Abstract
An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.
Similar content being viewed by others
References
Adams CP, Brantner VV (2006) Estimating the cost of new drug development: is it really $802 million? Health Aff 25:420–428
Alesandri TM, Ford DN, Lander DM, Leggio KB, Taylor M (2004) Managing risk and uncertainty in complex capital projects. Q Rev Econ Finance 44:761–767
Baeyens K, Vanacker T, Manigart S (2006) Venture capitalists’ selection process: the case of biotechnology proposals. Int J Technol Manag 34:28–46
Bayer JC, Norton GW, Falck-Zepeda JB (2010) Cost of compliance with biotechnology regulation in the Philippines: implications for developing countries. AgBioForum 13:53–62
Chen S-S, Chung T-Y, Ho KW (2007) Intra-industry effects of delayed new product introductions. Rev Pac Basin Financ Mark Policies 10:415–443
Cohen LP (1992) Biotech Stocks are Caught in Centocor Downdraft. Wall Street J, April 16, C1
Food and Drug Administration (FDA) (2007a) Nanotechnology task force report. http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm. Accessed 31 August 2010
Food and Drug Administration (FDA) (2007b) Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays. http://www.fda.gov/cdrh/oivd/guidance/1610.pdf. Accessed 30 August 2010
Heesen MG (2010) Letter to Margaret Hamburg, FDA Commissioner, from National Venture Capital Association President Mark Heesen regarding novel therapies and technologies. http://www.nvca.org/index.php?option=com_docman&task=doc_download&gid=549&Itemid=93. Accessed 30 August 2010
Hendricks KB, Singhal VR (1997) Delays in new product introductions and the market value of the firm: the consequences of being late to the market. Manag Sci 43:422–436
Hoerr RA, Gupta A, Matuszewski M (2009) Developing practices for safe handling of nanoparticles and nanomaterials in a development-stage enterprise: a practical guide for research and development organizations. In: Webster TJ (ed) Safety of nanoparticles: from manufacturing to medical applications. Springer, New York
National Science Foundation (NSF) (2008) National Patterns of R&D Resources: 2008 Data Update. Detailed Statistical Tables, NSF 10-314, March 2010. http://www.nsf.gov/statistics/nsf10314/pdf/nsf10314.pdf. Accessed 30 August 2010
Oberdörster G (2010) Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. J Int Med 267:89–105
Price W (2007) Introduction to venture capital. http://www.slideshare.net/pricew/introduction-to-venture-capital. Accessed 31 August 2010
Ramachandran G, Wolf SM, Paradise J, Kuzma J, Hall R, Kokkoli E, Fatehi L (2011) Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology. J Nanopart Res. doi:10.1007/s11051-011-0233-2
Sjöö K (2008) The influence of uncertainty on venture capital investments in renewable energy technology: an exploratory study. Master thesis, University of Oslo, Norway. http://www.duo.uio.no/publ/tik/2008/85712/Uppsatsen.pdf. Accessed 31 August 2010
Acknowledgments
Preparation of this article was supported by National Science Foundation (NSF) grant #0608791, “NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context” (Principle Investigator: S.M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). The views expressed are those of the author and do not necessarily reflect the views of NSF.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Hoerr, R.A. Regulatory uncertainty and the associated business risk for emerging technologies. J Nanopart Res 13, 1513–1520 (2011). https://doi.org/10.1007/s11051-011-0260-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11051-011-0260-z