Seeking Life Science Inno-vation Opportunities and Beyond: The Art of Blending Science, Medicine, and Business
Main Article Content
Abstract
This update on life science innovation extends Boni's 2018 works1,2 to include industry stakeholder expert opinion. This paper’s focus is to address three research questions relevant to innovation within the biopharmaceutical industry concerning 1) its current state, 2) challenges, opportunities, and frameworks, and 3) existing examples in the extant literature and practice relevant to progress and challenges. It utilizes mixed methods involving a 1) narrative review to establish a current understanding of the extant literature and frameworks and 2) qualitative interviews to coalesce themes around the core research questions. The first section summarizes current industry challenges, successes, and best practices that support sustained and disruptive innovation in the biopharma industry. It charts a brief overview of proven models for innovation, entrepreneurial thinking, and for development of open innovation as applied to this complex, challenging, continuously evolving industry. This initial discussion advocates the pursuit of commercialization that 1) incorporates a phased, interdisciplinary, collaborative approach and 2) blends the principles of business, science, and technology through diverse, collaborative teams, networks, and alliances. The paper transitions to a second section. This effort builds on these concepts and provides insights and alternative perspectives from a cohort of leading experts within the biomedical investment, development, and commercialization space. It also illustrates and leverages collective intelligence through interdisciplinary perspectives across the life science landscape and reinforces trends for pursuing innovation.
Keywords:
Biopharma, Digital health, Entrepreneurial thinking, Innovation, Life sciences, MedTech, Open innovation, Pharma 4.0, Triple chasm
Article Details
How to Cite
BONI, Arthur A. et al.
Seeking Life Science Inno-vation Opportunities and Beyond: The Art of Blending Science, Medicine, and Business.
Medical Research Archives, [S.l.], v. 11, n. 2, feb. 2023.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/3443>. Date accessed: 21 dec. 2024.
doi: https://doi.org/10.18103/mra.v11i2.3443.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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45. Seltenrich ML. Pharma 2.0 Business Plan. Accessed October 1, 2022. https://summit.sfu.ca/item/700.
46. Boni AA, Joseph D. Four models for corpo-rate transformative, open innovation. J Commer Biotechnol. 2019;24(4). doi:10.5912/jcb911
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59. Mack GS. Pharmas partner in venture seeking drug discovery tools. Nat Biotechnol. 2008;26(9):960-962.
60. Boni AA, Joseph D. Aligning the Corpora-tion for Transformative Innovation: Introducing In-novation Dashboard 2.0. J Commer Biotechnol. 2019;24(4). Doi.10.5912/jcb910
61. Boni AA, Gross DM, Gunn MA, Levine DS. Companies Recognized as Innovators for 2021. J Commer Biotechnol. 2021;26(2). doi.10.5912/jcb986
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64. Teece DJ, Pisano G, Shuen A. Dynamic capabilities and strategic management. Strategic management journal. 1997;18(7):509-533.
65. Boni AA. Keys for Building and Leading Teams for Innovation in Organizations: Three Book Reviews and Author Commentaries. J Commer Bio-technol. 2022;27(2):12-27.
66. White G. The Mystery of Collective Intel-ligence. Ethics Press;2022.
67. Bethune KG. Reimagining Design: Unlock-ing Strategic Innovation. MIT Press; 2022.
68. Mangold M. Today’s Superpower: Build-ing Networks: 7 Mindset Principles to Thrive in a Fast-Changing World. NewDegreePress; 2021.
69. Isaacson W. The Code Breaker--Young Readers Edition: Jennifer Doudna and the Race to Understand Our Genetic Code. Simon and Schus-ter; 2022.
