The development cost and time for a single protein based therapeutic, from Discovery through FDA submission, is enormous and continues to climb. The cost for this entire process, including both out-of-pocket and capitalization costs, is over $2 billion. For the Discovery and Pre-Clinical stages alone, the average out-of-pocket cost exceeds $400 million. When capitalization costs are included, the total balloons to over $1 billion.
The timeline required for the entire Discovery through FDA submission is also daunting. Ten to 15 years, on average, is the amount of time spent on the development of a single protein product. Nearly half of this time is spent on the Discovery and Pre-Clinical stages.
The biopharma industry is always looking at ways to reduce these costs and timelines, with approaches such as artificial intelligence now being utilized to maximize information gained from both research data and clinical trial data. However, this does not provide a solution for reducing the ever-climbing costs and timelines.
ProteoNova has developed the AcPET system, a platform technology that has the power to address both the increasing cost and increasing timeline for the Discovery and Pre-Clinical stages of new product development. This transformative technology will be able to reduce the out-of-pocket cost to just a few million dollars for each drug candidate, and reduce the timeline to a few weeks. Further, since the AcPET system can produce protein product candidates for virtually any purpose, including in such high market arenas as therapeutics and diagnostics, this will allow a significant increase in the number of drug products that biopharmas are able to develop at any one time.