Previous post edits with the correct YouTube video: The Early Development Estimand Nexus (EDEN) from the Estimands in Oncology WG shares in this fourth short video of the series how to implement the ICH-E9 addendum and which opportunities it presents in early clinical development studies (see the first comment if you missed the previous videos). Francois Mercier and Stefan Englert explain in this video why it’s beneficial to embrace the estimand thinking in early clinical development and how to define estimands and associated estimators in this setting of Phase 1a (dose-escalation) and Phase 1b (expansion cohorts) studies. Keep an eye on EFSPI (European Federation of Statisticians in the Pharmaceutical Industry), PSI: Statisticians in the Pharmaceutical Industry and ASA Biopharmaceutical Section as they will be posting the next videos soon! #collaboration #oncoestimand https://lnkd.in/g6bSJAvq
ASA Biopharmaceutical Section’s Post
More Relevant Posts
-
Early/Late Phase and Regulatory Strategy, RWE & RWD, Market Access, Logistics at Parexel Biotech
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
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers :: Parexel
share.parexel.social
-
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
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers :: Parexel
share.parexel.social
-
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
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers :: Parexel
share.parexel.social
-
Supporting my Clients on Regulatory CMC from Clinical Development Through to Licensing, Thereby Ensuring Patient Access to Valuable Biological Medicines.
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
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development :: Parexel
share.parexel.social
-
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
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers :: Parexel
share.parexel.social
-
Vice President (Global leader) Integrated Solutions Strategy, DEI Leader, Co-Lead of Global Disability Steering Committee, Professor (h.c.), Entrepreneur in Residence, GlobalScot, Speaker and Board member.
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
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers :: Parexel
share.parexel.social
-
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)
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development :: Parexel
share.parexel.social
-
💡 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
-
-
Business Development Manager @ Parexel | Sales Target Management | French, Spanish, English speaker
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 #ParexelBiotech
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development :
share.parexel.social