70. Pisano GP. Science Business: The Promise, the Reality, and the Future of Biotech. Harvard Business Press; 2006.
71. Agrawal P. Advantages and challenges in drug re-profiling. J Pharmacovigil. 2015;2:2-3.
72. Spinelli S, Ensign PC, Adams RJ. New Ven-ture Creation. McGraw-Hill Ryerson; 2014.
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78. Rong Y. Building technology enabled plat-form companies in Biopharma–a perspective on early-stage value creation from Millennium, Alnyl-am, Moderna, & Kymera. J Commer Biotechnol. 2021;26(2). doi.10.5912/jcb990
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2. Boni AA. Bridging Theory and Practice for Commercialization and Innovation–a Market-Centered Perspective for Cross-Industry Applica-tions. J Commer Biotechnol. 2018;24(1): :7-36. doi.10.5912/jcb850
3. U’Prichard DC. New paradigms in drug R&D: A personal perspective. J Commer Biotech-nol. 2012;18(2). doi.org/10.5912/jcb502
4. Boni AA, Abremski D. Commercialization Challenges and Approaches for Digital Health Transformation. J Commer Biotechnol. 2022;27(1). doi.org/10.5912/jcb1024
5. Eppley HB, Zhou W, Wilson GA, Toscani M, York JM. Using Lean Startup to Discover Cus-tomers in the mHealth Industry: Current Landscape and Challenges. J Commer Biotechnol. 2021;26(3): 25-38. doi.org/10.5912/jcb1015
6. Boni AA. The “Art of Collaborations”: Un-derstanding the Anatomy of Transformative Trans-actions in Biopharma. J Commer Biotechnol. 2020;25(4). doi.org/10.5912/jcb955
7. Budden P, Murray F. MIT’s stakeholder framework for building and accelerating innova-tion ecosystems. Published online 2019. Accessed October 1, 2022. https://innovation.mIt.edu/assets/MIT-Stakeholder-Framework Innovation-Ecosystems pdf.
8. Christensen CM, Raynor ME, Dyer J, Gregersen H. Disruptive Innovation: The Christen-sen Collection (The Innovator’s Dilemma, The Inno-vator’s Solution, The Innovator’s DNA, and Harvard Business Review Article" How Will You Measure Your Life?")(4 Items). Harvard Business Press; 2011.
9. Christensen CM, Grossman JH, Hwang J. The innovator’s prescription. A disruptive Solution for Health Care. McGraw-Hill; 2009.
10. Kim WC, Mauborgne R. Blue ocean strat-egy. Harv Bus Rev. Oct;82(10):76-84, 156.
11. Verganti R. Design Driven Innovation: Changing the Rules of Competition by Radically Innovating What Things Mean. Harvard Business Press; 2009.
12. Ulwick AW. Turn customer input into inno-vation. Harv Bus Rev. 2002;80(1):91-97.
13. Christensen CM, Hall T, Dillon K, Duncan DS. Know your customers’ jobs to be done. Harv Bus Rev. 2016;94(9):54-62.
14. Phadke U, Vyakarnam S. Camels, Tigers and Unicorns: Re-Thinking Science and Technolo-gy-Enabled Innovation. World Scientific; 2017.
15. Moore GA, McKenna R. Crossing the Chasm. HarperCollins; 1999.
16. Rogers EM, Singhal A, Quinlan MM. Diffu-sion of Innovations 1. In: An Integrated Approach to Communication Theory and Research. Routledge; 2019:415-434. doi:10.4324/9780203710753-35
17. Rogers EM. What are innovators like? Theory Pract. 1963;2(5):252-256.
18. Boni A. Project, product or company. J Commer Biotechnol. 2012;18(2):13-19.
19. Lambert WJ. Considerations in developing a target product profile for parenteral pharma-ceutical products. AAPS PharmSciTech. 2010;11(3):1476-1481.
20. Tebbey PW, Rink C. Target product pro-file: a renaissance for its definition and use. Jour-nal of Medical Marketing. 2009;9(4):301-307.
21. Tyndall A, Du W, Breder CD. Regulatory watch: the target product profile as a tool for reg-ulatory communication: advantageous but un-derused. Nat Rev Drug Discov. 2017;16(3):156-157.
22. Box GEP. Science and statistics. J Am Stat Assoc. 1976;71(356):791-799.
23. Blumer A, Ehrenfeucht A, Haussler D, Warmuth MK. Occam’s razor. Inf Process Lett. 1987;24(6):377-380.
24. Domingos P. The role of Occam’s razor in knowledge discovery. Data Min Knowl Discov. 1999;3(4):409-425.
25. Blank S. The Four Steps to the Epiphany. K & S Ranch; 2005.
26. Kern E. Marc Andreessen: Not Every Startup Should Be a Lean Startup or Embrace the Pivot. Accessed September 1, 2018. https://blogs.anderson.ucla.edu/gap/2013/05/marc-andreessen-not-every-startup-should-be-a-lean-startup-or-embrace-the-pivot.html
27. Mehta SS. Commercializing Successful Bi-omedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices. Cambridge University Press; 2008.
28. Ries E. The Lean Startup: How Today’s Entrepreneurs Use Continuous Innovation to Create Radically Successful Businesses. Crown Books; 2011.
