Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry

This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms. This is but the latest development which adds to an existing catalogue of challenges including the decline of the traditional generics markets, regulatory hurdles in advanced country markets and failures in managing new drug development. Using case studies of three Indian firms we show that dynamic managerial capability is a key driver of heterogeneity in learning processes involved in acquisition of technological capabilities for biosimilars and market access strategies. It further highlights the important role of pre-existing capabilities in enabling and constraining the development of new biosimilar capabilities

Intelligent systems in manufacturing: current developments and future prospects

Global competition and rapidly changing customer requirements are demanding increasing changes in manufacturing environments. Enterprises are required to constantly redesign their products and continuously reconfigure their manufacturing systems. Traditional approaches to manufacturing systems do not fully satisfy this new situation. Many authors have proposed that artificial intelligence will bring the flexibility and efficiency needed by manufacturing systems. This paper is a review of artificial intelligence techniques used in manufacturing systems. The paper first defines the components of a simplified intelligent manufacturing systems (IMS), the different Artificial Intelligence (AI) techniques to be considered and then shows how these AI techniques are used for the components of IMS

The Role of the Health Care Sector in Expanding Economic Opportunity

This report provides an overview and critical assessment of the ways in which multinational pharmaceutical companies currently participate in expanding economic opportunities in developing countries. As pharmaceutical companies become more involved in both business and philanthropic activities in developing countries, it will be important for each company to identify the best strategies available to it to create new economic opportunities and to leverage the benefits of activities already underway. While the primary focus of the industry is, and will most likely continue to be, on increasing access to health care, the potential for expanding economic opportunities through its activities should not be overlooked as a significant outcome. The analysis and case studies contained in the report highlight companies' contributions to economic opportunity expansion through job creation, training and capacity building, and shaping public policy. The report also offers recommendations for future work to increase economic opportunities. This paper is part of the Economic Opportunity Series published by the CSR Initiative at Harvard University Kennedy School

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 1: Executive summary

The feasibility of the commercial manufacturing of pharmaceuticals in space is examined. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is presented. Antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon were studied. Production mass balances for antihemophilic factor, beta cells, and erythropoietin were compared for space verus ground operation

The Workforce Needs of New Jersey's Pharmaceutical and Medical Technology Industry

This report is based on an online survey conducted in spring 2006 of pharmaceutical and medical technology companies in New Jersey. It identifies the current and future workforce needs of the pharmaceutical and medical technology industry in New Jersey

Shared Value in Emerging Markets: How Multinational Corporations Are Redefining Business Strategies to Reach Poor or Vulnerable Populations

This report illuminates the enormous opportunities in emerging markets for companies to drive competitive advantage and sustainable impact at scale. It identifies how over 30 companies across multiple sectors and geographies design and measure business strategies that also improve the lives of underserved individuals

Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology method

Racing against COVID-19: a vaccines strategy for Europe. Bruegel Policy Contribution Issue n˚7 | April 2020

The fast development of vaccines is an essential part of the long-term solution to COVID-19, but vaccine development has high costs and carries the risk of high failure rates. There are currently too few promising projects in the clinical trial pipeline to guarantee at least one vaccine soon. More projects need to pass through the development pipeline in parallel. Vaccines should ultimately be widely available to all who need them at low cost. Private life-sciences companies under-invest in vaccine development, especially when compulsory licensing and/or price regulations are imposed. Public funding is needed to reduce the risks of investing in vaccine development, and also to balance compulsory licensing and/or price regulations with incentives for private firms. The public funding being put into identifying COVID-19 vaccines is too limited to carry enough projects through so that at least one vaccine, and preferably more, become available at large scale and low cost. Public budgets for these efforts need to be multiplied up several times over. We propose a staged support scheme to tackle the COVID-19 vaccine challenge and a moon shot programme to meet the challenge of future pandemics. We calculate the public budget needed to ensure supply of COVID-19 vaccines. Although substantial, the budget represents a bargain compared to the avoided health, social and economic costs

Effects of Geopolitical Strain on Global Pharmaceutical Supply Chain Design and Drug Shortages

Pharmaceutical supply chains are global and exhibit geographic and industrial concentration for some drugs. In this context, geopolitical risk and company decisions threaten drug availability, where countries with low manufacturing capacity are most at risk. We present the first supply chain design model that considers geopolitical strain, i.e., export bans and export ban-induced price increases, and the role of alliances in mitigating those risks. Uncertainty is also included in suppliers, production, and demand. The model takes the company's perspective as a decision-maker looking to locate plants and minimize costs by satisfying worldwide demand. The model is solved by integrating the Sample Average Approximation and L-shaped methods. Our case study is based on vincristine, a generic oncology drug. We find that geopolitical strain may reduce shortages in the short term and affect investment decisions and their outcomes. Bilateral alliances between nations result in minor improvements for the company and drug shortages. The results also reveal disparities in drug access. The global expected shortage at the base case is 21%. For high and upper-middle-income countries, expected shortages are 3.1% and 3.7%. However, expected shortages are 98.7% and 95.2% for low and lower-middle-income countries. New pricing policies may improve drug access