24, 2003: San Diego Business Journal
Sky Software Looks to Cut Costs
Biotech: New Product
BY MARION WEBB
drug company executives talk about the biggest challenge in getting a drug
to the marketplace, they typically point to the U.S. Food and Drug
agency maintains strict requirements that drug firms must meet before they
deem a drug safe and effective. And, the proof of burden lies with the
companies. They do this by hiring experts knowledgeable in areas ranging
from drug testing in mice and men, production processes, and packaging
data for electronic submission to the FDA, all of which aims to improve
their chances of scoring the big win —
Schmerler of Deep Sky, a 2-year-old San Diego-based software firm,
said it has developed an automated solution to validate computer systems
faster and at a lower cost than what consultants typically charge to the
same by hand.
will make consulting less expensive,” Schmerler said. No one else sells
validation software to comply with what is known as FDA 21 CFR Part 11
guidelines, he said.
regulation seeks to prevent fraud and promote complete record-keeping,
Sky’s software has multiple uses: It can validate computer systems used
in producing drugs and medical devices, and it can also be used to track
the data trail from the trial center to its sponsor, the drug firm.
said the $1 billion validation industry is dominated by consultants who
charge by the hour and take weeks, even months, to do one job. He claims
by automating validation, firms can save 25 percent to 75 percent in time
and money compared to the “paper and pen” approach. Deep Software runs
$15,000 and is expected to bring $400,000 in sales next year, he said.
2002, Deep Sky joined forces with another closely held San Diego-based
software firm, Mainsaver Software, formerly JB Systems.
two firms have coupled their software programs to maintain and validate
the drug production process at two major pharmaceutical companies.
Shlager, vice president of field operations at Mainsaver, declined to name
the drug makers involved. He said one is located on the West Coast, while
the other is in the Midwest.
are among the largest pharmaceutical firms in the world,” he said.
The firm also sold a software to monitor preventive maintenance during drug manufacturing. But drug makers complained that it lacked validation.
FDA is so strict that when a piece of equipment is taking off line, or
when repairs are being done while it (the machine) is off-line … someone
touches it or parts are being used, it wants to ensure that our software
strictly adheres to their requirements,” Shlager said. “The overlay of
Deep Sky’s software allows that to happen — We are not FDA experts — Deep Sky is.”
big test whether the marriage will last, Shlager admits, is yet to come.
That is when the FDA comes to review and inspect the plants.
will be the true test, after they’ve been through one or two
inspections,” he said.
one local validation consultant remains
skeptical. “I have a hard time imagining how one software can do
validation,” said Antoinette Azevedo, who has done consulting work at
such local biotech firms as Isis Pharmaceuticals Inc. and CancerVax.
there are so many different systems that analyze and process data,
including customized systems at individual drug companies. There is no one
standardized system, so it’s hard to imagine how one validation system
can do it all, she said.
insists Deep Sky found the solution.