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🌟 #Webinar This Thursday: Mastering Project Optimus in Oncology Drug Development Join us for a must-attend webinar on the FDA's Project Optimus and its implications for oncology drug development. 👉 Secure your spot: https://lnkd.in/eGhgEFSx Covering: 🔹 An introductory overview of Project Optimus 🔹 Its impact on oncology trials and drug development 🔹 Practical strategies for navigating the new regulatory framework The Experts: 🎙️ Giles Partington, Principal Statistician, Phastar 🎙️ Sam Hinsley, Principal Statistician, Phastar (Moderator) Don't miss out on this crucial opportunity to stay ahead in oncology drug development. Register today! #Oncology #DrugDevelopment #ProjectOptimus #FDA #ClinicalTrials #Webinar #Phastar

Elektrofi Signs a Collaboration and License Agreement with Janssen Biotech, Inc. to Develop Five Programs for Oncology #elektrofi #janssenbiotech #cancer #pharma #licenseagreement #collaboration #commercialization #research #collaboration #oncologyprograms #upfrontpayment #exclusiveright #regulatory #milestones #clinicaldevelopment

Thoughts on this? >> #ASCO24: Gilead presents more data on failed Trodelvy lung cancer study >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #biotech #pharma #productmarketing

To run a successful oncology development program under the FDA's Project Optimus, it's crucial to focus on identifying the optimal dose range for your asset. In our latest blog, James Matcham and Mike Fossler provide valuable insights into Project Optimus and discuss key factors that can enhance your chances of success. Read the full article: https://bit.ly/3W8e2Dc #FDAProjectOptimus #FDA #Oncology #oncologydevelopment #clinicaltrials #optimaldose #drugdevelopment #pharma #biotech

Thoughts on this? >> #ASCO24: Gilead presents more data on failed Trodelvy lung cancer study >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #productmarketing #biotech #pharmaceutical #healthcare

On Tuesday 25 June we will host a special webinar tailored for oncology applications. Reserve your spot today: https://lnkd.in/eu__ZVSK Formulators and developers face a significant challenge. During this webinar, we will evaluate stability data of several small molecule drugs for cancer. Degradation and instability in chemotherapeutics can lead to: - Extended development timelines - Regulatory challenges - Compromised product efficacy. This ultimately delays lifesaving treatments for those who need it most - the patients. We will show you how we can optimise oncological drug delivery resulting in long-term formulation stability, extended drug shelf life, and ultimately improved drug performance and efficacy.

Thoughts on this? >> #ESMO24: Sun, surprises and new summits at Europe’s biggest cancer conference >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #biotech #pharmaceutical #pharma #productmarketing

Thoughts on this? >> #ESMO24: Sun, surprises and new summits at Europe’s biggest cancer conference >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #pharmaceutical #healthcare #productmarketing

To effectively optimize drug dosage in early phase oncology, sponsors should plan for added operational load from increased data collection, assessments and strict turnaround time for assay work. In this Contract Pharma article, IQVIA Biotech’s VP of Immuno-Oncology & CAGT Erin Finot, MS, MBA discusses operational considerations for clinical trial stakeholders. Read the article to learn more. https://bit.ly/3X3qvIF #IQVIABiotech #clinicaltrials #oncology

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