Industry News, Oncology, RWE Study

Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–2020

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Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov and George D. DemetriDOI: 10.1158/1078-0432.CCR-21-2639 Article Figures & Data Info & Metrics  PDF Abstract Real-world evidence (RWE) has garnered great interest to support registration of new therapies and label expansions by the United States Food and Drug Administration (FDA). Currently, practical insights on the design and analysis of regulatory-grade RWE are…

Collaborations, Partner and Collaborator News, Product Updates

Gilead and AWS Collaborate on Development and Delivery of New Medicines for Patients

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With AWS as its preferred cloud provider, Gilead uses AWS machine learning and analytics to better inform clinical trial design and advance data-driven decision making, while prioritizing patient privacy and security Gilead also transforms its enterprise resource planning workloads on AWS to implement SAP S/4HANA across its global business November…

Ethics, Industry News, Internal

Data in healthcare: regulation, commercialization and trust

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Ethical AI To listen to podcast, visit: https://podcasts.apple.com/gb/podcast/data-in-healthcare-regulation-commercialisation-and/id1569063462?i=1000541475903 This week, Elina is joined by James Kugler, Chief Digital Officer of Merck. James received his Bachelor of Science in Biomedical Engineering from Washington University in St. Louis, USA. A passionate bioinformaticist / computer scientist, he has pursued several research activities at…

Government/Regulatory, Industry News, International, Middle East, Oncology

Department of Health – Abu Dhabi and Roche collaborate to provide preventive and treatment innovations

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Source: http://wam.ae/en/details/1395302997705 A declaration of collaboration between both entities was signed by Dr. Jamal Al Kaabi, Undersecretary of the Department of Health – Abu Dhabi, and Dr. Mohamed ElShaarawy, General Manager, UAE Roche Pharmaceuticals, in the presence of Abdulla bin Mohamed Al Hamed, Chairman of the Department of Health –…

China, Government/Regulatory, Industry News, International, Oncology

Real-World Data for Healthcare Research in China: Call for Actions

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Highlights Many new data sources have emerged in response to the increasing demand for real-world evidence to support healthcare decisionmaking in China. Nevertheless, public information regarding these data sources is limited. The existing healthcare real-world data sources have not been systematically evaluated for the purposes of epidemiology, health economics, and…

HR, Oncology, Pharma

Senior Director, Real-World Evidence (RWE)- Virology Product Lead

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Senior Director, Real-World Evidence (RWE)- Virology Product LeadUnited States – California – Foster CityUnited States – District of Columbia – WashingtonUnited States – New Jersey – Morris PlainsUnited States – North Carolina – RaleighUnited States – Washington – Seattle Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops…

AI, Fundraising/IPO, Oncology

Medical AI Provider Lunit Raises $61M in Funding Round Led By Major Global Healthcare Investors

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– New investors include US life science investors HealthQuest Capital, Casdin Capital, and American Cancer Society BrightEdge, and Asia-based global healthcare investors Tybourne Capital Management and NSG Ventures – Following the most recent strategic investment of $26 million from Guardant Health, the company has now secured more than $135 million in total ahead of…