The lower technological risks would mean lower business risks. Their collaborative relationships, however, will differ substantially in form and number from those that currently dominate the sector. Public equity markets are not designed to deal with the challenges of enterprises engaged in R D only, which compose most of the biotech sector. It would be hard to overstate the importance of learning to the long-term health of science-based sectors. Homepage, science-to-Business Marketing Research Centre, whatsApp. The advance of biotechnology would have been slowed considerably had recombinant DNA, monoclonal antibodies, and other basic genetic-engineering techniques been exclusively licensed to a single firm. Yes, for two reasons. What is their structure? Profound, persistent uncertainty translates into high, long-term risks.
A more suitable anatomy might include the following elements. The biotech sector has relied heavily on the market for know-how to link these islands. Such collaborations are a step in the right direction. Granting an exclusive license to an existing firm is necessary when the technology in question is specific and further downstream in its development, its value declines as access to it grows, and certain complementary assets and capabilities are needed to fully exploit. For-profit enterprises now often carry out basic scientific research themselves, and universities have become active participants in the business of science. Discovering and developing drugs effectively requires that all the pieces come together. Genentechs wildly successful initial public offering in 1980 demonstrated that a firm with no product revenues or income could go publicwhich made the sector even more attractive to venture capitalists.
These new tools are opening up new opportunities, but each sheds light on only one piece of a very complex puzzle. Generally accepted accounting principles (gaap) typically dont require companies to disclose their R D projects, and although biotech and pharmaceutical firms must disclose information on the state of their development pipelines, the requirements are vague. This model consists of three interrelated elements: technology transfer from universities to the private sector through creating new firms rather than selling to existing companies; venture capital and public equity markets that provide funding at critical stages and reward the foundersinvestors. Biotechs champions in the scientific and investment-banking communities believed that its technologies would create an avalanche of profitable new drugs. Tweet, post, share, save, buy Copies, print. Finallyand perhaps not surprisinglythe biotech sector appears to be retreating from its distinctive position at the radical and risky end of the R D spectrum. Weitere Informationen sowie die Mglichkeit zum Widerruf finden Sie in unserer. Once again, its system for monetizing intellectual property is to blame. After 30 years of experimentation, it is clear that biotech is not just another high-tech industry.
The basic feasibility of technologies is not an issue for R D in most industries, where the effort and resources go primarily into developing concepts already known to be technically feasible. This is already starting to happen with the NIH Roadmap for Medical Research, an initiative launched by the agencys director to identify and address major opportunities and gaps in biomedical research. The sequencing of the human genome and the invention of so-called industrialized R D techniques further bolstered predictions that biotech would generate breakthrough therapies and tremendous gains in R D productivity. The process of drug R D cannot be broken neatly into pieces, meaning that the disciplines involved must work in an integrated fashion. Fewer, closer, longer-term collaborations. The reasoning was that the massive amount of biological data produced would help enormously in identifying the precise causes of diseases, and that techniques such as combinatorial chemistry (for creating new compounds high-throughput screening (for testing the compounds medicinal potential and computational. Putting the science into the hands of more explorers is likely to accelerate the pace of advance. (See the exhibit Biotech Has Produced No Breakthrough in R D Productivity.) Nor has industrialized R D dramatically increased the number of compounds that make it to human clinical testing, let alone into the market.
