Stephanie Gallagher’s Post

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

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

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

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

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

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

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 Parexel colleagues, Sinan B. Sarac (MD, MSc, PhD) and Gwyn Bebb in our latest Regulatory Navigator blog. #CancerResearch #Immunotherapy #clinicaltrials #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 B. Sarac (MD, MSc, PhD) and Gwyn Bebb in our latest Regulatory Navigator blog. #CancerResearch #Immunotherapy #clinicaltrials #WithHeart

Roche's Tiragolumab is ending it's phase 3 SKYSCRAPER-06 clinical trial after showing reduced efficacy vs Merck's Keytruda. https://lnkd.in/gKMGVU9d Back in September, Roche introduced stricter criteria for drugs that would advance to phase 3 clinical trials after data from 2018-2022 showed Roche had a 58% success rate in phase 3 trials compared to a 76% success rate among their peers. https://lnkd.in/gwJ3YJY9 It will be interesting to see how Roche continues to discover and develop drugs with AI, and how the returns on investment look going forward. https://aiwithroche.ca

💡 Learn how Project Optimus is reshaping dose optimization in oncology drug development. During this webinar, our experts James Matcham and Mike Fossler will cover key regulatory updates and real-world case studies. 💡 Gain valuable insights to improve clinical trial design and stay ahead in this evolving space. Don’t miss out! 📅 Date: October 29 🕐 Time: 9 AM (ET) / 2 PM (CET) Register here 👉https://hubs.ly/Q02TpCSC0 #Oncology #DrugDevelopment #ClinicalTrials #ProjectOptimus #Pharma #Biotech