Introducing a new drug candidate to market is a complex and time-intensive process that can cost pharmaceutical companies $1 billion and more than a decade of research and development. Coupled with the fact that only about 11% of new drugs make it from discovery to clinical trials - and only about 1% of them ever make it to consumers' medicine cabinets - drug development is clearly a risky endeavor. Every drug candidate must demonstrate safety and efficacy to gain U.S. Food and Drug Administration (FDA) approval, but not all drugs are created equally. A drug's therapeutic area will often determine the length of time and financial investment needed for development. For example, oncology and immuno-modulatory drug candidates typically require greater resources than dermatology ones, but no drug development process should be considered risk-free. Product reformulation, safety/efficacy concerns and unforeseen ADME characteristics can derail a program during early-phase development. But one of the most overlooked, and perhaps most perilous, risks to any drug development program is poor team management and ineffective partnership. Following fundamental de-risking tips like protecting timelines, having the right leaders in place, knowing where to start and putting together a submission strategy, drug developers can mitigate risks and improve the quality of preclinical work.
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