Syapse’s Post

Join Consilium for our first post-summer event on Thursday, 5th September! ❓ Do we need Phase 3 trials in oncology? 📅 Thursday 5th September, 5pm London Time 🎫 Sign up here: https://lnkd.in/djYW5eQu Waste in cancer research has been disappointing to many whilst allowing significant capitalisation for pharmaceutical industry. Many improvements have been made and many more are yet to come. How should cancer research evolve? How can we decrease the waste and ensure better selection of pre-clinical models moving to clinic? Will we need phase 3 trials and what role RWE evidence will play? Will synthetic comparators give answers clinical practice needs? How can we overcome current incentives in the oncology market and stop over-production of expensive me-toos? In conversation with Marty Tenenbaum, Julian Adams, Ian Tannock and Jonathan Kimmelman.

(Benefit-Risk Management / Multi-regional cancer studies / NEW Draft FDA Guidance) For your essential reading pile if you’re looking after oncology studies and particularly if recruitment is from several geographic areas; this would be an important guidance for you to read. But this being said, the principles of multi-regional study guidance provided by FDA is new so might be a good pickup anyway if you’re running a global study with patients from various countries (Easter egg - look for the special aspects of this guidance). Enjoy. #fda #CDER #drugs #CBER #biologics #cancerstudies #oncologystudies #clinicalresearch #clinicaltrials #clinicalresearch

Day 2 at #ESMO2024 It's amazing to witness firsthand how the oncology landscape has transformed in the last few years. The drug development pipeline in oncology is evolving at an unprecedented pace, driven by advancements in precision medicine, immuno-oncology, and AI-driven clinical trials. What’s fascinating is how we’ve moved from a one-size-fits-all approach to personalized therapies targeting specific mutations and pathways. Immunotherapies and CAR-T therapies are showing remarkable promise, offering hope where there once was none. Furthermore, the integration of real-world evidence (RWE) is playing a pivotal role in shaping decisions on safety, efficacy, and patient outcomes. The energy here is palpable, and I’m excited to continue networking with like-minded professionals who are passionate about making a difference in oncology. #OncologyInnovation #PrecisionMedicine #Immunotherapy #RealWorldEvidence #Pharma #DrugDevelopment #PatientCentricity

Breaking ground in Oncology: Europe's Next Chapter 🌍💡 In an unprecedented move, leading pharmaceutical giants are gearing up for a series of large-scale clinical trials in oncology across Europe. With innovative therapies on the horizon, the focus is sharpening on the critical role of staffing to ensure these trials succeed. Groundbreaking research promises not just hope, but real change. From targeted therapies to immunotherapies, these trials could redefine cancer treatment as we know it. As each phase demands precision and expert knowledge, the need for top-tier clinical researchers, data analysts, and medical professionals is at its peak. Europe stands at the forefront of this endeavour, and it's our shared mission to see it thrive. We're talking cutting-edge science meeting top talent to transform lives. Join the conversation - what's your take on Europe's potential to lead the next wave of oncology breakthroughs? #OncologyInnovation #ClinicalTrials #PharmaCareers #HRS #Science

We are thrilled to share the publication entitled "Evaluation of real-world tumor response derived from electronic health record data sources: A feasibility analysis in mNSCLC patients treated with chemotherapy”, published in JCO Clinical Cancer Informatics in collaboration with Friends of Cancer Research and other real-world data organizations. Read the manuscript here: bit.ly/3LGcdqS. This publication shares the findings from the latest pilot project in Friends’ Real-World Evidence Portfolio, which establishes methodology for using real-world data (RWD) to evaluate benefit for patients. 💡 The study explored the feasibility of using RWD from EHR to evaluate tumor response in patients with metastatic NSCLC treated with chemotherapy. 💡 Seven RWD partners, including Syapse, each analyzed data from 200 patients. We found that clinician-documented response data was the most available source data across datasets, with variability in the availability of imaging data. The study demonstrated the potential to use clinician-stated response to generate a consistent measure of rw-response across different #RWD sources. 📌 Further standardization and methodological development are needed to support drug effectiveness evaluations using RWD. 📌 The #RWE portfolio generates evidence for best practices for analyzing RWD to help support incorporation of RWE into oncology drug development and regulatory-decision making. Thank you to Thomas Brown, M.D., M.B.A. and Connor Sweetnam for your contributions to this study! #RWEFriends

