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MAIN PAGE | EVENTS & PROGRAMS | 2001 | IGM | SPEECHES | KENJIRO NAGASAKA

Additional Info: Policy Statements Speeches Photos Speakers & Noted Participants Featured Biographies Registration Media Information Conference Statement Regional Vitality in the 21st Century April 6-10, 2001 — Tokyo, Japan Mr. Kenjiro Nagasaka Chairman & CEO Banyu Pharmaceutical Co., Ltd. Contents 21st Century - the Era of Biotechnology Sequencing of the Human Genome Application of Genomics to Drug Designing Ramifications for the Asia-Pacific Economy Construction of a 'Bio-Island' Conclusion 1. 21st Century - the Era of Biotechnology (Significance of Biotechnology) It is an axiom in economics that social progress is begotten of technological innovation. Towards the end of the 20th century there were waves of new technologies in the electronics field centering around computers an telecommunications. This momentum for innovation is still very much alive. Asked what will be the technology next to arrive, no one would hesitate to name bio-technology, or bio-tech for short. As I will discuss very soon, bio-tech is still in its infancy. At this stage it is still unclear what it will look like in the future. However, it may be said that this very opacity represents a golden opportunity for the Asia-Pacific region to play a leading role in the world economy of the 21st century. First, I would like to present a brief overview of today's bio-tech, and then proceed to propose construction of a 'Biotech Island' - a project that will be a driving force for the Asia-Pacific economy in this new century. (Major Playing Fields of Bio-Tech) The deeper we delve into the mechanisms of life sustenance in various organisms, the more we come to realize how delicately and efficiently they are designed. We cannot help marveling at the grand work of God. In this sense, Bio-tech seems to harbor promises of radically changing many of the manufacturing technologies of our times, and becoming one of the most basic technologies for the mankind in years to come. For the time being, areas attracting hottest public attention are applications to drug designing and foodstuff production. (Caution Against Too Much Expectations) It is a fact that the advent of a new technology has always been met with hypes. However, in order to effectively harness a new technology we need to make coolheaded assessment of it and come up with a viable strategy which is firmly based on correct understanding of its status quo. The craze over high-temperature (or room-temperature) super- conductivity provides a good example in point. When this new technology came into the highlights in the 1980s, hopes were flying high that it might immediately lead to an energy revolution or a traffic revolution. However, as known to every one of you, super conductivity researches are still in a stage where day in day out scientists are quietly slogging through unglamorous experiments. The technology is yet to make any major impact on everyday life. Likewise, hopes are soaring over bio-tech, and there is no dearth of people who talk it up as a magic technology that will solve overnight food shortage problems, provide remedies for hard-to-cure diseases and give birth to tailored drugs (or drugs customized to individual patients). All these applications are still distant dreams. Now, prior to moving on to the economic impacts of bio-tech, please let me briefly review some facts about it. 2. Sequencing of the Human Genome (Implications of Human Genome Sequencing) I'm not a scientist, but happens to be in the pharmaceutical industry. Therefore, for reasons you will readily see, I would like to focus my discussion today on drugs, leaving out bio-tech's impacts on foods. On June 28, 2000, President Clinton announced completion of the sequencing of the human genome, and pledged that America would endeavor to develop breakthrough drugs for hard-to-cure-diseases like cancer, diabetes, dementia, etc. and produce genetically modified crops. He also predicted that America's shares in these fields will further grow in the 21st century. To help your understanding of the significance of his statement, I would like to touch on the subject of the genome in passing. (Chromosome) A human body consists of about 60 trillions of cells. Each cell has 23 pairs of chromosomes. A chromosome has double strands of DNA with basic proteins wrapping around them. A DNA strand, when extended, measures up to two meters. Chromosomes are, so to speak, the blueprints of human body. The DNA sequence on a chromosome is in most part common from person to person, but a fraction of it can vary among individuals. Such uniformity or variance gives expression to common or distinctive features in individuals. (Genome) Surprisingly, there are only four types of bases - A.T.G.C. - and approximately 3 billion bases are scattered among the chromosomes. The old saying "Nature is simple" holds true here, because the blueprints for a human body, for all its complexity, is written with only four types of building blocks. The project of sequencing the human genome was started on an agreement among major powers of the world, which divided the work among themselves. Apart from this international undertaking, Celera Genomics in the private sector also set to decipher the human genome, employing batteries of DNA sequencers and super computers. Both groups nearly completed the work almost at the same time. The success of both projects prompted President Clinton to make the aforesaid announcement. The levels of precision of these sequencing attempts are said to be 99.99% for the international team and 99.96% for Celera Genomics. Efforts