Innovation in biopharmaceutical drug development is often driven by small biotech companies.
A healthy venture capital market is now enabling small biotech companies to take their new treatments and products all the way through to commercialization for niche indications. This is a departure from the past, when they would more often license out their drug candidate to a large pharmaceutical company after Phase II.
Complementing the increased availability of capital, regulatory bodies have also created a number of accelerated approval options (i.e., FDA’s breakthrough designation and EMA’s PRIME) allowing innovators to bring their new treatments to market more quickly.
However, while larger companies typically have the experience in-house to navigate complex regulatory processes and the ability to scale manufacturing flexibly to meet market demand, small and virtual biotech companies tend to lack this expertise due to their size and focus.
As small biotechs seek to retain their independence further along in the development process, they must address these gaps in resources and experience.
External partners such as contract development and manufacturing organizations (CDMOs) play an important role to close such gaps.