🌟 Shining a Spotlight on Innovation: BeiGene’s Remarkable Achievements 🌟 Working onsite at BeiGene has given me a front-row seat to witness some of the most groundbreaking advancements in modern medicine. Their commitment to transforming cancer treatment with therapies like Baiyueze (zanubrutinib) and Baizean (tislelizumab) is nothing short of inspiring. • Baiyueze has become a global game changer, with its incredible success in treating B-cell malignancies and achieving phenomenal growth worldwide. • Baizean, a leading PD-1 inhibitor, continues to expand its reach, bringing hope to patients battling some of the toughest cancers. These achievements highlight BeiGene’s mission of delivering innovative, accessible, and affordable medicines to improve patient outcomes globally. It’s truly remarkable to see how their research, dedication, and innovation are reshaping the landscape of oncology. While I don’t work for BeiGene, I’m honored to work onsite at a facility that plays a role in such transformative efforts. Their impact on the healthcare industry inspires me to reflect on what we can all achieve when we push the boundaries of possibility. What innovative efforts in your field inspire you the most? Let’s celebrate these breakthroughs together. #BeiGene #Baiyueze #Baizean #InnovationInHealthcare #CancerResearch #OncologyLeadership #GlobalImpact #MedicalInnovation #LifeSciences #Pharmaceuticals #PurposeDrivenWork

Learn from Lydia King, PhD, MPH, Director, Biostatistics, Catalyst Oncology, and Craig McIlloney, Senior Vice President, Catalyst Flex, as they discuss the significance of pharmacokinetic (PK) data in advancing oncology therapeutics. Watch our video to discover how Catalyst Oncology's comprehensive PK services can be tailored to your specific needs. #Pharmacokinetics #CancerResearch #Oncology https://lnkd.in/gQ54z2d5

Catalyst Oncology now offers PK analysis services in-house, which is particularly helpful in the context of Project Optimus. Watch this video to learn more about the importance of PK in early oncology development...

FDA ODAC Vote Today: Implications and Insights Watch Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she quickly breaks down the upcoming FDA Oncologic Drugs Advisory Committee (ODAC) vote and its potential impact on drug development. Key points covered: • Background on today's ODAC vote on AstraZeneca's lung cancer trial • FDA's concerns about trial design and patient over-treatment • Implications for future perioperative trials in oncology Dr. Singh’s insights: • The importance of trial design in proving treatment efficacy • How this vote could affect drug developers across multiple cancer types • Potential changes in FDA requirements for perioperative trials See what this could mean for patients, providers, and the future of cancer drug development. 💬 What are your thoughts on the FDA's stance? How might this impact your work in oncology drug development? Follow Dr. Singh for more FDA insights and expert analysis. #fdainsights #OncologyTrials #DrugDevelopment #ClinicalTrialDesign

Did you know less than 10% of cancer drugs that are tested in clinical trials end up being approved? That is just one out of 10, meaning pharmaceutical companies need to spend nearly $3bn to get that single success case. The need for faster and more effective trials has never been stronger — and recent advancements in artificial intelligence have the potential to help change cancer drug discovery and development forever. Using AI can help accelerate the rate at which clinical trials are carried out, which could be a game-changer for cancer research and a crucial example of how AI drives real-world impact. We’ve collaborated with BBC StoryWorks Commercial Productions and the Union for International Cancer Control (UICC) to show how our colleagues are helping our clients unlock insights with AI that could potentially improve cancer diagnosis, treatment, identification of risk factors, prediction of disease progression, and personalization of treatment plans. Read the full article to learn more. 👉 https://lnkd.in/eaGj5MyB #AIbyMcKinsey #Healthcare #ArtificialIntelligence #RewritingCancer