Ricardo Toshio Yugue
Doctorate – Contributing factors to performance in product development projects: the case of generic drugs
Advisor: Prof. Dr. Roberto Sbragia
Comission: Profs. Antonio Cesar Amaru Maximiano, Adriana Marotti de Mello, Roque Rabechini Júnior and Humberto Gomes Ferraz
Class: 217, FEA-5
Investments in new drugs can be significantly high and, consequently, the performance of their development projects is of great relevance. The development of generic drugs represents a significant portion of investments in new products made by pharmaceutical laboratories established in Brazil. However, recent analyzes with data from the Brazilian Health Regulatory Agency (Anvisa) show that a relevant portion of requests for generic drug approval are denied. These results gave rise to questions about the reasons for such a high failure rate and whose answers were not found in the literature. Thus, this study aimed to identify the factors that contribute to the performance of development projects for generic drugs in the pharmaceutical industry installed in Brazil. In the qualitative phase, the categories of data were identified and a theoretical model was proposed to represent the relationships among the performance of generic drug development projects (GDDP) and their contributing factors, which defined the research hypotheses. In the quantitative phase, the structural model defined from the data of the first phase of the study was analyzed together with its constructs and indicators. The data collected through an electronic questionnaire were analyzed using partial least squares structural equation modeling (PLS-SEM). The results allowed to identify and validate 5 indicators for the performance of the GDDP for the Performance construct and 44 indicators of contributing factors for the Managerial, Structural and Technical constructs. The analysis of the structural model indicated that there is a relationship between managerial difficulties (Managerial construct) and low performance (performance construct) of the GDDP. However, the relationship between technical difficulties and low performance and the relationship between structural difficulties and low performance could not be confirmed. The structural model also tested the indirect effect of technical difficulties and structural difficulties on low performance of the GDDP through the mediation of managerial difficulties. Both indirect effects have been confirmed. Thus, the study concluded that the low performance of the GDDP is directly influenced by the difficulties in managing the GDDP. It also concluded that even factors that theoretically would be out of project control, such as structural and technical requirements for the drug products, can be influenced by management. The study also identified the factors with the greatest contributions to low performance, such as: deficiencies in project management, project portfolio management and integration with other GDDP members. In addition, it pointed out the possibility that the difficulties in the GDDP are influenced by organizational specific characteristics and decisions, such as its culture, organizational structure and companies’ strategic decisions.
*Abstract provided by the author