The BIEM Verification Study: Experienced Venture Capitalists Assess a Biopharmaceuticals Innovation Expertise Model

Authors

  • Moira A. Gunn University of San Francisco, School of Management, Director, Business of Biotechnology Program; Producer and Host, BioTech Nation
  • Nola Masterson Managing Director, Science Futures Management Company, LLC Adjunct Professor, Business of Biotechnology Program, University of San Francisco
  • Paul Lorton, Jr. Professor, Management Information Systems School of Management University of San Francisco
  • Jacques Baronet Professor of Entrepreneurship and Innovation Management University of Sherbrooke, Quebec, Canada

DOI:

https://doi.org/10.5912/jcb749

Keywords:

BIEM model, Bioenterprise Innovation Expertise Model, entrepreneurial model testing, business model testing, biopharmaceutical failure, biopharmaceutical success

Abstract

Developing biopharmaceutical therapies is a scientifically complex endeavor, requiring from ten to fifteen years of effort with successive rounds of increasingly greater investment capital in a risk-intensive landscape. With failure rates at 88%, and an all-attempts-averaged investment of over $2B per approved drug, discussions of what leads to success and/or failure are pervasive. In this milieu, the BIEM (Bioenterprise Innovation Expertise Model) model was developed so that the status of a bioenterprise could quickly be assessed. Assessing the BIEM model, 20 biopharmaceuticals venture capitalists with 30 years average biotechnology industry experience, all having board experience, most having served as board chairs, and 80% having been CEO’s and/or presidents, rated the innovation expertise disciplines of BIEM 2.0 as to their importance in the scientific discovery through market-ready product innovation phase of biopharmaceutical development. Despite a small sample size, statistically significant insights were produced, verifying the BIEM model. The most important innovation expertise disciplines were intellectual property, science, regulatory expertise, and venture capital, in that order. Further, the strongest correlations linked regulatory expertise and science, and equally so, intellectual property and venture capital. Additional insights with respect to the profiles of the biopharmaceutical venture capitalists themselves is also presented.

Author Biographies

Moira A. Gunn, University of San Francisco, School of Management, Director, Business of Biotechnology Program; Producer and Host, BioTech Nation

founded and directs the Business of Biotechnology Program in the School of Management at the University of San Francisco, where she is an assistant professor. The former President of SIBER, the Society for International Bioentrepreneurship Education and Research, she also hosts Tech Nation, and its regular segment BioTech Nation, which air on the NPR channel of SiriusXM, among other venues.

Nola Masterson, Managing Director, Science Futures Management Company, LLC Adjunct Professor, Business of Biotechnology Program, University of San Francisco

is Founder and Managing Director of Science Futures Management Company, LLC, and an Adjunct Professor in the Business of Biotechnology Program in School of Management of University of San Francisco

Paul Lorton, Jr., Professor, Management Information Systems School of Management University of San Francisco

is a Professor of Management Information Systems in the School of Management at the University of San Francisco

Jacques Baronet, Professor of Entrepreneurship and Innovation Management University of Sherbrooke, Quebec, Canada

is a Professor of Entrepreneurship and Innovation Management at the University of Sherbrooke, Quebec, Canada

References

P&S Market Research Report. (2015). Global Biopharmaceuticals market Size, Share, Development, Growth and Demand Forecast to 2020 – Industry Insights by Type (Monoclonal Antibodies, Recombinant Proteins, Interferon, Colony-Stimulating Factor, Erythopoietin, Recombinant Human Insulin, Vaccines, Growth Hormones, Infectious Diseases, Metabolic Disorders, Neurological Disorders, Cardiovascular Diseases and Others) Report Code HC1174. Retrieved June 12, 2016, from - https://www.psmarketresearch.com/marketanalysis/biopharma ceuticals-market

DiMasi J.A., Grabowski H.G. and Hansen R.A. (2016). Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics, 47:20-33.

Yang, W. (2016). 2015 – another banner year for biotech. Nature Biotechnology, 34:127.

Giniatullina, A., Boorsma, A., Mulder, G.J. and van Deventer, S. (2013) Building for big pharma. Nature Biotechnology 31:284-287, doi:10.1038/nbt.2583.

