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.