Pharmaceuticals: Worldwide Vision

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September 22, 1997

PHARMACEUTICALS:
Worldwide Vision

Drugmakers turn to workflow and the Net to speed products to global markets
By Jeff Angus
IW 500 slug orkflow, document management, and Internet technologies are helping a number of leading pharmaceutical companies improve their business process with customers, business partners, and regulatory organizations. They're also helping to deliver products to a worldwide market more quickly.
The tools to support this emerging business model are maturing at the right time for this document-intensive industry. "The financial st akes in the industry are higher every year, says Scott McCready, an analyst at International Data Corp. "Profits are there when you can speed the cycle on drugs-and it's automation technology that can speed cycles."
The movement toward partnership and global marketing has been in place since the late 1980s, says Vita Cassese, VP of business technology at Pfizer Inc. in New York. "The capabilities have changed, the software tools have improved, and the speed of processors that support that software is better," she adds.
According to a survey conducted earlier this year by consulting firm Deloitte & Touche, pharmaceutical companies' CIOs expect workflow and Internet technologies to have a great impact on their organizations in the next two years. A change in the way workflow products are marketed has made interest in the category turn into implementation, says IDC's McCready. "There was always the justification to use workflow to assure vital forms were being processed," he says, "but with prices for w orkflow clients dropping-especially for thin Web clients-pharmaceutical companies can integrate a lot of document-management [capabilities], too."
One of the reasons this technology is so important is the way it can help improve the relationship with business partners. The use of outside companies with specific expertise-called contract research organizations (CROs)-has risen about 300% in the last three years, says Lee Evans, manager of the SAS Institute's PharmaTechnology Center in Cary, N.C. CROs have proliferated because the pressure to get drugs to market quickly, combined with downsizing in the industry, has created a need for outside expertise, rapid simulation, evaluation, and testing of drugs.
"The pharmaceutical companies develop relationships with CROs and contract out a ton of work," Evans explains, "and that means networking with all these little external companies and all that data is out there. What's happened is the companies have created separate IT functions simply to deal with C ROs." Much of the effort, Evans says, deals with data and making sure the different organizations' applications can work with one another.
Most of that data exchange is done now either by sending paper printouts via overnight courier or by exchanging media, such as diskettes. Pfizer has formalized the process by having explicit agreements with its CROs that describe how systems will talk to one another.
Increasingly, new drug invention is coming from outside partners-such as biotechnology companies-from which pharmaceutical companies will buy the rights. But such arrangements amplify the need to share information. Whenever a company buys rights to a product, it needs access to all the research information, the Food and Drug Administration (FDA) submissions, and the lab notes, for example. That has prompted some biotechnology companies to use document-management, imaging, and workflow systems, IDC's McCready says.
McCready also says that although Documentum's document-management technology is virt ually a standard among large pharmaceutical houses, biotechnology companies such as Hybritech Inc., a Beckman Instruments Inc. subsidiary in San Diego, are largely users of Docs Open document-management software from PC Docs Inc. According to Paulette Loeh, Hybritech's principal data-management specialist, the primary use of the technology is for electronic submissions to the FDA.
Racing The Calendar
Baxter Healthcare Corp.'s Hyland division in Glendale, Calif., was the first company to use PC Docs' technology for electronic FDA submissions, and its current implementation is spreading across the country.
According to Kathryn Davidson, Baxter Hyland's project manager, the system will interface with the Documentum system of Recombinant Factor VIII co-developer Genetics Institute Inc. The purpose: to share data between their different systems.
"Technically, we know it can happen," Davidson says. "We're still working out some legal issues in connecting another company to our data."
Ph armaceutical companies' ultimate challenge is dealing with the FDA. "Patent life drives the industry," says IDC's McCready. "From the day a patent is granted, its life starts running down. Every day you can't get it to market, you're losing revenue-and the financial stakes are higher every year." He notes that almost no drug takes longer to develop than it does to get approval to sell it. And the process of getting there is costly-requiring huge volumes of reports and forms that get submitted to the FDA for approval, says Pfizer's Cassese.
Industry and government are collaborating on developing technical solutions to help speed this process. The FDA's Smart (Submission Management and Review Tracking Program) project will let pharmaceutical companies submit forms electronically. On the back end, it's also intended to allow FDA reviewers to better access, analyze, and share relevant information.