29. Thomke S, Reinertsen D. Agile Product De-velopment: Managing Development Flexibility in Uncertain Environments. Calif Manage Rev. 1998;41(1):8-30. doi:10.2307/41165973
30. Thomke S, Manzi J. The discipline of busi-ness experimentation. Harv Bus Rev. 2014;(December 2014):71-79.
31. York J. Status of the Lean Startup Meth-odology (2020): From Theoretical Foundations to Practice Experience and Current Academic Discus-sions. J Entrepren Organiz Manag. 2020;9(6):287.
32. Popper K. The Logic of Scientific Discov-ery. Routledge; 2005.
33. Carreyrou J, Provenzo N. Bad Blood: Se-crets and Lies in a Silicon Valley Startup. Alfred A. Knopf; 2018.
34. Boni AA, Sammut SM. “ The Good, the Bad, the Ugly”: Leadership Lessons From two Companies-Amgen and Theranos. J Commer Bio-technol. 2019;24(4):67-71. doi: 10.5912/jcb918
35. Martin R, Martin RL. The Design of Busi-ness: Why Design Thinking Is the Next Competitive Advantage. Harvard Business Press; 2009.
36. Bingham CB, Haleblian J. How firms learn heuristics: Uncovering missing components of or-ganizational learning. Strategic Entrepreneurship Journal. 2012;6(2):152.
37. Bingham CB, Howell T, Ott TE. Capability creation: Heuristics as microfoundations. Strategic Entrepreneurship Journal. 2019;13(2):121-153. doi.org/10.1002/sej.1312
38. Holcomb TR, Ireland RD, Holmes Jr RM, Hitt MA. Architecture of entrepreneurial learning: Exploring the link among heuristics, knowledge, and action. Entrepreneurship theory and practice. 2009;33(1):167-192.
39. Bettis RA. Organizationally Intractable Decision Problems and the Intellectual Virtues of Heuristics. J Manage. 2017;43(8):2620-2637. doi:http://dx.doi.org/10.1177/0149206316679253
40. Ghezzi A. How Entrepreneurs make sense of Lean Startup Approaches: Business Models as cognitive lenses to generate fast and frugal Heu-ristics. Technol Forecast Soc Change. 2020;16:120324. doi:10.1016/j.techfore.2020.120324
41. Day E, Dear PH, McCaughan F. Digital PCR strategies in the development and analysis of molecular biomarkers for personalized medicine. Methods. 2013;59(1):101-107.
42. Jain S, Venkataraman A, Wechsler ME, Peppas NA. Messenger RNA-based vaccines: Past, present, and future directions in the context of the COVID-19 pandemic. Adv Drug Deliv Rev. 2021;179:114000.
43. Ernest and Young. Life Sciences: Beyond Borders. (Young E&, ed.). Ernest & Young; 2021. Accessed October 1, 2022. https://www.ey.com/en_us/life-sciences/beyond-borders
44. Li JJ. Beginning of an Era The First Block-buster Drug, Tagamet. In: Blockbuster Drugs. Ox-ford University Press; 2014.
45. Seltenrich ML. Pharma 2.0 Business Plan. Accessed October 1, 2022. https://summit.sfu.ca/item/700.
46. Boni AA, Joseph D. Four models for corpo-rate transformative, open innovation. J Commer Biotechnol. 2019;24(4). doi:10.5912/jcb911
47. Chesbrough, H, Vanhaverbeke, W, West J. Open Innovation: Researching a New Paradigm. Oxford University Press; 2006.
48. Rader RA. (Re) defining biopharmaceuti-cal. Nat Biotechnol. 2008;26(7):743-751.
49. Manzano T, Langer G. Getting ready for pharma 4.0. Pharmaceutical Engineering.
Accessed October 1, 2022, https://www.ispe.gr.jp/ISPE/02_katsudou/pdf/201812_en.pdf.
50. Hariry RE, Barenji RV, Paradkar A. To-wards Pharma 4.0 in clinical trials: A future-orientated perspective. Drug Discov Today: 27(1):315-325. https://doi.org/10.1016/j.drudis.2021.09.002
52. Boni AA, Foley SM. Challenges for Trans-formative Innovation in Emerging Digital Health Organizations: Advocating Service Design to Ad-dress the Multifaceted Healthcare Ecosystem. J Commer Biotechnol. 2020;25(4). https://doi.org/10.5912/jcb957
53. Burns LR, Burns LR. The Business of Healthcare Innovation. Cambridge University Press; 2012.
54. McCullough A, Patrick K, Boni AA. New Clinical and Commercial Opportunities in Digital Health: A Special Issue of Journal of Commercial Biotechnology. J Commer Biotechnol. 2022;27(1):4-6. doi: 10.5912/jcb1022
55. Frost and Sullivan. Monetizing the Future: Business Model Transformation in Healthcare: Digi-tal Health Technologies and Value-Based Reim-bursement Spur New Opportunities. Accessed Oc-tober 1, 2022. http://healthcarethinktank.org/wp-content/uploads/2016/12/Business-Model-Briefing.pdf.
