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
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Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III) in our webinar Feb. 8. Secure your spot today: https://lnkd.in/e_pyYq8j #oncologytrials #eCOA #webinar #lifesciencesevents
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Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III) in our webinar Feb. 8. Secure your spot today: https://lnkd.in/ek7BT3jd #oncologytrials #eCOA #webinar #lifesciencesevents
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Join us on Feb. 8 when @Bill Byrom and @Anthony Todd Everhart will talk about recent updates to FDA guidances, practical applications of computerized adaptive tests (CATs), and leveraging PROs in early-phase oncology trials. Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III). Secure your spot today: https://lnkd.in/eMP5Xj-z #oncologytrials #eCOA #webinar #lifesciencesevents
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Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III) in our webinar Feb. 8. Secure your spot today: https://lnkd.in/gJVGzJJx #oncologytrials #eCOA #webinar #lifesciencesevents
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Many #oncology manufacturers might assume that a drug’s inclusion on pathways is more important than payer coverage—but both are critical. In BioPharma Dive, MMIT’s Carolyn Zele explores how #RWD can help #pharma companies fix policy/pathway misalignment. Read the article: https://ow.ly/JMqj50PZg2i. #BPDOncologyRWD
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Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III) in our webinar Feb. 8. Secure your spot today: https://lnkd.in/e2CZUWaJ #oncologytrials #eCOA #webinar #lifesciencesevents
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Engage with industry experts, explore use cases, and gain practical tips for implementing PROMs throughout #oncology drug development (from early phase to phase III) in our webinar Feb. 8. Secure your spot today: https://lnkd.in/eKA6Kr4Z #oncologytrials #eCOA #webinar #lifesciencesevents
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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
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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 :
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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 :
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