Thursday, April 26, 2007

Knowledge Management in Pharmaceutical Industry

Knowledge Management – An Introduction

Knowledge Management is simply one of many tactics that organizations can adopt to improve their performance. Knowledge management is not new: the first time that a scientist documented the exact procedure used in an experiment and shared it with colleagues was a form of knowledge management. Knowledge management sounds like a new term for data management or information management, the focus of bioinformatics. It is not. Knowledge management is a systematic, organization-wide effort that: -

=> Recognizes that it is the employees of the organization - scientists, engineers, sales representatives, technicians, and executives - who have profound and deep understanding of the data, information, work processes, competitive environment and societal context that contribute to organizational success
=> Promotes the creation, preservation, transfer and use of that knowledge in order achieve organizational goals and objectives
=> Supports and rewards the creation and dissemination of knowledge in a collaborative, non-individualistic manner
=> Controls and protects knowledge from leakage outside the organization.

Knowledge management involves an intentional effort to stimulate the sharing and use of knowledge, instead of relying on ad-hoc and informal knowledge sharing activities, while at the same time keeping the knowledge secured within the organization and it's selected alliance partners. While knowledge management efforts often entail investments in advanced information technology tools, knowledge management is more than IT projects. Knowledge management is about changing the way that employees create, share and use their knowledge, so that the organization retains and builds upon the knowledge. It is the cultural aspects of transforming individual-held implicit knowledge to organizational-shared explicit knowledge that distinguishes knowledge management from bioinformatics.

Reasons Leading to the Failure of KM
As with other high profile initiatives that have gone before, such as business process reengineering, knowledge management is attracting its critics and various initiatives have stalled or failed. The setbacks can usually be traced to one or more of the following factors:

Knowledge management is seen as a quick win - One of the trickiest aspects is to create a culture where knowledge is freely shared within an organization. Such a culture change is not an overnight job.

Too much emphasis is put on technology - While there are a growing number of excellent knowledge management tools, such as document management, concept mapping and visualization, intranets and intelligent agents, technology is only an enabler. The knowledge it conveys needs organizing, for example through knowledge maps.

Over-ambitious in scope - Some of the most effective corporate-wide initiatives start as selective pilot projects. The pilots are used to develop understanding, build capabilities, and derive lessons for a wider roll-out.

Inappropriate skills - Good information management skills, of the information science / library type provide an essential perquisite. Good networking and facilitation skills are also important. Many knowledge management teams do not have sufficient breadth and depth in the range of skills needed.

Lack of leadership - Like any significant new initiative knowledge management needs business champions and top-level commitment. A senior executive at knowledge initiative had stalled. “We know what to do, but don’t do it”. It was only when the top management team committed their own time, and formalized it as a core activity, that the program moved forward.

Knowledge Management in Pharmaceutical Industry

Pharmaceutical companies need knowledge management solutions that allow users to store, analyze, interpret and share information as part of coordinated processes. They must also provide ways to collect and manage diverse information, and use it effectively to support decision-making. This means not only text documents, but also non-text files such as molecular structures, gene sequence alignments, images, results tables, entry forms and other information. It also includes links to key internal and external resources, discussion items, key e-mails, external search results, and status and summary reports.

The sheer volume of information companies must wrestle with in the course of developing new drugs. Advances in biological and chemical research techniques have caused an explosion in raw data by several orders of magnitude. This compels companies to obtain automated analytic systems to deal with such large portfolios of data. It has also placed a priority on developing and offering timely access to summary information. This requires a range of knowledge, project and portfolio management tools that promote deposition, sharing and coordination, such as: workflows, task lists, intelligent agents, portals at the personal, project and departmental level, advanced query tools, intranet spiders, etc., all of which can be tied together as part of an integrated knowledge management solution.

Life science companies, collaborative software tool vendors, and industry consultants all seem to hold out great hope for this something call knowledge management. The reason is simple: With such massive data overload in the life sciences, companies realize it is to their advantage to find better ways to deal with and use this information. To use knowledge as a strategic advantage, life science companies take one of three broad approaches, which can be generically described as follows:
=> Help scientists know what's already been done and by whom
=> Extract information, relationships, or new insights from existing diverse data sources
=> Capture the expertise and intellectual property of scientists

One approach in using knowledge management is to give researchers a means to better understand what's already been done and who did it. A number of knowledge management projects aim to provide scientists and managers with tools that help them stay informed about what is going on within the company. This helps prevent researchers from duplicating a completed experiment or following a nonproductive path that has already been rejected. The worst-case scenario — one that happens far too frequently — is for a researcher to spend six months eliminating a particular drug candidate, only to find that a colleague had already drawn the same conclusion. Informing researchers that a co-worker is interested in the same topic is one way to avoid such duplication. Such an approach can also reap other benefits — namely, timesavings.

