Julie Tibbets’ Post

Data are abundant, quality is paramount: The FDA released new draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” – have you seen it? https://bit.ly/4bK6lYv #FDADraftGuidance #InVivoStudies #DataIntegrity

When the pharmaceutical industry comes together in the name of patients to share challenges, learnings, and solutions, progress like we’ve never known before is possible, probable and within our reach. Johnson & Johnson’s ongoing partnership with TransCelerate BioPharma Inc. – a non-profit organization comprised of pharmaceutical representatives from companies across the industry – is a key example of collaboration’s significant impact. Through TransCelerate, participating companies continue to make headway on a variety of topics, including real-world evidence, pharmacovigilance (PV) policy and more, with GMO colleagues – such as John van Stekelenborg – helping lead the way. As part of our TransCelerate commitment, John co-authored a research article focused on the complexity and challenges of Individual Case Safety Reports (ICSR) in drug safety, especially due to differing global reporting requirements and the many agreements between Marketing Authorization Holders (MAHs) and Health Authorities (HAs). The study, involving seven companies, reveals that ICSR information, including multiple versions of a single case, often gets replicated in differing formats across multiple recipients, leading to inefficiencies and potential variations in clinical assessments. The average number of recipients per ICSR case version is about three, with considerable variability in the specific HAs that receive these reports. The article proposes various solutions, such as a globally unified regulatory framework and advanced technology platforms, to improve the efficiency and reliability of ICSR reporting. Earlier this month at a TransCelerate-hosted webinar, John and his fellow authors presented these findings and participated in a robust panel discussion. They joined forces to discuss their findings and generate support to implement solutions. This important work supports our Office of the Chief Medical Officer’s commitment to identify proactive, research-backed solutions to advance patient safety science innovation, and we’re proud of cross-industry partnerships such as this, which puts patient safety first.   #drugsafety #MyCompany #JNJ

We are a week away from the World Orphan Drug Congress (WODC) in Boston. I look forward to seeing several of my current contacts and meeting some new ones. Stop by to see me and the Halloran team to learn about how we support clients developing products for rare and orphan diseases. Set up a meeting with us or visit us at Booth 424 #WODC2024 #regulatory #clinicaldevelopment #quality #compliance #programmanagement

Thrilled to have completed the Overview of Drug Safety course! 🚀📖 Equipped with insights to ensure the well-being of patients in the dynamic landscape of drug development. Ready to champion safety and efficacy! #DrugSafety #PharmaEducation #HealthcareLeadership #ContinuousLearning"

How to enhance regulatory acceptability of novel techniques to test medicines? Engage with regulators at an early stage. Read my interview for Oncode Accelerator https://lnkd.in/e3P-cbKd #regulatoryscience

Data submissions are highly regulated, and every #drug and drug development are different. To present #data in the Common Technical Document, #statisticians must consider appropriate data integration and pooling. Florence Le Maulf discusses presenting #clinical data for #regulatory submission from a stats perspective. Click to learn more 👉 https://bit.ly/455UeSO #CDISC #regulatoryaffairs #FDA #statistics

Harnessing real-world data for better regulatory decision-making! 💡📊 RWD and evidence are emerging as game-changers in drug development! #RealWorldData #RealWorldEvidence #RegulatoryDecisions #DrugDevelopment #BiologicalProducts #InnovationInHealthcare #EvidenceBasedMedicine #DataDrivenDecisions #SymmetricTraining

Regulatory agencies are reshaping manufacturing norms for #cellandgenetherapies. This paradigm shift allows for #GMP-like operations, offering scientists in discovery organizations newfound autonomy. By streamlining processes and enhancing success rates, this approach holds promise for accelerating clinical development. Robust #riskmitigation strategies and vigilant quality oversight are paramount, ensuring both #patientsafety and #regulatory adherence. Cross-functional collaboration and adaptive control strategies continue to serve as essential pillars in successfully addressing industry challenges. #BiotechRegulation #CellTherapies #GeneTherapies #GMPCompliance #ClinicalSupplies #RegulatoryAdaptation 

𝗪𝗵𝗮𝘁 𝗗𝗼 𝗬𝗼𝘂 𝗦𝗲𝗲 𝗔𝘀 𝗧𝗵𝗲 𝗠𝗼𝘀𝘁 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗢𝗿 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗢𝗻 𝗧𝗵𝗲 𝗛𝗼𝗿𝗶𝘇𝗼𝗻 𝗙𝗼𝗿 𝟮𝟬𝟮𝟰 (𝗢𝗿 𝗕𝗲𝘆𝗼𝗻𝗱)? Colin Grant, Director of Quality & Regulatory Affairs, shared key insights on evolving regulations in this recent Pharma's Almanac roundtable. Read more ➡️ https://bit.ly/48jf9mT #RegulatoryInsights #Bioprocessing

Industry collaboration is essential to solving challenges or overcoming obstacles within #pharmacovigilance. As part of the #JNJ partnership with TransCelerate BioPharma Inc., we are tackling these challenges across the R&D ecosystem. Earlier this month, one of my co-authors, Vijay Kara , and I presented during a webinar on the topic of the replication of Individual Case Safety Reports (ICSRs), based on a study published in Drug Safety. This study provides the first quantification of #ICSR replication across health authority and marketing authorization holder safety databases. Our research included safety data from seven TransCelerate member organizations, accounting for approximately 20% of all FDA Adverse Event Reporting System data. Our findings demonstrated that replication of ICSRs were substantial, resulting in duplicative work and potentially differing clinical assessments and decisions. We identified several opportunities and solutions to help reduce and potentially eliminate the phenomenon of ICSR replication in the healthcare industry to enable an increased focus on activities benefitting patient safety. We were also joined by pharmaceutical industry and health authority experts for an interactive and informative panel discussion about the broader industry impact of these findings. While there is more work to be done, I’m pleased to be part of the team at Johnson & Johnson  and TransCelerate driving change to help optimize and improve upon this critical aspect of #pharmacovigilance.      To learn more about the findings and hear insights from the panel discussion, tune in here: https://lnkd.in/eGtry6h3 You can also read more about the study published in Drug Safety here: https://lnkd.in/eT3XnJZz #drugsafety #MyCompany