Offshoring in the Pharmaceutical Industry

Impact of stronger intellectual property rights regime on innovation: Evidence from de alio versus de novo Indian bio-pharmaceutical firms

Global competition and uncertainties call for manufacturers to adopt advanced supply chain practices that help them achieve competitive advantages in a volatile business environment. In this essence, the current research examines how supply chain integration, just-in-time practice, and quality management boost a firm operational and financial performance during a pandemic crisis like COVID-19. Similarly, this study examines the moderating effect of IT advancement on the relationship between a firm operational and financial performance. The sample size of this study is assessed with a priori power analysis. Data were collected from employees working in manufacturing firms, including construction equipment, transportation, electronic products, engineering, chemical, pharmaceutical, and healthcare manufacturers. For empirical analysis, 380 responses were estimated with a structural equation modeling approach. Constructs validity and reliability are tested in the measurement model. Empirical findings revealed that factors such as internal integration, process integration, product integration, just-in-time, and quality management collectively explained R^2 75.4 % variance in firm operational performance. In addition, effect size analysis 〖 f〗^2 shows that product integration has the highest importance in determining a firm operational performance. The research model has shown substantial predictive power Q^2 54.2% to predict firm operational performance. The moderating impact of IT advancement is established and revealed that IT advancement in the supply chain will strengthen the relationship between the firm’s operational and financial performance. Theoretically, this research has developed an integrated supply chain model that combines supply chain integration factors, just-in-time, quality management, and IT advancement to investigate the firm’s operational performance. To practice, this study suggests that policymakers should concentrate on process integration, just-in-time supply chain strategy, and IT advancement, which boosts the firm’s operational and financial performance. This study is unique as it discloses several useful findings which would help manufacturers deal with an unprecedented situation like the COVID-19 pandemic.

While the information systems scholarly and practice literatures both stress the importance of senior executive engagement with IT management, the recommendations for doing so remain, at best, limited and general. Examining the influence of serious IT-related deficiencies on CEO/CFO turnover within the post-SOX financial reporting context, specific CEO/CFO IT management responsibilities are identified: CEOs are shown to be held accountable for global IT management responsibilities, and CFOs are shown to be held accountable for demand-side IT management responsibilities. Implications for information systems research, management research, and information systems practice are provided.

Strategic information systems planning: A case study from the financial services industry

BackgroundThe use of cells in research and diagnostic studies is important. This is of paramount importance in the biopharmaceutical product industry because cells are one of the most important platforms in the biopharmaceutical industry.ObjectiveThe availability of highly efficient and suitable cells that can be continuously used for the mass production of biotechnological products is crucial for maintaining human health and hygiene. So, the cells used in this comprehensive system were studied, evaluated, documented, and stored for continuous and efficient use.Study designThis review article discusses all aspects of cells involved in establishing this system as a Cell Bank System (CBS). Cell banking facilities, specialized laboratories, appropriate equipment, cold rooms, cryopreservation instruments, and cell authentication and characterization are mentioned. Cell handling, row materials tests, documentation, intellectual property registration, storage, backup, and transportation were explained. In addition, policies for cell retesting and revival are discussed.ResultBased on the roadmap designed in this study, a comprehensive cell bank system can be formed for using in cell preparation, propagation, storage, and use of cells.DiscussionConsidering that in the pharmaceutical industry, there is a need for a reliable, permanent, and uniform source of cells to produce and quality control the product, which can have significant effects on the products, by using this system and performing all of its aspects, diagnostic centers, researchers, and pharmaceutical manufacturers can access a reliable and persistent source of culture for related operations.

Everybody On Board Stage 3 Meaningful Use in 2018

This paper examines the growth of dynamic capabilities among firms in the Indian software industry by looking in some detail at the changing constraints, opportunities and competition facing incumbent firms. It emphasizes the important role played by tight labour market conditions in inducing investment in process capability and the role of entrepreneurial experimentation in evolving a business model (outsourced software) that was best suited to limited resource advantages of Indian software firms. The growth of the Indian software industry has been a phenomenal success when measured against standard indicators such as growth in sales, employment and exports, and especially when contrasted with the performance of other industrial sectors in India. Even measured against successful new exporters of software, such as Israel and Ireland, the Indian software industry stands out in terms of the volume of employment created and the indigenous nature of its growth. The largely untold story of the Indian software industry centres on the abilities of the pioneer firms in the industry who learnt how to transform the programming skills of their labour force into firm-specific capabilities, and to become credible rivals of firms such as Accenture, EDS and IBM Services in the outsourced-software market. The particular strength of Indian firms was their ability to assemble teams of talented engineers and deliver a technical, outsourced service to exacting and different customers anywhere in the world. They also leveraged their capabilities for maximum economic value through the adaptation and perfection of a new business model. This model was based around an outsourced service offering, and different variants of it were developed by Indian firms as new economic opportunities arose. Over time, one variant of this outsourcing model commonly known as offshoring, has come to be applied to other domains and areas: call centres, financial services and other forms of content management services of large firms that can be done remotely. As a result, India now enjoys a ‘created’ comparative advantage in outsourced services and offshoring. An interesting aspect of the history of outsourcing is that the factors that were crucial to the emergence of outsourced software exports from India were quite distinct

