Researchers tackle ‘tidal wave’ in genomics

Molecular biologists left Celera to launch Human Workflows data startup

‘‘No one expected the tidal wave of data that has overwhelmed the abilities of pharmaceutical research and development, biotechnology and university studies to use the data,” Ribaudo said. He and Pihl were genome ‘‘interpreters” at the former Celera Genomics Inc., which in 2000 was racing federal scientists to sequence all the genes in the human genome.

As Celera restructured in 2005, the men saw a business opportunity to help manage those data. Human Workflows helps researchers, both public and private, draw what they need from the genome data. The work is part of a post-genomics industry called ‘‘translational research,” or as the National Institutes of Health Web site explains it, ‘‘the movement of discoveries in basic research to application at the clinical level” despite a ‘‘lack of uniformly structured data across related biomedical domains.”

When they left Celera in 2005, Ribaudo and Pihl thought they knew nothing about business. But they unwittingly had been in entrepreneurial training for their new venture.

While representing Celera, they were forced, through ‘‘trial by fire,” to network and communicate the business side of genomics to scientific leaders. In their five years at Celera Genomics and its sister company, Applied Biosystems Inc., Pihl and Ribaudo met and worked with the world’s top leaders of pharmaceutical and biotechnology companies and university scientists.

‘‘We had to learn to be public speakers, because Celera was getting hammered,” Ribaudo said. ‘‘There was this whole public relations issue between ‘mean’ Celera charging money for these databases — which was public information despite the fact that we had shareholders — and the human genome project at NIH, which was doing everything for the benefit of mankind.”

Things were getting crazy at Celera, they said.

Although the data were universally seen as extremely valuable, Pihl said, ‘‘there was a sense of scrambling to try to handle it.” It soon seemed that no one really knew how to work with the data to relate to the annotation or explanation of the genes’ exact expressions in cells, he said.

‘‘The buildup was enormous to get the new information ... that this is where the new blockbuster drugs were going to come from,” Ribaudo said. ‘‘The stakes were really high. Celera was charging millions of dollars in subscriptions for that genome information.”

At the finish line — the White House announcement in 2000 that Celera and NIH had each deciphered the hereditary codes of human life — a.k.a. the human genome — the NIH team was giving the genomic data away for free on the Internet.

But fulfilling the ballyhooed promise of the human genome was delayed, because, in addition to the large amount of data, researchers soon discovered that the data constantly change as genes are turned on and off, Pihl said. When President Clinton said at the time that the Celera and NIH teams had learned God’s language of life, ‘‘we didn’t yet know that he speaks it in different languages,” Pihl said.

‘‘Our whole experience in translating from Celera’s technology to users revealed another huge problem developing: the siloed nature of all that biological information,” Ribaudo said. ‘‘All of the different technologies exist in their own silo, much like scientific studies exist largely within separate disciplines.”

‘Didn’t want to sellboxes for a living’

In 2005, Celera and Applied Biosystems restructured, with the latter returning to its core competency of making sequencers. Celera, after dropping ‘‘Genomics” from its name, now develops diagnostics tests.

And Ribaudo and Pihl had to rethink their careers. They ‘‘didn’t want to sell boxes for a living,” Ribaudo said.

Fortunately, Celera’s severance package included a business course from a career-training firm, Lee Hecht Harrison. The men learned how to be entrepreneurs from instructor Larry Petcovic.

‘‘A big part of his talk was about your network. That hit both of us independently,” Ribaudo said.

‘‘I had gotten really excited about it and as we were walking out of the seminar together and I said to Todd, ‘I don’t know about you but I might make a go at this. Are you interested?’ and he said, ‘You bet I am.’”

After the course, they reconnected with Petcovic, who taught them how to incorporate, and what to look for in hiring lawyers and accountants. They worked with Petcovic to get the company off the ground, eventually bringing him in as vice president for communications.

With low overhead, the men were able to finance the launch themselves.

After incorporating Human Workflows in late 2005, Ribaudo and Pihl — still the company’s only full-time employees — spent most of 2006 recharging their valuable network of potential clients and partnering companies.

The company partnered with Johns Hopkins University spinoff BioFortis Inc. of Columbia to help one of its first clients, an Irish hospital-university research consortium, Dublin Molecular Medicine Center. Human Workflows helped the center align separate data on prostate cancer gene expressions and clinical work at its three universities and six teaching hospitals into a single project.

BioFortis, a biomedical informatics company, then ‘‘did some very nice work” with the Irish center, said BioFortis scientific director Ethel Rubin.

According to the U.S. Food and Drug Administration, nine out of 10 experimental drugs fail in clinical studies. It’s difficult for researchers to predict how the drugs will behave in people, despite ‘‘a background of ever-growing masses of data from separate areas of testing — e.g., animal models, toxicity, biostatistics, clinical trial designs,” Janet Woodcock, deputy commissioner, said in a statement.

Human Workflows is currently helping four pharmaceutical companies navigate that process and take a more efficient path to clinical trials. Its translational research is ‘‘real knowledge” for drugmakers, Ribaudo said.

The company has already lined up as much work for 2008 as it did in 2007. Ribaudo and Pihl declined to reveal last year’s revenue figures, except to say that they each made more than their top salaries at Celera.