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What is next in biotechnology?
Dr Edison T Liu

Dr Edison T Liu, Executive Director of the Genome Institute of SingaporeMarch 1, 2007: Throughout the world, biotechnology is synonymous with the likes of Amgen, Vertex Pharmaceuticals, and Genentech, companies centered on the development of therapeutics; and companies such as Caliper Life Sciences, Affymetrix, Celera (the original company) and Illumina who provide technology platforms for research and pharmaceutical development. In Asia, as governments and investors push to develop local and regional biotechnology industries, the focus has been on establishing entities based on these existing models. On the whole, the majority of Asian biotechnology companies emerging in the first wave of investment from Taiwan to New Delhi have followed this format. This is all well and good, and both money and societal benefit can still be extracted from this model, but a new business opportunity is arising that is being overlooked by investors. It is one that will inevitably rise in clinical importance and in terms of profit margins. This emerging sector will be in medical informatics, a discipline defined as information technology dedicated to the collection, storage, indexing, processing, retrieval, and analysis of medical information. The prediction is that this underserved sector will see an expansive growth in the next two decades as the need and demand for efficiency, portability, and safety in medical care rises in both the developed and emerging economies.

What is the origin of this need? The cost of medical care has become a significant burden to most countries both advanced and developing. This trend of increased expenditures in health care is seen in every developed nation with the US showing the most dramatic increases. In the US, the national health spending as a percentage of the GDP exceeds 15 percent and is projected to rise to 18 percent by 2012. These levels are unsustainable and are already affecting the competitiveness of US industries such as the automotive industry. Though the pharmaceutical industry has been able to thrive relying on the US market, there are political signs that these progressive increases will not be tolerated in the future. Therefore, in the beginning of the 21st century, there will be much pressure to limit the rise in health care spending from all governments. This of course will have ramifications to the biotechnology and pharmaceutical industries which rely on government buyers and pricing policies.

Earlier, the main driver for medical information technology was for billing, but now, medical informatics is needed for directly medical reasons. A series of reports from the US Institute of Medicine described the dire state of affairs: 44,000-98,000 Americans die because of preventable medical errors, US one-third of the $1.6 trillion health care spending in 2003 went to inappropriate or duplicate procedures, and 190,000 hospitalizations per year could have been prevented by better information technologies 1,2. Across North America and Europe, hospitals are progressively implementing barcode-tracked drug dispensing systems which significantly reduces system errors in dispensing drugs. Any of us who has worked in a hospital system knows the frustration of not being able to obtain a medical chart, X-ray, or lab data of a patient in the emergency room or in the clinic simply because of lost medical records or X-ray files. Whereas health economists have pondered the costs of medical innovation, these reports raise the possibility that major improvement in health care, and major cost savings have been achieved simply by better management of medical information.

Today, in an era of electronic medical records and digitalized radiographs, the only rational medium for medical information is digital and electronic. Yet, this domain has not been exploited by the IT sector as a key business opportunity. It may be because of the earlier disappointments with the cost and inefficiencies of the first medical IT systems, and the "boutique" nature of some of the systems. Moreover, the first systems were geared solely for components within a hospital and not integrated as a health delivery system. The key challenges now are in data integration and interoperability, and in indexing and retrieval.

So what kind of innovation are these? Instead of the medical records locked in hospital vaults, the individual patient will carry his or her complete medical records potentially in a portable memory device, or more likely, in virtual electronic medical record warehouses that will be under the complete control of the patient who can give access to doctors anywhere in the world. This will change the focus of control of medical records to the patient rather than the hospital. Online services will emerge that will allow physicians and patients to intelligently search their medical records for the appropriate information – just like current web search engines do. The digital radiographs/X-rays can be rendered searchable and automated alert systems will be developed that will notify physician and patient of an unusual change in patterns. Online medical "concierge" services will be developed whereby a patient can access medical information about a disorder, or a medical product pertinent to his/her medical concerns. When linked to whole genome sequencing, the individual will have the option of archiving his or her genetic code in a very private vault that can be automatically interrogated as new information arises. The client will be given feedback as to the ramifications of these findings.

I can imagine that medical educational systems, annotated medical literature, and textbook references will be linked to this medical information access platform. In this manner, organized medical educational content can be employed by healthcare workers to build a culture of continuous information expansion as much as continuous quality improvement (CQI) has become an important business process in the manufacturing industry. Business opportunities would be open to those servicing the infrastructure for these medical informatics systems. Clinically relevant information needs to be accessed with the widest bandwidth possible, but also with stringent requirements for data security and confidentiality. The need for medical information to simultaneously have open access to a distributed community but to be highly secure is a difficult problem to resolve. However, solutions are available and drawn from banking and defense IT experience. Those who resolve these security and confidentiality problems will probably sweep the field in as much as IT data security systems are exceedingly profitable today.

By my estimate, medical informatics will be the next "big thing" in biomedicine. I predict that like what happened in the computer industry, where the search engines like Google have achieved market capitalization that exceeded that of the hardware makers, and that rivals that of the software giants, the same will happen in medical IT as compared to medical information hardware.

