of colorectal cancer and identified clock-dependent changes controlling the number of myeloid-derived cells that suppress T cell activation. They discovered that disruption of the internal clock in the epithelial cells lining the intestine alters secretion of cytokine proteins, leading to heightened inflammation, increased numbers of immunosuppressive myeloid cells and cancer progression. These findings were leveraged to demonstrate that providing immunotherapy at the time of day when these immunosuppressive myeloid cells are most abundant significantly enhanced the efficacy of immune checkpoint blockades in solid tumors. https://lnkd.in/eJFkhSVi https://lnkd.in/ena2V39T

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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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New approach methods (NAMs) continue to pave the way for more effective human risk assessments for FDA-regulated compounds. To help guide best approaches to these emerging methods, the FDA has released “Potential Approaches to Drive Future Integration of New Alternative Methods for Regulatory Decision-Making,” the latest report detailing recommendations from a NAMs subcommittee of the FDA Science Board. Read on to learn the six recommendations: https://lnkd.in/d24eFe9K

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Full:empty ratios aren't good enough. Partials are something you can't ignore. FDA requirements will only get more stringent.  Stay ahead of the curve. You'll need a single device that can precisely measure all 3 types of AAV on a single plate. And if it can do that with crude samples, even better. That's what the Tessie can do for you.  - Full partial empty ratios (with titers) - Precise results from crude sample - Readings in less than 4 hours If you'd like to learn more, you can: 1. Send me a DM, or... 2. Book a 15-minute exploratory meeting: https://lnkd.in/gGJkVZzV #biotechnology #genetherapy #aav #innovation

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Checkout this video for out initial thoughts on the final rule for LDTs.

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Are you doing the same things twice? When CPV and APQR programs aren't aligned 2 different teams may be doing the same work: Duplicate data collectionRepeating similar data analysisRedundant review of CAPAsSimilar reports and duplicate documentation Join us on September 19th at 10 AM EST/4 PM CET for this webinar in which we present practical advice on CPV-APQR integration strategies and learn how to stop doing the same things twice.

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