Parts of the Smart initiative have already been implemented. For example, the FDA's Center for Drug Evaluati on & Research (DER) lets companies submit product applications electronically. The client-server system is based on Documentum's document-management system, Adobe Acrobat documents, and an Oracle7 database. It runs on Digital Equipment's Alpha-based VMS and Microsoft's Windows NT servers.
Baxter Hyland's Davidson says the electronic submissions may not save money, but they help the company avoid some of the more onerous burdens involved. "It actually doesn't seem to save any money, but it saves a lot of logistical support," she says. "Because the FDA takes submissions electronically, they require only three copies of the primary report; we save about 30,000 pages per submission."
Sales Balloon Abroad
Globalization-the ability to test and market a drug once in one country and then market it in many countries-is considered one of the key areas of growth for the industry, according to the Pharmaceutical Research & Manufacturers Association, a lobbying group in Washington. Industry asso- ciati on figures indicate that while U.S. sales have increased 37% since 1992, sales abroad have ballooned 55%.
One key to capitalizing on global opportunities is the Internet. As SAS Institute's Evans says, "the infrastructure that will make globalization work is the Internet. It makes many of the communication issues go away."
Evans says companies such as Pfizer can take advantage of the Web to deploy intranet applications in various-weight clients so people with different needs can share data. "Mixing client sizes is important because there are so many different kinds of contributors in this industry," he says. "People writing standardized reports can use a browser or other thin client, but others, like biostatisticians, need to evaluate data on the fly, and they need bigger clients. The Web can bring the data to anyone who needs it and help extend the size and functions of the teams working together."
Merck Markets On The Net
On the Internet, companies such as Merck & Co. of Whitehouse Station, N.J., use the Web to market their products in unusual ways. The "Health Infopark" area of Merck's Web site uses individual "tour guides" to take the general public through key medical issues as interpreted by Merck. The site also includes a searchable online version of the definitive Merck Manual, a leading medical text, and soon will add an area to market to the company's true customers-the health-care professionals who apply Merck's products.
Pfizer's Cassese sees the Net as a fuse that will set off rapid deployment models. "Development will accelerate both through the application of the Internet and intranets," she says. "The technology allows a wider population to have access to information, both within companies where it can better integrate operations, and in reaching out to the customer."
Communication is another area being altered by the Internet, says Cassese. "The advent of the Internet and intranets is really changing the way most companies are looking to communicate internally and externally," says Cassese. She also believes that advances in telecommunications, both in reduced costs and greater capacities, are helping companies act globally by making it easier to afford a wider, richer set of applications, as well as support them.
Helping the globalization trend is the International Conference on Harmonization, a project of developed nations' regulatory bodies and major pharmaceutical firms to create a standard set of data forms and fields to get to the goal of single product registration and testing requirements. The ICH steering committee met in mid-July and finalized 10 more guidelines.
"This makes much simpler and cheaper the process of creating enabling technologies such as data warehouses," SAS's Evans says. The hope is that the costs of deploying worldwide systems to support worldwide businesses will go down in some cases, and, in others, be feasible in places where they weren't before.
Cutting Corners
Another key technology that could help transform th e industry is computer-assisted modeling and simulation. Such tools can help simulate a clinical trial, and cut time of completion by 25%, says Bob Powell, VP of pharmacokinetics at Warner-Lambert's Parke-Davis division in Ann Arbor, Mich.
Powell says modeling and simulation could take a huge bite out of the average $350 million and eight to 12 years it takes to get a drug to market. On average, more than 60 clinical trials are performed, and studies indicate that only half actually expose useful new information that makes an application more likely to be accepted. "The industry can produce more if we can decrease the number of studies," says Powell, who is testing Trial Designer from Pharsight Corp.
"It costs $500,000 to $1 million a month to run a trial," according to Camilla Olson, founder of Pharsight, in Palo Alto, Calif., a company that provides drugs for trial design and simulation. She explains that rather than make a best guess about what might work, a multidisciplinary team of users can in tegrate their knowledge into the model, describe variances, and run thousands of simulated trials in a few hours, selecting the ones most likely to succeed.
Powell says a product such as Trial Designer could cut months or even years off the trial process and help get drugs to market faster.
"It's absolutely critical for effective trial design that people understand what they're going to do with the information before they design their systems," says Powell. "Many people with access to all this are blinded by tons of data when there's only three or four pieces that really need to be known. To make the process work in this coming vast change, you need wisdom, but you also need the guts to follow a cycle of continuous alteration and improvement."

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