By Debbie Strickland
He earned an M.D. from Yale University in 1993, but Gualberto Ruano didn't wear a white coat for long.
"My clinical experience was short but sufficiently long," he said, "to become frustrated and look for better ways of doctoring."
His rebellion was directed at the one-size-fits-all nature of most drugs.
"The responses of the patients to medications were so different, and it was my responsibility to handle it, to put people on different medications and see who responds and see who doesn't and who has adverse reactions," he said.
Reflecting his physician experience, the start-up company Ruano now heads as CEO, Genaissance Pharmaceuticals Inc., of New Haven, Conn., has adopted as its mission the development of "personalized medicines" by researching isogenes, variants that occur in patient populations. The idea is to methodically stratify patients based on isogene profiles that identify who will respond well to a given drug and who won't.
Described as an "integrated approach," the company's research and development goals consist of the following components:
* Discovery of isogenes and profiling their variability in sequence and in expression using proprietary technologies.
* Development of mednostics (medication prognostics) indices for accurately prescribing medicines based on isogene profiles.
* Development of isogene targets for drug screens.
* Design and synthesis of isogene-targeted lead compounds to improve treatment precision.
For its first drug-development project, Genaissance is scouting around for promising compounds developed elsewhere that could be "rescued" and used to treat genetically distinct segments of a patient population. A clinical trial could commence as early as 1998.
But the first priority is securing an additional $7 million to $10 million in financing through a collaboration with one or more larger companies, or additional private investment. Already, a strategic deal with an unnamed instrumentation company is near completion, as is a research agreement with Yale, Ruano said.
In another Yale connection, Frank Ruddle, Sterling Professor of Biology and professor of genetics at the university, has joined the company's scientific advisory board as chairman.
The company currently has a research and licensing agreement with the University of Connecticut's Drug Discovery Institute, headed by Alex Makriyannis, also a member of the Genaissance scientific advisory board. Two or three drug candidates may come out of that partnership, Ruano said.
Genaissance co-founder Kevin Rakin, vice president and chief financial officer, said partners are crucial, but they have to be "correct" ones.
"The big decision is whom should you dance with," he said, "who's going to add value, not just looking one or two years down the road, but five years down the road."
Genaissance's partners have to share the company's vision of becoming a fully integrated biopharmaceutical company in its own right, he said.
The company's start-up investment of approximately $10 million came from a variety of sources: selling the assets of its predecessor company, BIOS Laboratories Inc., which Ruano headed as CEO in 1995-96; management investment; Yale University; Connecticut Innovations, a state venture capital fund for high-tech companies; and private investors.
The bulk of Genaissance's current funding was secured when BIOS brought in new managers--Ruano and Rakin--to revamp the company. They licensed its proprietary DNA sequencing technology, invented by Ruano in 1991, to Amersham International plc, of Buckinghamshire, U.K., and Visible Genetics Inc., of Toronto. Visible is now a research partner with Genaissance. Montreal-based Quantum Biotechnologies licensed worldwide marketing and distribution rights on BIOS' genomics products.
"The board of directors looked at what the company could do, did some management changes and started with a clean slate," Rakin said.
In that spirit, the BIOS trademark was sold to Quantum and Genaissance Pharmaceuticals was born.
"We did the name change because we wanted to be clear about the big vision" Rakin said. "The old name was very much identified with research products, and the new company is very much focused on the therapeutic market."
Ruano said he hopes Genaissance is ready to go public within two years, but the company will wait if key financing milestones are met.
"A lot of companies go public too soon," he said. "A public offering has to be done when the company has a defined product pipeline."
Among the company's other growth goals are 25 employees by year's end, 45 in 1998; and a doubling of office and lab space from 6,000 square feet in Yale's Science Park to 13,000 square feet. *