are continued with an aim to achieving 'six nines' (six-digit nines). One may question if that level of precision is necessary at all. However, if we are told that the human genome is different from that of the chimpanzee only in 1% of the sequence, we will be convinced of the importance of extraordinarily high precision. (Gene) Then how will the 3 billion DNA bases translate into the blueprints of a human body? Of the four types of base, each three bases in a row specifies a code for one of the around 20 classes of amino acid present in our body. Amino acids bind together to form proteins which respectively possess important functions. Thus, each set of three contiguous bases reveals information on proteins. The protein-encoding triplets, or genes, in a genome number around 30,000 to 40,000 at the most. *) *) Estimate by the international team approx. 31,000 Estimate by Celera Genomics 26,000-39,000 The number of genes in a human body is no more than double that of a Drosophila. This fact hints at the enormous complexity of the protein-synthesizing process in our body. (Non-Protein-Encoding Fraction of the Genome) It is said that only 1.5% of bases in a genome represent genes that encode proteins. Then is the rest of DNA a meaningless presence? At the present stage it looks that way. However, it may be just that scientists have not yet uncovered the functions of the remainder. Some of the researchers suspect that activities of genes may be triggered by such DNA. (Present State of Gene Deciphering) Sequencing the 3 billion bases in the human genome is about all that has been achieved so far. Unraveling what the sequence represents is yet to come. In other words, the mankind is only at the start line of the research race, and only God knows how the race will unfold in the future. (Deciphering Plant Genomes) Attempts to decipher the genomes of various life on earth other than human being have only recently succeeded in DNA sequencing of many kinds of microbes, such as yeast and E. coli, a Drosophila and a canine. Regarding plant genome projects, DNA sequencing of rice plant has been in great progress. In these various forms of life, neither the exact numbers of genes encoding proteins nor their functions are yet defined. Nevertheless, researches in such direction will one day provide important clues for solution of food shortage problems. 3. Application of Genomics to Drug Designing (Genomics in Chaos) With such status quo of genomic research in mind, I would like to discuss its application to creation of drugs. For all hypes it has had in recent times, genomic researches are just in an incipient stage. Nevertheless, the stage is being set for scientists of the world to squarely grapple with identifying SNPs (Single Nucleotide Polymorphisms), unraveling genetics of diseases, clarifying three-dimensional structures and functions of gene-encoded proteins, defining gene-activating triggers, etc. It is impossible to predict at this stage whether giant companies, which, with some exceptions, have aggrandized themselves through global mergers or consolidations, will overwhelmingly win the race also in this field, whether smaller upstart ventures will have the upper hand of huge competitors, or whether a third group, apparently out of the field so far, will jump out in front like a dog making off with a bone two others were fighting over. In a sense, genomic study is in a primeval chaos. (Three Possible Scenarios) At present there are three likely scenarios: The first scenario is that some of the existing giant drug companies will become major players. This scenario is based on the assumption that steady efforts will be amply rewarded in the end, because there are no more than 30,000 or so protein-prescribing genes. Huge global operations already have legions of brilliant scientists and are spending enormous amounts of money on drug researches every year. Their modus operandi has been to sift through at least 10,000 candidate compounds, out of which, if they have the luck, one new drug may make it to the market. One may flinch at the mention of 30,000 genes. But this is not necessarily a mind-numbing undertaking for such big players. The second scenario has smaller venture companies as potential winners. It may be said at the risk of a little over-simplification that bio-tech business is radically different from conventional enterprises. Ideas liberated from the yokes of orthodoxy, sometimes even verging on heresy, may be the key to success in this field. Existing big companies are often prisoners of their own success of the past and reluctant to run the risk of taking drastic measures, both in management and R&D. As often as not, they would be left behind the times. In contrast, smaller ventures or subsidies of big companies might be better poised to succeed and grow into big enterprises themselves, because they are free from conventional lines of thinking. There is no shortage of examples: Honda, Fujitsu, Sony, NTT Docomo, to name just a few. In the third scenario, computer-related companies have a vantage point. The sequencing of the human genome was accomplished on computers which deciphered and recorded more or less automatically. It is not that biologists or pharmacologists tackled with the 3 billion DNA bases one by one. This is why Celera Genomics, which came to the race later than the international team, could rapidly catch up and finished neck and neck. Their strengths essentially came from efficient mobilization of computers. In research of genes and proteins in the future, application of bio-informatics, or computerized data-processing techniques, is indispensable. In this light, it is highly likely that computer-related companies, instead of drug companies, will reign over the bio-tech industry in this century. 