EntityRisk的动态

?????? ???????????????????????? ???????????????????? ???????????????????? ???? ????????! In 1998, the approval of Herceptin marked a pivotal moment in the life sciences industry, ushering in the era of personalized medicine. By leveraging molecular diagnostics, Herceptin ensured that only those who could benefit received treatment. Fast forward to today, and the integration of companion diagnostics and ?????????????????? ???????????????? ?????????????? (??????)? assessments is transforming patient care. For life sciences organizations, this revolution means rethinking strategies to accelerate product introductions and enhance manufacturing processes. Embracing real-time data capture and operational analysis tools is essential for compliance and efficiency. Christian Berg ???????? ???????????????? ?????????????????? ?????????????????? ????????????????????, Emerson? ?? ???????? ???????? ?????????? ?????? ???????????????????????? ?????? ?????? ???????? ????????????????: https://lnkd.in/gYthPzTf ?????????? ???????????? ?????????? ????????: https://lnkd.in/dxkGndFf #personalizedhealthcare #lifesciences #innovation #healthcarerevolution #moleculardiagnostics #mrd #biotech #pharmaceuticals #healthcaretechnology #genomics #targetedtherapies #datadriven #gmp #manufacturing #patientcare

?? The Hidden Costs of Clinical Trial Decision-Making ?? An insightful article by our very own Zoran Antonijevic, VP of Statistical Consulting at Bioforum, has been published in Pharmaphorum! In this thought-provoking piece, Zoran delves into the risks and hidden costs of focusing excessive R&D resources on a single drug. He emphasizes the critical need for smarter clinical trial-level decision-making to optimize resources and drive better outcomes in drug development. ?? Read the full article here: https://lnkd.in/dtppGRM7 ?? For more insights, expert perspectives, and solutions in clinical research, visit our website: www.bioforumgroup.com #ClinicalTrials #DrugDevelopment #Biostatistics #RD #Bioforum #ThoughtLeadership #Pharmaphorum

Is behavioural science the answer to fully understanding patient priorities? Find out more about patient-focused drug development here https://bit.ly/3YkZLVg in The Pharma Letter from behavioural science advocate William Hind from Alpharmaxim and SSI Strategy's Lisa Campbell. #behaviouralscience #PatientPriorities #PatientCentricity #LifeSciences #Healthcare ?

?? Exciting Update! ?? I'm thrilled to share that I recently wrapped up an incredible journey in "Pharmacogenomics in Drug Safety - Basics," offered by VigiServe Foundation! And guess what? I scored a perfect 100% on the final assessment! ??? ?? Key Takeaways: ?? What is Pharmacogenomics? It’s all about understanding how our unique genetic makeup can impact our response to medications. ?? Imagine a world where your genes guide your treatment—fascinating, right? ?? Why does it matter? By leveraging pharmacogenomics, healthcare providers can personalize treatment: they can select the right drugs, tailor dosages, and monitor responses more effectively. This means better safety, fewer side effects, and optimized outcomes for each patient. ?? The Future of Medicine: Pharmacogenomics is paving the way for precision medicine, transforming how we approach treatment and putting patient safety at the forefront. I can’t wait to apply these insights to help make healthcare safer and more personalized! ???? Here’s to a future where treatments are as unique as our DNA! #Pharmacogenomics #DrugSafety #PrecisionMedicine #VigiServeFoundation #LearningNeverStops #LatePost #100Percent

???????????????????????? ?????? ?????? ?????????????????????? ???? ????????-?????????? ???????? ???? ???????? ?????????????? ???????????? In the pursuit of combating rare diseases, ????????-?????????? ???????????????? (??????) studies are revolutionizing the #clinicaltrial landscape. Unlike the controlled settings of ???????????????????? ???????????????? ???????????? (????????), ????????-?????????? ???????? (??????) provides invaluable insights into the effectiveness of ?????????????????????????????? ?????????????????? ???????????????? (????????) in diverse, real-world scenarios. RWD is integral to decentralized trial approaches, offering a unique perspective on patient outcomes and treatment effectiveness across varied populations. This data reveals how IMPs interact with other #medications, an aspect often overlooked in traditional trials. In this insightful article, Karen Ooms delves into the applications and limitations of RWD in #genetherapy trials, shedding light on its transformative potential and inherent challenges. ?? ???????? ?????? ???????? ?????????????? ????????: https://lnkd.in/eeVUYv5X #GeneTherapy #RealWorldData #RWE #ClinicalTrials #KarenOoms #HealthcareInnovation #RareDiseases #MedicalResearch #Biotech #Pharma #PatientOutcomes

