KATRINA ROGERS

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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🚀 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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The world of LDTs is changing. If you're curious what that means for labs, check out this MedTech Dive article. https://lnkd.in/gYPuzuWa

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PharmaPro Consulting at the AAPS 2024 Pharm Sci 360! Join us from October 20-23, 2024, at the Salt Lake City Convention Center. Don't miss the opportunity to explore our poster presentation on “Gaps in Non-Binary Populations in Clinical Trial Participation: A Comparative Analysis of Cardiovascular and Solid Tumor Studies”, created in collaboration with FourFront. By Manu Datta and Patrick Valdivia. Connect with PharmaPro Consulting to discuss your Clinical Pharmacology, Pharmacometrics, and Regulatory needs, and with FourFront for your Data analytics and Digital Marketing solutions. We look forward to seeing you there! #PharmSci360  #clinicalpharmacology #Pharmacometrics #Regulatory #Dataanalysis #FDA #RegulatoryAffairs #PharmaceuticalIndustry #LifeSciences #HealthcareInnovation #pharmaproconsulting

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Wondering how you will navigate the new FDA stance on LDTs? We are here to discuss strategies and paths to success. Contact i5 BioPartners to learn more.

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Potential Impact of U.S. Legislation on Biotech in 2025 from this article The omission of the Biosecure Act targeting major Chinese biotech contractors like WuXi AppTec from the National Defense Authorization Act signals a pivotal moment for the biotech industry. As 2025 approaches, here are key considerations: Supply Chain Stability: The exclusion of immediate legislative action avoids potential disruptions for U.S. and global biotech companies reliant on WuXi AppTec and similar firms for critical services. Global Collaboration vs. National Security: The debate highlights the tension between maintaining secure supply chains and addressing concerns about sensitive data sharing with entities linked to foreign governments. Regulatory Uncertainty: A pending compromise involving executive branch review signals that regulatory scrutiny could still intensify, impacting long-term planning for biotech partnerships and outsourcing strategies. Investor Sentiment: Uncertainty over legislation may influence investment decisions, as biotech companies weigh risks tied to reliance on international contractors. As the industry navigates this shifting landscape, the evolving regulatory environment will demand strategic adaptability to ensure progress in life-saving therapies. #bioSecureAct #cellandgenetherapy #advancedtherapies #biotech #biotechnology #legislation #uncertainty #supplychain

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Interested in the latest developments at the FDA's Office of Therapeutic Products (#OTP)? Join a free, public webinar on June 14th featuring Dr. Nicole Verdun, OTP's Super Office Director, and Rachael Anatol, Ph.D., Deputy Super Office Director. What you'll learn: The new "Super Office" structure of the OTP Progress on hiring new staff An overview of the OTP's organization Brought to you by Alliance for Regenerative Medicine. Please use the link in the post below. #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #lifescience #lifesciences #regulatory #structure #biotech #biotechnology #webinar #productupdate #regulatorystructure

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The U.S. Food and Drug Administration issued final guidance on what is required to claim “healthy” in food, beverage, or supplement products. This is important progress as consumers begin to understand what they are ingesting and the possible long-term positive and negative effects.

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Regenerative therapy is the future of medicine that holds the promise for an end to many chronic debilitating diseases and the increase of health span in humans and animals. SMSbiotech is introducing an accessible and affordable approach to regenerative therapy using their unique and novel stem cells….

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The top regional #healthcare and #biotech news for January 10th via the Big4Bio newsletters: San Diego: Timberlyne Therapeutics Launches With $180M; Shoreline Biosciences, Inc. Cuts Staff; Belharra Therapeutics Hires CSO https://lnkd.in/gP4pb3wY SF Bay: Exec Hires; Ouro Medicines, Kardigan Launch; Layoffs at IGM Biosciences, Inc.; Biotech Ecosystem Venture Fund https://lnkd.in/gGbr4gvn Seattle: Transcarent, Accolade, Inc. $621M Deal; Slaoui & Phelan Join Achieve Life Sciences Board; AGC Biologics, Pandorum Technologies Collab https://lnkd.in/gAhtyWxk Los Angeles: Biocom California's New Directors; TAE Life Sciences & Kyoto University Breakthrough BNCT Results; UC Irvine's Bioluminescent RNA https://lnkd.in/gHWSiS92 Boston: Exec Changes; City Therapeutics, etherna, HARBOUR BIOMED Strike Deals; Restructuring at Repare Therapeutics, Intellia Therapeutics, Inc. https://lnkd.in/g_M8nQBp Philadelphia: Kardigan Launches; RhyGaze AG Raises $86M; How Fungi Make a Key Medicinal Molecule https://lnkd.in/g-ydsewW Capital Region: VERALOX Therapeutics to Acquire Nudge; Danaher Corporation, Innovaccer Partnership; Hot Investor Mandates; More on Vanda Pharmaceuticals NYC: Kardigan Launches; Pacira BioSciences, Inc.'s Five-year Plan; Pfizer Prospect Beats Incumbent; More on Johnson & Johnson https://lnkd.in/gP-cTPRZ

