Navitus Health Solutions’ Post

BGH Annual is here! See if you can find Colton Miller, Rebekah Gregg, or Renee Malarbi Rayburg to have a conversation about how we can support your pharmacy benefit strategy for topics like GLP-1s, biosimilars, cell and gene therapies, and more. #BGHAnnual #glp1 #biosimilar #cellandgene #conference

Understanding Big Pharma's Pricing formulas for New Medicines. The cost of certain cures, particularly those addressing complex cancers or gene therapy, can be staggering. Contrary to the assumption that these prices are solely justified by extensive research or component scarcity, Big Pharma employs a multifaceted process. They scrutinize a drug's societal value, contemplating factors such as reduced hospital visits, discontinued prescriptions, and gained quality years of life. However, the eventual price tag often appears inflated, with more emphasis on rhetoric than on a robust numerical foundation. #PharmaPricingAnalysis #MedicalCosts #DrugPricingStrategies #HealthcareEconomics #SocietalValueInMedicine #ShareEcard #AJBerman

DON’T MISS OUT—On April 30, our distinguished panel of industry experts will walk you through strategies for efficiently accelerating your drug development process. Topics include:  • selecting the optimal regulatory pathway to swiftly secure market access;  • successfully navigating pivotal stages in early clinical development;  • essential considerations for designing studies, defining laboratory endpoints, and adhering to regulatory guidelines in gene therapy development. Register now: https://lnkd.in/eZZwVM49 #Lifescience #DrugDevelopment #RegulatoryAffairs

Lizette Janse van Rensburg presents on how recently the manufacturing of Cell and Gene Therapeutics (CGT) has been a subject of discussion among various organizations. Although both CGT therapies have been in existence for several years, the key focus now lies in their advantages and widespread acceptance at a manufacturing scale. This is crucial to ensure that these technologies can be made accessible to a larger population. The flexibility of the industries involved will play a vital role in meeting the growing demand for these therapies. #ISPE #ISPEAseptic #aseptic #asepticprocessing #asepticfilling #annex1

🧬 Investigating genome integrity of viral vector preparations just got easier. Learn how QIAcuity brings precision to your analysis of AAV genome integrity and beyond. Get the details in our new application note, entitled "Analysis of DNA integrity and stability using digital PCR," which you can download in our dPCR gateway to cell and gene therapy. Find it here https://lnkd.in/ebPfPKA5

The European Medicines Agency (EMA) has updated its guidelines on advanced therapy medicinal products (ATMPs), emphasizing a collaborative approach with stakeholders. Key takeaways include: 🧬 Separation of guidelines for Gene Therapy Medicinal Products (GTMPs) and Cell Based Medicinal Products (CBMPs) was suggested but not implemented; 🧬 Updates on stage-appropriate CMC expectations to alleviate high validation demands; 🧬 Clarification on potency assay validation and process evaluation/validation for clinical trials. Check out the full article by Pam Dhadda, Associate Director at PharmaLex, for an in-depth analysis of the changes and their impact on ATMP development in Europe. Read more: https://lnkd.in/geBbj4_i #PharmaNews #ATMP #GeneTherapy #CellTherapy #PharmaLex #EMA

Discover strategies for overcoming the distinct obstacles associated with commercializing your cell and gene therapies (CGTs). Dive into our most recent blog post! https://gag.gl/NJNQ1Q and also explore the accompanying white paper accessible through our blog. #cellandgenetherepy #CGT #CMC #biopharma #drugdevelopment #regulatoryaffairs #pharma

Discover strategies for overcoming the distinct obstacles associated with launching your cell and gene therapies (CGTs). Explore our newest blog post! https://gag.gl/NJNQ1Q and also take a look at the accompanying white paper accessible through our blog. #cellandgenetherepy #CGT #CMC #biopharma #drugdevelopment #regulatoryaffairs #pharma

The European Medicines Agency (EMA) has updated its guidelines on advanced therapy medicinal products (ATMPs), emphasizing a collaborative approach with stakeholders. Key takeaways include: 🧬 Separation of guidelines for Gene Therapy Medicinal Products (GTMPs) and Cell Based Medicinal Products (CBMPs) was suggested but not implemented; 🧬 Updates on stage-appropriate CMC expectations to alleviate high validation demands; 🧬 Clarification on potency assay validation and process evaluation/validation for clinical trials. Check out the full article by Pam Dhadda, Associate Director at PharmaLex, for an in-depth analysis of the changes and their impact on ATMP development in Europe. Read more: https://lnkd.in/dDcaNFVE #PharmaNews #ATMP #GeneTherapy #CellTherapy #PharmaLex #EMA

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