Kruse, S., Slomiany, M., Bitar, R., Jeffers, S. and Hassan, M. (2014) Pharmaceutical R&D productivity: the role of alliances. Journal of Commercial Biotechnology 20(2): 12-20.

Czerepak, E. & Ryser, S. (2008) Drug approvals and failures: Implications for alliances. Nature Reviews Drug Discovery. 7(3): 197–198.

Gunn, M.A., Dever, J., Tzagarakis-Foster, C., Lorton, P., Kane, K. and Masterson, N. (2013). An agile, cross-discipline model for developing bio-enterprise professionals. Journal of Commercial Biotechnology, 19(4):72-87.

Sacks, L.V. et al. (2014) Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA: the journal of the American Medical Association 311(4): 378–384.

FDA. (2016) New Drugs at FDA: CDER’s New Molecular Entitities and New Therapeutic Biological Products. Food and Drug Administration. Retrieved June, 26, 2016 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugInnovation/ucm20025676.htm

Wang, B., Avorn, J. and Kesselheim, A. (2013) Clinical and regulatory features of drugs not initially approved by the FDA. Clinical Pharmacology and Therapeutics. 94(6): 670–677.

Schueler, J. and Ostler, T. (2016) Biopharmaceutical Startup’s Need for Regulatory Intelligence. Journal of Commercial Biotechnology 22(1): 6-14.

Ringel, M., Tollman, P., Hersch, G. & Schulze, U. (2013) Does size matter in R&D productivity? If not, what does? Nature Reviews Drug Discovery 12(12): 901–902.

Gunn, M. (2007) Welcome to BioTech Nation: My Unexpected Odyssey into the Land of Small Molecules, Lean Genes, and Big Ideas. New York: AMACOM.

Gunn, M. & Lorton, P. (2014) Measuring the Effectiveness of Global Immersive Study Tours to Attract Non-Scientific Working Professionals to the Bio-Enterprise. Technology Transfer and Entrepreneurship, 1(2): 117-131.

Siconolfi, M., Weaver, C. & Carreyrou, J. (2016, June 13). Walgreen’s Terminates Partnership With Blood-Testing Firm Theranos. The Wall Street Journal. Retrieved June 26, 2016 from http://www.wsj.com/articles/walgreen-terminates-partnership-with-blood-testing-firm-theranos-1465777062

Weaver, K.M., Liguori, E.W. and Vozikis, G.S. (2011), Entrepreneur business climate perceptions: Developing a measure and testing a model, Journal of Applied Business and Economics, 12,(1): 95-104.

Hansen, D.J., Lumpkin, G.T. and Hills, G.E. (2011), A multidimensional examination of a creativity-based opportunity recognition model. International Journal of Entrepreneurial Behaviour and Research 17(5): 515-533.

Antoncic, B. and Hisrich, R.D. (2004), Corporate entrepreneurship contingencies and organizational wealth creation, The Journal of Management Development, 23(5-6): 518-549.

Kaufman, J.C., Baer, J., Cole, J.C., and Sexton, J.D. (2008), A comparison of expert and non-expert raters using the consensual assessment technique, Creativity Research Journal, 20( 2): 171-178.

Holthausen, R.S., Wisdom, M.J., Pierce, J., Edwards, D.K., and Rowlands, M.M. (1994) Using Expert Opinion to Evaluate a Habitat Effectiveness Model for Elk in Western Oregon and Washington, United States Dept. of Agriculture, Research paper PNW-RP-479.

MacCallum, R.C. and Widaman, K.F. (1999) Sample size in factor analysis.Psychological Methods 4(1): 84-99.

Hair Jr., J.F., Black, W.C. Babin, B.J. and Anderson, R.E. (2010) Multivariate Data Analysis, 7th edition. Upper Saddle River, NJ: Prentice Hall.

De Winter, J.C.F., Dodou, D. and Wieringa, P.A. (2009) Exploratory factor analysis with small sample sizes, Multivariate Behavioral Research, 44: 147-181.

Geoff Norman (2010) Likert scales, levels of measurement and the ‘laws’ of statistics. Advances in Health Sciences Education: Theory and Practice 15(5): 625-32.

Published

2016-08-30

Issue

Section

Article