Minefields on the way to a Biotech Product

A long and winding road filled with minefields must be crossed on the way to launch of a biotech product. The long (~12.5 years^1,2,3), expensive ($ 0.3 to 1 B^2,3) and highly risky (87-98% failure^1,2) road starts in finding the right idea/compound/molecule which, it is believed, has the potential to become a product at the time it will be approved (10-15 years from start). The potential product must be more effective, safer and preferably not more expensive than its competitors in order to be able to compete and penetrate the market and cover its development expenses.

Development of a biotech process requires consideration of: the host cell to be used for cloning, i.e. bacterial, plant or mammalian cells, or whole plants (or animals). Additional parameters to be taken into account are: single vs. multiuse bioreactors, recovery and purification systems, formulation, primary and secondary packaging systems. Ideally, eventual product sales revenues must enable recovery of development expenses before market entry of new products.

Key product issues include clinical efficacy, adverse events, patentability (clone, process, formulation and/or delivery system), shelf life and storage conditions.

References

1. The drug development and approval process. Available at http://www.fdareview.org/03_drug_development.php
2. William B. Failure rates in drug discovery and development: will we ever get any better? Drug Discovery World Fall 2004; 9-18.
3. Mundae M.K el al. The long road of biopharmaceutical drug development: from inception to marketing. Q J Med 2010; 103:3-7.