While venture capital funds have enjoyed some stellar years, and individual biotech stocks have performed spectacularly, average returns overall have been disappointing relative to the risks. Its shares are publicly traded, but a large company with a long-term strategic interest in the biotech firms success owns a majority stake. Novartis, for one, has been pursuing both strategies. So the willingness of Merck or Novartis or Eli Lilly to invest in a biotech companys project should signal that its prospects are good, right? It involves university-spawned start-ups that focus on specific pieces of the R D value chain; a role for the venture capital and public equity markets; and a market for know-how. The allure of equity ownership has encouraged scientific entrepreneurs to take the risks inherent in starting new firms. The fragmented nature of the industry, with scores of small, specialized players across far-flung disciplines, is a potentially useful model for managing and rewarding risk, but it has created islands of expertise that impede the integration of critical knowledge. It does mean that biotechs anatomy needs to changean undertaking that would have a major impact not only on drug R D and health care but also on university- and government-funded scientific research, other emerging industries engaged in basic science, and the.S. Second, there is no sign that biotechnology has revolutionized the productivity of pharmaceutical R D, despite many claims to the contrary. By anatomy, I mean the sectors direct participants (start-ups, established companies, not-for-profit laboratories, universities, investors, customers the institutional arrangements that connect these players (markets for capital, intellectual property, and products and the rules that govern and influence how these institutional arrangements work (regulations.
The rapid formation of new firms has given rise to a plethora of experiments. A new priority for universities. While all this sounds pretty gloomy, it does not mean that the industry is doomed. Genentech has been highly profitable; its R D programs have been among the most productive in the industry; and despite its growth it has maintained an entrepreneurial and science-based culture. Nor can newer ventures afford to learn through experience.
This learning will be not only the aggregate of what individuals know but also the insights shared by the community. We simply cannot expect independent enterprises to share knowledge and engage in true collaboration within a business-development framework that focuses on short-term goals and emphasizes the law of large numbers over commitment. What constitutes a strong signal of potential efficacy for one researcher may give pause to another. Because human biology is extraordinarily complex, target identification is extraordinarily multifaceted. They patent their discoveries; their technology-transfer offices actively seek commercial partners to license the patents; and they partner with venture capitalists in spawning firms to commercialize the science emanating from academic laboratories. For example, a novel cancer therapy might be more fully exploited if licensed to an organization with experience in both developing cancer drugs and designing and managing clinical trials.
Venture capitalists have a time horizon of about three years for a particular investmentnowhere near the ten or 12 years most companies take to get their first drug on the market. Since the mid-1990s, a combination of genomics, combinatorial chemistry, high-throughput screening, and IT has been used to create new drugs and to identify possible targets in the body for attacking diseases. These companies cannot be valued on the basis of earnings; most of them dont have any. Given the breadth and rate of technological change, not even the largest companies can explore all facets of the R D landscape without help from outside partiesuniversities and smaller, specialized biotech firms. Mistakes are common, not because people or firms are incompetent but because they are constantly dancing on the edge of knowledge. A piece of software code, for instance, is a fairly distinct entity that can be protected by legal mechanisms, and its theft can be detected quite easily. There are indications, however, that this market cant facilitate the flow of information and the collective problem solving needed to develop new drugs. A closer examination, however, suggests that hidden flaws in the system have impeded the overall business performance of the sector. We can hope that biotech will similarly evolve and create a model for emerging science-based businesses like nanotechnology. Genomics, proteomics, systems biology, and other advances will make it possible to identify promising drug candidates with a high degree of precision at extremely early stages of the R D process, which should lead to a dramatic reduction in failure rates, cycle times, and costs.
With new drugs unable to compensate for the major drugs that were losing their patent protection, financial analysts questioned the sustainability of the industrys profits. Genentech, which is majority-owned by Roche, is one of the few existing examples. No clear disclosure and valuation standards exist for intangible assets in general and R D projects in particular. Not only must the many problems be solved, but the solutions must ultimately work together as a whole. For example, the development of the rail and telegraph systems, which required enormous investments and the management of vast operational complexity, gave rise to the modern corporation, which separated ownership (shareholders) from management (salaried professionals). The process does an excellent job of ensuring that decisions are based on scientific merit, but reviewers tend to award grants to projects within their own disciplines. The first is by extending the reach of government funding further downstream. One is that many of the elements I have listed already exist, even if they are still the exception, and their success will undoubtedly attract a following. A scientist who has spent decades doing research on cell growth factors, for instance, will have accumulated quite a lot of knowledge, and the lab in which he worked will have learned many new things from his. In commercial drug R D, the fragmentation of the knowledge base into highly specialized niches is a major barrier to integration.