Strengthening Academia-Industry Collaboration to Advance Pharmaceutical and Biotechnological Innovation – a Call for Papers

The management and exploitation of biotechnological product innovation have proven to be more difficult than initially expected because the number of currently marketed biotechnological products is far from sufficient to counter deficits in pharmaceutical innovation. This study provides insight into the role of governance structures in interfirm cooperation and their effects on biotechnological product innovation and company success. Most of the existing literature regarding alliances and mergers and acquisitions (M&A) examines their effects on technology recipients' innovation performance. Here, the effects of alliances and M&A on both the innovation success and financial performance of technology suppliers (i.e., sources) are examined. Drawing from a sample of 220 human therapeutic biotechnology and biopharmaceutical firms over a period of 32 years (1980–2011), an analysis of the effects of biotechnology clusters, strategic alliances, and acquisitions is provided. This study reveals the existence of a risk‐return trade‐off for strategic alliances between biotech companies and larger, more established firms. Increased biotech company involvement in product development alliances decreases risk by increasing the likelihood of future product introductions. The trade‐off, however, is that biotech companies earn lower returns when their products are developed through such alliances. A similar risk‐return trade‐off effect is found for clusters. However, acquisitions generally affect both product introductions and product returns in a negative way. These findings have strategic implications not only for managing the development of biotechnological product innovations and technology platforms but also for commercialization strategies with respect to interfirm cooperation and risk reduction.

The Future of Biotechnology Funding

\n O presente trabalho apresenta uma alternativa para despertar nos principais players do setor da inovação farmacêutica e biotecnológica um interesse maior em utilizar os resultados das invenções brasileiras de empresas e instituições de pesquisa na produção de novos medicamentos. Considerando o atraso brasileiro em relação aos processos de inovação que derivam do conhecimento cientifico e as inúmeras peculiaridades dessas inovações nas áreas farmacêuticas e biotecnológicas apresentamos algumas sugestões de incremento no arcabouço jurídico nacional com base em estruturas legais e, também, usando parte da legislação americana como paradigma para algumas mudanças. Nesse sentido, sugerimos a criação de sociedades de propósito específico entre os setores público e privado para o desenvolvimento da inovação, o que permitiria que questões estratégicas, como a co-titularidade das patentes, fossem dirimidas em acordos societários (quotistas ou acionistas). Além disso, recomendamos a constituição de um núcleo de inovação tecnológica em institutos de pesquisa como no Instituto Butantan para usufruir dos benefícios da lei de inovação, principalmente em relação ao licenciamento de patentes e, nos moldes do Bayh Dole Act em vigor nos Estados Unidos, sugerimos que o setor público, ao licenciar as patentes, privilegie as empresas nacionais de pequeno porte.\n

Contents: Introduction (I. Farquhar, K. Summers, A. Sorkin). INNOVATION IN REGULATORY AND OUTCOMES RESEARCH APPLICATIONS (1) After-Market Drug Regulation: Promoting Public Trust in Innovation (R. Field) (2) Transcending Tradition: Quality of Life as the Inextricable Link Between Activities of Daily Living and Specific Organ and Disease States (E. Vinik and A. Vinik) (3) Development and Validation of Eleven Symptom Indices to Evaluate Response to Chemotherapy for Advanced Cancer: Measurement Compliance with Regulatory Demands (S. Rosenbloom, D. Cella et al.) (4) Confounding in Health Services Research: Issues and Solutions (F. Shaya and A. Gu). ECONOMICS OF INNOVATIVE BIOPHARMACEUTICALS (5) Prices, Regulation and Innovation in Pharmaceuticals and Biotechnology (J. Hay) (6) The History and Economics of Pharmaceutical Patents (A. Wertheimer and T. Santilla). INNOVATION IN SYSTEM-OF-SYSTEMS APPLICATIONS (7) Modernization of the Joint Forces Ammunition Logistics Information System: Agile, Adaptive, Serving the Modular Forces (I. Farquhar and A. Sorkin) (8) Innovation in Health, Environmental and Safety Research Infrastructure (I. Farquhar et al) (9) The Value of Information Technology Innovation in Healthcare (M. Bhor et al) (10) Costing Innovation (N. Hulkower).

This chapter examines the role of pharmaceutical patents in the on-going support of pharmaceutical innovation. The social value of pharmaceutical innovation and the importance of its sustained growth are explained. The government buy-outs of patents to reduce drug prices for all American consumers while preserving vital drug innovation are proposed.

