Increased understanding of human diseases at molecular and cellular levels is leading to development of novel life-science technologies. Such advancements typically pertain to discovery and manufacturing of novel human therapeutics, new modes of drug delivery, and novel diagnostic technologies. The majority of those technologies are developed by early stage biopharmaceutical companies that have a greater appetite for risk than do larger companies.Early stage biopharmaceutical companies, however, have limited capital raised through personal sources, angel investors, venture capital, or government grants. So these companies usually focus on a single product or technology. As a result, their survival is contingent upon demonstrating successful product development within available capital.
A number of statistics have been cited about the survival and success rates of early stage biotechnology companies. Nearly all authors agree that the majority of those companies do not attain success and that poor management is a key reason for most failures. SMC Consulting Group (SMC) has identified critical management factors contributing to the failure of early stage biotechnology companies. Among these is insufficient early planning, specifically the following:
- - Lack of a detailed target product profile
- - Limited planning for product development from research through clinical manufacturing in early stages of development
- - Limited financial potential or lower probability of success for a selected target disease area
- Limited differentiation of a target product from other products developed by competitors.
Without detailed target product profiles and pre-development planning, early stage biotechnology companies spend valuable and limited time and resources non-productively. SMC recommends that such companies perform comprehensive due diligence to develop target product profiles and plan their development processes before initiating research and development (R&D) activities. To learn more,
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