OR WAIT 15 SECS
Julie Williamson is a freelance writer living in Arizona.
Advancements are paving the way for promising new drug platforms.
Although the 21st century is barely underway, there's a reason it is already being dubbed the "Biotech Era" by researchers, industry observers, medical professionals and patients alike. Since 2000, researchers have managed to successfully map the human genome, penetrate the molecular basis of disease to identify triggers and enable more individualized care, and offer new hope to those with diseases for which there currently is no cure.
These critical and ongoing advancements are greatly expanding the targets for pharmaceutical intervention. Through collaboration between biotech and pharmaceutical companies, industry experts agree the emphasis of drug therapies will ultimately shift from diagnosis and treatment to prediction and prevention of disease. According to a report from the Pharmaceutical Research and Manufacturers of America in Washington, more than 250 million people have already benefited from medicines and vaccines developed through biotechnology. What's more, a recently released PhRMA survey revealed that 371 new biotechnology medicines are in the pipeline, offering hope for treating some 200 diseases.
"Advancements in biotechnology have really grown across the board, and are fundamentally altering the field of pharma," explains Gillian Woollett, associate vice president for biologics and biotechnology at PhRMA. "Considering the first biotech drug came in 1982, we have seen an incredible amount of success and development in a very short period of time. We are way past proof of principle. Through this better understanding of disease, we are not just treating the condition, but treating it in the context of the patient. With that comes a better understanding of dosing and the ability to choose the right drug the first time, based on the individual."
It's little wonder the biotechnology industry is making such headway. The biotech sector has more than tripled in size since 1992, with revenues jumping from $8 million in 1992 to $27.6 billion in 2002, figures from the Washington-based Biotechnology Industry Organization show. Biotechnology is also one of the most research-intensive industries in the world, with $15.6 billion spent on research and development in the United States alone in 2001.
Much of that success can be attributed to the alignment of biotech and big pharma companies. Because drugs are often difficult â and costly â to manufacture, the biotech sector has had to rely on pharmaceutical companies to bring the developments to fruition.
"Biotech companies have scientists, but they don't always have the connections and engineers that the pharmaceutical companies do," says J. Lyle Bootman, dean and professor of the College of Pharmacy, and executive director of the Center for Health Outcomes and Pharmacoeconomic Research, both at the University of Arizona in Tucson. "Pharmaceutical companies have the ability to take science and apply it to a much larger scale, which is why we're seeing biotech companies and pharma companies getting more aligned."
Not that biotech companies are the only ones seeking the partnership â companies like Indianapolis-based Eli Lilly and Co. and New York-based Pfizer Inc., for example, are buying more heavily into the biotech business to expand their portfolios and better enable themselves to address more diseases, Bootman says. Through the purchase of Warner-Lambert in 2000, Pfizer acquired Agouron Pharmaceuticals - a deal that enabled Pfizer to broaden its capabilities in the areas of cancer, AIDS and other diseases.
Although the biotech industry is experiencing growth across the board, scientists are seeing tremendous success and opportunities in treating certain diseases, with cancer ranking high on the list. In fact, 178 of the 371 biotech drugs either in clinical trials or awaiting approval by the Food and Drug Administration specifically target the disease.
Experts in the field of cell biology predict that, in the near future, more angiogenic inhibitors (therapies that restrict blood supply in an effort to cut nourishment of a tumor) will be discovered and made available in many forms, including oral drugs, patches and time-released formulations. Beyond that, cancer drugs will be increasingly non-toxic, unlike the chemotherapy drugs used today. In an article entitled "Biotech 2030: Eight Visions for the Future," Judah Folkman, professor of cell biology at Harvard Medical School, predicts physicians will soon be adding angiogenesis inhibitors to radiotherapy and chemotherapy, "and then perhaps maintaining patients just on the angiogenesis inhibitors."
In great part, Bootman credits genomic research for the advancements in biotech cancer research. The disease, he says, has garnered significant attention, not only because of its widespread impact on patients and healthcare costs, but also because research suggests that a genetic element is behind the development of the disease.
"Genomic research is playing a pivotal role in the areas of biotechnology and pharmaceutical development," Bootman says. "There are new enterprises developing new therapies and promising technology almost every day, which is very exciting. And because we are almost certain that there's a genetic link to this disease, we can now start to understand why certain treatments work for some and not others, and develop different drugs that can better help us manipulate the disease." Bootman adds that schizophrenia is another disorder currently attracting a great deal of attention in terms of genomic research.
French Anderson, director of gene therapy laboratories and professor of biochemistry and pediatrics at the University of Southern California's School of Medicine in Los Angeles, also believes gene-based treatments will be at the heart of 21st century medicine. He predicts the FDA will approve the first gene therapy drug by 2005 and a number of treatments will be available by 2015 that "will either add or correct genes" for conditions such as hemophilia and cystic fibrosis. He also thinks researchers will develop small therapeutics that will regulate the function of different genes in complex, multigenic diseases, such as cardiovascular disease, arthritis, cancer and immunodeficiency disorders. Once gene therapy treatments are approved, they "will be marketed just like other biologics, with actual sales being done by the pharmaceutical reps," he comments.
Advancements in genomic research will likely change the face of traditional drug treatment as we know it, says Bootman. "Although we certainly won't be injecting a gene, we can use the knowledge we have about the gene and apply it to the development of new drugs that allow us to better treat and manage the condition. It's also important to realize that a better understanding of the molecular basis of disease opens the door for many treatment possibilities. When something works for one disease, it may not take too much tweaking for it to show promise in others."
Other key biotech developments currently underway include an epidermal growth factor inhibitor that targets and blocks signaling pathways used to promote the growth and survival of cancer cells; monoclonal antibodies that target asthma, Crohn's disease, rheumatoid arthritis, lupus, various types of cancer and other diseases; and therapeutic vaccines designed to jump-start the immune system to fight off AIDS, diabetes and some cancers.
Another key aspect of biotechnology's progress is the advancement of preventative therapies. While treating disease once it has already manifested is critically important, Woollett says having the ability to use biotech research to determine the likelihood of developing a certain disease - and perhaps being able to prevent it altogether â greatly reduces therapeutic hurdles.
"We are just beginning to scratch the surface on the prevention side, and the research so far looks very promising," Woollett says. "We are, I believe, on the brink of some great discoveries that will reshape our entire thinking on traditional healthcare." PR