OF STEPHEN PORTER
TO THE GOVERNMENT REFORM COMMITTEE
ON OCTOBER 11, 2000
10:00 A.M., 2154 RAYBURN
here for U.S. House of Representatives link)
was formed in order to capitalize on the opportunity to
develop early stage pharmaceuticals. The Company licenses
attractive product development opportunities from academic
institutions, biotech firms and pharmaceutical companies.
VDDI focuses on pharmaceutical product opportunities where
general proof-of-principle has already been established
in pre-clinical or early human testing, and where the
products are novel and offer significant potential advantages
over those currently in the market or in development.
VDDI pursues early-stage products qualifying for fast
track approval, primarily in cancer, cardiovascular disease
and infectious disease. As its name suggests, VDDI utilizes
a virtual business model. Virtual drug development entails:
(i) a small core group of employees responsible for strategic
management, regulatory strategy, and financial control,
(ii) outsourcing all non-core business functions, including
manufacturing preclinical and clinical drug development,
(iii) global strategic resources and internet based enabling
technology, and (iv) electronic data capture and data
submission to regulatory authorities. By adopting this
model, VDDI believes it can reduce total drug development
program costs by at least 25% and development times by
up to 50%.
principal, a vaccine for anthrax is a good and necessary
part of a complete protection "package" against
anthrax, but the present vaccine program has suffered
from a number of problems. Providing effective interdiction
for persons threatened with exposed to anthrax endospores
must remain a national priority. Despite numerous animal
studies, the efficacy in humans of the AVA vaccine in
the face of inhalational anthrax remains in serious doubt.
Practical issues surrounding providing the vaccine to
those in need of it also constitute real problems. The
rapid progress and fatal nature of this disease, the vague
early symptoms and the distinct possibility of human-engineered
multiple antibiotic resistance suggests traditional antibiotic
intervention may be of limited utility. More importantly,
recent knowledge of the cloning of additional virulence
factors (e.g., toxins from other bacteria) into the B.
anthracis host raises the possibility that the nature
and pathogenesis of the disease can be manipulated to
the point of rendering our current interdiction strategies
impotent. Clearly, new ways to block the disease state,
at its earliest stages --before dissemination and production
of its lethal toxin-- represent an exploitable and potentially
valuable addition to our abilities to combat this disease.
the utility of a novel prophylactic antibiotic regimen
that provides active protection against all forms of anthrax
natural and engineered, be a useful addition to our treatment
armamentarium against this bioweapon?
function by initiating the development of host antibodies
that will quickly recognize B. anthracis or a component
of its protein toxin. Unfortunately, it may be relatively
easy for the enemy to genetically alter the surface of
proteins (this also occurs naturally, without intervention
by man) that these antibodies recognize, thereby making
vaccine treatment ineffective; or to use molecular biological
techniques to insert the virulence genes into a different
bacterium. More importantly, recent knowledge of the cloning
of additional virulence factors (e.g., toxins from other
bacteria, cereolysin ab) into the B. anthracis host raises
the possibility that the nature and pathogenesis of the
disease can be manipulated to the point of rendering our
current interdiction strategies impotent.
the ability to use a technology that would allow for the
near immediate deployment of our troops and personnel
be of strategic and practical advantage over an immunization
schedule that requires months to be deemed as possibly
the ability to deploy and store a treatment regimen that
is stable in field conditions, offer advantages over a
regimen that requires refrigeration.
the ability to offer very rapid scale up and production
of an alternative prophylactic and/or treatment regime
confer significant advantages over an immunization regimen?