The Usefulness of Biotechnology Firms' Drug Development Status in the Evaluation of Research and Development Costs

2003 ◽  
Vol 18 (1) ◽  
pp. 163-196 ◽  
Author(s):  
Kirsten Ely ◽  
Paul J. Simko ◽  
L. G. Thomas
Author(s):  
Amit B Patil ◽  
Bharath Kumar B ◽  
Ajay P Karnalli

Technology Transfer (TT) is vital action from drug development in Research and Development (R and D) Department to commercial manufacturing till the product discontinuation. This review is an attempt to give an insight about the transfer of pharmaceutical product from R and D to production including necessary documents required to review the supporting documents and execution procedures in production shop floor. TT is considered effective, if there is a documented evidence that the process and its parameters, repeatedly results in desired product quality which was established upon during TT between the transferee and transferor. For the execution of TT process, expertise from different department such as Engineering, R and D, QA, process analyst and production are teamed. the transmission comprises of arrangements procured in these flows of improvement to achieve the quality as planned throughout manufacture.


1992 ◽  
Vol 19 (1) ◽  
pp. 51-78 ◽  
Author(s):  
Paul E. Nix ◽  
David E. Nix

This study reviews the literature and the practice of accounting for research and development (R&D) costs from the first reference in 1917 to the current treatment. The conceptual treatment of R&D is compared to current financial accounting rules and explanation of the evolution of the current rules is presented. The economic and social consequences of the current rules which require R&D costs to be expressed are examined. The paper explores possible alternative treatment of R&D costs. As a contrast to U.S. practice, the accounting treatment of R&D costs in other countries is discussed. Given the findings of this paper, a strong case can be made for changing the way that R&D costs are accounted for in the United States.


2018 ◽  
Vol 243 (14) ◽  
pp. 1125-1132 ◽  
Author(s):  
Jennifer L Wilson

An engineering perspective views cells as complex circuits that process inputs – drugs, environmental cues – to create complex outcomes – disease, growth, death – and this perspective has immense potential for drug development. Logical rules can describe the features of cells and reductionist approaches have exploited these rules for drug development. In contrast, the reductionist approach serially characterizes cellular components and develops a deep understanding of each component’s specific role. This approach underutilizes the full system of biomolecules relevant to disease pathology and drug effects. An engineering perspective provides the tools to understand and leverage the full extent of biological systems; applying both reverse and forward engineering, a strength of the engineering approach has demonstrated progress in advancing understanding of disease and drug mechanisms. Drug development lacks sufficient engineering specifications, or empirical models, of drug pharmacodynamic effects and future efforts to derive empirical models of drug effects will streamline this development. At this stage of progress, the scientist engineer is uniquely poised to solve problems in therapeutics related to modulating multiple diseases with a single or multiple therapeutic agents and identifying pharmacodynamics biomarkers with knowledge of drug pathways. This article underscores the value of these principles in an age where drug development costs are soaring and finding efficacious therapies is challenging. Impact statement Many untreated diseases are not monogenic and are instead caused by multiple genetic defects. Because of this complexity, computational, logical, and systems understanding will be essential to discovering novel therapies. The scientist engineer is uniquely disposed to use this type of understanding to advance therapeutic discovery. This work highlights benefits of the scientist engineer perspective and underscores the potential impact of these approaches for future therapeutic development. By framing the scientist engineer’s tool set and increasing awareness about this approach, this article stands to impact future therapeutic development efforts in an age of rising development costs and high drug attrition.


2021 ◽  
Vol 9 (4) ◽  
pp. 85
Author(s):  
Yingjie Xie

<p><span lang="EN-US">Biosimilar has the advantages of precise efficacy, high safety and stable quality, and occupy an important position in the field of anti-tumor therapy. In order to reduce the expenditure of drugs, the research and development of biosimilar drugs has attracted much attention. Compared with European and American countries in the development of the anti-tumor biosimilar industry, there are still some shortcomings and parts that need improvement in China. According to the current development status of China, analyzed the reasons for the development dilemma of my country’s anti-tumor biosimilar industry, and put forward suggestions for the development of this industry.</span></p>


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