Biotech: New Product
Helps Streamline Validation
Process Before FDA Approval

 BY MARION WEBB

 When 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 Administration.

 The 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 — drug approval.

 Jurgen 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. 

 “We 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.

 The regulation seeks to prevent fraud and promote complete record-keeping, Schmerler added.

 Deep 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.

 Schmerler 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.

 In 2002, Deep Sky joined forces with another closely held San Diego-based software firm, Mainsaver Software, formerly JB Systems.

 The two firms have coupled their software programs to maintain and validate the drug production process at two major pharmaceutical companies.

 David 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.

 “They are among the largest pharmaceutical firms in the world,” he said.
Mainsaver learned about Deep Sky during an industry meeting. It was a natural match.  Mainsaver, a wholly owned unit of Ameritege Technology Partners LLC, has been selling software for production systems for years.

 The firm also sold a software to monitor preventive maintenance during drug manufacturing. But drug makers complained that it lacked validation.

 “The 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.”

 The 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. 

 “That will be the true test, after they’ve been through one or two inspections,” he said.

 Still, 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.

 Considering 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.

Schmerler insists Deep Sky found the solution.