Dear Reader, Introspection and open debates are called for in the current context of the clarion call for innovation in pharmaceuticals, biotechnology, diagnostics and preventive healthcare. The Indian pharmaceutical industry is lagging behind in the global innovation index as well as in all forms of research and innovation. India is known as a source of qualified technical human resources. However, the quality of this resource is far inferior and often appears unfit for the higher echelons of innovative research. Who is to blame? The quality standards of education in many of the Indian Universities are relatively mediocre, to put it softly. Indian universities do not figure in the top 200 universities of the world. The Indian student community is not to be blamed for this pathetic state. Over the years, the Indian education system has de-emphasized the objective of knowledge acquisition and all-round development of the student as the goal of education. Education in Indian universities generally concentrate on training for employment and nothing more. Higher learning objectives have been diluted over the last few generations, so much so, that many of the current crop of teachers, professors and research scientists are themselves falling short of needful training and teaching skills. The student community has become the victim of the mediocre quality of teaching faculty. Therefore, it is imperative that the Indian educational system and infrastructure should emphasize more intensively on “training the trainers” and helping the teaching community to “learn, unlearn and relearn” to meet the growing demands on upgrading the quality of Indian education. In these times of ongoing disputes and debates on language education, it is indeed shocking to observe the poor English language skills of highly “qualified” doctorates and researchers. The agencies and organizations responsible for the quality of education in India should wake up now or it will be too late.

Unlocking the secrets: Structure-function dynamics of plant proteins.

Inherency in the Patenting of Biotechnology and Pharmaceutical Innovation

Identification of NRPS and type II PKS biosynthetic gene cluster (s) encoding decaplanin and kigamicin from Amycolatopsis regifaucium DSM 45072T.

The pharmaceutical industry has long been one of the most innovative industries and, unlike industries such as computers and aircraft, has remained relatively unconcentrated. In recent years, however, there have been contrasting industry developments that could have far-reaching, long-run effects on the industry's structure. This paper examines the impact of the entry of new biotechnology firms, the increasing real cost of innovation, and the recent important mergers among leading firms. Also, a regression analysis reveals disproportionately high innovative contributions from both new biotechnology firms and the very largest multinational pharmaceutical firms.

The last decade has witnessed an increase in the development of extraction techniques for volatile components from different matrices. Meanwhile, analytical methods have shifted toward the miniaturization of sample preparation procedures, the reduction of solvent consumption, and the adoption of solventless or solvent-minimized extraction techniques to lessen the use of organic solvents and toxic reagents. These innovations plan to enhance extraction efficiency, improve sensitivity, and side with sustainability goals by reducing environmental impact. In this context, the present review article aims to provide the readers with a comprehensive understanding of sample preparation and extraction techniques for the analysis of plant volatilome. The elucidation of plant aromatic and fragrant substances is of great significance due to their diverse roles in fragrance, flavor, agriculture, and medicine and for their potential application in biotechnological and pharmaceutical research innovations. Particularly, this review compares conventional extraction methods with alternative and more appealing, solventless methods, evaluating their efficiency, scalability, and applicability on both laboratory and industrial scale. The discussion revolves around the development of high-throughput sample preparation procedures, sampling protocols, and their different aspects and areas of application. Finally, the greenness of the different methodologies is critically evaluated in terms of solvent, time, and energy consumption, pointing out sustainable and cost-effective approaches for plant volatilome analysis.

Using automated patent landscaping and legal geography analysis to spot biopiracy activities in the island of Hispaniola

The paper suggests an accounting-based methodology for defining open innovation adoption modalities, based on economic and financial transactions in inbound and outbound processes. The framework is applied to a sample of 274 top research and development spending companies operating in bio-pharmaceutical and technology hardware and equipment industries. For biotechnological companies open innovation represents a core activity, with most of them having high values of revenues deriving from joint development projects and licensing. On the other side, for pharmaceutical companies open innovation is somehow ancillary: even if most open innovation activities are widespread, their values are not really significant if compared to the total business volume. For companies in the technology hardware and equipment industry the use of spin-ins as a mean for incorporating external knowledge is a characteristic activity and also the acquisition and selling of innovation-related intangibles is quite pervasive. Further, a limited number of semiconductors companies have remarkable values of licensing revenues.

Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

Building on a technology-centric framework, this book questions whether the system of supplementary protection certificates (SPC) for medicinal products established in Europe in the 1990s is still fit for purpose in light of the current pharmaceutical innovation landscape. After comprehensively setting the stage by describing the legal and economic environment surrounding the pharmaceutical market, the book rapidly dives into in-depth analysis of regulatory texts and case law, establishing itself as a key reference for practitioners, scholars, judges and legislators in life sciences. Traditionally, the pharmaceutical industry was focused on patenting small-molecule medicines. Over the last decades, the industry has pivoted towards biotechnological medicinal innovation and is increasingly securing secondary patents for new indications, formulations, dosages and so forth. The SPC Regulation was built to serve the former model. The book aims to assess whether these technological developments and go-to-market patenting strategies challenge the nearly unchanged SPC system. The main output of the book is a systematic and well-balanced disentanglement of the case law surrounding the SPC Regulation, which lays out the evolution and inconsistency of the decisions of the Court of Justice of the European Union and their application to biotechnological medicinal products and secondary innovation. This technical differentiation benefits greatly from the scientific expertise of the book’s author and her ability to dissect said subject matter with ease and precision. The incorporation of historical materials, opinions by advocate generals, national judgments and summary tables augments the strength of the author’s arguments.