Keynote review: Is declining innovation in the pharmaceutical industry a myth?

Strategic Management Group, Laboratories, Pfizer Global Research and Development, Sandwich, Kent, UK.
Drug Discovery Today (Impact Factor: 5.96). 09/2005; 10(15):1031-9. DOI: 10.1016/S1359-6446(05)03524-5
Source: PubMed

ABSTRACT Increasing the rate of innovation is a requirement to achieve much-needed advances in patient care, as well as to secure the future of the pharmaceutical industry. Currently, there is a perception in the external environment that pharmaceutical R&D is no longer innovative, fails to bring new drugs to market or, at best, produces a rising number of 'me-too' drugs with no advantage over existing treatments. In addition, the cost to discover and develop new medicines (i.e. cost per launch) has risen dramatically in recent years. The quoted development cost per medicine is a reality, and is not disputed here. However, data are provided that demonstrate that with regard to innovation rates, the current perception is wrong - although there have been, and continue to be, fluctuations in drug launches, there has been a steady increase in the number of new chemical entities launched, both in absolute numbers of FDA-approved medicines and in the proportion of priority reviews.

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    • "The process of chemical drug discovery is long and arduous that it begins from the search of a potential candidate to the development of a marketable drug. It can span the course of more than a decade, and can cost an average of 800 million USD in the USA [1] [2] [3]. Under special circumstances such as the search for effective drugs to treat AIDS, the Food and Drug Administration (FDA) in USA and other countries have encouraged an abbreviated process for drug testing and approval (called fast tracking) [4] [5]. "
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    ABSTRACT: Synthetic chemical drugs, while being efficacious in the clinical management of many diseases, are often associated with undesirable side effects in patients. It is now clear that the need of therapeutic intervention in many clinical conditions cannot be satisfactorily met by synthetic chemical drugs. Since the research and development of new chemical drugs remain time-consuming, capital-intensive and risky, much effort has been put in the search for alternative routes for drug discovery in China. This narrative review illustrates various approaches to the research and drug discovery in Chinese herbal medicine. Although this article focuses on Chinese traditional drugs, it is also conducive to the development of other traditional remedies and innovative drug discovery.
    Evidence-based Complementary and Alternative Medicine 03/2011; 2011:403709. DOI:10.1093/ecam/neq056 · 1.88 Impact Factor
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    • "In fact, the number of new molecular entities submitted to the FDA for review has decreased from 44 in 1996 to 22 in 2006 (Fuscoe et al., 2007). At the same time the cost of development to bring a new molecular entity to market has been estimated to be nearly $1 billion (Kola and Landis, 2004; Schmid and Smith, 2005). "
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    ABSTRACT: Systems toxicology is the integration of the classic toxicology paradigm with parallel global analyses across multiple levels of biological organization, and holds the promise of new biomarker development for predictive, preventive, and personalized public health. It typically involves measuring and integrating transcriptomic, proteomic, and metabolic (Omics) data. The aims of each of the Omics technologies are to extract information that has mechanistic and diagnostic value. Although each Omic technology can associate changes in a gene expression, protein, or metabolite profile with a physiological endpoint, the combination of these data may provide a holistic picture of the mechanism for the physiological endpoint of interest. Because each individual Omic method provides large numbers of potential alterations, several alternative models may be formed to explain the toxicology. By integrating the results of these new Omics tools, the number of possible models will be reduced and the functional activity of complete biochemical pathways and a more complete assessment of cellular alterations can be obtained. The application of a systems toxicology approach will result in maximizing the information obtained for each experimental animal, and thus reduce the number of animals used in experiments. The development of mechanistic-based biomarkers will result in potentially limiting or avoiding the subsequent use of additional animals. Introduction The mission of the United States Food and Drug Administration is two-fold ( opacom/morechoices/mission.html). First, the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, medical devices, cosmetics, and products that emit radiation. Second, the FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. Thus, the role of the FDA is one of regulation, but also of encouraging the innovations that will deliver safe and effective medical products and foods. One of the new research areas that promise great benefits is Omics technologies. Omics technologies are defined here as tools for making comprehensive measurements of many or all of the expressed genes (microarray gene expression profiling), proteins (proteomics), and endogenous metabolites (metabolomics) of a tissue or organ. Systems toxicology is the integration of the classic toxicology paradigm with the parallel global measurements made possible by Omics technology, and will result in new biomarkers for predictive, preventive, personalized public health. While these technologies have obvious applications to understanding toxicity and disease mechanisms, they also may have tremendous potential for the 3 Rs -refinement (by the development of early biomarkers), reduction (by obtaining more information per animal), as well as replacement (by allowing monitoring of humans).
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    • "For this industry, a large part of the profits and value of the firms depends on the results of the R&D activities. Compared with other industrial sectors, the pharmaceutical industry has a high number of patents and inventions developed in entrepreneurial environment, and a R&D experience of more than 200 years (Achilladelis & Antonakis, 2001; Attridge, 2007; European Commission, 2007a, 2007b; IMS, 2005, 2006, 2007; Orsenigo, Pammolli, & Riccaboni, 2001; Quere, 2003; Schmid & Smith, 2005). "
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