| | Working on an early phase oncology trial? Your trial design can make or break it. Targeted therapies are a cornerstone of precision medicine and how you design your trial is a critical factor. Download our guide to stay on the path to success. |
Regeneron's Praluent sidekick nabs speedy FDA review, with February PDUFA date Researchers call out Gilead over diversity of remdesivir trials Roche offloads clinical-phase cancer drug to Celleron F2G raises $61M for late-phase antifungal R&D Life science incubator Paragon Biosciences grabs new CEO for investment arm Alphabet’s Verily opens own lab to speed up COVID testing How a protein implicated in Alzheimer’s could enhance cancer immunotherapy Featured Story | By Ben Adams Regeneron has taken a step closer to getting a green light for its experimental high cholesterol drug as the FDA allows a swift review of evicanumab. read more |
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| | CROs rely on data analytics to provide sponsors with continuous clinical insight of trends that could predict safety, and more importantly, efficacy for investigational products. Learn more about strategies for data analytics and evaluation from our free white paper. |
Top Stories By Nick Paul Taylor Researchers have called for sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an analysis of Gilead’s remdesivir clinical trials that found the studies “failed to provide equal representation of Black, Latinx and Native Americans.” read more By Nick Paul Taylor Roche has offloaded its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics. The licensing deal comes almost two years after Roche dropped the tumor microenvironment modulator after putting it through a clutch of early-phase studies in solid tumor patients. read more By Nick Paul Taylor F2G has raised $60.8 million to fund late-phase clinical development of its antifungal agent olorofim and prepare for commercialization. The Cowen Healthcare Investments-led round comes four years after F2G raised a similar sum to take the dihydroorotate dehydrogenase inhibitor into phase 2b. read more By Ben Adams Biotech, digital health and medtech incubator Paragon Biosciences has hired Kerensa Jimenez as the new CEO of its capital markets group Paragon Health Capital (PHC). read more By Ben Adams The buzzy life sciences company Verily is looking to speed up COVID testing with a new lab based at its native South San Francisco. read more By Angus Liu Variants of TREM2, a receptor expressed by immune cells, have been linked to the development of Alzheimer’s disease. Now scientists at Washington University School of Medicine have demonstrated that targeting the protein could be a potential new way to enhance the power of immuno-oncology drugs. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, High Quality, GMP) manufacture for pre-clinical to commercial supply. Now part of the Cognate BioServices family, Cobra has rebranded – look around our updated website. |
Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. | 