Navigating roadblocks to clinical success: from molecule to clinic

For emerging biotech and small companies in early-stage clinical development, accessing the market as quickly as possible is of paramount importance. Biopharma executives must make important decisions at this stage that will impact the success of their commercial strategy. The key to success is making the right decisions at the right time. This article addresses the key considerations for companies to advance a molecule from the laboratory to the clinic expediently without sacrificing product quality, process efficiency or patient safety.


Business considerations

Accessing the market is a matter of exigency for early-stage companies. Heavy investment is made in research and development at the front end of the drug development pipeline in the absence of revenue. This period can be challenging as the financial viability of the company and its programmes critically depend on how fast the company can demonstrate clinical value or market a successful product.

To achieve these goals, small companies must answer these important strategic questions:

  1. Should the molecule be licensed to a larger biopharma company?
  2. Should manufacturing of the molecule be outsourced to a Contract Manufacturing Organisation (CMO)?
  3. Should manufacturing be carried out internally by building a biomanufacturing facility?

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