On an innovation path that begins with a discovery in basic biology and ends with a new drug, independent research institutes play a role that is unusual, often unseen, and more crucial than ever. Labs like the Salk Institute, the Cold Spring Harbor Laboratory on Long Island, and the Whitehead Institute for Biomedical Research in Cambridge, Mass., are vital to a biotechnology industry increasingly in need of their support.
The twin threats of bioterrorism and new virulent diseases like severe acute respiratory syndrome (SARS) underscore the continuing need for innovative therapeutics. Yet despite a recent recovery in the shares of biotech companies, investors remain reluctant to fund basic research. With commercial entities concentrating on later-stage drug development efforts, the independent laboratories have a fresh mandate to pursue the basic science that leads to breakthrough drug discoveries.
“Bioterror — it’s terrible that we have to deal with that, but in some ways it has catalyzed the new relationship between government and industry in medicine,” says Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, the arm of the National Institutes of Health (NIH) that focuses on diseases such as AIDS, hepatitis, and other viral and bacterial infections. “Successful partnering is one way of keeping up with these infectious microbes, to fill the gap between research and medicine. Nothing is more true than the need for a successful biotech industry to partner with government and academic institutions. There is no one group that can do it alone.”
In some ways the biology world is seeing a return to an old model, one in which medical research was funded and directed by the National Institutes of Health, with academic institutions providing both the breakthrough insights and the tedious but essential bench work that makes science pay off. Increasingly, the Centers for Disease Control and Prevention (CDC) is also funding basic research in the United States, and government investment in biology has been growing across Europe and Asia for the past several years.
But today there is a new environment, with a new sense of urgency, particularly in the United States. Project BioShield, a proposal now before Congress, would increase the authority and flexibility of the NIH to expedite research and development of critical biomedical countermeasures against bioterror and untreatable infectious diseases, and would provide up to $8 billion in new funding. NIH and CDC officials say they are counting on an unprecedented level of collaboration among independent labs, academia, and industry to meet these challenges.
One of the first manifestations of this new three-way collaboration will be a massive database integration project intended to help public and private researchers share their findings more easily. In the long run, with or without Project BioShield, the NIH intends to foster more numerous and more profound shared research and development of new drugs.
Biotech in Check
Prior to the advent of biotechnology in the late 1970s, pharmaceutical innovation was largely a matter of serendipity coupled with varying degrees of refinement in the chemist’s lab. To cite one ready example, aspirin, introduced by F. Bayer & Company in 1899, was a purified form of salicylic acid, derived from the bark of the willow tree. In the decades that followed its release, the large pharmaceutical companies — most of them other chemical companies, specifically, makers of textile dyes — developed vast libraries of other naturally derived chemical compounds that were tested on a broad array of diseases in hopes of finding a random “hit” that could be purified for use as a drug.