Pharmaceutical firms discover the therapeutic value of KM
KM technologies are just starting to make their way into widespread use in the pharmaceutical industry, according to experts in the field.
“Pharmaceutical companies have not been getting whiplash from technological implementation,” says Carol Rozwell, VP distinguished analyst at Gartner. “They’re just now gaining an appreciation for the value of knowledge management.”
Better use of KM will help enable pharmaceutical firms to ensure that drugs in the pipeline can continue in process, can be pulled and modified more quickly, and can work as promised without dangerous and costly side effects, Roswell says, pointing to some key failures of late-stage trials in the past year and the much-publicized recall of major arthritis drugs in 2005 and 2006.
Sharing both ways
Knowledge management capabilities are designed to help protect against such disasters, according to Christian Marcazzo, senior director of life sciences analytics at Spotfire. It used to be that as the drug progressed from test tube development to animal trials to successive human trials, the knowledge gained in the process moved only in one direction, and was rarely passed back to earlier stages so that modifications could be made quickly, Marcazzo says. That is changing, however, as developers throughout the drug pipeline are sharing information in both directions.
“What pharmaceutical companies are doing is changing the way things work,” Marcazzo explains. “It’s becoming a less siloed process.”
Marcazzo explains that pharmaceutical companies have adopted analytics technologies and strategies that give chemists and other scientists at the first stage of development immediate access to any knowledge gained at later stages. That enables them to start immediately on any changes to enhance the drug’s effectiveness. And pharmaceutical companies can use the information gained in a later stage to start development of a new drug (i.e., using information from an animal trial of a blood pressure drug to start development of a combined blood pressure and cholesterol-reducing drug).
Because it takes five years or more for a new drug to come to market, drugs that were already in the pipeline have not necessarily benefited from the analytics capabilities adopted in the past few years.
Communications standards
Pharmaceutical companies also are working closely with the Clinical Data Interchange Standards Consortium to develop communication standards to ensure that they, their technology providers and their contract research firms can efficiently exchange knowledge. According to Gartner, by 2010, a 30 percent improvement in clinical trial efficiency will save the industry $7.5 billion to $8.7 billion annually.
RFID takes hold
The FDA Counterfeit Drug Task Force Report, issued in mid-2006, has prompted some major drug companies to start using radio frequency identification (RFID) tags to track prescription drugs throughout the supply chain, says John Jordan, TagSys president of worldwide field operations. While the FDA report did not mandate RFID tagging of prescription drugs, it did recommend that the industry “move quickly to implement this technology.”
Barcoding offers another way to track drugs from manufacturer to pharmacy, but that requires active use of a scanner—passing the device over the barcode or vice versa. RFID tags, on the other hand, can be scanned passively as shipments move, much in the same way that some toll way systems read RFID tags from motor vehicles. So there’s no need to remove a carton from a case or a bottle from a box. The industry is still debating whether barcodes or RFID tags should be adopted as the industry standard. California and Florida have passed laws that will require tracking at the state level. Other states are expected to follow suit, according to Jordan.
The use of either method helps identify the supply chain to ensure that the patient receives the prescription medicine he or she expects, rather than some counterfeit, Jordan says. Such tagging can also help trace drugs in case of a bad—though not counterfeit—drug, Jordan adds, citing the famous Tylenol scare of the 1980s in which some deaths were attributed to the use of tainted Tylenol. Part of the challenge in the case was tracing the medicine backward from the store shelf through the supply chain.
However, the use of either form of tracing also leads to some data management issues that the industry has yet to fully address. “One knowledge management piece that is still a problem is the data,” Jordan says. “The industry has yet to address the data warehouse structure and how different databases will interact with one another.”
The manufacturer will likely have one database, and different levels of the distribution chain will likely have other databases—each designed to meet their own needs, Jordan explains. So the industry will need to develop standards regarding communication.
By this time next year, Jordan expects major drug companies to expand their use of tracing via RFID or barcodes, with as many as 100 major drugs, up from only a few now, using one of those technologies.
Rozwell says that by 2008, Gartner expects to see the FDA more strongly encouraging or mandating use of the RFID tags.
As important as it is to track medicines throughout development and supply chains, it’s also important that pharmaceutical companies leverage their knowledge about their products throughout the organization, says Tony Lopresti, VP of sales and marketing for Clarabridge.
So pharmaceutical companies are starting to use context-mining software to provide information to customers about rebates, drug interactions and other information that is commonly available via a company’s internal resources, Lopresti says. By making appropriate information available to those outside the firm, pharmaceutical companies can enable customers to answer their own questions regarding many issues, which is less expensive than using customer service agents to answer calls.
“There’s increased interest among pharmaceutical companies to be more responsive to customers,” Lopresti says, citing industry competition as the reason. “If you can mine large amounts of information, you can be more responsive to the requests.”
The next stage, according to Lopresti, will be to use the same technology to mine content from blogs and other consumer-generated content on the Web, to add to more traditional knowledge sources.
So while knowledge management has been underutilized by the pharmaceutical industry to date, regulatory, competitive and business pressures are expected to continue to increase adoption of KM technologies and strategies in the next few years.
Global trials make translation critical
Pharmaceutical companies are running more and larger trials than ever to ensure that their new drugs meet all of the necessary parameters for the next phase of trials, win eventual approval from regulatory bodies and, most importantly, don’t have any dangerous side effects for users.
Those trials have also become more global in nature, so pharmaceutical companies have to be extra careful to ensure that any knowledge derived from the trials is translated properly from not only one
language to another, but also from one dialect to another, according to Mark Wade, global practice leader for life sciences at Lionbridge, a global translation company.
“Pharmaceutical translation is very specialized. It’s not like a manual for a car,” Wade says. “Some clinical trials include several groups from several different countries. You have to make sure all of the general qualifications are identical. You have to make sure all of the patient release forms are correct.”
The documentation also must be properly translated from technical language to lay language or vice versa, Wade adds. Beyond just meeting regulatory requirements, proper translation is necessary to avoid lawsuits. “We live in a very litigious society,” Wade says.
Just as important as the accuracy of the translation is the speed of the translation, he says. Every additional day a blockbuster (such as a cholesterol-reducing) drug is on the market means another seven figures in revenue to the pharmaceutical company.