Where Next for Genomics?

By Edwin Colyer, QX Health (http://www.qxhealth.com)

Genomics may be changing the face of medicine. But if the revolution is to continue, then genomics companies need to change too, argues Edwin Colyer of QX Health.

First came germ theory with antibiotics. Then came replacement theory with insulin and growth factors. Now the paradigm for drug development has shifted once again: We have entered the era of genomics-based medicine.

In less than a decade a new genomics industry has taken hold. Gemomics companies now ferret through miles of genetic code to identify the genetic causes of disease, select potential target genes, and help big pharma find the next blockbuster.

But the face of genomics—or at least its role in drug discovery—is about to change, due largely to its own success. "We're knee deep in potential targets," says Nicholas Dracopoli, executive director of pharmacogenomics with Bristol-Myers Squibb. "Prioritising the targets is the rate limiting step."

Les Hudson, senior VP of group research at Pharmacia & Upjohn, echoes this view. "What we now require from our genomics collaborators are target validation and selection." He stresses that companies are now looking for ways to assess the wealth of genomics information produced through their own research and earlier collaborations. "We now need decision-making tools and functional genomics."

Naturally, genomics companies are responding to this need by developing tools, protocols, and technologies that add value to their raw sequence data. "What will define the successful genomics company is the ability to go beyond simply data generation," Hudson says.

In the past, several companies have relied on building their own proprietary sequence databases. As the Human Genome Project nears completion and its errors are ironed out, however, the value of proprietary human genome databases will lose some of their intrinsic value. The companies that have relied purely on sequencing and database provision to provide raw data will have to evolve, most obviously into annotation.

Leaders in the genomics field, as in any other industry, will be companies that offer a value-added service. Large pharmaceutical companies agree on what that service should be: integration of all the genomics information available. With more information readily accessible, companies can easily decide on whether to continue investigating potential targets.

So the future of genomics companies may rest in their IT and software capabilities, a view held by Celera Genomics, a newcomer to genomics. "We are entering an era of ‘cyberpharmaceutical' drug development," says Samual Broder, executive VP and chief medical officer. "Pharmaceutical corporations will use genomic databases, and other relational databases involving gene expression, proteomics etc. as the foundation of their drug discovery pipelines. One of the immediate goals... is to produce appropriate databases and software to link biologic and genomic information." Thus, Celera intends to focus on being an information company supplying researchers with databases, software tools ,and high-performance computing capabilities.

Incyte Pharmaceuticals, also with vast computing capabilities, has been focusing on the development and integration of its databases for seven years. Despite possessing databases crammed with potential candidate genes they have chosen to remain purely information-based. "Our decision not to develop any drugs is almost a theological position," says Roy Whitfield, CEO. "Most genomics companies have ended up saying they will develop a drug themselves through their genomics research. But in order to remain effective you have to keep on the ball with genomics technologies. Only a few companies are concentrating on a purely genomics platform."

That most genomics companies are looking to pharmaceutical products as their long-term source of revenue is not necessarily a bad thing, however. Bristol-Myers Squibb's Dracopoli believes that drug discovery could be the ‘value-added service' that many genomics companies will offer.

Curagen, for example, already considers itself a biopharmaceutical company. "Successful genomics companies will have to have drug discovery programs. This will provide them with a revenue stream down the road," says Mark Vincent, director of corporate communications. But in all such cases, the genomics companies will have to deliver more than candidate genes. Instead they will seek to develop pharmaceutical products, and as they take their product through development it will command a higher value and involve less risk for potential partners.

In short, over the next few years, in-house gene discovery will rapidly adapt into drug development. Those genomics companies which lack the IT resources to compete with the likes of Incyte and Celera must look to taking their in-house research further through the development process.

Millennium realized this back in 1993. "We asked ourselves what the biotech company of the future would have to look like to exploit the knowledge of the human genome," says Alan Crane, VP business and commercial development. His company foresaw that the whole method of drug discovery would change as a consequence of genomics research. Thus, Millennium has sought, through acquisition (e.g. of LeukoSite) and licensing of technologies, to build an integrated drug discovery platform. "We have a whole gene-to-patient paradigm," says Crane.

Genomics thus promises to transform the drug discovery process and become the foundation of future pharmaceutical products. It is a long-term approach to R&D. But the decade-old industry must dramatically transform itself to meet the evolving demands of its pharma partners. Of most value will be the companies that successfully annotate and integrate genomics, proteomics, and pharmacogenomic data.

Most companies are hedging their bets. Apparently ephemeral "information" doesn't have the same security as a blockbuster drug in the pipeline. Most of today's genomics companies are tomorrow's biopharmaceutical firms.

For more information: Edwin Colyer, Editor, QX Health, Enterprise House, Manchester Science Park, Lloyd Street North, Manchester M15 6SE, UK. Tel: +44 161 232 3300. Fax: +44 161 232 0000. Email: info@qxhealth.com. Web: http://www.qxhealth.com.

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