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Pharmaceutical Research And Development (pharmaceutical + research_and_development)
Selected AbstractsNonprofit organizations and pharmaceutical research and developmentDRUG DEVELOPMENT RESEARCH, Issue 7 2009Walter H. Moos Abstract Not-for-profit or nonprofit organizations (NPOs) are playing an increasingly important role in providing solutions to the significant challenges faced by both large pharmaceutical and smaller biotechnology companies in today's world. NPOs chartered for the public benefit are common in the United States and in selected other parts of the world. The largest NPOs in the U.S. with bioscience programs include Battelle, the Midwest Research Institute, the Research Triangle Institute, Southern Research, and SRI International. To provide a perspective on NPO business models, 10 SRI case studies spanning a broad range of technical and business initiatives are summarized herein, including basic and contract research, discovery of new drugs and biologics, pharmaceutical and biotech R&D services, technology pivots, company spin-ins and spin-outs, and the creation of new NPOs. The article concludes with lessons learned and food for thought for both pharmaceutical companies and outsourcing participants. Drug Dev Res 70: 461,471, 2009. © 2009 Wiley-Liss, Inc. [source] Examining the link between price regulation and pharmaceutical R&D investmentHEALTH ECONOMICS, Issue 1 2005John A. Vernon Abstract This paper examines the link between price regulation and pharmaceutical research and development (R&D) investment. I identify two mechanisms through which price regulation may exert an influence on R&D: an expected-profit effect and a cash-flow effect. Using established models of the determinants of pharmaceutical R&D, I exploit a unique fact to quantify firm exposure to pharmaceutical price regulation: relative to the rest of the world, the U.S. pharmaceutical market is largely unregulated with respect to price. Using this fact within the context of a system of quasi-structural equations, I simulate how a new policy regulating pharmaceutical prices in the U.S. will affect R&D investment. I find that such a policy will lead to a decline in industry R&D by between 23.4 and 32.7%. This prediction, however, is accompanied by several caveats. Moreover, it says nothing about the implications for social welfare; therefore, these issues are also discussed. Copyright © 2004 John Wiley & Sons, Ltd. [source] Mixture and mixture,process variable experiments for pharmaceutical applicationsPHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 4 2004Christine M. Anderson-Cook Abstract Many experiments in research and development in the pharmaceutical industry involve mixture components. These are experiments in which the experimental factors are the ingredients of a mixture and the response variable is a function of the relative proportion of each ingredient, not its absolute amount. Thus the mixture ingredients cannot be varied independently. A common variation of the mixture experiment occurs when there are also one or more process factors that can be varied independently of each other and of the mixture components, leading to a mixture,process variable experiment. We discuss the design and analysis of these types of experiments, using tablet formulation as an example. Our objective is to encourage greater utilization of these techniques in pharmaceutical research and development. Copyright © 2004 John Wiley & Sons Ltd. [source] Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and developmentBRITISH JOURNAL OF PHARMACOLOGY, Issue 7 2010József Bodrogi The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals. [source] | ||||||||||