Wednesday, December 23, 2020 Daily Archives

eBook: Biomarkers — Improving Clinical Studies to Enhance Commercial Success for Biologics

The biopharmaceutical industry continues to invest heavily in technologies for identification of predictive biomarkers. Drug developers want not only to find quantitative evidence that their therapies will work as designed, but also to anticipate which patient populations will respond positively to those regimens. Doing that could streamline clinical trials, accelerate approvals, and ultimately improve patient outcomes. Advances in next-generation sequencing and increases in computational capability now are facilitating biomarker inquiries, especially in the realm of immunooncology. However, predictive biomarkers remain…

LucasPye harnessing strategic partners to bring down CDMO costs

Strategic vendor partnership, lean manufacturing, and cloud-based process control systems will help drive down the cost of making biotherapeutics, says Philadelphia-based CDMO LucasPye Bio. Count the number of contract development and manufacturing organizations (CDMOs) in the US capable of making GMP viral vector products and you get seven, according to Tia Lyles-Williams. They are Lonza, Thermo Fisher, Catalent, Emergent, KBI Biopharma, Fujifilm Diosynth Biotechnologies (FDB), and Lyles-Williams’s own company LucasPye Bio. Meanwhile, only the Emergent, KBI, FDB, and LucasPye have…