BETHESDA, Md--Of the more than 1,300 biotech companies in North America, up to 70% are involved in health care, and many are working on cancer research, Frederick Craves, PhD, of Burrill & Craves, a merchant bank in San Francisco, said at a meeting of the National Cancer Advisory Board (NCAB).
"Although the biotech industry is a young one," Dr. Craves said, "there are real products out there now being sold for use in cancer."
A number of experts from the biotech industry, Wall Street, the legal profession, and the NCI spoke to the NCAB about the role of the biotech industry in cancer research and expressed some concerns about the industry's financial health.
Dr. Alan Goldhammer, director of technical affairs, Biotechnology Industry Organization, Washington, DC, said that the cost to develop new drugs has increased over the rate of inflation, "and so we need to look at how the approval process can be improved to speed up getting drugs developed and to market."
Fortunately, he said, FDA approval time has come down because of recent changes allowing companies to pay part of the costs for FDA reviews. What remains to be done is the streamlining of the approval process for changes once the drug is being manufactured.
Brian M. Poissant, a senior partner at the law firm of Pennie & Edmonds, New York, said that obtaining patents for new cancer drugs can be a tricky process for young biotech companies, and sometimes the secrecy required for patent approval can work against cancer research.
Originally, only three things were required for a patent, he said: "The product had to be new; it had to be different; it had to do what you said it did." But in 1990 the Patent Office changed the rules for biotech products, requiring human clinical data showing treatment efficacy. This alone added 4 to 6 years to the patenting process.