In drug development, you have to be first to market; the returns for coming in second are slim. 

Sound familiar? Your company has a promising clinical candidate pipeline and a robust preclinical development pipeline, which makes you look really strong in the market. But have you considered the disparate business drivers that can derail your go-to-market plans for completely non-scientific reasons? You have to be first to market; the returns for coming in second are slim. 

Research shows that as companies grow, they experience “go-to-market” slippage times. Small companies are more nimble and are able to maintain the market delivery time under the industry minimum of eight years, but as they grow, their market delivery times invariably move closer to the 8 year timeframe1, 2. That slippage has serious ramifications for the (now) midsize company’s survival, so the precipitating issues need to be addressed to stop the downward slide towards 10 to 12 years2 market delivery time that is standard in most global pharma companies.  For a midsize company, the fallout of not being the first to market with a novel therapeutic can not only cost millions in lost revenue, but also places them in the crosshairs of the takeover market as larger companies will seek to capitalize on their strong in-house candidate pipeline.

Some midsize companies are more susceptible to the danger associated with slippage than others, but two factors that can reveal the level of risk are the quality of the pipeline and area of focus. For example, a company with a robust portfolio of novel candidates for rare diseases that does not move to market fast enough to capitalize on market share becomes an acquisition target for a larger company that is interested in quickly acquiring a pipeline in a high potential but underfunded area.

There are ways to streamline the identification and validation of novel candidates to avoid slippage and the dreaded failure of being first to market. Taking a translational approach to drug discovery and development maximizes the chance of success at each step of the continuum and also supports the “fail early” dogma so that the R&D focus is on viable compounds. Additionally, using technologies that support translational biology and have clear benefits (increased sensitivity and/or specificity, improved signal compared to background etc.) compared to gold standard methods are a best practice to streamline successful drug discovery. A third method is to consider tapping into the increasingly sophisticated outsourcing community. Contract research organizations (CROs) have evolved from simple fee-for-service providers to scientific partners and collaborators. Partnering with experienced CROs can help reduce delivery time to the clinic and allow biotech companies to focus on advancing novel target discovery and optimize market delivery methods.

1 http://www.pharmtech.com/how-long-does-drug-development-take

2 http://www.fdareview.org/03_drug_development.php