Design management systems have been developed and researched for traditional product and service industries. For interaction design little research has been performed on design management. The objective of this paper is to describe aspects of and provisions for industrial interaction design that influence approaches to design management within system and software development. We discuss whether there are specific conditions for design management of interaction design within the software and system development industries. The research is based on three short case studies from industrial software development. We identify some of these specific conditions; the difference between a usage and a product perspective, the design tools and practices, and the modularized and distributed processes. These issues point towards challenges facing design management within the software and system development context, as well as the need for interaction design to clarify its position as a strategic resource in software companies. The conclusions point towards the need for continued research on strategic possibilities and alternatives to organize and manage design work in software and system development.

Indian IT industry had a very late start when compared to US or Europe. Yet in the last decade, Indian IT firms have emerged as a global powerhouse in computer software development. Indian firms have transformed from a modest coding and body shopping operation to become a global competitor in a leading edge sector. Indian IT consulting companies are now competing globally with the established industry giants. One of the most important characteristics of globalization is the opening of the national markets to foreign firms, something that has led to intensified competition in these markets (James Leontiades, 1986). Firms all over the globe realize that they cannot expect their sales and profits to grow at satisfactory rates unless they implement appropriate business strategies to sustain and possibly improve the competitiveness of their products in the international markets.

Empirical evidence on the association between firm value and corporate governance has mixed results depending on the chosen attributes for governance and firm value. The study investigated this relationship for financial services firms in India. Based on the literature review, four attributes of corporate governance were chosen: ownership concentration, institutional ownership, board independence, and CEO duality. Tobin’s Q value was taken as a proxy for firm value. The dataset consisted of 20 companies formin part of the National Stock Exchange financial services index. An additional two control variables are included in the model: the firm’s size and leverage ratio. All data were sourced from the annual reports of the companies, and the period of study is from 2016 – 2020. The panel data were analyzed using the generalized method of moments. The empirical findings revealed a positive and significant impact of ownership concentration, institutional ownership, and board independence on firm value, while the CEO duality role had no impact on firm value. The study contributed to the corporate governance literature of financial services firms in India.

The search for waste minimization and the valorization of by-products are key practices for good management and improved sustainability in the food industry. The production of almonds generates a large amount of waste, most of which is not used. Until now, almonds have been used for their high nutritional value as food, especially almond meat. The other remaining parts (skin, shell, hulls, etc.) are still little explored, even though they have been used as fuel by burning or as livestock feed. However, interest in these by-products has been increasing as they possess beneficial properties (caused mainly by polyphenols and unsaturated fatty acids) and can be used as new ingredients for the food, cosmetic, and pharmaceutical industries. Therefore, it is important to explore almond’s valorization of by-products for the development of new added-value products that would contribute to the reduction of environmental impact and an improvement in the sustainability and competitiveness of the almond industry.

In a rapidly changing IT and business management environment the demand for competent IS personnels is increasing. However, it is ironic that the number of IT and IS majors has sharply decreased as well as the widespread skepticism of IS identity. This research suggests directions to differentiate MIS to other IT majors, diversify IS core competency and make general improvements in MIS curriculum. The research recommend the courses of IS Strategy and policy, ITA/EA, Global IT Management, Emerging Technologies, DW/DM, BI, IT Service Science, Project Management, IT Consulting and integrated capstone which are few in Kore universities. This research also stress the course of soft skills like business communication, team building, analytic/logical thinking, rational problem solving and so on as a important IS competency. The pedagogy of course is important, so the research recommend the internship, mentoring programme, lecturers in industry according to industrial - educational cooperation.

