Canopy Life Sciences’ Post

Looking to reduce the high cost of clinical trials? Try using real-world data that has a direct correlation to reducing the number of amendments to your trial data and therefore reduced cost!! #realworlddata #rwd #oncologyresearch

How has the new FDA guidance on #ProjectOptimus impacted #clinicaltrials in our industry? Our Chief Development Officer, Gilles Gallant, BPharm PhD FOPQ will be joining industry experts for an insightful webinar discussion on the transformative impact of Project Optimus on early-phase #oncology drug development. Register for the event and learn more, here: https://bit.ly/4e1uFX1 

Are you handling the increased complexity of oncology forecasts? The oncology space is constantly evolving and, as a result, so are your forecasts. Greater efficacy – with improved disease progression – and greater control of a product’s use across different lines of therapy are just two examples of current complexities of forecasting in the oncology space. The question is: are you accounting for them in your forecasts? Read more about these new complexities here: https://lnkd.in/etM8tddP Editor: Sam Johnson, director of research and development #pharma #oncology #forecasting 

Real-world data (RWD) has the potential to transform oncology trials by accelerating drug development timelines, reducing costs, and ultimately improving patient care. Yet, its adoption remains limited in oncology research. In a compelling discussion, COTA CEO Miruna Sasu and Paul Simms delve into this issue, highlighting the challenges of messy data and how companies like COTA clean and curate it. They share real-world scenarios demonstrating how RWD can streamline drug development processes. By embracing RWD, the pharma industry can make significant strides in delivering innovative treatments faster and more efficiently. Watch the clip to learn more about the untapped potential of RWD in oncology. #ImpatientHealth #RWD #RealWorldData #OncologyResearch #Pharma Real-world data (RWD) has the potential to transform clinical trials by accelerating drug development timelines, reducing costs, and ultimately improving patient care. Yet, its adoption remains limited in many therapeutic areas specifically in psychiatry, oncology, and rare disease research. In a compelling discussion, COTA CEO Miruna Sasu and Paul Simms delve into this issue, highlighting the challenges of messy data and how companies like COTA clean and curate it. Would highly recommend watching the clip to learn more about the untapped potential of RWD. #ImpatientHealth #RWD #RealWorldData #OncologyResearch #Pharma

Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to adaptive trial design to aligning your trial with investment priorities, and much more. 🎉 Here are some of the top topics covered this year: https://bit.ly/478MP5m 👏 A big thank you to all of the authors represented in these posts: Ulrika Andersson, Ari Brettman (Blackstone Life Sciences), Bodil Fornstedt Wallin, Mike Fossler, Martin Frenzel, Bengt Hedin, Åsa Holmgren, James Matcham, Natalia Mühlemann, and Ann-Kristin Spiik! 👏 #pharma #phamaceuticalindustry #biotech #regulatoryaffairs #Phase1 #clinicaldevelopment #pharmacology #adaptivetrials #oncology #earlphasetrials #ESMO #immunotherapy #Bayesian #realworldevidence #RWE #CMC #patients

The FDA’s Project Optimus is revolutionizing early oncology trials, aiming to improve patient quality of life through increased drug effectiveness and safety. The increased data requirements have displayed benefits for both the patient and sponsor; however, they incur additional costs and time. In 2022 and 2023, increased dose-optimization requirements, inflation, and high interest rates posed significant challenges to the biotechs that play a critical role in precision oncology. From 2010 to 2020, such companies originated 46% of first-in-class cancer drug approvals. Parexel experts have identified three strategies to help sponsors overcome regulatory challenges in achieving dose-optimization requirements within their business constraints: Here’s what we know works:  1️⃣ Design an integrated first-in-human study  2️⃣ Reach agreement with FDA at each step  3️⃣ Challenge guidelines with a compelling rationale Read the full article and explore more #NovelInsights from our latest report on advancing precision oncology: https://lnkd.in/gm_wX_5y #ParexelBiotech #PrecisionOncology #Regulatory

We know real-world data can accelerate drug development timelines, reduce costs, and ultimately improve care for patients - but why do we use it so sparingly in oncology trials? Watch this clip of COTA CEO Miruna Sasu and Paul Simms discussing this very issue. They cover the messy factor, how companies like COTA clean and curate data, and real scenarios where you can use RWD to reduce the time and cost to develop new drugs. Impatient Health #rwd #realworlddata #oncologyresearch #pharma

The FDA has released draft guidance on generating clinical evidence from oncology multiregional clinical trials (MRCTs), emphasizing the importance of diverse patient populations and U.S. representation in global trials. Key takeaways: ✅ Single-country or single-region data no longer sufficient to support a marketing application ✅ Increased focus on U.S. population representation ✅ Emphasis on diverse study sites ✅ Comprehensive evaluation of regional differences Want to know how this affects your oncology clinical trials? Read our latest Regulatory Navigator blog post for a deep dive into the new guidance and its implications for oncology drug development. #ClinicalTrials #Oncology #FDA #WithHeart Mwango Kashoki MD MPH Sinan B. Sarac (MD, MSc, PhD)

The the US FDA has just released a new draft guidance on multi-regional clinical trials and how to ensure their representativeness to the US population.   Key takeaways: ✅ Single-country or single-region data no longer sufficient to support a marketing application ✅ Increased focus on U.S. population representation ✅ Emphasis on diverse study sites ✅ Comprehensive evaluation of regional differences Want to know how this affects your oncology clinical trials? Read the below Parexel Regulatory Navigator Blog post from my colleagues Mwango Kashoki MD MPH and Sinan B. Sarac (MD, MSc, PhD) for a deep dive into the new guidance and its implications for oncology drug development. #ClinicalTrials #Oncology #FDA #WithHeart

An FDA advisory committee recommends against PD-1 inhibitors as first-line treatment for ESCC patients with low/negative PD-L1 expression. This represents a clear policy shift from the FDA, moving away from broader approvals towards more targeted indications based on biomarker status. Drug developers should anticipate this trend and plan their clinical development and regulatory strategies accordingly, focusing on identifying and validating predictive biomarkers that can guide patient selection and optimize treatment outcomes. Find out more from my colleagues Sinan Sarac and Gwyn Bebb in our latest Regulatory Navigator blog. #CancerResearch #Immunotherapy #clinicaltrials #WithHeart