Manufacturing Process Innovation in the Pharmaceutical Industry

Published Online:https://doi.org/10.1287/msom.2021.1035

References

  • Aharonson BS, Schilling MA (2016) Mapping the technological landscape: Measuring technology distance, technological footprints, and technology evolution. Res. Policy 45(1):81–96.CrossrefGoogle Scholar
  • Anderson NG (2012) Practical Process Research and Development: A Guide for Organic Chemists (Academic Press, Amsterdam).Google Scholar
  • Argote L, Hora M (2017) Organizational learning and management of technology. Production Oper. Management 26(4):579–590.CrossrefGoogle Scholar
  • Argote L, Beckman SL, Epple D (1990) The persistence and transfer of learning in industrial settings. Management Sci. 36(2):140–154.LinkGoogle Scholar
  • Baessler H, Lehmann F (2013) Containment Technology: Progress in the Pharmaceutical and Food Processing Industry (Springer, Berlin).CrossrefGoogle Scholar
  • Beneito P (2006) The innovative performance of in-house and contracted R&D in terms of patents and utility models. Res. Policy 35(4):502–517.CrossrefGoogle Scholar
  • Benkard CL (2000) Learning and forgetting: The dynamics of aircraft production. Amer. Econom. Rev. 90(4):1034–1054.CrossrefGoogle Scholar
  • Benner MJ, Tushman ML (2003) Exploitation, exploration, and process management: The productivity dilemma revisited. Acad. Management Rev. 28(2):238–256.CrossrefGoogle Scholar
  • Bennett B, Cole G (2003) Pharmaceutical Production: An Engineering Guide (IChemE, Rugby, United Kingdom).Google Scholar
  • Blakeney M (2005) Guidebook on Enforcement of Intellectual Property Rights (Queen Mary Intellectual Property Research Institute, London).Google Scholar
  • Boyer KK (1999) Evolutionary patterns of flexible automation and performance: A longitudinal study. Management Sci. 45(6):824–842.LinkGoogle Scholar
  • Bruccoleri M, Perrone G, Mazzola E, Handfield R (2019) The magnitude of a product recall: Offshore outsourcing vs. captive offshoring effects. Internat. J. Production Res. 57(13):4211–4227.CrossrefGoogle Scholar
  • Burns LR (2012) The Business of Healthcare Innovation (Cambridge University Press, Cambridge, UK).CrossrefGoogle Scholar
  • Cardinal LB, Alessandri TM, Turner SF (2001) Knowledge codifiability, resources, and science-based innovation. J. Knowledge Management 5(2):195–204.CrossrefGoogle Scholar
  • Carroll S (2009) Goodbye blockbuster medicines; hello new pharmaceutical business models. Pharmaceutical J. 282(7555):681–682.Google Scholar
  • Caves RE, Whinston MD, Hurwitz MA (1991) Patent expiration, entry, and competition in the U.S. pharmaceutical industry. Brookings Papers Econom. Activity Microeconomics 1991(1991):1–66.Google Scholar
  • Chaudhuri A (2013) Simultaneous improvement in development time, cost and quality: A practical framework for generic pharmaceuticals industry. Res. Management 43(3):227–241.Google Scholar
  • Cohen WM, Levin RC, Mowery DC (1987) Firm size and R&D intensity: A re-examination. J. Indust. Econom. 35(4):543.Google Scholar
  • Crossan MM, Apaydin M (2010) A multi-dimensional framework of organizational innovation: A systematic review of the literature. J. Management Stud. 47(6):1154–1191.CrossrefGoogle Scholar
  • Damanpour F (2008) Organizational complexity and innovation: Developing and testing multiple contingency models. Management Sci. 42(5):693–716.LinkGoogle Scholar
  • Deconinck E, Van Nederkassel A, Stanimirova I, Daszykowski M, Bensaid F, Lees M, Martin G, Desmurs J, Smeyers-Verbeke J, Vander Heyden Y (2008) Isotopic ratios to detect infringements of patents or proprietary processes of pharmaceuticals: Two case studies. J. Pharmaceutical Biomedical Anal. 48(1):27–41.CrossrefGoogle Scholar
  • Dennis D, Meredith J (2003) An empirical analysis of process industry transformation systems. Management Sci. 46(8):1085–1099.LinkGoogle Scholar
  • Ernst H (2001) Patent applications and subsequent changes of performance: Evidence from time-series cross-section analyses on the firm level. Res. Policy 30(1):143–157.CrossrefGoogle Scholar
  • Ettlie JE (1998) R&D and global manufacturing performance. Management Sci. 44(1):1–11.LinkGoogle Scholar
  • Ettlie JE, Reza EM (1992) Organizational integration and process innovation. Acad. Management J. 35(4):795–827.CrossrefGoogle Scholar
  • Fader PS, Hardie BG, Shang J (2010) Customer-base analysis in a discrete-time noncontractual setting. Marketing Sci. 29(6):1086–1108.LinkGoogle Scholar
  • Fleming L, Sorenson O (2004) Science as a map in technological search. Strategic Management J. 25(89):909–928.CrossrefGoogle Scholar
  • Funk RJ, Owen-Smith J (2017) A dynamic network measure of technological change. Management Sci. 63(3):791–817.LinkGoogle Scholar
  • Gilbert R, Shapiro C (1990) Optimal patent length and breadth. RAND J. Econom. 21(1):106–112.CrossrefGoogle Scholar
  • Griliches Z (1990) Patent statistics as economic indicators: A survey. J. Econom. Literature 28(4):1661–1707.Google Scholar
  • Grimaldi M, Cricelli L, Di Giovanni M, Rogo F (2015) The patent portfolio value analysis: A new framework to leverage patent information for strategic technology planning. Tech. Forecasting Soc. Change 94(C):286–302.CrossrefGoogle Scholar
