Policymaking for innovation in Vaccine development & production, an overview to the current challenges

Document Type : Research Paper

Authors

1 Ph.D. Candidate, Department of Technology Management, Science and Research branch, Islamic Azad University, Tehran, Iran.

2 Faculty of Management and Accounting – Allameh Tabatabaei University, Tehran, Iran

3 Associate Professor / Department of Educational administration, Science and Research branch, Islamic Azad University, Tehran, Iran.

4 Assistant Professor / Pasteur Institute of Iran, Tehran, Iran

Abstract

Today, the importance of vaccines becomes more important: by influencing the society's health system, the country's economy is being affected and regarding the bio-security issues, these become highlighted for defense affairs. Moreover, innovation capability in vaccine production is assumed as engine of biotechnology development which is propounded as one of the new emerging technologies which support countries technological development. This study is based on analysis of scientific documents with subject of innovation and challenges in vaccine production, followed by deep interview with experts, content analysis and multiple Delphi method which completed with statistical analysis to be used as policy recommendations. Not long ago, the most important challenge in this field was assumed as technical or budget issues but due to the changed paradigm of vaccine production, other challenges in commercialization have stepped in. The nine identified current challenges and provided enablers/blockers parameters for vaccine development can be used for policymaking in health issues and realization of goals set in domestic health system. Concentrating on integrated policy-making, enabler laws, and regard to geopolitical issues are some of the most important identified policy issues.

