Cell therapies aim to treat, prevent, or potentially cure diseases. They are a relatively new and evolving area, which presents both opportunities and complexities. When developing these types of drugs, biopharmaceutical companies often struggle with three key challenges:
- Dose optimization. Too low a dose might exclude that patient from any future benefit, while too high a dose can be very dangerous, since any immunogenic side effects may be irreversible and could last for years.
- Chemistry, manufacturing, and controls (CMC). Cell therapy programs require substantial time and effort in product development including developing a testing methodology, establishing process controls, defining critical steps, and, most importantly, understanding how the components of the final product can impact cellular kinetics, safety, and efficacy.
- Commercialization. Cell therapies pose pricing and market access challenges as payers wrestle with paying upfront for a lifetime of patient benefits.
Clinical pharmacology and pharmacometric modeling can be used to help simplify these complexities by identifying the key aspects that have most influence on the performance, safety, efficacy, and durability of the cell therapy.
By watching this webinar, you’ll learn how cell therapies are helping to address unmet medical needs, hear about a typical patient’s cell therapy journey, and understand how clinical pharmacology and pharmacometrics can be used to optimize and accelerate the development of these drugs.