  • He ZL, Wong PK (2004) Exploration vs. exploitation: An empirical test of the ambidexterity hypothesis. Organ. Sci. 15(4):481–494.LinkGoogle Scholar
  • Howard DH, Bach PB, Berndt ER, Conti RM (2015) Pricing in the market for anticancer drugs. J. Econom. Perspect. 29(1):139–162.CrossrefGoogle Scholar
  • Jacobs T, Signore A, eds. (2016) Good Design Practices for GMP Pharmaceutical Facilities, Drugs and the Pharmaceutical Sciences (CRC Press, Boca Raton, FL).CrossrefGoogle Scholar
  • Johnston A, Stafylas P, Stergiou GS (2010) Effectiveness, safety and cost of drug substitution in hypertension. British J. Clinical Pharmacology 70(3):320–334.CrossrefGoogle Scholar
  • Kanavos P (2014) Measuring performance in off-patent drug markets: A methodological framework and empirical evidence from twelve EU member states. Health Policy 118(2):229–241.CrossrefGoogle Scholar
  • Lee HH, Zhou J, Wang J (2018) Trade credit financing under competition and its impact on firm performance in supply chains. Manufacturing Service Oper. Management 20(1):36–52.LinkGoogle Scholar
  • Leonard-Barton D (1988) Implementation as mutual adaptation of technology and organization. Res. Policy 17(5):251–267.CrossrefGoogle Scholar
  • Levinthal DA (1997) Adaptation on rugged landscapes. Management Sci. 43(7):934–950.LinkGoogle Scholar
  • Mansfield E (1986) Patents and innovation: An empirical study. Management Sci. 32(2):173–181.LinkGoogle Scholar
  • Meyer MH, Dalal D (2002) Managing platform architectures and manufacturing processes for nonassembled products. J. Product Innovation Management 19(4):277–293.CrossrefGoogle Scholar
  • Mihm J, Sting FJ, Wang T (2015) On the effectiveness of patenting strategies in innovation races. Management Sci. 61(11):2662–2684.LinkGoogle Scholar
  • Morton FMS (1999) Entry decisions in the generic pharmaceutical industry. RAND J. Econom. 30(3):421–440.CrossrefGoogle Scholar
  • Nally JD (2016) Good Manufacturing Practices for Pharmaceuticals (CRC Press, Boca Raton, FL).CrossrefGoogle Scholar
  • Nusim S (2016) Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (CRC Press, Boca Raton, FL).CrossrefGoogle Scholar
  • OECD (2005) Oslo Manual: Guidelines for Collecting and Interpreting Innovation Data, 3rd ed. (OECD Publishing, Paris).CrossrefGoogle Scholar
  • OECD (2016) Improving ISSSTE’s Public Procurement for Better Results (OECD Publishing, Paris).CrossrefGoogle Scholar
  • Piening EP, Salge TO (2015) Understanding the antecedents, contingencies, and performance implications of process innovation: A dynamic capabilities perspective. J. Product Innovation Management 32(1):80–97.CrossrefGoogle Scholar
  • Pinheiro E, Vasan A, Kim JY, Lee E, Guimier JM, Perriens J (2006) Examining the production costs of antiretroviral drugs. AIDS 20(13):1745–1752.CrossrefGoogle Scholar
  • Pisano GP (1997) The Development Factory: Unlocking the Potential of Process Innovation (Harvard Business Press, Boston).Google Scholar
  • Reitzig M (2003) What determines patent value? Res. Policy 32(1):13–26.CrossrefGoogle Scholar
  • Sampath P (2010) Reconfiguring Global Health Innovation (Taylor and Francis, London).CrossrefGoogle Scholar
  • Schlapp J, Oraiopoulos N, Mak V (2015) Resource allocation decisions under imperfect evaluation and organizational dynamics. Management Sci. 61(9):2139–2159.LinkGoogle Scholar
  • Simonetti R, Archibugi D, Evangelista R (1995) Product and process innovations: How are they defined? how are they quantified? Scientometrics 32(1):77–89.CrossrefGoogle Scholar
  • Taneri N, De Meyer A (2017) Contract theory: Impact on biopharmaceutical alliance structure and performance. Manufacturing Service Oper. Management 19(3):453–471.LinkGoogle Scholar
  • Tenn S, Wendling BW (2013) Entry threats and pricing in the generic drug industry. Rev. Econom. Statist. 96(2):214–228.CrossrefGoogle Scholar
  • Tushman M, Nadler D (1986) Organizing for innovation. Calif. Management Rev. 28(3):74–92.CrossrefGoogle Scholar
  • USFDA (2018) Generic drug facts. Accessed August 12, 2020, https://www.fda.gov/drugs/generic-drugs/generic-drug-facts.Google Scholar
  • Utterback JM, Abernathy WJ (1975) A dynamic model of process and product innovation. Omega 3(6):639–656.CrossrefGoogle Scholar
  • Verhoeven D, Bakker J, Veugelers R (2016) Measuring technological novelty with patent-based indicators. Res. Policy 45(3):707–723.CrossrefGoogle Scholar
  • Vernon JA, Hughen WK, Trujillo AJ (2007) Pharmaceutical manufacturing efficiency, drug prices, and public health: Examining the causal links. Drug Inform. J. 41(2):229–239.CrossrefGoogle Scholar
  • Zahra SA, Das SR (1993) Innovation strategy and financial performance in manufacturing companies: An empirical study. Production Oper. Management 2(1):15–37.CrossrefGoogle Scholar
INFORMS site uses cookies to store information on your computer. Some are essential to make our site work; Others help us improve the user experience. By using this site, you consent to the placement of these cookies. Please read our Privacy Statement to learn more.