Productivity, in research and development

Gamier, Jean-Pierre. Rebuilding the R D Engine in Big Pharma. Harvard Business Review 86, no. 5 (May 2008) 68-76. An analysis of recent declines in stock prices of pharmaceutical companies identifies one major source of the problem—declining productivity in research and development of new drugs. The author recommends reorganization of the research divisions to become more flexible and decentralized and to better exploit the enthusiasm of scientists. 

Terpene chemists use mainly gas chromatography in dealing with terpene mixtures in research and development as weU as in quahty control. Capillary gas chromatography with stable bonded-phase columns, the primary analytical method, is also being used more frequendy in the 1990s in product quahty control because its greater resolution is helpful in producing consistent products. 

Progress in research and development in the wood-based industry and in the adhesive industry has shown many successes during the last decades. On the other hand, many industrial requirements still require considerable and important developments in this area. The main driving forces today are cheaper , quicker and more complex . The first two are caused by the heightened competition in the above-mentioned industries and the attempt to minimize costs while maintaining a certain level of product quality and performance. The key word more complex stands for new and specialized products and processes. Adhesives play a central role in wood-based panel production. The quality of bonding, and hence the properties of the wood-based panels, are determined mainly by the type and quality of the adhesive. Development in wood-based panels, therefore, is always linked to development in adhesives and resins. 

Rocky Flats is a Government-owned and contractor-operated facility which originated in 1952. The plant s primary missions are metal fabrication, assembly, and chemical processing—with emphasis on production-related research and development. Chemical processing activities involve the recovery of plutonium from Rocky Flats Plant scrap, waste materials and residues, and effluent streams. The final product of this recovery and purification effort is high-purity plutonium metal for use in foundry operations. 

This detailed article discusses how new environmental regulations (in particular regarding volatile organic compounds, or VOCs, in solent products) affect research and development in the field of adhesives and sealants. 

Over the past 40 years, capillary electrophoresis (CE) has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrumental-based method for micro-scale separation, but also emerged as an indispensable tool in the biotech and pharmaceutical industries. CE has become a method of choice in research and development (R D) for molecular characterization, and in quality control (QC) for the release of the therapeutic biomolecules.In the biopharmaceutical industry, more and more CE methods have been validated to meet International Conference on Harmonization (ICH) requirements. In this chapter, we present real industrial examples to demonstrate the role of CE in R D of pharmaceutical products. The focus in this chapter is on method development analytical control for manufacturing and release of therapeutic proteins and antibodies. 

The term person means any natural person, corporate entity, partnership, association, joint venture, or trust which is engaged in research and development, planning and design, production and manufacturing, distribution, or sales and marketing of any Drug Product. 

The productivity of research and development efforts within the pharma industry has declined significantly in the past decade. While large numbers of INDs are submitted each year, only a small proportion in the pipeline emerges as NDA submissions or approvals. NDA submissions have fallen by half, from a high of 50 in 1995,... 

The development of a new pharmaceutical product continues to be costly and time consuming. In 1997 the FDA approved 38 new molecular entities for marketing, and the pharmaceutical industry spent about 35 billion dollars in research and development. This amounts to about 1 billion for each new drug brought to market that year. A more conservative estimate, based only... 

The process of scale-up in the pharmaceutical industry generally involves moving a product from research and development into production. Numerous pitfalls could be met on this path. It is a well-known fact that often the production process cannot achieve the same product quality as was envisioned in the development and pre-approval stages. Losses in terms of effort and money can be enormous, which is why scale-up and postapproval changes are so important and so strictly regulated. 

Robert McNamara, the secretary of defense, and few policymakers in London cotdd have remained unaware of the concept of opportunity cost when considering the long-range resource implications of new projects for weapons systems. Opportunity cost, represented by alternative uses to which resources employed in research and development, or production, or strategic deployment, could be put, and cost-effectiveness of weapons systems and strategies, provide the conceptual bases of this book. 

In the past, the principal factors that a businessman had to take into account when plotting a future course of activity for his firm were the attitude of the public toward his products and the likely actions and reactions of actual and potential competitors. If he chose to engage in research and development, he added a third category of worries—the possibility that nature might prove fickle and prevent his scientists and engineers from developing the new products and processes upon which his plans... 

However, investments in research and development are characterized by special risks. First there is the risk that the technical objective sought will not be achieved. Then there is the risk that the product or process cannot be profitably marketed. Mansfield s work makes clear that the latter are generally more important than the former (due in part perhaps to the small technical advances typically sought in industrial research projects) but that taken together, these risks are high. 

Obviously, each material in a formulation can be characterized in this way by use of instrumented press studies and Ileckel plot analysis in research and development. This approach can be of use to formulators in selecting specific excipients for specific drug entities. However, the characterization and performance of the final formulation are the critical measurements in the scale-up/production compaction operation. 

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