Biotechnology firms face a largely uncertain landscape. The science is uncertain, the development of targets is costly, and the industry is heavily regulated.  As a result, product development can run for decades before a product realizes profitable revenue streams. Through hands-on, field-based research, the Sloan Biotechnology Industry Center examines the industry’s concerns and provides insight into the challenges that affect industry competitiveness in the United States.

   The interdisciplinary makeup of the Center faculty is fundamental to its approach. Teams of researchers include individuals from the life sciences, engineering, public policy, management, ethics and agriculture economics. These diverse perspectives bring a range of expertise that helps enrich the insights and knowledge gained from the research.

 This is considered critical to this area of exploration in that the broad applications of biotechnology – from the environment and national security to health care and food – bring forth a wide range of issues for scientists, business managers, ethicists, policy-makers and others.

   A previous study of the Maryland Biotechnology Cluster examined the success factors and challenges faced by leading biotechnology companies in Maryland. The Center’s location within this national biotechnology cluster provides researchers with important access to major companies, as well as many of the country’s influential regulatory bodies.

   Research is currently focused on two key projects. The first, “Uncertainty in Biotechnology” looks at the unique issues faced by biotech companies and the factors that affect their success or failure. This work addresses a range of potential “uncertainties” for companies, including scientific, technological, capital, market and commercialization. The initial phase of this project involves in-depth interviews with company executives at firms of varying stages of evolution. Combined with original large scale survey data collection and secondary data, this work will provide fine-grained, generalizable findings for industry participants.

   The second project, “Product Cycle Time Reduction” is of great interest to biotechnology firms that can spend about 12 years and $1 billion to bring a product to market. Researchers are investigating practices used to develop products from discovery through FDA approval, in order to understand the impact that innovations in scientific processes, manufacturing, information technology, and regulatory changes have on cycle time and product development costs. The project will ultimately identify obstructions in the overall process and provide recommendations for accelerated product development.

   Additional research areas will address the economic, social and competitive consequences of existing and emerging operational arrangements, including the impacts of globalization and offshoring, and the “spillover effect” of biotechnology and its effects on other industries.