How big is this market? It is very premature to estimate, but it could be in the billions of dollars once mature. There are already signs that the big companies are not only thinking about the issues but acting on them. IBM recently launched a system for their US employees whereby all of their medical information can be digitalized and made accessible to the employee wherever he or she is transferred to within the international company3. In addition to employee private medical information, it is envisaged that the service will later evolve so that these health records will be co-populated by other data sources, such as detailed information about their health plans, and catalogues from drug mail-order companies providing prescription and pharmacy services to their employees — thus, metamorphosing to a medical "concierge" system.

A most intriguing development has been the establishment of Dossia4,5, by Omnimedix Institute, a non-profit organization based in Portland, Oregon (USA)6 at the behest of a consortium of five major companies: Applied Materials Inc., BP America Inc., Intel, Pitney Bowes Inc. and Wal-Mart Stores. Each are spending "seven figure" amounts to fund this web-based framework for 2.5 million workers, dependents and retirees to keep their standardized, portable, and interoperable personal health record (including X-ray data) in a secure database that is available only to those health care providers approved by the employee. The role of Omnimedix is not only as a service provider, but also as a "trusted third party" that has official firewalls to ensure employee confidentiality especially from his/her employer. Thus, the parent companies cannot access personalized information that can be linked to individual identifiers. In this manner, aggregate information about employee health can be provided to the company for financial and strategic planning without jeopardizing patient identities. Already IT spin-off products and projects have emerged from the Dossia effort. Angeldocs is a web-based application that allows health care centers, social services workers, and emergency room staff match uninsured patients with physicians willing to free services. The advantage to the medical provider is a "paper" trail of activity that can be used for tax purposes, and, in the future, a system to validate the truly needy patient.

Clearly the need is there and the human and technical capabilities are available to answer this need. If so, then why has there not been more activity? In fact, much of the activities in medical informatics in the past have been either premature, misplaced or hampered by confidentiality issues and regulatory uncertainties. Earlier efforts in artificial intelligence to mimic the medical expert did not address any core needs from the medical community. Medical IT during the dot com boom was simply too expensive and cumbersome focusing only on medical billing. Moreover, most systems were neither flexible nor scalable. A number of medical information service providers failed because they were too small or too focused on one narrow area of medical informatics such as patient referrals, or on archiving only the printed medical records. This fragmentation of the medical information provide only local departmental solutions (i.e. procurement or billing), but did not address the need for integrated and often heterogeneous information. Finally, security of comprehensive systems dealing with private medical information is a very sensitive issue and trust by the subscriber is paramount. In dealing with confidential health information, most for-profit business models have not developed adequate strategies to gain and then ensure that trust. This is why Omnimedix may be a very important first effort in the US: it is structured as a not-for-profit organization which is more likely to be structured for public-good. However, for the first time, the need is recognized by organizations with the resources to implement change, and by governments desperate to control medical care costs. So there are reasons to be optimistic.

Why should Asia be interested in this projected medical informatics boom? The first should be the obvious follow through from the IT miracle model of India and Greater China. The human resources, technical and business savvy is resident in this region. The second, however, is less well-known and is based on the significant economic expansion of Asia. With the rise of the middle class in all of Asia, the demand for quality medical services both for local consumption and for medical tourism is very high. New hospitals and medical systems are being built at an accelerated pace in China, India, and Southeast Asia. Each of these systems will strive to have the most advanced information systems to enhance efficiency and safety. The business opportunities not only lie in the provision of services, but also in developing novel IT systems tailored to specific needs and conditions. Therefore, I predict that much of the innovation in medical informatics will come from Asia.

Biotechnology as we knew it in the past must and will change to remain relevant to the medical market place. Here, we explored one new form of biotechnology and that is in informatics. In future essays, we will explore other trends, some obvious, and others more subtle but equally important. In all cases, what you will get will be an honest opinion coming from an Asian source, with a global perspective. Stay tuned.

1. Linda T Kohn, Janet M Corrigan, and Molla S Donaldson, Editors; Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. Institute of Medicine Report, 1999
2. L L Leape and D M Berwick, "Five Years After To Err Is Human: What Have We Learned?" Journal of the American Medical Association 293: 2384–90, (2005)
3. "IBM Provides Its US Workers With Digital Medical Records" http://www.informationweek.com/showArticle.jhtml?articleID=172302570
4. "Health care in America: Bit by bit, Wal-Mart and other big firms are pushing for electronic medical records". The Economist print edition. December 7, 2006. http://www.economist.com/business/displaystory.cfm?story_id=8381465
5. Gregory Lopes "5 firms fund network to fight medical costs".
The Washington Times. December 7, 2006. http://washingtontimes.com/business/20061206-100002-6877r.htm
6. http://www.omnimedix.org/dossia.html

The author is the Executive Director of the Genome Institute of Singapore, Dr Edison T Liu, is a physician-scientist who trained with Nobel Laureate, J Michael Bishop. Dr Liu has authored over 220 papers, reviews and book chapters. He sits on a number of scientific boards for biotechnology and pharmaceutical entities and is also the Executive Director for the Singapore Cancer Syndicate — a funding agency, the Singapore Tissue Network — the national tissue repository, and is Chairman of the Health Sciences Authority of Singapore, the country’s FDA equivalent.

© BioSpectrum Bureau
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