Ann: Positive preclinical data for deoxymabs in vasculitis, page-54

What’s the average time to bring a drug to market?

According to industry group PhRMA, it takes 10-15 years on average to develop one new medicine from initial discovery through regulatory approval.

Other sources corroborate this number. Biotechnology Innovation Organization (BIO), another industry group, analyzed 9,704 clinical development programsover the course of a decade from January 2011 to November 2020. They found that, on average, it took 10.5 years for a drug to get from Phase I to regulatory approval.

Looking at individual stages of the process, the averages were 2.3 years for Phase I, 3.6 years for Phase II, 3.3 years for Phase III, and 1.3 years between Phase III and regulatory approval.

According to BIO, a drug’s disease area impacts how long it takes to get to market. While 10.5 years was the average for drugs across all disease areas, averages for specific areas ranged from 9.2 to 12.2 years. At the lower end were drugs focused on allergic, metabolic, and infectious diseases. Meanwhile, drugs focused on neurological, cardiovascular, and urologic diseases had the longest development timelines.”

It is probably reasonable to place a drug crossing the Blood Brain Barrier in the hope of treating a hitherto basically untreatable disease at the long end of this timetable.

This end of the market is only for patient risk takers who understand the huge rewards that come from the ludicrous levels of risk in this sector or the intelligent opportunist who has a bet at the last minute with fingers crossed.

If the sporadic issue had not occurred Dr. Campbell would have been ahead of the average going into Phase 1 now if this one is OK he will be about average.

My opinion only DYOR

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