Featured Story | By Ben Adams A major global pandemic was not enough to stop surging rates of biopharma research and development, but trial productivity still remains below the long-term average. read more |
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Top Stories By Annalee Armstrong CytoDyn President and CEO Nader Pourhassan begged his investors to stop trashing the FDA after the agency issued a rare public rebuke over the company’s public statements on a pair of failed COVID-19 clinical trials. “You can throw all kinds of eggs and tomatoes, whatever you like, at me. I deserve it,” Pourhassen said. “But please don’t do that to the regulatory agency.” read more By Nick Paul Taylor Gary Romano, M.D., Ph.D., has left gene therapy startup Passage Bio with immediate effect. The biotech and its chief medical officer “mutually agreed” they should part company Tuesday, and Romano left the same day. read more By Kyle LaHucik Novartis Institutes for Biomedical Research is bleeding leaders as a third in as many weeks exits the door to lead Tevard Biosciences into the clinic. read more By Annalee Armstrong Two weeks after Sarepta reported a new safety concern in a Duchenne muscular dystrophy clinical trial, the company says another gene therapy candidate has shown some early success and will be brought to the FDA for permission to kick off further testing. read more By Nick Paul Taylor A phase 2 clinical trial of BerGenBio’s bemcentinib in hospitalized COVID-19 patients has missed its primary endpoint. The AXL inhibitor failed to accelerate time to sustained clinical improvement over standard of care, but BerGenBio identified a subgroup analysis of a secondary endpoint as a reason to continue development. read more By Ben Adams Cancer trials saw the most disruption in early summer of last year amid the first wave of the pandemic but were swift to get back on course. read more |  | LabConnect is the leader in innovative central laboratory services for cell and gene therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. |
Resources Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. 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: 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. | 
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