Christopher Kavlick, MBA’s Post

Check out our blog post on Understanding the Backbone: Drug Safety Databases and Leading Platforms https://wix.to/b2zeqJR #newblogpost

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

The US Food and Drug Administration ( FDA ) has approved a #manufacturing #process change resulting in a shorter #manufacturing time for Gilead Sciences Kite's #production of the Yescarta #CAR T-cell #therapy (#axicabtagene #ciloleucel). Find out more on Scientist Live - https://loom.ly/pWfS-ys Subscribe to our newsletter here - https://loom.ly/km0X6OM #science #sciencenews #scientificresearch

The US Food and Drug Administration ( FDA ) has approved a #manufacturing #process change resulting in a shorter #manufacturing time for Gilead Sciences Kite's #production of the Yescarta #CAR T-cell #therapy (#axicabtagene #ciloleucel). Find out more on Scientist Live - https://loom.ly/pWfS-ys Subscribe to our newsletter here - https://loom.ly/km0X6OM #science #sciencenews #scientificresearch

The final FDA guidance, entitled, ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’, reflects the agency’s current thinking about the use of real-world evidence in regulatory decision-making. Read at The Evidence Base® #realworldevidence #realworlddata #rwd #rwe #regulatoryaffairs #drugdevelopment

Brilliant breakdown into the FDA recommendations on supporting #regulatory decision making. This includes ensuring transparency in data collection, accessibility to #realworlddata and regular safety reporting. Are you considering all of these factors in your #realworldevidence study design?

Post-market drug safety surveillance is critical for discovering and addressing unforeseen adverse drug events. Problem: the quality and volume/velocity/variety of data from spontaneously reported systems create barriers to operational analytic pipelines. Learn how to use Dataiku to prepare data from the FDA Adverse Event Reporting System and more in this session | https://bit.ly/3MOBOix #DataQuality #DrugSatefy #Pharma

Ensuring raw material integrity is vital for drug quality and safety. A risk-based approach to testing and specification setting ensures regulatory compliance and protects patient health. Our latest blog, authored by Bryan Abney, explores critical aspects such as risk assessment, tailored impurity testing, adherence to pharmacopeial standards, and effective supplier quality agreements. Read the blog: https://bit.ly/44UL2kS #PharmaceuticalManufacturing #DrugDevelopment

Acknowledgment by authorities that changes may occur during establishment/validation activities is critical as long as they are critically evaluated for impact to product and other produced material. Get more information on Expedited Drug Development here: https://bit.ly/3Fctrsy

Sharing with my networks the recent document launched by FDA titled ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’. FDA is issuing this guidance as part of its RWE Program to satisfy, in part, the mandate under section 505F of the FD&C Act to issue guidance about the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support post-approval study requirements. How do you expect these tendencies to Brasil??