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A Short History of Biotechnology, Business and Industry Trends Analysis

While the 1900s will be remembered by industrial historians as the Information Technology Era and perhaps the Advanced Physics Era, the 2000s may be marked by many as the Biotechnology Era because rapid advances in biotechnology will completely revolutionize many aspects of life in coming decades.  However, the field of biotechnology can trace its true birth back to the dawn of civilization, when early man discovered the ability to ferment grains to make alcoholic beverages and learned of the usefulness of cross-pollinating crops in order to create new hybrid strains—the earliest form of genetic engineering.  In ancient China, people are thought to have harvested mold from soybean curd to use as an antibiotic as early as 500 B.C.
Robert Hooke first described cells as a concept in 1663 A.D., and in the late 1800s, Gregor Mendel conducted experiments that became the basis of modern theories about heredity.  Alexander Fleming discovered the first commercial antibiotic, penicillin, in 1928.
The modern, more common concept of “biotech” could reasonably be said to have its beginnings shortly after World War II.  In 1953, scientists James Watson and Francis Crick conceived the “double helix” model of DNA, and thus encouraged a spate of scientists to consider the further implications of human DNA.  The Watson/Crick three-dimensional model began to unlock the mysteries of heredity and the methods by which replication of genetic material takes place within cells.
Significant steps toward biotech drugs occurred in the early 1970s.  In 1973, Dr. Stanley N. Cohen, a Stanford University genetics professor, and Dr. Herb Boyer, a biochemist, genetic engineer and educator at UC-San Francisco, introduced the concept of gene-splicing and created the first form of recombinant DNA.  In 1974, Cesar Milstein and Georges Kohler created monoclonal antibodies, cells that clone over and over again to create large quantities of a specific antibody.  Many of today’s top biotech drugs are monoclonal antibodies.  These two discoveries (recombinant DNA and monoclonal antibodies) created the building blocks of the first modern commercial biotech drugs.
Boyer and Cohen’s gene-splicing technique enabled scientists to cut genetic material from the cells of one organism and paste it into another organism.  This was an important discovery because the genetic material they moved from one place to another instructs a cell as to how to make a particular protein.  Over time, scientists have perfected the technique of splicing material that enables cells to create proteins that control the creation of insulin, the level of blood pressure and many other human functions.  Such genetic engineering enabled, for the first time, the creation of massive vats of isolated proteins grown in bacteria or in cells harvested from animals—in quantities large enough for the commercial production of new drugs.  (In fact, Boyer and Cohen’s early experiments involved inserting a gene from an African clawed toad into bacterial DNA for duplication.)
In 1975, the first human gene was isolated, opening the door to gene therapy and creating the interest that led to the beginning of the massive, publicly funded Human Genome Project in 1990.  A working draft of the Human Genome was released in 2000, and a complete genome was released in 2003.
In 1976, Bob Swanson of the now-famous Silicon Valley venture capital firm Kleiner Perkins formed a new business, Genentech, in conjunction with Herb Boyer (see above).  Other early biotech firms were founded soon after, generally funded by venture capital firms, angel investors and corporate venture partners.  These early biotech startups included many companies that grew into super-successful biopharma corporations:  Amgen, Novartis Diagnostics (formerly Chiron), Biogen Idec and Genzyme.  The creation of these startups, focused on the development of new drugs, was particularly noteworthy because it was the first time in decades that new drug companies were launched in significant numbers.  In fact, most major drug companies in existence at the beginning of the 1970s were very mature and could trace their histories back to the early 1900s or before.
The commercial introduction of genetically modified (GM) seeds is a relatively new branch of biotech.  By 1987, researchers were gaining enough progress with GM seeds that applications for approval for field testing and certification began to pour into the USDA (U.S. Department of Agriculture).  The first commercialized food to emerge was the Flavr Savr Tomato, which was the result of a gene splicing.  The added gene prevented the breakdown of cell walls as the fruit ripened, which meant that the tomatoes remained firm for an extended period of time in the truck or on the shelf.  In 1995-1996, GM corn with gene modification that enables the plant to produce its own pesticide received regulatory approval and became commercially available.  Today, millions of acres of GM plants, from cotton to soy to corn, are grown worldwide with tremendous efficiency.  Significant new advancements in biotech crops are on the horizon. Many researchers are experimenting with GM seeds that grow plant-based pharmaceuticals.
In 2010, one of the most significant biotech developments in years was announced when genetic engineering was used to create an entirely new organism.  This is a field known as “synthetic biology.”
2014 saw the launching of Guardant Health’s liquid biopsy test, which scans blood samples for small DNA fragments released by malignant tumors.  Guardant’s test searches for any of 68 identified cancer genes, making it a far less invasive (and less expensive) procedure than standard biopsies.  As of 2016, one of the most exciting developments is the use of “checkpoint inhibitors,” which control immune response, as a way to boost the effectiveness of new immunotherapies in treating cancers.
Another breakthrough in gene therapy is CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats).  The technology focuses on the use of a DNA-cutting protein that is guided by an RNA molecule, targeted at a specific gene.  This technology enables a scientist to quickly and easily edit or re-engineer specific bits of DNA.  A defective gene can be precisely edited within the laboratory, and then reintroduced to a patient's body as a form of gene therapy with far more accuracy than previous gene therapies.  CRISPR is sometimes referred to as “genetic editing,” and it is considered to be a very significant breakthrough.   Practical applications may include treatments or even cures for sickle-cell anemia, HIV and cystic fibrosis.  Libraries of CRISPRs have been created by researchers at MIT that account for nearly all human genes.  CRISPR is also being utilized to modify seeds and plants for agricultural use.
The Coronavirus pandemic spurred a landmark breakthrough with the rapid development of vaccines using messenger RNA (mRNA) technology.  mRNA is a molecule of RNA that carries genetic information to ribosomes, which then create proteins that include the delivered genes.  The technology enables rapid development time for vaccines, by utilizing the body’s own molecular ability to teach cells how to mimic a protein similar to that found in the vaccine, thereby triggering an immune response.  In addition, mRNA vaccines can be adjusted quickly so that vaccines will respond to virus mutations and declines in immunity.  Both the Pfizer and Moderna vaccines for the Coronavirus were developed using mRNA.

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