TESTIMONY OF STEPHEN PORTER
TO THE GOVERNMENT REFORM COMMITTEE
ON OCTOBER 11, 2000

10:00 A.M., 2154 RAYBURN
(click here for U.S. House of Representatives link)

VDDI 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%.

In 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.

Questions:

Would 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?

Vaccines 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.

Wouldn’t 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 effective?

Wouldn’t the ability to deploy and store a treatment regimen that is stable in field conditions, offer advantages over a regimen that requires refrigeration.

Wouldn’t 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?