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KM and the pharmaceutical industry: A roundtable discussion—Part 2

[Editor's Note: Last month, we concluded Part 1 with a discussion of the proper use of technology tools in the pharmaceutical and biotechnology areas. We dig a little deeper this month and look at the true promise of successful KM.]

Participants In this final installment of our discussion, KMWorld speaks with several people who helped organize or were speakers at a recent seminar presented by the Boston KM Forum and entitled "Knowledge Management IT Innovations in Life Sciences," held at Bentley College in Waltham, Mass. Included in the discussion are:

Seth Earley, the founder and president of Earley & Associates, a technology consulting firm specializing in Web application development; strategic planning; and research in the areas of knowledge management, content management and e-business.

Mark Gordon, a managing partner with Knowledge Resource Group (KRG), who leads KRG's Global Pharma Solutions practice, and has spent the last five years helping large pharmaceutical companies' business development and licensing groups use IT to meet their goals.

Robert Howard, senior VP of Kendall Strategies, who has particular expertise in marketing strategy for technology science companies including new technology assessment and the management of R&D.

Lynda W. Moulton, director of KMPro New England and head of LWM Technology Services.

Dr. Harvey L. Wiener, associate director in knowledge integration resources at Bristol-Myers Squibb (BMS) in Wallingford, Conn.

Earley: There are lots of different places where organizations can poll data. and part of the problem is reconciling that. Bob, maybe you could talk about the different data sources that are available in the industry and maybe the volume of data and the number of pieces of information that might be available on a given compound. What I understand is that there may be research names for these compounds. There could trademark names. There could be a lot of different ways of describing compounds and there are multiple data sources out there, and this all has to be resolved in some way.

Howard: That's right. There are a number of standardized databases that people in the industry can purchase or license that track the progress of different drugs in development and one of the things, we recently did an assessment doing just this, looking at some of the different sources in the area of hypertension. It's really hard to believe how much different--or I should say conflicting--information is out there about some of the same compounds depending on which database that you go to and look at. Part of that is what Seth pointed out, due to the fact that they may be calling it one chemical name in one database and they may be calling it a trademark name in another one.

Moulton: From a content management standpoint, it's very important to devise naming conventions for the reports themselves. Nomenclature and the terminology must be consistent. And this is actually a practice that goes back many, many decades in the chemical industry. Usually, there has been a group that actually assigns people report numbers and series of laboratory notebook names and that kind of thing. Even without computers. So, it's just a matter of going back and revisiting some very practical, pragmatic ways of looking at things to make sure that everybody is talking about the same thing. In fact if you look at what they were describing earlier about the various data sources for the same compounds, if you are looking at registry numbers or something like that you wouldn't necessarily have those problems.

You may have an intermediary who actually builds those taxonomies, and it's really important that there's a community of practice here that includes the scientists and the people who are using them.

Earley: One of the challenges is to effectively pull together what are now fairly standard tools and classes of technology--document management; real-time collaboration; virtual, collaborative work spaces; workflow tools; portals; online learning systems and the like. It's really the way those can be assembled to meet the work process.

KMWorld: Let's take a view through the looking glass into the future of knowledge management in the pharmaceutical industry and speculate on what it might mean ultimately for consumers--are these compounds going to get to market faster? Are they are going to be less expensive? Will companies be able to develop compounds that perhaps we never would have imagined had we not had this collaborative knowledge sharing?

Earley: The future of this industry is going to be highly dependent on how people are managing this knowledge because "we ain't seen nothing yet." The human genome project has revealed a lot, but the human proteome project [designed to uncover the secrets of human proteins] coming up is orders of magnitude more complex. I'll defer to the scientific experts to talk more about the future, but I think it's going to be unimaginable in terms of health and to treatment of disease. Dr. Weiner?

Weiner: Certainly personalized medicines is a possibility. Why do some patients respond to some drugs but not to others? That could be due to neurogenetic disposition. And personalized medicine will be something very important, if you could identify patients who may have adverse reactions to a new medicine, you could improve safety as well.

Earley: So the compounds could be designed or configured in some way for one's own personal chemistry?

Weiner: Right, and thus they will be more safe and effective. And when considering knowledge management and the consumer and what medicines will be put in the patient, of course, we must also think about information that the consumer receives. We can't lose sight of the fact that the pharmaceutical industry is very tightly regulated by the Food and Drug Administration, and the pharmaceutical industry has to be cognizant of what information they are allowed to actually present to the consumer.

Earley: Right. Bob do you have thoughts on the future and the impact of knowledge management on the industry?

Howard: I'd like to emphasize that the proliferation of information occurring as a result of this genome project and later the human proteome project will allow for a customization of therapies as well as more integrated approaches to diagnosis and treatment--hence the creation of terms like "theranostics." Imagine a compound that is a hybrid device and drug--for example, a diabetic person has some sort of chip installed that when her insulin is not at the right level, a signal is sent and the appropriate release of insulin occurs.

Gordon: That's pretty exciting when you think about the future of combining diagnostics and medicines. R&D organizations are applying these technologies now, and they are able to accept or reject things faster and spend resources on the more promising compounds more quickly. They are able to get them to market faster and through the FDA-approval process more quickly. And, in licensing, [companies using sound KM practices] can find other firms that have innovative medicines on the drawing board but don't have funds [to develop them in a timely manner]. It will ultimately mean for the patient that there are cures to more diseases, more more often. Better solutions.

Weiner: You'll see more efficiency in the process. Maybe the drugs today that are considered the "orphans" that aren't commercially feasible will become so. Maybe they can be cost-effective to market to the smaller population. For example, non-profit organizations may be able to fund drugs, say, to cure a disease that only affects 50,000 people in South America, that would not be otherwise commercially viable. This sharing knowledge will bring resources together to make something happen that otherwise would never have a chance—and make it happen more quickly.

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