Efficacy and Effectiveness are different terms. Especially in Clinical Research / Medical Statistics. In well controlled Randomized Controlled Trials we may get efficacy using the same formula as we would use to get the Effectiveness in the RWE (Real World Evidence) post marketing Research (eg. 1-RR as i discussed in one of my previous posts). But, the variable structures are different and the Efficacy and Effectiveness would even be interpreted with differences. The Efficacy from an RCT would yield more accurate and controlled results for a specific population studied. Effectiveness would cover a more realistic scenario, wider population, often with better coverage of specific subgroups, but would be more prone to bias originating from both known and unknown (latent variables). The best evidence base is created when combining both approaches to make regulatory, research decisions. This is one of the reasons why both Clinical trials such as phase III RCTs and post marketing evaluation as RWE are needed for best decisions in Pharma industry and Clinical Research frameworks. #biostatistics #datascience #research #clinicaltrials #rct #rwe #hta #stats #pharma #biotech

?? ALS Research Hits a Bump: AbbVie & Denali Therapeutics's Trials Fail ?? Tough news from the ALS research world: Both fosigotifator (AbbVie/Calico) and DNL343 (Denali) didn't slow disease progression in the HEALEY trial. ???? Quick Takeaways: -No Significant Progress: Neither drug met primary goals after 24 weeks. -Stock Drop: Denali's shares fell 7% to $18.40. -Silver Lining: Some potential benefits at high doses noted; more data analysis coming. Looking Ahead: -Denali to delve deeper into data for next steps. -The ALS community's push for rapid results underscores the urgency. The fight against ALS isn't over; it's just more challenging. #ALSTreatment #Biotech #HealthInnovation #ClinicalTrialSetback

Last week, I collaborated with my esteemed colleagues Ofra Barnett, Adri Erasmus, and Amanda Cross to deliver a webinar on ISS/ISE projects at Bioforum the Data Masters. These documents offer a comprehensive perspective on the safety and efficacy of medicinal products and are very important for submissions in all ICH regions, not just the USA. If you missed the webinar, you can catch up by viewing the recording through the following link: https://lnkd.in/dXM_ZDFD #drugsafety #drugefficacy #statistics #analyses #FDA #CRO #webinar #knowledgesharing #submissions #projectmanagement #medicalwriting #reports #data #dataset

?? ?? Is PubMed Leading You Down a Rabbit Hole? ?? ?? If you're in drug development, you undoubtedly rely on PubMed or similar services. However, the overwhelming amount of data can make it challenging to extract real insights. How can researchers test the actionability of the data in PubMed? There’s a critical need to compare and contrast research findings with real-world results. Imagine identifying a potential target on PubMed and instantly comparing that finding against every approved drug label, clinical trial, and safety data. You might discover that a drug based on the target in question failed a phase III trial, uncover a detailed mechanism of action for a similar target, or find a side effect profile suggesting a possible label expansion. This process could be the deciding factor between pursuing further development or redirecting resources. Basil Systems delivers these comparative insights today. We equip drug development leaders with the tools to make informed decisions, driving innovation and efficiency. If you are interested in learning more, please reach out.

Is behavioural science the answer to fully understanding patient priorities? Find out more about patient-focused drug development in The Pharma Letter from behavioural science advocate William Hind (Alpharmaxim) and SSI Strategy's Lisa Campbell. https://bit.ly/3YkZLVg #behaviouralscience #PatientPriorities #PatientCentricity #LifeSciences #Healthcare