TriNetX’s Post

Join WI's Britta Jacobsen, PhD, for a fascinating session on the FDA's Oncology Center of Excellence Real-Time Oncology Review (RTOR) with experts from industry and the FDA. Need insights into process, best practices, and how RTOR can impact global submission planning? This session is for you. #DIA2024 #WeSpeakScience #medicalwriting

Join WI's Britta Jacobsen, PhD, for a fascinating session on the FDA's Oncology Center of Excellence Real-Time Oncology Review (RTOR) with experts from industry and the FDA. Need insights into process, best practices, and how RTOR can impact global submission planning? This session is for you. #DIA2024 #WeSpeakScience #medicalwriting

$GNPX The spin-out, if completed as presently contemplated, would result in NewCo focusing on developing GPX-002, while Genprex would retain its oncology clinical development programs & other oncology pipeline assets. #WednesdayWisdom @genprex @SCStocks https://lnkd.in/gDpSuzY8

Starting January 2025, the European Union’s Joint Clinical Assessment (JCA) is set to transform the market access landscape for oncology and advanced therapy medicinal products (ATMP). At Putnam, we’re ready to guide you through these changes with tailored strategies that ensure your success. With our strategic planning, market access roadmaps, and patient-centered outcomes expertise, your product will be positioned for success. Connect with us to learn more about how our JCA offerings can help you thrive in this evolving landscape: https://lnkd.in/eS55xEbc #JCA #MarketAccess #Oncology #RegulatoryStrategy

Register for “The New Era of Project Optimus: Implications for Oncology Development Strategy” webinar! Use the link below and join us at 1:00 p.m. (Eastern) today to hear from oncology drug development experts discussing examples and case studies of what has changed in the Project Optimus era, uncovering lessons learned, best practices, and exploring the changing regulatory landscape. If you aren't able to attend live, register to watch the replay! https://hubs.li/Q02R1THX0... #Webinar #Oncology #DrugDevelopment #ProjectOptimus

In collaboration with Nigel Rawson, Pharmalytics Group is excited to share a new study publication.    This study found that among oncology drug assessments submitted to CADTH in 2020-2022, a condition of price reduction was recommended by CADTH for the majority of submissions, despite a clear clinical benefit. CADTH recommended price reductions of ≥70% off the list price in these submissions. Where CADTH recommended price reductions were ≥90%, pCPA negotiation times were notably longer.   To learn more about this work and our HTA services, please contact Chak Balijepalli.   #HTA #oncology #drugpricing #pharmalyticsgroup

The oncology community has embraced pan-tumor products with enthusiasm, signaling that this #precisionmedicine approach is likely to transform the oncology treatment landscape for the next decade. However, pan-tumor strategies prioritize overarching asset strengths vs. the unique considerations potentially required in individual therapy areas, like addressing unique unmet needs, treatment approach and HCP concerns. #Pharma has to find the right balance between pan-tumor and tumor-specific approaches to maximize commercial success for pan-tumor products. #pharma

Use Real-World Data to Optimize Design of Your Oncology Clinical Trials Join IQVIA as Sergio Sanchez-Gambetta uncovers how using more precise sub-population estimations to design your oncology clinical trial can lead to shorter recruitment times and avoidance of costly amendments. Register now: https://ow.ly/Qz2T50Rsqcx

In this edition of the New Medicines, Novel Insights newsletter, Martin Roessner, Corporate VP of Biostatistics at Parexel, discusses the potential for oncology trial acceleration through the implementation of flexible trial designs and master protocols. Learn how deviations from traditional approaches can increase efficiencies as Martin reviews key trial considerations, the case for real-world data (RWD), best practices, and potential use cases. Read the full article and subscribe to get the latest #NovelInsights each week! #Oncology #ClinicalInnovation #InnovativeTrial #RWD

In this video series with Applied Clinical Trials Magazine editor Andy Studna, Parexel's Mwango Kashoki shares her reaction to the FDA's new guidance on conducting multiregional clinical trials in oncology. The guidance requires companies to proactively plan trials to ensure data applicability to the US population ─ considering factors like patient characteristics ─ to improve patient access and ensure broader representation. Did you read the FDA's guidance? Let me know what you think! #regulatory #oncology #clinicaltrials #fda