Despite the in silico research ideals of many genomicists, no one has yet found a way around the basic requirement for using human tissue in gene expression studies-a broad array of it, well characterized, from healthy and diseased patients, and from world populations at large. That's why start-ups, drug discovery firms and others are creating a new resource: biorepositories--banks of tissue samples and data to serve the diagnostic, pharmaceutical and tissue engineering industries. As providers of services and products to research-based companies, these companies believe they are operating in a market that ranges from $500 million to $5 billion.

Advice of Counsel addresses the question of whether genomics companies are using new business models and deal structures to commercialize their technologies.

New technologies enable the rapid processing of genetic information, but since gene data isn't associated with specific diseases and diseased tissues, in and of itself it isn't clinically useful. A new breed of start-ups aims to provide both the phenotypic and genotypic sides of the equation by creating databases of patients and patient samples. Still unclear is how much drug firms will pay for disease-associated gene data; genetics firms are taking various approaches to monetizing their databases, from focusing initially on high-value diagnostics to creating true target-discovery businesses, to selling their data along with associated software and services. There are also ethical issues to hammer out. The new companies must take care to protect patients' rights. They must consider the need for explicit consent to use the information collected from patients, especially when they are participating in research whose purpose is as yet undefined.

In Vivo summarizes the technologies of several recently founded companies: Ardais Corp., is creating information products from consolidating high-quality, reliable biological samples and related information for use in drug discovery and development. BeneCor Heart Systems was founded in September 1999 to develop and commercialize a totally implantable, permanent heart replacement device. Chronix Biomedical will focus on the diagnosis and management of chronic diseases by detecting what it calls "reshuffled genes," the detours the human genome map takes when confronted with viruses or other toxins. Founded in July 1999 by a group of former Columbia University physicians and scientists, MediData Solutions Inc. will offer new software and technology for managing clinical trials. Spiration is developing devices to treat pulmonary diseases, in particular chronic obstructive pulmonary disease (COPD), for which no cure exists.