DDP 2010: Interactive Audience Panel & Polling: the Dollars and Sense of Drug Delivery – Facts, Figures and Trends that Impact Product Performance

Josef Bossart, PhD
Managing Director
BioNumbers LLC (Moderator)

Are we going for more difficult products, or are there more rookies in the game? The time for drug approval has significantly increased. DDEP has increased steadily over the years. The FDA is not the problem when it comes to approval times. The median average is about eleven months for FDA approval. If the data is poor, the FDA will send you back. The FDA is not the problem in drug delivery approvals. If you’re a drug development company, you should have 4-6 products in the pipeline in order to get one approved.

Many companies believe that $15 million to the MDA submission. There are $228 million dollars to get products developed in the early 1990s. Now that coast for DDEP is about $85 millions. The direct cost when risk is adjusted is $160 millions.

Key numbers:
Data Points – In a study of drug development, Bossart found that one in six Pharma products that start in the market get approved.

There are a total of 197 DDEP have been approved in the period of 2000-2009, an average of 20 per year. The top year for approvals was 2007 with 28 DDEP approved by the FDA.

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