56. Boni A. Emerging Business Models and Strategies to Accelerate Innovation in the Bio-pharmaceutical Industry. J Commer Biotechnol. 2017;22(4).doi:10.5912/jcb753
57. Boni AA, Moehle C. Biotechnology lessons for robotics: Adapting new business models to ac-celerate innovation. J Commer Biotechnol. 2014;20(4). Doi.10.5912/jcb673
58. Boni AA, Molloy PL. A conversation on accel-erating innovation in biopharma and life sciences through global collaboration and alliances. J Commer Biotechnol. 2021;26(4). Doi.10.5912/jcb1004
59. Mack GS. Pharmas partner in venture seeking drug discovery tools. Nat Biotechnol. 2008;26(9):960-962.
60. Boni AA, Joseph D. Aligning the Corpora-tion for Transformative Innovation: Introducing In-novation Dashboard 2.0. J Commer Biotechnol. 2019;24(4). Doi.10.5912/jcb910
61. Boni AA, Gross DM, Gunn MA, Levine DS. Companies Recognized as Innovators for 2021. J Commer Biotechnol. 2021;26(2). doi.10.5912/jcb986
62. Eisenmann T. Why Startups Fail: A New Roadmap for Entrepreneurial Success. Currency; 2021.
63. Boni AA. “Why Startups Fail: New Roadmap For Entrepreneurial Success” By Tom Eisenmann Currency, An Imprint Of Random House (2021). J Commer Biotechnol. 2022;27(2):7-11.
64. Teece DJ, Pisano G, Shuen A. Dynamic capabilities and strategic management. Strategic management journal. 1997;18(7):509-533.
65. Boni AA. Keys for Building and Leading Teams for Innovation in Organizations: Three Book Reviews and Author Commentaries. J Commer Bio-technol. 2022;27(2):12-27.
66. White G. The Mystery of Collective Intel-ligence. Ethics Press;2022.
67. Bethune KG. Reimagining Design: Unlock-ing Strategic Innovation. MIT Press; 2022.
68. Mangold M. Today’s Superpower: Build-ing Networks: 7 Mindset Principles to Thrive in a Fast-Changing World. NewDegreePress; 2021.
69. Isaacson W. The Code Breaker--Young Readers Edition: Jennifer Doudna and the Race to Understand Our Genetic Code. Simon and Schus-ter; 2022.
70. Pisano GP. Science Business: The Promise, the Reality, and the Future of Biotech. Harvard Business Press; 2006.
71. Agrawal P. Advantages and challenges in drug re-profiling. J Pharmacovigil. 2015;2:2-3.
72. Spinelli S, Ensign PC, Adams RJ. New Ven-ture Creation. McGraw-Hill Ryerson; 2014.
73. Blank S. Why the lean startup changes everything. Harv Bus Rev. 2013;91(5).
74. Blank S, Dorf, R. The Startup Owner’s Manual. Vol. 1: The Step-by-Step Guide for Build-ing a Great Company. K&S Ranch, Inc.; 2012.
75. Osterwalder A, Pigneur Y. Business Model Generation - Canvas. Wiley; 2010.
76. Almquist E, Cleghorn J, Sherer L. The B2B ele-ments of value. Harv Bus Rev. 2018;96(3):18.
77. Almquist E, Senior J, Bloch N. The elements of value. Harv Bus Rev. 2016;94(9):47-53.
78. Rong Y. Building technology enabled plat-form companies in Biopharma–a perspective on early-stage value creation from Millennium, Alnyl-am, Moderna, & Kymera. J Commer Biotechnol. 2021;26(2). doi.10.5912/jcb990
79. IQVIA. Disparities in Pharmaceutical Ac-cess: How Demographics Impact Patients’ Abilities to Overcome Prescription Initiation Barriers. Ac-cessed October 1, 2022. https://www.iqvia.com/locations/united-states/library/white-papers/disparities-in-pharmaceutical-access-how-demographics-impact-patients