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ISBER 2024 Best Paper Award Webinar: Quality Measures of Stored Breast Cancer TMAs ISBER is pleased to feature the winner of the 2024 Best Paper Award in Biopreservation and Biobanking through this webinar. This award recognizes a most impactful paper that was published in Biopreservation and Biobanking each year. Selection of the Best Paper Award is based on qualities including both originality/novelty of the research and its potential applications in biopreservation and biobanking fields, ranging from biobanking governance, operation, management, cryobiology, cryopreservation, cold chain, ethical/legal/social issues, to biospecimen science and quality control. At the end of this presentation, the learner will be able to: 1. Understand the impact of poor storage of TMAs 2. Understand that water is a primary driver of TMA degradation 3. Failure to appreciate the risk of degradation can result in errors in evaluation of biomarkers 4. Some biomarkers are more subject to degradation than others When: Wednesday, August 7th       9:00 AM - 10:00 AM Pacific Discover the paper being featured in this webinar! Quality Assessment of Proteins and RNA Following Storage in Archival Formalin-Fixed Paraffin-Embedded Human Breast Cancer Tissue Microarray Sections Kyungeun Kim, Kris Ylaya, Candice Perry, Mi-Yeon Lee, Jeong Won Kim, Joon-Yong Chung, and Stephen M. Hewitt https://lnkd.in/ea279MeZ

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Reno, NV, is quickly emerging as a hidden gem in the biotech world. With its lower costs, access to top-tier talent, and cutting-edge startups driving innovation in muscular dystrophy and sustainable agriculture, the potential for growth is unmatched. Now is the time to explore investment opportunities in this rising biotech hub. 🚀 #BiotechInnovation #InvestInReno #EmergingMarkets

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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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[UPDATED FOR SEPT 2024] Global Regenerative Medicine Industry Database – 1,550+ Companies - https://lnkd.in/eYxEsiw Regenerative medicine (RM) companies are multiplying rapidly in number. There are now an astonishing 1,550+ companies developing regenerative medicine products for therapeutic use in humans. The rapid growth of RM companies is being driven by: - Unprecedented rates of RM clinical trials - Accelerated pathways for RM product approvals - Growing numbers of regulatory approvals for cell and gene therapies - Increased interest among pharmaceutical companies in RM partnerships We define regenerative medicine companies as those pursuing therapeutic approaches which include: stem cell therapies, cellular immunotherapies, gene therapies, tissue engineering and biomaterials, direct cell reprogramming, exosome therapeutics, cellular scaffolds and matrices, and 3D bioprinting. It takes our team of analysts countless hours of research to uncover newly launched companies from across the globe. We also utilize translators to discover companies doing business in a wide range of languages. Additionally, we crowd-source feedback from BioInformant’s partners, clients, and readership who contribute new additions and submit company profiles. The end result is the world’s only searchable, sortable database of regenerative medicine companies that is publicly available. Because it is an essential resource within our company, we are confident it will be an invaluable resource to you too. This week only, you can claim it for 50% off ($150 off): https://lnkd.in/eYxEsiw #regenerativemedicine #stemcells #exosomes #celltherapy #genetherapy #immunotherapies #tissuengineering

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As competition increases for biotech funding, the need for an effective pitch deck continues to grow. A common mistake is neglecting to address potential risks or setbacks. Companies may feel that this will give the impression of an ill-equipped organisation and ultimately erode investor confidence. However, it can have the opposite effect. Acknowledging the risks or potential setbacks you may face demonstrates a clear understanding of the volatile nature of biotech and can show investors that you're prepared to deal with this. If done well, addressing risks can drastically boost confidence and increase your chances of securing funding. #Funding #Biotech #PitchDeck

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Using 'representation vectors' instead of prompt engineering to modulate #LLM responses enables tuneable behavior: https://lnkd.in/eUwSUvtg

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xcellbio Biosciences Inc. (Xcellbio) announced the advancement of its collaboration with Labcorp through the installation of a new AVATAR™ Foundry system at Labcorp's Ann Arbor, Michigan site. This beta access program installation enables scientists to extend potency benefits from small-scale to large-scale automated cell therapy manufacturing workflows. Labcorp, a longstanding collaborator of Xcellbio, joins the early members of the AVATAR Foundry beta access program. Xcellbio's AVATAR incubator system, including the AVATAR Odyssey and the latest AVATAR Foundry system, delivers innovative capabilities for enhancing the potency of cell and gene therapies. These advancements are crucial for optimizing cell therapies targeting solid tumors, particularly in challenging tumor microenvironments. #potency #celltherapy #advancedtherapies #regenerativemedicine #collaboration #betasite #expansion #biotech #biotechnology #lifescience #lifesciences #persistence #tumormicroenvironment #TME #genetherapy #enhancedworkflows #automation #solidtumors #oncology #cancer

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