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05.17.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare     State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions....

05.10.21 -- The Benefits Of A Functional Service Provider (FSP) Model In Uncertain Times     YPrime eCOA Platform — Isn’t it about time for a globally proven eCOA technology that gives you peace of mind? One that provides a better user experience for patients, sites, and sponsors? YPrime’s eCOA platform delivers even the most complex protocol seamlessly. Developed to integrate intelligently with your other technologies, all modalities are available for site- or home-based trials and paired with secure web backup for guaranteed accuracy and confident, ...

04.19.21 -- How To Navigate Compliance With FDA's 21 CFR Part 11   CUE Biopharma CEO Dan Passeri, JD joins the Business of Biotech to discuss the development of their Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares how the CUE-100 series of candidates in its pipeline are being developed to address a scourge of HPV-related head, neck, and other cancers. Listen now and subscribe so you never miss an episode. Featured Editorial By Kyle Neuman, SAFE Identity 21 CFR Part 11, the FDA's regulation on electronic records an...

03.15.21 -- The Asia-Pacific Region: A Hot Spot For Clinical Trials     Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.   Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!   By Mathini Ilancheran, Beroe Inc. The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of r...

03.08.21 -- Appili's CRO Selection Reflects Realities Of Clinical Studies In A Pandemic     Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.   Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!   By Ed Miseta, chief editor, Clinical Leader When Appili Therapeutics was ready to enter a Phase 3 trial for a COVID-19 t...