4. Ramifications for the Asia-Pacific Economy (In Scenario 1.) In Scenario 1., that is to say, if existing giant drug companies become dominant, chances are very slim for new entrants to build their footholds in the bio-tech industry (in this case drug industry), which will be one of the core industries of the 21st century. In other words, most of the East Asian countries will have to stay out of the arena. Japanese drug companies, with a few exceptions, will also be left out. (In Scenarios 2. and 3.) In case Scenario 2. or 3. becomes a reality, there will be good chances for many enterprises across the Asia-Pacific region, large and small alike. Taiwan, ROK and Singapore, in particular, have already recorded long strides forward, riding the booming of the electronics industry. Nowadays, it is next to impossible to talk about computers and software without referring to Taiwan or India. Moreover, the bio-tech industry will prove more beneficial to these countries, because, unlike steel manufacturing or oil refining, it does not necessarily require massive capital outlays on facilities and equipment. At the Harima Science Garden City in Hyogo Prefecture, a huge synchrotron radiator, SPring-8, was constructed and is already in operation. Not only Japanese companies, but also Taiwanese businesses are using part of the about 60 beam lines there. What such an arrangement implies is that parties attempting to define three-dimensional structures of proteins do not have to privately own the colossal facilities any more, but can share their use for a fee. It may follow that, if Scenario 2. or 3. sounds realistic enough, Asia-Pacific countries will have chances of becoming an economic power as a region in the 21st century. 5. Construction of a 'Bio-Island' (Broad Application Fields of Bio-Tech) I have been discussing the possibilities bio-tech offers to our economies, and to the drug industry in particular. As I said at the beginning, bio-tech harbors vast possibilities for drug companies, agriculture and various other industries, as it represents high-precision and high-efficiency manufacturing techniques applicable in many ways. For instance, simplification of acryloamide synthesis and purification of plant sewage with the help of microorganisms are already in practical use. According to this line of reasoning, even if Scenario 1. holds, and giant drug companies carry the day, bio-tech as the basic industrial technology of the 21st century will be worth pursuing for broad application. (Proposal for a 'Bio-Island') Such thinking has prompted me to propose construction of a 'Bio-Island' in the Asia-Pacific region. It will serve as a regional center for bio-tech research and application studies. As witnessed in Silicone Valley, even in a world where an efficient network of telephone, fax and internet is in place, it is very meaningful to get researchers to mingle in person, exchange information and mutually enlighten themselves. As it seems, such cumulative effect is felt most strongly in new research areas. In this light, the 'Bio Island' will play a major role in ensuring the leading role of the Asia-Pacific region in the industrial scene of this century. (Checkpoints for the 'Bio-Island' Plan) It is important to keep the following in mind in drawing a blueprint for the Bio-Island, so that it will help foster biological research and industry: i) Consolidation of Infrastructures Needless to say, there should be solid IT and other social infrastructures for the Bio-Island. Also indispensable are facilities where researchers make presentations and exchange information. ii) Rigorous Ethics and High Level of Safety Measures Bio-tech involves diverse genetic engineering techniques in its research and application. Therefore, if anything goes wrong, monsters like cloned humans or highly toxic bacteria, which are simply unacceptable from the ethical and safety viewpoints, could be spawned accidentally. Therefore, the Bio-Island should never be allowed to grow into an extraterritorial zone, but should be subjected to ethical and safety standards even more rigid than elsewhere. iii) Preferential Tax System and Other Measures In order for the Bio-Island to be a success, it will be necessary to introduce preferential tax rates for a certain period of time as well as other measures which will facilitate fluxes of capital and personnel. iv) Removal of Pointless Controls On top of the conditions i.)-iii.) I have just mentioned, it is also important that excessive controls by competent authorities that would unduly restrain activities of individuals or groups of people are eliminated. Speaking of Japan's experience, a common thread weaves through the various segments of its economy now teetering along - banking, construction and public engineering, realty, agriculture, etc. All of these industries had once been overly controlled by the government. 6. Conclusion Summing up, in the field of bio-tech, expectations alone are running ahead, with research and application trailing far behind. Nevertheless, when we come to think of the breadth and depth of the potential this technology holds, there is no doubt that it will be the technology of the 21st century. Construction of the Bio-Island at an early date while bio-tech is still very young is highly desirable, so that the Asia-Pacific region will be in a leading position in this century through technological innovation in this field. It is my sincere hope that this idea will be realized as early as possible supported by the understanding and enthusiasms of all of you in the audience today. Thank you very much for your attention.