Conference Agenda

A vast body of literature has analyzed Quality by Design (QbD) within the biopharmaceutical sector. This examination includes mainly experimental and technical aspects. However, while the QbD concept itself originates from quality management literature, the understanding of its implementation from this theoretical angle has received scant attention. Our objective is to bridge this gap by analyzing the organizational practices that could facilitate QbD implementation, along with the relevance that it has for innovation and other advantages for biopharma firms.

Through a systematic literature review combined with an evaluation of the regulatory landscape and some industry examples, we propose a conceptual framework and further research agenda.

Our analysis suggests that regulatory agencies and multinational corporations play pivotal roles in facilitating the adoption of QbD. Regarding the benefits of QbD, we posit that firms stand to gain through both incremental and radical innovation upon its implementation. This article contributes to the literature by examining the QbD through a management lens, especially given the generalized neglect of this concept by management scholars over the past two decades, with research predominantly conducted by experimental scientists.

Academic literature shows conflicting findings about whether supplier integration (SI) provides the promised performance for SI forms (white box, grey box, black box). Moreover, practitioners have doubts about whether suppliers are a source of innovation. Given these considerations, this paper explores how SI form influences the performance of component development project, with a particular focus on black box integration. This study adopts an embedded case study design. Based on semi-structured interviews, five component development projects in a multi-national defense company were selected; three of which were investigated in depth. The early findings show that information sharing deficiency and information requirements impact the performance of SI projects. SI forms are categorized according to information sharing requirements and supplier innovativeness. The findings showed that the intended form of SI might be different from the form of integration required by the project. A new type of SI emerged that we called abyssal box integration. This study contributes to the conceptualization of SI forms and particularly black box integration; and discusses the fit between the actual (intended) SI form and required SI form. Another contribution of this study is that configurational perspective may explain performance influences of SI.

Objective: This study explores if firms’ environmental performance, captured by ESG scores and ISO 14001, has a regional environmental benefit, specifically improving regional air quality.

Theoretical framework: Drawing from the ESG and voluntary environmental certifications literature, this paper covers the gap on the effect of corporate environmental practices on regional air quality. The moderating effect of the degree of ISO implementation at the regional level on how firms’ ESG environmental scores influences air quality.

Methodology: For a sample of 1,064 European regions containing more than 190,000 European firms, cross-sectional robust regressions are performed. Exploratory analysis is based on cluster analysis.

Results: The environmental component of the ESG score does not improve air quality unless the region shows a high degree of ISO 14001 implementation among its companies. In addition, ISO certification also has a direct effect on the regional environment: the higher the intensity of ISO 14001 certification, the better the air quality.

Contribution: This is one of the first studies to relate two of the most widely implemented sustainability-oriented practices, ESG and ISO 14001, to air quality at the regional level. From a policy and practice perspective, this research yields several implications.

Chief executive officers (CEOs) are the primary decision-makers in small and medium-sized enterprises (SMEs). However, there has been little research on how CEOs’ dynamic managerial capabilities (DMCs) affect digital transformation (DT). In particular, we focus on three managerial capabilities: expertise breadth, external connectivity and empowering leadership, which are critical to sense, seize and reconfigure resources and capabilities to design digital processes and implementing DT. In addition, higher DT may promote higher new product development (NPD) performance. An empirical analysis of 434 innovative Spanish SMEs suggests that CEO’s digital expertise, external connectivity, and empowering leadership are positively associated with DT. Moreover, DT is positively related to NPD performance. We contribute to expand the concept of DMCs to CEOs of innovative SMEs and to provide new light on mechanisms by which DT and NPD performance can be fulfilled. Finally, we provide managerial implications and future research avenues.