History
Role of the NIH
See also: The National Institutes of Health
The National Institutes of Health (NIH), have played a major role in the development of the life science industry boom in Maryland, and thus the creation of DNA Valley. The NIH originally moved its headquarters from the Old Naval Observatory to Bethesda, Maryland in 1938. In 1989, as part of the launch of the Human Genome Project, the National Center for Human Genome Research (now known as The National Human Genome Research Institute) was founded in Bethesda. [10] This made Bethesda the national hub for genetic research as genetic researchers from around the country came to help sequence the human genome. [11] This project, being one of the most influential scientific projects of the last century, planted the seeds for the eventual biotechnology hub that has formed in the area since. The infrastructure and attention to the industry that the NCHGR and the HGP brought to Maryland are what opened the door to the extensive cell and gene therapy industries that Maryland and DNA Valley are now home to. [6]
The NHGRI is not the only NIH subsidiary that has led to DNA Valley becoming such a major life science hub. The NIH as a whole has fueled the biotech industry in Maryland as the research done at the federally funded facilities has resulted in new fields of research, new tools, and highly trained researchers that often remain in the area and create their own life science companies. [12]
For example, the work done by Roscoe Brady, MD, PhD on viral vectors caught the attention of entrepreneur Jeff Galvin, inspiring him to found American Gene Technologies and pursue potential cures for diseases like HIV, PKU, and certain cancers.. The NIH also funds outside research in the area, which further allows for the industry to flourish as more companies want to be based near the NIH headquarters in Bethesda. [13]
A variety of life science-related conferences are held annually at the NIH headquarters in Bethesda, such as workshops, trainings, and professional conferences, all of which not only bring attention and prestige to the life science industry in Maryland, but also result in a better trained and educated population in the area, allowing for the further success of the industry. [14]
The NIH is not exclusively located in Bethesda and has a variety of campuses in Maryland. The Bayview Campus in Baltimore contains the research programs of the National Institute of Aging and the National Institute of Drug Abuse. The Frederick National Laboratory and Riverside Research Park are home to the National Cancer Institute, which includes the Center for Cancer Research. [15] The widespread footprint of the NIH in Maryland directly correlates to the biotech boom that resulted in DNA Valley, as the highest concentrations of life science companies are located in the same locations of Rockville, Frederick, and Baltimore. [6]
Rise of Genetic Medicine
Main articles: Gene therapy and History of Genetic Medicine
The first speculation about the plausibility of introducing DNA sequences into patient's cells to cure diseases occurred in the 1960s. [16] Then in 1972, Theodore Friedman and Richard Roblin published a paper in Science named "Gene Therapy for Human Genetic Diseases?", which detailed the possibility of inserting unmutated or healthy DNA to cure patients with genetic diseases. [17] However, this paper also urged that the technology be furthered with caution as a result of the lack of understanding of the technology and its potential effects. [18] They were primarily worried about the lack of knowledge about genetic recombination and gene regulation, lack of understanding about the relationship between genetic mutations and diseases, and the lack of understanding of the potential side effects of gene therapy. [19]
For 18 years after that paper was published, further research was conducted to help limit the risks detailed by Theodore Friedman and Richard Roblin. Then in 1990, the first successful gene therapy trial was launched. A four-year-old girl named Ashanthi De Silva with severe combined immunodeficiency (SCID) was treated with gene therapy. Ashanthi was lacking the enzyme adenosine deaminase (ADA), which caused her T-cells to die, leaving her with little to no protection against infection. [16] To treat this, Dr. W. French Anderson from the National Heart, Lung, and Blood Institute in Bethesda, Maryland, delivered the correct ADA gene, using a disabled virus, to white blood cells that had been removed from her body, and then injected the cells back into her body. [20]
The rise of gene therapy was not easy as it suffered a major setback in 1999 with the trials at the University of Pennsylvania. During the trials, an 18-year-old named Jesse Gelsinger who had the genetic disease ornithine transcarbamylase deficiency, died from an immune response after being treated with a working gene carried by an adenovirus. [19]
The early 2010s brought back the evolution of gene therapy as a potential cure to many different diseases. New delivery methods for the gene therapies were discovered, thus making the techniques significantly safer. Researchers also added enhancers and promoters, which allowed for better control of the gene as they could decide when and where it would be turned on and to what extent. [16] These discoveries, along with others made during this period, allowed gene therapy to regain its momentum and move to the forefront of Medical Technology development. There was then a wave of approvals for gene therapy techniques from 2003 to 2012, including therapies for cancer, artery disease, and others. Since then, the rate of development and approval of gene therapies has increased, with the FDA expecting to approve between 10 and 20 gene therapies each year until 2025. [21]
