Models that depict innovation as a smooth, well-behaved linear process badly misspecify the nature and direction of the causal factors at work. Innovation is complex, uncertain, somewhat disorderly, and subject to changes of many sorts. Innovation is also difficult to measure and demands close coordination of adequate technical knowledge and excellent market judgment in order to satisfy economic, technological, and other types of constraints—all simultaneously. The process of innovation must be viewed as a series of changes in a complete system not only of hardware, but also of market environment, production facilities and knowledge, and the social contexts of the innovation organization.

An Overview of Innovation

A survey of the CRISPR patent landscape shows the improvement of technology, a diversity of potential sectors of application, and a new geopolitical balance of forces in the field.

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Worldwide CRISPR patent landscape shows strong geographical biases.

Despite the success of tissue engineered medical products (TEMPs) in preclinical translational research, very few have had success in the clinical market place. This gap, referred to as the "valley of death" is due to the large number of ventures that failed to attract or retain investor funding, promotion, and clinical acceptance of their products. This loss can be attributed to a focus on a bench to bedside flow of ideas and technology, which does not account for the multitude of adoption, commercial, and regulatory constraints. The implementation of an alternative bedside to bench and back again approach permits investigators to focus on a specific unmet clinical need, defining crucial translation related questions early in the research process. Investigators often fail to accurately identify critical clinical adoption criteria due to their focus on improved patient outcomes. Other adoption criteria (such as price, time, ethical concerns, and place in the workflow) can cause a product to fail despite improved patient outcomes. By applying simplified business principles such as the build-measure-learn loop and the business model canvas to early-stage research projects, investigators can narrow in on appropriate research topics and define design constraints. Additionally, 86% of all clinical trials fail to result in Federal Drug Administration approval, resulting in significant economic burdens. On the reverse side, approval through the European Medical Agency is widely considered to be more direct but has its challenges. The Committee for Advanced Therapies within the European Medical Agency has received 22 market authorization applications for advanced therapy medicinal products, of which only 10 received authorization. A thorough understanding of the various regulatory pathways permits investigators to plan for future regulatory obstacles and potentially increase their chances of success. By utilizing a bedside to bench and back again approach, investigators can improve the odds that their research will have a meaningful clinical impact.

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Beyond the Present Constraints That Prevent a Wide Spread of Tissue Engineering and Regenerative Medicine Approaches.

Purpose – The paradigm shift in global competition and the resulting business challenges have led manufacturing enterprises, particularly in the developing world, to take a different look at their operations Responding to this climate meant reassessing their competitive advantage, and re‐engineering their business models and operations The purpose of this paper is to discuss many of these new challenges and present potential solutions from the practitioner point of viewDesign/methodology/approach – This paper discusses many of these new challenges and presents potential solutions The results are from interviews with the enterprise managers and ownersFindings – The issues are divided into three categories based on who can manipulate them: regional and international, national, and enterprise factors The level of enterprises' ability to respond to these issues varies from full control to partial or no control Nevertheless, issues' impact could be minimized by certain adopted polices and action plansP

Challenges and remedies of manufacturing enterprises in developing countries

Despite continuous efforts to improve the process of drug discovery and development, achieving success at the clinical stage remains challenging because of a persistent translational gap between the preclinical and clinical settings. Under these circumstances, the discovery of human induced pluripotent stem (iPS) cells has brought new hope to the drug discovery field because they enable scientists to humanize a variety of pharmacological and toxicological models in vitro. The availability of human iPS cell-derived cells, particularly as an alternative for difficult-to-access tissues and organs, is increasing steadily; however, their use in the field of translational medicine remains challenging. Biomarkers are an essential part of the translational effort to shift new discoveries from bench to bedside as they provide a measurable indicator with which to evaluate pharmacological and toxicological effects in both the preclinical and clinical settings. In general, during the preclinical stage of the drug development process, in vitro models that are established to recapitulate human diseases are validated by using a set of biomarkers; however, their translatability to a clinical setting remains problematic. This review provides an overview of current strategies for human iPS cell-based drug discovery from the perspective of translational research, and discusses the importance of early consideration of clinically relevant biomarkers.

Translational Prospects and Challenges in Human Induced Pluripotent Stem Cell Research in Drug Discovery.

http://oa.upm.es/6813/2/INVE_MEM_2010_74896.pdf

Technology and industrialization at the take-off of the Spanish economy: New evidence based on patents.

In an environment of crisis and cuts, innovative patent management strategies may offer a way for countries to improve return on R&D investment.

Biotech patents and science policy: the Spanish experience

http://digital.csic.es/bitstream/10261/171902/1/pateevide.pdf

Patenting and licensing by Spanish firms: Available survey evidence

Analyzing the impact of the European unitary patent system on worldwide biotechnology.

Spain’s economy recorded a high rate of growth from the mid-1990s onwards. At the same time, the resources allocated to Research and Development (R&D) grew at a much faster pace than in other European Union (EU) countries. Spain’s growth recorded an average rate of 2.93% from the early 1990s to 2004. Over the same period, the average growth in the EU was 0.46%. This circumstance, together with several sound policy decisions implemented between 2004 and 2009, ushered in a “golden age of Spanish biotechnology”. In terms of the national patent licenses issued by the Spanish Patent and Trademark Office (SPTO) between 2004 and 2009, the number in biotechnology grew from 84 to 151. However, the current economic situation in Spain, along with a series of political decisions taken over the past two or three years to cut spending on R&D, predicts a sharp downturn in the performance of Spanish biotechnology. This scenario makes Spain one of the best places to study the successes and failures of the management of science and allows transfer this experience to the other international regions. We need to analyze the influence of political decisions as a major factor with a bearing on the quality of science. Using patents as an indicator of scientific development, this paper analyzes the evolution of the biotechnology sector in Spain and its relationship with scientific policy and the management of R&D.

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Gerardo Penas

Papers

Technology and industrialization at the take-off of the Spanish economy: New evidence based on patents.

Biotech patents and science policy: the Spanish experience

Patenting and licensing by Spanish firms: Available survey evidence

Analyzing the impact of the European unitary patent system on worldwide biotechnology.

The Use of Patents to Assess National Innovation Systems: Evidences from Spanish Biotechnology