Products and Health Care Delivery

 Gary R. Hooper
 Genentech, Inc.
 South San Francisco, California

 It's a real pleasure to be here today for the symposium, "Biotechnology:
Perspectives, Policies and Issues." Since this section addresses commerciali-
zation issues of biotech products, I thought I would share with you some of
the issues we have faced over the years, beginning with the selection of
recombinant DNA products, move into the development and manufactur-
ing of these products, and conclude with regulatory and clinical issues
which must be considered prior to successful marketing.
 In the time allowed, it will be impossible for me to cover all the numer-
ous issues and problems faced by companies, like Genentech, involved in
biotechnology. Thus, I will focus on a few areas which most frequently
arise in conversations with people looking at the commercialization of re-
combinant DNA technology.
 However, in order for everyone to appreciate the decisions we have
made in commercializing our technology, I must say a few words about the
technology and the goals of Genentech. Obviously, decisions which we
have made over the years are tied directly to who we are, where we are,
and where we want to be in the future.
 Who is Genentech? In very simple terms, Genentech is a company
which looks at a human disease and determines what is naturally found
inside the human body which will either treat or cure the disease. Next, we
isolate the substance, determine its structure and locate the gene which
codes for the production of that human protein. As you may recall from
your high school science class, a gene is a blueprint, or set of instructions,
that tells a cell what protein to produce. Once we locate the gene, we
remove it from the human cell and place it inside microorganisms such as
Escherichia coli, a bacterium found in human intestine, or saccharomyces,
simple baker's yeast.
 Now we have microorganisms that contain the blueprint for the protein
we desire. These organisms are then grown through a process of fermenta-
tion. In fermentation, we provide an environment that is conducive for the
organisms to grow. As the microorganisms proliferate and use their own
genes to produce proteins required to sustain their lives, they also manu-
facture the protein we desire by using the gene which we have placed