Anita Kavlie’s Post

Today is truly special: it is my first post on LinkedIn, and my first paper in 15 years. 🔔 EFPIA - European Federation of Pharmaceutical Industries and Associations has just released a position paper on the use of Next Generation Sequencing (#NGS) for Adventitious Virus Detection in Biological Medicinal Products.✨ This insightful publication is the result from cross-company collaborative efforts of dedicated experts who want to pave the way for the implementation of this groundbreaking technological innovation. The paper was written for scientists and regulatory specialists and provides valuable and comprehensive recommendations on analytical method validation, analytical comparability, and regulatory strategies, with the goal of facilitating the use of NGS and encouraging global alignment on expectations related to this transformative technology. 🧬 🚄 Do you want to learn more and take a speed train to NGS implementation ? Deep dive into the full paper to learn more about our recommendations and feel free to share this material within your network.  https://lnkd.in/gTScwRgu 📣 Your support in spreading awareness about our publication is greatly appreciated. #NGS #ViralSafety #EFPIA

Nataraj Dasgupta will be presenting how #AI is an enabler at the #PMSA in Denver, Co. If you are attending the #PMSA2024, add the Monday 4:20pm poster session presentation to your agenda. #RxDataScience

Discover the most exciting and innovative approaches for precision medicine this year with our white paper, featuring insights on five key trends: 👩💻 Leveraging innovative technology for secure data linkage and access 💊 Utilising diverse data in clinical trials for drug discovery 👶 Implementing genomic sequencing for newborns 🤝 Involving the public to earn and strengthen trust 🌍 Fostering global collaboration among biobanks, pharmaceutical companies, and healthcare providers Join the conversation by downloading our white paper and sharing your thoughts using #PrecisionMedicineTrends: https://bit.ly/430kzkT #HealthInnovation #HealthcareRevolution #Lifebit

More than a catchy title... Add this to your summer reading list!  The Launch and Lifecycle Special Interest Group (PSI: Statisticians in the Pharmaceutical Industry) just published a manuscript in Pharmaceutical Statistics: "Do You Want to Stay Single? Considerations on Single-Arm Trials in Drug Development and the Postregulatory Space." The choice of study design has critical implications for the quality of the results and conclusions. We examine herein the compromises one makes in single arm trials, the important questions to ask, and communication strategies to influence decision making and optimize study design to address evidence needs. https://lnkd.in/dBFqhAty We welcome your feedback! Thanks to SIG co-authors: Yulia Dyachkova, Cornelia Dunger-Baldauf, Nathalie Barbier, Stefan Franzén, Gbenga Kazeem (PhD, CStat), Thomas Künzel, Pierre Mancini, Giacomo Mordenti, Knut Richert, Antonia Ridolfi, Daniel Saure, PhD

In honor of #RareDiseaseDay, we're highlighting an upcoming session at #ACRP2024! Join Stephanie Christopher, MA, CCRC, FACRP from Pfizer for a discussion on the pivotal role rare disease patient advocates play in shaping innovative clinical research methodologies. The rare disease community, actively partnering with academic and pharmaceutical researchers, is at the forefront of driving patient-led research initiatives and pushing the boundaries of clinical research. Learn more about the session > https://bit.ly/42XrBa9 #ClinicalTrialDesign #RareDisease #GoForIt #GoForEducation #ClinicalTrials #ClinicalResearch

Arvato has already supported top companies in serialization. Now, we want to help #Pharmaceuticalcompanies# from other areas to simplify their tasks! #Logistics#: How could a #containermanagement# solution improve your value chain? (connected to your ERP) #Manufacture#: Could #TaskManagement# prioritize work on a paperless shop floor? (automatically) #Quality#: Can #AIsupport# you with error detection, inconsistency detection, data cleaning, and transformation? #Regulatory#: Next step in documentation: #Structured Component Authoring# (SCA) – What are the benefits? Our symposium will focus on how #AI and #DataManagement can put your pharmaceutical business to the next level. We will focus on Quality, Regulatory, Logistics, and Production. SAVE THE DATE!

We are thrilled to announce that Chief Scientific Officer, ARMELLE PINDON, PhD, and Board Member, Alexis Elder, will both be panelists at the 2024 World Orphan Drug Congress USA in Boston, MA on April 24-25. "The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies." -WODC Website We look forward to sharing more about all the wonderful discussions! #WorldOrphanDrugCongress #WODC #VCPdisease #raredisease #CureVCPDisease

The #diagnostics of #MentalDisorders 🧠 need a fundamental renewal❗ The current session IN01 at #ECNP2024 in Milan 🇮🇹 focuses on a new diagnostic framework, based on the underlying biology, to help patients more effectively!  🏥🩺❤🩹 Martien Kas European College of Neuropsychopharmacology (ECNP)  EFPIA - European Federation of Pharmaceutical Industries and Associations  #PRISM2

With the increasing complexity of modern clinical trials and growing restraints on internal resources, it can be a challenge to meet today’s study demands. Get the insights you need for success during AAPS PharmSci 360! Hear from LabConnect’s experts at these two sessions: 💡 Overcoming Global Analytical Challenges with Scientific Central Lab Expertise (10/22 at 11am) 💡 Overcoming Challenges: ctDNA Liquid Biopsies in Early Phase Clinical Trials (10/22 at 3:30pm) Need support now? Arrange a dedicated meeting time with our team by emailing ADSTeam@LabConnect.com.  #PharmSci360 #ClinicalResearch #DrugDevelopment  American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Stacy Kirn-Barker John Bauer

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