Katie Jeschke

Curious about how the FDA's guidance on Benefit-Risk Assessment for New Drug and Biologic Products impacts your development program? Read our blog here: https://lnkd.in/enfY73V9

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In this #poster, learn how our bioanalysis team created an assay to determine six pharmaceutically relevant N-nitrosamines in both #drugsubstance and #drugproducts to test for and identify potential risks, helping ensure patient safety: https://bit.ly/49cj2K6

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Understand the EMA Orphan Drug Designation with our new whitepaper -- perfect for organizations aiming to enter or excel in the rare disease market. Our whitepaper provides key strategies for navigating the application process and leveraging designation benefits. 🔗 Download it now: https://ow.ly/w30750SaZ0Q #ODD #OrphanDrugDesignation #EMA #OrphanDrug #RareDisease #Biotechnology #Biopharmaceutical #Pharmaceutical#DrugDevelopment #LifeSciences

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Citeline's Lya Rebelo will be part of a roundtable discussion on the FDA's revised guidance for diversity in clinical trials and how it will impact both sponsors and sites. Register now: https://ow.ly/jcRi50SVWj3. #FDA #DiversityActionPlans #ClinicalTrialDiversity #DiversityInResearch #FDARegulations #InclusiveTrials #ClinicalTrialInclusion

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Developmental and reproductive toxicology (DART) studies can be difficult to manage. When you need DART support for your chemical product, rely on a partner with more than 90 years of experience. Our environmental Center of Excellence in Greenfield, Indiana, has open capacity to drive quick results. Book your study today. #DARTStudy #OECDStudy #Toxicology

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Mark your calendars. Our brilliant scientist, Leo Liu, is all set to share SEC-MALS insights on July 18th webinar, "Episode 6: USP Chapter 129 Updates and SEC-MALS" in collaboration with Waters Corporation and US Pharmacopeia. Make sure you’re there for this exchange of wisdom!

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Save the date! On July 18th join scientist Leo Liu for the "Episode 6: USP Chapter 129 Updates and SEC-MALS" webinar. This event, in collaboration with Waters Corporation and US Pharmacopeia, promises valuable insights into SEC-MALS. Don't miss it! #Webinar #SECMALS #PharmaceuticalScience #USPharmacopeia #WatersCorporation

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Are your current methods for analyzing immune repertoire data holding back your antibody discovery efforts? In this case study, we empowered a client's antibody discovery by building a robust, high-throughput pipeline for immune repertoire data analysis: https://hubs.la/Q02zgwz20 This pipeline efficiently processed hundreds of millions of reads within their cloud environment, allowing for: • Scalability for diverse data sets • Customized processing options • Clear visualizations for comprehensive analysis Witness how our innovative methodologies have dramatically accelerated data analysis, leading to the discovery of groundbreaking antibodies #Excelra #antibodydiscovery #dataanalysis #datavisualization #casestudy #drugdiscovery Bindu Ajithkumar Puneet Saxena Chandra Sekhar Pedamallu Uzma Saeed Jan Ghyssaert Martijn Heeneman

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Lipid Based formulations in drug development can improve the bioavailability of poorly soluble drugs providing a fast and cost-effective path to the clinic and beyond. Hear the experts discuss the nuances of LBF & softgels in this on demand webcast. https://ow.ly/X91k50S7rZB

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Lipid Based formulations in drug development can improve the bioavailability of poorly soluble drugs providing a fast and cost-effective path to the clinic and beyond. Hear the experts discuss the nuances of LBF & softgels in this on demand webcast. https://ow.ly/X91k50S7rZB

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Lipid Based formulations in drug development can improve the bioavailability of poorly soluble drugs providing a fast and cost-effective path to the clinic and beyond. Hear the experts discuss the nuances of LBF & softgels in this on demand webcast. https://ow.ly/X91k50S7rZB

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🎙️Derek Leishman, Vice President Translational and Quantitative Toxicology, Eli Lilly and Company, will focus on the opportunities a sponsor now has available to increase the efficiency and effectiveness of QTc assessment by leveraging the ICH S7B core assays. There will also be times when the already conducted core hERG and in vivo assays do not meet the new expected ‘best practice’. The talk will address how gaps in best practice or limitations in tested exposures could be mitigated. Secure your place at the webinar on 16th May: 🔗 https://hubs.la/Q02tVs1W0 #drugdiscovery #ionchannels #cardiacsafety #cardiacrisk #lifesciences

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Explore #AAV gene therapy solutions that improve titer, enhance recovery, and inform decision making. https://sar.to/cpccq #SimplifyingProgress #InThisTogether #AdvancedTherapies #CellandGeneTherapy #GeneTherapy

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Gain insights as experts explore new technologies for developing and delivering optimal dosage forms that address adherence and acceptability in pediatric populations. https://ow.ly/fV8050SAFiv

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Mark your calendars for an insightful keynote at AAPS 2024 PharmSci 360! Our CSO, Dr. Lauren Stevenson, examines current practices in drug development: 📢 Keynote: "Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry"   📅 Wednesday, October 23   ⏰ 1:30-2:30 PM MT Dr. Stevenson advocates reconsidering our approach to drug development guidance as therapeutics evolve. Here's what you'll explore: 🔬 New Modalities, Old Rules: Why existing guidance, designed for simpler therapeutics, may not fully address today's complex landscape. 🤔 Beyond Analogy: How relying on reasoning by analogy has influenced approaches in drug development and bioanalysis. 💡 First Principles Thinking: The value of approaching challenges (both new and old) from first principles – embracing scientific thinking. 💰 Real-world Impact: How specific approaches affect time, money, and resources, potentially impacting the delivery of therapies to patients. 📊 Data-Driven Insights: Lessons from two decades of industry data, illustrating the importance of rationales in crafting industry guidance.  Dr. Stevenson will discuss shifting from traditional practices to those grounded in scientific rationale. This talk aims to offer fresh perspectives on navigating the complexities of modern drug development. 🤝 Continue the Conversation: We'd love to chat at Booth #1530 after the keynote. Our team is ready to discuss how these insights might apply to your drug development and bioanalysis work. Let's explore how this approach could enhance your strategies! Reach out to us and schedule your meeting now. https://lnkd.in/eYM6GGMZ to arrange a personalized discussion on optimizing your drug development program. We're looking forward to talking with you more. See you at AAPS 2024 in Salt Lake City! #AAPS2024 #PharmSci360 #CRO #DrugDevelopment #Bioanalytical #RegulatoryScience #ImmunologixLabs 

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🧬 Join the American Pharmacogenomics Association for a FREE online event to discuss hot topics in PGx. ☕️ Here's what you can expect: ✅ Discuss the latest PGx developments ✅ Explore the impact of new legislation ✅ Ask your burning questions Date: Thursday, May 16th Time: 7:30 AM - 8:30 AM PST 🔷 Reserve Your Spot and Register here! https://lnkd.in/g9AVfw_w #pharmacogenomics #genetics #personalizedmedicine #coffee #webinar

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