Drug development is an expensive proposition. Discovery and preclinical work are estimated to cost $318 million per compound, with an additional $800 million to $1.1 billion required to advance a molecule from first-in-human testing to market approval.
For small biopharmaceutical innovators, steep development costs are compounded by the fact that large molecules are becoming increasingly complex and serious clinical or manufacturing problems may not surface until late in the process. Building upon this risk, events such as mergers, acquisitions, restructurings, political uncertainty and even public criticism can all have a huge effect on a small company’s stock and monetary resources. With a limited amount of money at their disposal for generating clinical data, biopharma firms are often waiting for the perfect moment to pull the trigger and move products quickly through development. This creates a situation where highly compressed process development timelines lead companies to overlook critical factors that could delay—or even suspend—efforts down the road.
In this whitepaper, we identify some important risks that consultants should put on the radars of their small biopharma clients. Doing so, along with choosing the right outsourcing partner, will ensure their risks—not their financial returns—are diminished.
Steve Lam, Senior Vice President, Biologics
Jennifer Stone, Vice President, Quality, Biologics