Monday, August 23, 1999
Industry insiders often are bemused by the great excitement
that is routinely generated in the general media about animal data published
in peer review journals or presented at scientific meetings. When the retail
crowd rushes in, the bemusement often turns to frustration as the valuations
of preclinical companies are bid up way out of proportion to their accomplishments.
Nevertheless, one of the keys to making money in biotech, whether
as a company or as an investor, is the ability to make go/no go decisions as
early as possible in the development process when the least amount of money
has been spent. While much is often made of the decision to move from Phase
II to Phase III human clinical development, the other critical juncture is earlier
- the decision to move from animals into humans.
Whether one is a biotech company, a corporate partner or an
equity investor, the issue is the same: Given statistically significant results
in, say, 25 mice treated with compound X, what are the right questions to ask
in order to make the best possible decisions based on the data?
To illustrate how such decisions are made, BioCentury asked
two experts to explicate how they would look at a single published study. For
each article, they looked at what questions were answered, what issues remained
to be explored, and what further studies they would want to see before making
a decision about licensing the compound or moving it into the clinic.
At the least, their answers reveal a complex process for going
from science to medicine to market. Thus although preclinical results may be
provocative, the decision to move into commercial development is unlikely to
be obvious. Nevertheless, the similarity in the thought processes of both CEOs
is striking, and should provide a guide for serious investors who want to do
S. aureus vaccine
In the May 28 issue of Science, researchers from Brigham and Women's Hospital, Harvard Medical School, and the Universitatsklinikum (Tubingen, Germany) reported on a Staphylococcus aureus vaccine based on an antigen, PNSG (poly-N-succinyl beta-1-6 glucosamine), that is expressed as a surface polysaccharide during infection.