March 1, 2005 (Vol. 25, No. 5)
Predictions Indicate a Mature Industry Possible by 2030
Great advances and industrial revolutions that impact modern society, such as the printing press, automobiles, computers, and biotechnology have a generational cycle that spans over 50 years, estimates Nola Masterson, Ph.D., of Science Futures (San Francisco).
Dr. Masterson believes that we are in the midst of biotechnology’s 50-year cycle. She points out that the first decade of the biotech revolution, in the late 70s and early 80s, was laying the foundation for research methodologies such as recombinant DNA and hybridoma technologies, which changed how we study and view biology.
The second decade in the cycle was devoted to a few new discoveries that became products using the methodologies that led to the formation of the industry.
The third decade of the cycle is marked by a flood of innovative products, derived from the new methodologies, which were refined and broadened along the way. Dr. Masterson points out we are now in the midst of the third decade of our industrial revolution in biotechnology.
In the fourth decade of an industrial revolution, the products become incorporated into daily life, and mainstream companies adopt the methods as standards for the industry.
In the final decade, biotech companies and products become an integral part of society, and the revolution that created them begins to fade in the minds of scientists and lay person alike.
The chemical industry is undergoing a similar cycle, according to Dr. Masterson, and is now in its fifth and final decade. The discovery of plastics and polyesters has led to products that are now an integral part of daily life.
The 50-year cycle for biotechnology will take us into 2030, at which time we will see the incorporation of biotech methods and products become fully integrated into agriculture, medicine, life science research and the retail sectors of our society, explains Dr. Masterson.
Assuming that biotechnology is in the midst of its 50-year cycle, one would expect a plethora of biotech products currently being commercialized and widely used. That is indeed the case. The first biotech products that defined the industry were Amgens (Thousand Oaks, CA) two stem cell growth factors, Epogen and Neupogen.
The second major breakthrough for biotech products in the first decade was the development of monoclonal antibodies as diagnostic reagents.
Hybritech was the first company to develop and commercialize monoclonal antibodies during the late 1970s and the early 1980s.
In 1986 Eli Lilly (Indianapolis) acquired Hybritech for $400 million. The initial founders of Hybritech parlayed their money into other biotech start-ups that eventually spawned the biotech industry in San Diego.
Today, Hybritechs products include the PSA (prostate-specific antigen) diagnostic test, one of the most widely used and successful biotech products in the diagnostic market.
With protein engineering and recombinant DNA technologies, scientist made major strides in humanizing rodent-derived monoclonal antibodies as therapeutics. Today, monoclonal antibodies are being widely used as therapeutic approaches for treating a variety of diseases ranging from cardiovascular and rheumatoid indications to cancer.
The biotech industry seems to be at a crossroads as it enters the second half of its 50-year cycle. With the focus now on developing products that are already in clinical development, the industry appears to be moving away from its core strength of research and innovation.
Frustrated by not reaping the benefits of the genomic and proteomic revolution of the 1990s, biotech investors now seem to be more risk averse. Their investment strategy is to focus on investing in companies with products in the late stages of clinical development, which they believe will receive FDA approval.
This change in investment philosophy has caused biotech executives to cutback on their research programs and execute a business strategy of in-licensing products that are already in clinical development. Similar to many other industrial sectors, this trend is more than likely a transient phase instead of a paradigm shift for the industry.
The biotech industry is experiencing a shift in its research focus. Biotech companies that had emphasized molecular biology and biochemistry are now emphasizing cell, developmental, and system biology. This shift in research has led to greater interest in stem cell research and cell-based therapies.
Major breakthroughs in stem cell research could dominate the third decade of this biotech revolution. The convergence of the knowledge developed from genomics and proteomics with the ability to use stem cells as a research platform could result in new biological pathways, ultimately leading to a better understanding of the aging process as well as discovering novel biological targets to cure human diseases.
Todays scientists have a better grasp on isolating and propagating stem cells (both embryonic and adult-derived). Scientists are reporting their ability to isolate stem cells in tumor biopsies. The data reported in the scientific literature are causing some cancer researchers to re-evaluate the principle of dedifferentiation in somatic cells as the process which gives rise to cancer cells.
The prevailing dogma for the natural history of cancers is that all cancers arise from somatic cells whose genome has been perturbed due to carcinogens, viruses, or mutations. These mutated cells subsequently divide, giving rise to daughter cells that have reverted (dedifferentiated) to cells that are more primitive, hyperproliferative, and neoplastic.
During the 1970s, Beatrice Mintz, Ph.D., of the Fox Chase Cancer Institute (Philadelphia) hypothesized and demonstrated in her seminal experiments with teratocarcinoma cells that many forms of cancers can be attributed to stem cells and a derangement of differentiation.
Dr. Mintz reported that when she transplanted her transformed cell lines into the blastocysts of another mouse strain, she was able to generate mosaic mice whose tissues expressed the phenotype of both the donor cells from the transformed cell lines and the recipient host embryo.
Dr. Mintz concluded that the host embryos provided a microenvironment that unblocked and induced the tumor cells to differentiate into normal cells within the tissues of the host. With new stem cell technologies, it is conceivable that many forms of cancer will be cured within this next decade.
Additionally, if regenerative medicine and stem cell-based therapies become a reality and are widely accepted, it is conceivable that these new treatment modalities may revolutionize the practice of medicine.
Advances in stem cell technology could, in the next few years, make these cells the ideal vehicle for gene therapy. Such advances would resurrect a field that has, in the last few years, become a poster child of what could go wrong in biotechnology.
Combining the rapid advances currently being made in cell biology with genomics, proteomics, and nanotechnology, it may be possible, over the next decade, that scientists will be able to create and engineer artificial cells for generating new tissues, limbs, and organs.
It may also be conceivable by 2030, when the biotechnology revolution reaches the end of its 50-year cycle, that the average life span of humans will reach 125 years, which would translate into todays 35-year-old adults being the equivalent of tomorrows 70-year-old adults. It may be a fact or just plain science fiction. Only time will tell.