SCTS was established in 2008 with the mission of advancing research and education in CTS so as to improve human health. Since CTS research is a cross-cutting enterprise, SCTS will focus on the multidisciplinary processes of conducting CTS research rather than on the results in any specific scientific area or disease. As the missions of many different professional societies overlap SCTS's mission and SCTS recognizes and respects the contributions that these societies have made in advancing the discipline of CTS, SCTS is eager to join with these societies in the common cause of advancing the field. By serving as the bridge between scientific discoveries and improved diagnosis, therapy, and prevention of human disease, CTS research differs from basic science discovery, which focuses on the generation of new knowledge without regard to its immediate application to medicine. The primary objective of CTS research is the improvement of human health at both the individual and community levels. Viewed from an economic perspective, CTS research is also essential for the success of the pharmaceutical, biotechnology, and medical device industries, facilitating the conversion of scientif c discoveries into new drugs and devices, and creating new jobs that derive from the manufacture, sales, and distribution of the drugs and devices. CTS research also has a role in national defense, including the development of methods to diagnose and treat diseases caused by biologic weapons. Thus, CTS is essential for achieving many of the goals the public expects from its investment in medical research through support of the National Institutes of Health (NIH). The creation by the NIH of the Clinical and Translational Science Award (CTSA) program in 2006 dramatically heightened awareness of the discipline of CTS in academic institutions, industry, and philanthropy, as well as among the broader public and the policy makers at local, state, and national levels. With its focus on developing and augmenting advanced degree-granting training programs in CTS, many of which built on the excellent curricula developed under the aegis of the NIH Clinical Research Curriculum K30 Award program, the CTSA program also provided encouragement and new resources to create imaginative educational experiences for individuals who seek careers in CTS. Based on 2007 data from the CTSAs, there are already more that 500 trainees in these programs and when the CTSA program reaches its stated goal of 60 centers, it is likely that there will be more than 1,000 trainees in these programs at any time. The past several decades have been marked by astounding advances in basic science, epitomized by the success of the human genome project and the growing “-omics” revolution. This explosion of knowledge has not, however, been matched by a comparable increase in the translation of that knowledge into new therapies. In fact, the number of truly novel drugs and biologics approved by the Food and Drug Administration each year has not substantially increased since the 1970s despite more than a 10-fold increase in inflation-adjusted investments by the pharmaceutical and biotechnology industries. While many factors Society for Clinical and Translational Science (SCTS) Governance Barry Coller (Rockefeller University) – President Harry Selker (Tufts Medical Center) – Vice President Rebecca Jackson (Ohio State University) – Secretary Anantha Shekhar (Indiana University) – Treasurer Board of Directors Robert Califf (Duke University) Marc Drezner (University of Wisconsin) Daniel Ford (Johns Hopkins University) David Guzick (University of Rochester) Gary Hunninghake (University of Iowa) Eric Orwoll (Oregon Health & Science University) Kenneth Polonsky (Washington University) Robert Sherwin (Yale School of Medicine) NIH Liaison to the Board of Directors John Gallin (NIH Clinical Center) Standing Committees Henry Ginsberg (Columbia University) – Annual Meeting Paul Marantz (Albert Einstein College of Medicine) – Annual Meeting John Gallin (NIH Clinical Center) – Membership Kenneth Polonsky (Washington University) – Nominations Philip Greenland (Northwestern University) – Publications Harry Selker (Tufts Medical Center) – Public Education & Governmental Affairs Anantha Shekhar (Indiana University) – Finance & Audit have contributed to this disappointing gap between scientifc opportunity and medical advance, one important factor is the increasing complexity of conducting CTS research. The full expression of CTS research requires the convergence of expertise across 3 dimensions. The first dimension is the multidisciplinary approach required to perform studies involving human participants. In the past a single investigator could examine a patient on the ward in the morning, take a sample back to the lab and perform an assay by midday, then return to the ward in the af ernoon and institute a novel therapy based on the experimental results. Today, such research requires the efforts of clinical research coordinators, research nurses, pharmacologists, research pharmacists, biostatisticians, bionutritionists, and clinical monitors and auditors, as a well as experts in the protection of human subjects, recruitment, community engagement, bioinformatics, and information technology. The laboratory evaluation itself requires a team approach, with a focus on advanced and expensive instrumentation and procedures commonly found only in large core facilities, supported by extensive quality control programs that meet the exacting standards for clinical laboratories. The second dimension is the continuum that extends from defining a health need, often via careful analysis of epidemiologic data, through basic investigation, preclinical evaluation, human studies, small and large scale clinical trials, analysis of clinical adoption and both therapeutic- and cost-effectiveness in the community, and, finally, returning to epidemiology. This dimension is composed of multiple bidirectional cycles, since each component contains information that potentially can advance every other component. As a result, the free flow of information across what are increasingly viewed as arbitrary boundaries is crucial for success. For example, the data from the Framingham Heart Study demonstrating the association between the risk of vascular disease and serum cholesterol levels played an important role in encouraging investigation of cholesterol metabolism at the molecular level, laying the groundwork for the development of drugs to reduce serum cholesterol levels. The third dimension links the academic community with its partners in the CTS enterprise, including granting, public health, and regulatory agencies; policy makers; the pharmaceutical, biotechnology, and medical device industries; and the philanthropic organizations that fund and support research. Most importantly, using the stem cell analogy, it is essential that the discipline of CTS has the capacity for self-renewal. A commitment to the training and mentoring of the next generation of investigative teams, as well as the support and recognition of the mentors who play the most important role in both training and career development, is crucial for the success and long-term stability of the enterprise. Fortunately, the Association for Clinical Research Training (ACRT) and the National CTSA Consortium Education and Career Development Key Function Committee recognize this need and have jointly conducted an outstanding meeting for trainees and mentors for the past several years. Become a Member For more information visit the SCTS Web site, http://www.societycts.org, or e-mail SCTS@smithbucklin.com. Based on the foregoing considerations, the immediate goal of SCTS is to conduct an annual meeting in cooperation with ACRT and the CTSA Education and Career Development Committee. The first annual meeting is scheduled for April 5-7, 2010, in Washington, DC. It is open to all individuals who participate in or support CTS in academic institutions around the world, as well as individuals from industry, government, and philanthropy. The meeting will focus on the needs of trainees and junior faculty; provide a forum for dissemination of new developments in the design and conduct of CTS research; provide a forum for leaders in governmental agencies, the private sector, and philanthropic organizations to provide updates on their programs related to CTS research; and facilitate scientific collaborations and the development of a cultural identity for the discipline through opportunities for social networking. Other societies with overlapping missions are encouraged to consider meeting in the same location and time as SCTS. SCTS was initially founded by all of the then 38 CTSA recipient institutions as well as the NIH Clinical Center. Since that time the list of founding institutions has extended beyond the CTSA program (an updated list is posted at http://www.societycts.org) and additional institutions are invited to join the list of founding institutions, which will remain open until the f rst SCTS annual meeting. To add your institution to the list of founding institutions, contact the SCTS administrator at (202) 367-1119. Governance is vested in a Board of Directors and of cers derived from institutional members and a liaison member from ACRT. The current Board of Directors, of cers, and committee chairs are listed in Table 1. CTS has been designated as an official journal of SCTS. SCTS wishes to express its deep appreciation to Arthur Feldman, MD, PhD, CTS editor-in-chief, and Danette Somers of Wiley-Blackwell for their support in establishing this relationship. As the founding president of SCTS I want to thank all of the individuals who have worked hard to convert the idea for SCTS into the reality of a newborn society, learning and adapting as it begins its journey, but filled with the excitement, enthusiasm, and expectations that uniquely mark a true new beginning. I look forward to working with each of you to make certain that SCTS achieves its remarkable potential.

