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Steve Walsh fig 1
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Robert Tierney
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David Tolfree
Robert Tierney, Nikos, University of Twente
David Tolfree, European VP of MANCEF
Steven Walsh, Regents Professor at UNM and Past President at MANCEF
Commercialisation professionals from entrepreneur and corporate executive to technologist and technology transfer professional search for market drivers when developing products. Traditionally these were limited to market drivers but often other drivers such as regulation, cost reduction and technology change can be equally important. We review those drivers that are promoting small tech (micro and nano technology) based innovations in the pharmaceutical industry.
Many commercial developers see the significance of at least three drivers for the commercialisation process. Here we provide the drivers of change related to the use of small technology based solutions in the pharmaceutical industry. Small technologies are making major inroads into the implantables, therapeutics, diagnostics, drug discovery and other segments of the industry.
Most pharmaceutical innovations are initiated by new sets of drivers. The inclusion of very differing drivers such as changing customer’s expectations, fluid intellectual property procedures and resource requirements are radically changing this industry. A comprehensive list of drivers is to be presented in the new pharmaceutical industry roadmap being developed by the Micro and Nanotechnology Commercialisation and Education Foundation (MANCEF).
We discuss three selected drivers that point toward small tech included or based innovations in segments I through III. We select one market driver (aging population), one technology competency driver (small technology capability to target affected cells) and one regulatory driver (intellectual property). An understanding of how these drivers affect industry is necessary. The emphasis of innovations in the pharmaceutical arena has clearly changed.
Driver I) The global population is aging
The world’s population is living longer so medical expenses are expected to dramatically increase. The more developed countries, as defined by the United Nations, have an overall median population age which rose from 29.0 years in 1950 to 37.3 years in 2000, and is forecast to rise to 45.5 years by 2050. The aging population is a function of both increased longevity and the decreasing birth rates in developed countries. Some suggest that this large increase in longevity is driving healthcare and food demand.
Many presenters at this year’s micro machine summit in Taiwan discussed the role that micro systems, nano systems and other emerging technologies can have on the healthcare policies and treatment of the increasingly aging population, particularly in more economically developed countries. Aging populations require more and cheaper medical therapies and diagnostics for improved longevity and quality of life. Sandia Biosensor and Nanotechnology department for example is investigating Cell-Based Biosensors. It is using molecular biology and genomic-scale technologies to create sensor arrays that utilise living cells as active sensing elements. These biosensors use innate sensing capabilities within living organisms to detect chemical and biological agents for environmental sensing applications. The main figure provides an example of a catalytic Nanoparticle from Sandia National Laboratory.
Driver II) Treating the human system is moving to treating the disease at the molecular level
Traditionally the treatment of a disease is not confined to the treatment of the affected cells but rather pharmaceutical treatments affect the patient as a whole. Today cancer is treated mainly by traditional approaches such as chemotherapy, radiation therapy and surgery. All of these treatment modes affect the whole body. But small tech based products hold the promise of drugs (silver bullets) designed to seek out and specifically eliminate only diseased cells. One early product Zevalin (2011) targets and eradicates CD20 antigens in B-Cell lymphomas or diseased cells preferentially to normal cells (Zevalin 2011). Whether this is accomplished by scaffolding or the preferential combination of the therapies to diseased cells, the convergence of biotechnology, chemistry, nano technology, computational science and MEMS are making their mark.
Driver III) Shifts in intellectual property rights
The dominant form of Intellectual Property (IP) protection strategy for entities in the pharmaceutical industry is patents. Yet there have been huge changes in this area. The first came with the United States-based Bayh Dole Act of 1988. This act provided research institutions ownership of IP as a result of federally funded research (Gross and Allen 2003). US universities, small businesses and non-profits organisation were given control of the intellectual property they generated. Further, the US has recently joined many nations in providing the rights of an invention to the researcher that is first to file, rather than the traditional US stance that the rights went to those who were first to invent (New York Times 2011; Mac Daily News 2011). Finally, the line between discovery and invention especially in molecular biology and nano technology has blurred. Patents rights provided to innovations which are provided closer to discovery have exceptional implications on ‘downstream’ therapeutic and diagnostic development (Allarakhia and Walsh 2010). The ability to appropriately assign intellectual property rights will advance small technology-based innovations in the industry.
These drivers and others are quickly disrupting or radically altering the pharmaceutical industry. They evolved a new business model based on: competency building, patient needs, the changing intellectual property landscape, funding requirements and risk.
Robert Tierney is Ph.D. ABD from the University of Twente Nikos in the field of technology innovation. He was a student hire at Sandia National Laboratory. He has a biology degree and a management of technology and Innovation masters from the University of New Mexico. He has had five ISI ranked journal publications in the last three years.
David Tolfree is the European Vice President of MANCEF. He was the co-founder of Technopreneur Ltd, a micro and nano technology consulting company in the late 1990s and one of the founders of the UK Institute of Nanotechnology. David has over 150 publications, including journal and news articles, conference proceedings, chapters for books, and has been an editor and reviewer for a number of scientific journals. He co-authored chapters for MANCEF’s International Microsystems and Nanotechnology Roadmap and was the co-editor and writer of books, ‘Commercialising Micro-Nanotechnology Products’ and ‘Roadmapping Emergent Technologies’.