Performance of the collaborative commercialization strategy: Strategic alliance

The biopharmaceutical industry has several notable characteristics such as high R&D costs of $ 125 million to $ 250 million per drug, long-term commercialization cycles, and very complex and often long-term legislative procedures. All of these are associated with a high level of inherent uncertainty in the innovation process. Another characteristic of the biotechnology industry is the division of the innovative workforce between biotechnology R&D firms and pharmaceutical firms (customers) according to their capabilities. Dynamic knowledge bases such as genomes, molecular biology and proteomics as well as the novelty and fluidity of the biotechnology industry's scientific and technical knowledge needed to develop new products. This shows that the collaboration between companies is beneficial. Because the biotechnology industry includes a population of relatively young companies (e.g., proprietary biotechnology companies), there exists research partnership among these venture entrepreneurs, established and sustainable companies, and / or universities (Sorrentino and Garaffo, 2012) As mentioned above, adopting a strategy of participatory commercialization in today's changing environment is one of the vital business strategies of the firm (Standing et al., 2008). The increasing trend of coalition building since the 1980s and the increasing share of revenue from the implementation of this strategy in firms indicate the growing importance of their use (Kanzanilo et al., 2017). The output of the participatory approach has received much attention as a commercialization strategy in the form of performance, and many researchers have looked at the issue from different dimensions and angles. However, the lack of a comprehensive view of all the dimensions and constructs that determine performance is felt in the research literature. Thus, the present study seeks to identify the determinants of the performance of the participatory commercialization strategy (strategic alliance) in the bio-pharmaceutical industry (biosimilar). The study helps to develop the theoretical foundations of commercialization strategies by reviewing the latest articles in the reputable scientific databases. Then, a model extracted from the research literature is validated through the group modeling technique by 20 industry experts and 10 academic experts. The results are presented as the final model in the research. In general, the design of the present study is based on the five-step approach presented by McKenzie et al. (1999). Accordingly, the research stages include 1) research design: explaining the problem and reviewing the theoretical background, 2) conducting research and model construction: developing a conceptual framework and determining the relevant structures, 3) research validation: general validation of research and data collection, 4) data analysis: analysis of the results using descriptive-analytical statistical methods and partial least squares, and 5) reporting the research summarizing the research findings and documenting the research analyses. The present study is in the field of combined research (qualitative-quantitative) in terms of the purpose and developmental in terms of data nature and analysis style. This research in the qualitative part is done through interviews and in the quantitative part through surveys. According to the objectives and type of the research, in terms of the methodology, survey is the most appropriate method. It is a method in which measurement tools are used to obtain data about the statistical sample with high accuracy, speed and efficiency, and its results can be generalized to a larger community. The sampling method in this research in the qualitative part is theoretical sampling, and the statistical population of the research is all the research published in valid domestic and foreign scientific databases until 2020. The studies have been scoured in order to obtain a sample that causes theoretical saturation. Theoretical validity was the basis of the validity of this study. In order to achieve it, extensive field studies, theoretical pluralism, and experts’ opinions were used. In addition, the model for performance prediction by the Biopharma's participatory commercialization strategy in Iran has been done through the validation steps of Lavache (1975). In this study, a group of 30 people was selected as the focus group. Based on the criterion of action and the structure of the conceptual model, the value of content validity ratio (CVR) was calculated. The demographic characteristics of respondents included age, level of education, gender, history of activity in the field of medicine, history of activity in the field of biosimilars, and research background in the field of biosimilars commercialization strategies. Most experts (more than 70%) were in the age range of 36 to 51 years. More than 83% of the responding experts had PhD degrees. Only one female respondent was present in the panel of experts. More than 75% of the experts had at least six years of experience in the pharmaceutical field. More than 46% of them had more than 10 years of experience in the field of biosimilars. In addition to the history of practical activities in the field of biopharma, the panel of research experts had research backgrounds. There were also master's theses, doctoral dissertations, books, dissertation consultations, articles, and research projects. The quorum required for the content validity ratio for each of the indicators waa 0.33. This study addresses a set of underlying factors including dynamic management of coalition capability, social capital, learning, ownership regimes, productive resource composition, coalition governance, opportunistic behavior, trust, conflict management, relational capital, partner appropriateness and environmental dynamics. The study aims at the formation of strategic alliances for the commercialization of biopharmaceuticals. In previous studies, however, these factors were not examined simultaneously and comprehensively. Currently, the dominant commercialization in the Iranian biosimilar industry is based on an independent and individualized strategy.