Biosimilars—why terminology matters (original) (raw)
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Innovation in the Biopharmaceutical Pipeline
The U.S. innovative biopharmaceutical industry leads the world in the development of new medicines: over the past decade some 300 new prescription medicines have been approved for use by the U.S. Food and Drug Administration (FDA). Together, these innovations have contributed to a range of new treatments resulting in improvements in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative new therapies for some of the most costly and challenging diseases and conditions has never been greater.
Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development
Continuous innovation is one of the pharmaceutical industry's most defi ning characteristics. New medications can be crucial for maintaining the quality of human life, and may even affect its duration. The sales potential is staggering: the global pharmaceutical market is expected to reach $1.1 trillion by 2015. The pressure to succeed is tremendous. Yet, pharmaceutical innovation is hardly an orderly, predictable process. It follows a technology-push model dependent on a meandering path of scientifi c breakthroughs with uneven timing and hard to foresee outcomes. Technological competency, decades of rigorous research, and profound understanding of unmet customer needs, while necessary, may prove insuffi cient for market success as the critical decision for commercialization remains outside the fi rm. Drug innovation as a business process requires savvy strategic, organizational, and managerial decisions. It is already enjoying intensive research coverage, giving rise to abundant but relatively dispersed knowledge of the mechanisms driving drug discovery and development. In this chapter, we present a comprehensive overview of the process of drug innovation from a business and academic perspective. We discuss the evolving organizational forms and models for collaboration, summarize signifi cant empirical regularities, and highlight differences in market positions related to fi rms' strategic orientation, innovation emphasis, attitudes to risk, and specialized resources. As a guide to future research, critical drivers and modes for drug innovation are systematized in a unifying framework of characteristics and process decisions, and multiple areas in need of further scrutiny, analysis, and optimization are suggested. Because of its rich potential and high signifi cance, research on drug innovation seems poised to gain increasing momentum in the years to come.
Technological Forecasting and Social Change, 2014
There is a widespread perception that pharmaceutical R&D is facing a productivity crisis characterised by stagnation in the numbers of new drug approvals in the face of increasing R&D costs. This study explores pharmaceutical R&D dynamics by examining the publication activities of all R&D laboratories of the major European and US pharmaceutical firms during the period 1995-2009. The empirical findings present an industry in transformation. In the first place, we observe a decline of the total number of publications by large firms. Second, we show a relative increase of their external collaborations suggesting a tendency to outsource, and a diversification of the disciplinary base, in particular towards computation, health services and more clinical approaches. Also evident is a more pronounced decline in publications by both R&D laboratories located in Europe and by firms with European headquarters. Finally, while publications by Big Pharma in emerging economies sharply increase, they remain extremely low compared with those in developed countries. In summary, the trend in this transformation is one of a gradual decrease in internal research efforts and increasing reliance on external research. These empirical insights support the view that large pharmaceutical firms are increasingly becoming 'networks integrators' rather than the prime locus of drug discovery.
Journal of Investigative Dermatology, 2020
In an era of increased complexity of clinical research, a demand for personalized medicine, an increasing value of diversity, a focus on digital health, and a call for patient centricity, the discovery and development of new medicines, more than ever, is dependent on collaboration between multiple stakeholders.
Expectations and visions in industrial practice On the case of modern biopharmaceutics
Expectations and visions play an essential role in building strategic intelligence. They give orientation in the dynamics of sciences, technologies, and industries. Investigation of these frames of mind is rapidly expanding, with many important results. Pharmaceutics has always been an innovative industry. Biotechnology is identified as having an immense potential for an industrial revolution that also revolutionizes pharmaceutics. Concerning R&D, the essential problem of the recently converging pharmaceutics and biotechnology is the innovation of innovation. This means that the search for innovation itself is awaiting a Schumpeterian creative destruction. History of modern biotechnology is a steady stream of spectacular visions of repeated revolutions. But the realised profound progress in R&D in the process of convergence have not diminished the strong tension of the increased challenges and the permanent productivity crisis of pharmaceutics which has become chronic in the past twenty years.
The positive impacts of Real-World Data on the challenges facing the evolution of biopharma
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Demand for healthcare services is unprecedented. Society is struggling to afford the cost. Pricing of biopharmaceutical products is under scrutiny, especially by payers and Health Technology Assessment agencies. As we discuss here, rapidly advancing technologies, such Real-World Data (RWD), are being utilized to increase understanding of disease. RWD, when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. Furthermore, RWD can inform the understanding of disease, help identify new therapeutic intervention points, and improve the efficiency of research and development (R&D), especially clinical trials. Pursuing precompetitive collaborations to define shared requirements for the use of RWD would equip service-providers with the specifications needed to implement cloud-based solutions for RWD acquisition, management and analysis. Only this approach would deliver cost-effective solutions to an industry-wide problem.