This article discusses the impact of regulation on competition and innovation in the pharmaceutical industry. Prompted by concern over attempts at regulating the industry on the European level, we discuss the two basic forms of regulation which we observe to be typical, quality regulation (licencing) and price regulation. In doing so, the analysis focuses on the research segment of the pharmaceutical industry and discusses forms of competition by innovation. Following a recent paper by Nelson, the specific characteristics of competition in the pharmaceutical industry are developed as well as their welfare implications. Regulatory behavior vis‐á‐vis the industry is analysed in terms of a behavioral model initially proposed by Stigler, and an attempt is made to incorporate into the analysis the experience of regulation in both Europe and the United States of America.

The purpose of this paper was to examine the importance of smart production planning for improving performance, considering the specific features of the planning environment in the pharmaceutical industry. This study uses four empirical case studies in the pharmaceutical industry. These four cases represent four companies producing different products within the pharmaceutical industry for various markets, each with distinct processes. Additionally, along with industry insights, these frameworks were used to identify, define, and structure the variables expected to have the greatest impact on the importance of smart production planning within the theoretical framework. This work was carried out through discussions within the project team and repeated multiple times. The framework was subsequently used to map and analyze the four empirical case studies in the biopharmaceutical pharmaceutical industry. The cases were selected to demonstrate different features of the planning environment and smart production planning approaches, ranging from make-to-stock (MTS) to assemble-to-order (ATO) and make-to-order (MTO). Data was collected through observations and site visits at pharmaceutical manufacturing facilities, workshops, consultations, and formal interviews with production managers, production planners, smart supply chain managers, innovation managers, and production line engineers. Internal and cross-case analyses were performed through several iterations within the pharmaceutical industry team. The fundamental finding is that the potential and importance of smart production planning for improving performance increase with the complexity of the production planning environment. As a result, nine final steps for the design and development of smart production planning importance are presented. The conceptual framework presented is based on the combination of smart production planning, the features of the production planning environment, and the elements of the Fourth Industrial Revolution. The developed framework serves two objectives. First, it provides a tool to structure and describe the planning environment in the pharmaceutical industry, considering product, market, and process features. Insights gained from such a framework regarding the planning environment's features can be useful for smart production purposes. The second contribution of the framework is linking the planning environment's features with smart production planning. The core logic is that the importance of smart production planning for improving performance increases with the intelligence and complexity of the planning environment.