Keywords

References

-         ستاد توسعه زیست‎فنّاوری کشور (اردیبهشت 1394) برنامه عملیاتی کارگروه واکسن، تهران.
-         سرلک، محمدعلی؛ ویسه، سیدمهدی؛ پوراشرف، یاسان ا... و مهدی‎زاده، حسین (1391) طراحی مدل سازمان معنویت‎گرا در آموزش عالی ایران، پژوهش‎هایمدیریتعمومی، (18)، 24-5.
-         کریمی، صدیقه؛ نصر، احمدرضا (1392)، روش‌های تجزیه‌وتحلیل داده‎های مصاحبه، عیار پژوهش در علوم انسانی، (7)، 94-71.
-         قدسی، محمد (1350) تاریخچه خدمات 50 ساله انستیتو پاستور ایران، تهران، انتشارات انستیتو پاستور.
-         مرندی، وحید (1382) شناسایی مزیت‌های نسبی و فرصت‌های سرمایه‌گذاری در کشور، شالوده رویکرد موثّر به تحقیق و توسعه، چهارمین همایش بین‌المللی مراکز تحقیق و توسعه: جامعه مراکز تحقیق و توسعه صنایع و معادن- وزارت‎های علوم، تحقیقات و فن‌آوری، صنایع و معادن.
-         مرندی، وحید (1380) توسعه صنعتی زیست‎فنّاوری در کشور، اهمیت و راهکارها، دومین همایش ملی بیوتکنولوژی: وزارت علوم، تحقیقات و فنّاوری- مرکز ملی تحقیقات مهندسی ژنتیک و تکنولوژی زیستی.
-         مرندی، وحید (1383) مورد کاوی تحقّق اهداف و تحلیل رویکردهای مدیریت در یک پروژه عمرانی ملّی، دومین کنفرانس بین‌المللی مدیریت: دانشگاه صنعتی شریف- سازمان گسترش و نوسازی صنایع ایران- گروه پژوهشی صنعتی آریانا.
-         مرندی، وحید (1384) تحلیل مؤلفه مدیریت دانایی در یک پروژه راهبردی ملّی، پنجمین همایش بین‌المللی مراکز تحقیق و توسعه: جامعه مراکز تحقیق و توسعه صنایع و معادن- وزارت علوم، تحقیقات و فن‌آوری- وزارت صنایع و معادن.
- ABPI. Written evidence to House of Commons Science and Technology Committee inquiry into EU regulation of life sciences (2016) Available from: URL: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/science-and-technology-committee/impact-of-european-regulation-on-uk-life-sciences/written/30729.html
- Amit, R. and Zott, C. (2001) ‘Value creation in e-business’, Strategic Management Journal, Vol. 22, No. 6, pp.493–520.
- Bernstein, B. Singh.P.J. (2006) an integrated innovation process model based on practices of Australian biotechnology firms, Technovation, 26, pp.561–572.
- Big pharma has higher profit margins than any other industry, (cited 2014 Nov.14). Available from: URL: https://www.andruswagstaff.com/blog/big-pharma-has-higher-profit-margins-than-any-other-industry
- Chaturvedi, K. and Chataway, J.  (2012) Strategic integration of knowledge in Indian pharmaceutical firms: creating competencies for innovation, Int. J. Business Innovation and Research, Vol. 1, No. 1–2, pp.27–50.
- Clemens. J.D. Jodar.L (2004)  Translational research to assist policy decisions about introducing new vaccines in developing countries, J Health Popul Nutr 2004; 22:223:31 pmid: 15609774
- Folkers.G.K, Fauci.A.S, (2003) Vaccine Research and Development: The Key Roles of the National Institutes of Health and Other United States Government Agencies, The Jordan Report, NIH Publications, USA.
- Garnier, J.P (2008), Rebuilding the R&D machine in big pharma, Harvard Business Review, May Vol. 86, No. 5,pp.68–76.
- Haeussler, C. (2007) Proactive versus reactive m&a activities in the biotechnology industry, Journal of High Technology Management Research, Vol. 17, No. 2, pp.109–123.
- Hardman Reis.T (2006) the role of intellectual property in the global challenge for immunization. J World Intellect Prop, 9 (4): 413–25. Doi:10.1111/j.1422-2213.2006.00284.x.
- How brexit would impact pharma, (cited 2016June7), Available from: URL: http://www.eiu.com/industry/article/1664152350/how-brexit-would-impact-pharma
- Innovation in Pharmaceutical Biotechnology: Comparing national innovation systems at the sectoral level (2006) OECD, ISBN-92-64-01403-9.
- International Monetary Fund Report (2014) IMF Survey: More efficient public investment Mideast, Central Asia priority, The International Monetary Fund (IMF).
- KFDA (2012) recent trends and Korea’s cases in the development of gene therapy products KFDA. 2008; Available from:
http://www.bioin.or.kr/upload.do?cmd=download&seq=7676&bid=industry.Accessedon 4/5/2012.
- Keen, P. Qureshi, S. (2006) Organizational transformation through business models: a framework for business model design, Paper presented in the Proceedings of the 39th Hawaii International Conference on System Sciences, pp.1–10.
- Kellogg, J.L. (2002) Managing R&D in the biotechnology Sector, Kellogg Graduate School of Management, Working Paper, pp.1–20.
- Kurdin.A (2012) Business models and opportunities for cancer vaccine developers, Landes Bioscience: Human vaccine & Immunotherapeutics, Oct. 2012, 8; 10, 1431-1438.
- Kleinbaum, A. Tushman, M (2007) Building bridges: the social structure of interdependent innovation, Strategic Entrepreneurship Journal, Vol. 1, No. 1–2, pp.103–122.
- Malone.K.M, Hinman.A.R, (2007) Vaccination mandates: The public health imperative & individual rights, Oxford University Press, New York, 262-284.
- Market entry of 9 new recombinant pharmaceuticals, (cited 2015 May 22), Available from: URL: http://www.parsine.com/fa/news/239114
- Matherne, B.P. (2007) Does whom you know matter in venture capital networks? The AcademyofManagement Perspectives, Vol. 21, No. 4, pp.85–86.
- McDonough, III, E.F. Athanassiou, N. Barczak, G. (2006) Networking for global new product innovation, Int. J. Business Innovation and Research, Vol. 2, No. 1–2, pp.9–26.
