Stem cells and other regenerative medicine products offer considerable benefits to patients as well as potential financial rewards for companies. At the same time, cell-based therapies present challenges to regulators because, in many cases, they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro with minimal to extensive manipulation, and then administering in some form the expanded (and possibly modified) cells population back into the patient.
Join BIOVIA for a complimentary lunch in Princeton, NJ (Nov 15) or Boston, MA (Nov 16) and learn how BIOVIA is helping pharma, biotech and agrochemical organizations execute on their cloud strategy to become more agile, lower total cost of ownership and collaborate more effectively.
Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.
The seminars will address multivariate data analysis and real-time process monitoring, where CAMO Software has over 35 years of experience.
Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.