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. It is difficult, if not downright impossible, to successfully develop a drug by solving problems individually in isolation, because each technical choice (the target you pursue, the molecule you develop, the formulation, the design of the clinical trial, the. 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. 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. How do they interact? A closer examination, however, suggests that hidden flaws in the system have impeded the overall business performance of the sector. A shift in the mentality and policies of universities is needed. These organizations tend to be privately funded, not-for-profit entities that focus on advancing treatments for specific diseases. 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.
Even some executives at major pharmaceutical companies appeared to believe this, as evidenced by their decisions to aggressively pursue alliances with biotech firms. Indeed, Genentech and Lilly, whose recombinant-insulin deal became a template for the industry in many ways, wound up in a legal contest over rights to use genetic-engineering technology to produce human growth hormone. Genentech, which is majority-owned by Roche, is one of the few existing examples. I learned that the anatomy of the biotech sectormuch of it borrowed from models that worked quite well in software, computers, semiconductors, and similar industriesis fundamentally flawed and therefore cannot serve the needs of both basic science and business. Because the products of the first wave of biotech companiesincluding Amgen, Biogen Idec, Cetus, Chiron, Genentech, and Genzymewere proteins found in the human body, scientists, managers, and investment bankers involved in the sector argued that they would have a much lower failure. 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. The days of inefficient, trial-and-error, craft-based, one-molecule-at-a-time approaches to drug discovery were deemed to be numbered.
Biotechs anatomy was based on the premise that it would be a lot like them. Pharmaceutical companies often make alliances in precisely those areas where they lack expertise. Biotechs champions in the scientific and investment-banking communities believed that its technologies would create an avalanche of profitable new drugs. Since 2001, when the genomics bubble burst, the strategies of start-ups and the preferences of venture capitalists have undergone a marked change. After codeveloping recombinant human erythropoietin, a synthetic protein that stimulates the bodys production of red blood cells, Amgen and Johnson Johnson fought a bitter legal battle over the division of marketing rights. 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.
The allure of equity ownership has encouraged scientific entrepreneurs to take the risks inherent in starting new firms. Its especially noteworthy that Genentech, after pioneering the system for monetizing intellectual property, then took a different path: along with Amgen, Genzyme, and a few others, it vertically integrated by investing heavily in manufacturing and marketing even as it continued to build internal scientific capabilities. For the science to advance, each of the disciplines with expertise needed to solve a problem must be able to leverage the collective wisdom. On June 16, 2020, S2BN Waterloo held a virtual event with an innovative pair of entrepreneurs. The same kind of integration must also occur further downstream in development but with still other disciplines, such as toxicology, process development, formulation design, clinical research, biostatistics, regulatory affairs, and marketing. This market for know-how has encouraged venture capitalists to provide seed money for start-ups. What some might call the Silicon Valley anatomy has worked wonderfully well in these other sectors. Moreover, the most valuable IP is often not a specific molecule but data, understanding, and insights relating to how that molecule behaves, what it can do, what its potential problems are, and how it might be developed. S2BN organizes outreach and networking events for graduate students to complement their academic training.
For-profit enterprises now often carry out basic scientific research themselves, and universities have become active participants in the business of science. (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. The challenge of integration is not unique to drugs. This suggests that we should expect a great number of drugs to emerge from the biotech pipeline in the future. New hypotheses and findings must constantly be evaluated, and decisions must be made about which options to pursue and which to discard.
There is deep knowledge within, say, chemistry and genomics, but much less knowledge about the connections between them. What genes might be at work? These decisions must occur in the fog of limited knowledge and experience. It will be most useful in the pursuit of the most scientifically innovative drugs. From 19, venture capital funds generated an average annual internal rate of return.6. Fewer independent biotech firms. As a result, sharing experiences over an extended period matters enormously in such endeavors, and the breadth of the sharing is extremely important.
For instance, it would probably make sense to incubate a highly novel technique such as tissue engineering inside a new firm that could build the essential capabilities from scratch. Virtually all R D involves solving multiple types of problems. Even in high-tech industries such as semiconductors, high-performance computers, and aircraft, it is usually fairly clear which commercial R D projects are scientifically feasible and which are not. Much of the knowledge in the diverse disciplines that make up the biopharmaceutical sector is intuitive or tacit, rendering the task of harnessing collective learning especially daunting. Facing a shortage of potential blockbuster drugs in their pipelines, these companies had dramatically increased their R D spending, but to no avail. No clear disclosure and valuation standards exist for intangible assets in general and R D projects in particular. Biotech has suffered both. Unfortunately, the biotech industry is not organized to learn from experience over time. Suits between former partners and collaborators have been fairly common.
To realize their potential as integrators, they will need new internal structures, systems, and processes to connect technical and functional domains of expertise. In return for the manufacturing and marketing rights to recombinant insulin, Lilly would fund development of the product and pay Genentech royalties on its sales. They should focus primarily on maximizing their contributions to the scientific community, not maximizing their licensing revenues and equity returns. Weitere Informationen und die Mglichkeit zum Widerruf finden Sie in unserer. 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. As a result, most alliances are at arms length and fairly brief. The process of drug R D cannot be broken neatly into pieces, meaning that the disciplines involved must work in an integrated fashion.
Second, there is no sign that biotechnology has revolutionized the productivity of pharmaceutical R D, despite many claims to the contrary. Answering these questions requires insights from different disciplinesincluding structural genomics, functional genomics, cell biology, molecular biology, and protein chemistryand also a broad range of approaches, including computational methods, high-throughput experimentation, and traditional wet biology. Far from being dead, vertical integration has an important role to play in the pharmaceutical industrys future. Translational research may be funded in two ways. Wed, Dec 16, online Event, s2BN Winter Networking Social, get ready for the S2BNs virtual networking event to end off the year! But while industry spending on R D continues to increase substantially, the attrition rate of biotech drugs in development has also grown over time. Only then can it deliver on its promise to revolutionize drug R D, conquer the most intractable diseases, and create vast economic wealth. The revenues of publicly held biotech companies have grown dramatically but their profits have hovered close to zero. When, as in the case of drug R D, failure is far more common than success, the ability to learn from failure is critical to making progress.