- McGrath, R. Nerkar, A. (2004) Real options reasoning and a new look at the R&D investment strategies of pharmaceutical firms, Strategic Management Journal, Vol. 25, No. 1, pp.1–21.
- Nerkar, A.Roberts, P. (2004) Technological and product-market experience and the success of new product introductions in the pharmaceutical industry, Strategic Management Journal, Vol. 25, No. 8, pp.779–799.
- Newall, A.T. Reyes, J.F. Wood, J.G. McIntyre, P. Menzies, R. Beutels, P. (2013) Economic evaluations of implemented vaccination programmes: key methodological challenges in retrospective analyses. February 2014, Vaccine 32 (7): 759–765. Doi:10.1016/j.vaccine.2013.11.067.
- Olesen.O.F, Lonnroth.A, Mulligan.B, (2009) Human vaccine research in the European Union. Vaccine 27 (5): 640–5. Doi:10.1016/j.vaccine.2008.11.064. PMID 19059446.
- Oyston.P, Robinson.K, The current challenges for vaccine development (2012) Journal of Medical Microbiology, 61, 889-894.
- Qian, G, Wang, D (2000) Factors that affect performance of US small and medium sized technology-based enterprises: does multinationality matter? J of Business andEntrepreneurship, Vol.11, No.4, pp.119–131.
- Qian, G, Li, L. (2003) Profitability of small- and medium-sized enterprises in high-tech industries: the case of the biotechnology industry, Strategic Management Journal, Vol. 24, No. 9, pp.881–887.
- Rathore. A. S, Bhalghat. M, Patra. A.K (2012) Key Considerations for Development and production of vaccine product, Biopharm. Int. J. s1_s6.
- Report in support of knowledge based companies, (cited 2017March28), Available from: URL: https://www.bmn.ir/fair/news/news/73755
- Rhyne.L.C (2009) Business model design for biotechnology firms, International Journal of Business Innovation and Research, Vol. 3, No. 3, pp.298-310.
- Rice, M. O’Conner, S. and Pierantozyi, R. (2008) Implementing a learning plan to counter project uncertainty, Sloan Management Review, Vol. 49, No. 2, pp.54–62.
- Rothaermel, F, Deeds, D. (2004) Exploration and exploitation alliances in biotechnology: a system of new product development, Strategic Management Journal, Vol. 25, No. 3, pp.201–221.
- Rottingen.J.A, Regmi.S, Eide.M, (2013) Mapping of available health research and development data: what’s there, what’s missing, and what role is there for a global observatory? Health Policy, The Lancet Journal, Oct.12, 2013, Vol. 382, 1286-1307.
- Seelos, C, Mair, J (2007) Profitable business models and market creation in the context of deep poverty: a strategic view, Academy of Management Perspectives, Vol. 21, No. 4, pp.49–63.
- Stam, W. Elfring, T (2008) Entrepreneurial orientation and new venture performance: the moderating role of intra- and extra-industry social capital, Academy of Management Journal, Vol. 51, No. 1, pp.97–111.
- Teece, D (1982)  Toward an economic theory of the multiproduct firm, Journal of EconomicBehavior and Organization, Vol. 3, No. 1, pp.39–63.
- Thomas, L (2004) Are we all global now? Local vs. foreign sources of corporate competence: the case of the Japanese pharmaceutical industry, Strategic Management Journal,Vol. 25, No. 9, pp.865–886.
- Thompson, K. M. Tebbens, R. J. Pallansch, M. A. Kew, O. M.Sutter, R. W. Aylward, R. B. et al.  (2008) The risks, costs, and benefits of possiblefuture global policies formanaging polioviruses. Am J Public Health, 98, 1322–1330.
- Tolstoy, D. Agndal, H. (2008) Network resource combinations in new international ventures, Paper presented in the Proceedings of the Global Business Innovation and DevelopmentConference, Rio de Janeiro, Brazil, pp.453–454.
- Voss, G. Sirdeshmukh, D. Voss, Z. (2008) The effects of slack resources and environmental threat on product exploration and exploitation, Academy of Management Journal, Vol. 51, No. 1, pp.147–164.
- Wasserman.E, (2016) Astellas cancer med Xtandi draws fire as U.S. lawmakers demand a pricing hearing, Fierce Pharma, Regulatory Notes, 29 March 2016, USA.
- Wells, R.M.J. (2008) the product innovation process: are managing information flows and cross-functional collaboration key? The Academy of Management Perspectives, Vol. 22, No. 1, pp.58–59.
- Widdus. R. (2010) Vaccine Innovation done differently, Bulletin of the W.H.O 2010; 88: 880-880. Doi: 10.247/BLT.10.082826
- Woiceshyn, J. Folkenberg, L (2008) Value creation in knowledge-based firms: aligning problems and resources, Academy of Management Perspectives, Vol. 22, No. 2, and pp.85–99.
- World Bank. (2006) Korea as a Knowledge Economy:Evolutionary Process and Lessons Learned. The World Bank, Washington D.C. 2-15.
- World Bank. (2017) Doing Business: 2018, the World Bank, Oct. 2017, Washington D.C. 2-15.
- Zhao, R. (2003) Transition in R&D management control system: case study of a biotechnology research institute in china, Journal of High Technology Management Research, Vol. 14, No. 2, pp.213–229.
 
 
 
 
 
 
 
Journal of Technology Development Management
Volume 5, Issue 3
October 2017
Pages 33-60

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History

  • Receive Date: 13 November 2017
  • Revise Date: 10 July 2017
  • Accept Date: 26 July 2017

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