Education Resources

Market Needs

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved.

DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. US FDA approvals in 2008 totalled 21 NMEs and 3 biologic licence applications (BLAs). More >>

Toxicogenomics Challenges

Next to drug efficacy, drug toxicity has been highlighted as the main reason for candidate molecule failure in drug development. The crucial need to focus on toxicity was highlighted in a, now often-cited, US FDA white paper, "Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products".

Toxicogenomics has been seen as a 'better, cheaper and faster' tool to greatly improve current toxicology, speed up chemical/drug development and reduce the burden on animal testing. More >>

"Animal toxicology tests often fail to uncover the types of toxicities seen after widespread human exposure."

 

The FDA Critical Path Initiative and Its Influence on New Drug Development - Janet Woodcock and Raymond Woosley