Some issues in biotechnology commercialization

Abstract

Commercialization of biotechnology discoveries has many challenges. One of the major hurdles to commercialization is achieving regulatory approval. This includes not only approval for the drug but also the process by which it is produced. The costs for developing a drug and achieving approval for its release are enormous. They average nearly a quarter of a billion dollars per successful drug. Many of the start-up biotechnology companies fail or necessarily become consumed by the large pharmaceutical houses because their managers fail to factor the risk of not achieving approval, or at least gaining approval in a timely fashion, into their business plan. Further, they do not take an integrated approach to product and process development. For the most part emphasis has been on drug discovery. Process development has been neglected. In fact, the knowledge base for development, design, and validation exists only with the large pharmaceutical companies. Therefore, the opportunities for a start-up biotechnology company to become a full-scale drug producer are extremely rare. A deeper appreciation of these problems is needed by managers of start-up biotech companies if they are to be successful.