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
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.