Need for Knowledge Management in Life Sciences Industry

The only sustainable competitive advantage of a pharmaceutical or biotechnology company is the organization's ability to efficiently create, protect and commercialize new intellectual property. Leadership in the pharmaceutical and biotechnology industry is less and less about day-to-day clinical testing, manufacturing or sales. While many pharmaceutical companies have extensive expertise in those functions, similar expertise can obtained by contracted out to specialized organizations as CROs.

The key competitive advantage for firms is the research and development of new intellectual property that forms the basis of successful research, manufacturing and distribution activities. New intellectual property not only includes the development of new chemical entities that can become INDs; it includes manufacturing techniques, regulatory compliance programs, marketing program design, and so forth. The active sharing of the knowledge held within the organization is essential if new intellectual property is to be quickly commercialized and with have a high degree of commercial success. Reducing "time-to-market" depends on knowledge management. At the same time, knowledge management is necessary to avoid repeated explorations of dead-ends - unless knowledge of failures is shared, failures are repeated.

US Food and Drug Administration Regulations
One of the biggest factors is regulation. For just one new drug, a company must maintain enormous volumes of information -- documents, research data, clinical trial records -- over an extended period of time. These millions of files have to be carefully managed in accordance with strict rules governing electronic information, whether they are included in submissions made to the FDA or simply kept for possible inspection by the Agency. The FDA's regulations cover good practices in laboratories, clinics and manufacturing facilities. While these "predicate" rules were written with the assumption that key information would be in paper form, increasingly this material is electronic. Accordingly the FDA developed the 21 CFR Part 11 regulations, to give the industry some ground rules for moving from paper-based to electronic systems, but the rules are complex in interpretation and implementation. In order to comply, companies are being driven toward centralized repositories for managing information to ensure consistent, compliant ways of developing and using information across an enterprise.

Globalization of R&D
Globalization of research and development requires collaboration across time zones and language barriers. The explicit focus of knowledge management on the sharing and use of knowledge can act to bridge diverse research and development teams. Few industries span the world in their research activities, as does the pharmaceutical industry. Lead synthesis, identification, validation, animal testing, formulation, and human testing can occur in a variety of nations. Sharing of knowledge also has applicability to manufacturing and marketing. The need for global uniformity in good manufacturing practices requires that personnel involved in that aspect exchange ideas to assure the highest quality production. While marketing channels differ across markets, knowledge from one market can have applicability in other, if only to avoid costly errors.

High Turnover of Human Capital
The pharmaceutical and biotechnology industry is in a period of rapid change, and employee turnover is increasing due to new opportunities. It is also important that organizational knowledge does not leave with an employee - the control aspects of knowledge management can act as an additional safeguard. High turnover of skilled scientists and other experts requires knowledge management in order to retain the key output of professionals: their own increase in knowledge from working within an organization. Every time a professional leaves an organization, they take with them the increase in their own knowledge that occurred during their tenure. Unless active steps are taken to extract that knowledge, synthesize and share it, so that it can be used, organizations lose the most important aspect of an employee's contribution.

Challenges for Knowledge Management Solutions
While the industry is driving the development of new knowledge management solutions (And finding better solutions to choose from), the industry's biggest challenge is increasingly the user. Many of the human-factor challenges (and costs) of moving to a knowledge management system come from the industry's long dependence on paper and paper processes. Pharmaceutical companies have very detailed, document intensive processes and approval procedures which, when combined with strict FDA rules and the common human-factor challenges, are a bad mix in a very high-stakes game. The biggest issues are proper use of systems to ensure compliance and user acceptance.

Access Rights
Pharmaceutical companies must have to ensure that only authorized and expected people can access records, and that any actions that they take which impact the records in any way are captured in an audit trail. When it comes to electronic signatures, FDA rules are very strict, so companies must carefully manage who can apply an electronic signature through workflows and password authentication to apply a signature. But they must also make sure that management staff understands that an e-signature is equivalent to signing in ink. Password policies should require that staff acknowledge this. In addition, a system that adds an image of a manager's signature to a record, while not required under FDA regulations, reinforces that message. The other major factor is the tendency for employees to write down their passwords, and sometimes share them with colleagues. Rigorous password policies are a necessity to prevent this, but companies must find ways to constantly reinforce the message with employees.

Shift from Paper to Electronic Records
Paper continues to play a significant role, despite the pervasive use of computers. Most people prefer to print out a large document before they read it. This common tendency among office workers has enormous implications for pharmaceutical companies. Companies must make sure they are carefully managing paper copies to avoid unauthorized or inappropriate use. They must also educate employees to make sure they recognize that a printout is not an original record. PDF format is widely employed, since it is possible to overlay watermarks that users cannot remove (e.g. defining document status, effective and expiration dates, etc.), and control whether the document can be changed or printed. Another solution is to consider new encryption techniques, which can prevent screen capture, while continuing to provide access controls on locally saved electronic copies. In this way, all electronic copies of a document, whether in a repository or saved on local computers, can become unreadable at a defined time, for example, when a new version is released.

User Friendliness
Critical information comes from the lab, so pharmaceutical companies must ensure that it's easy for lab workers to use and contribute to a knowledge management system, while working in their unique environment. Systems must offer features that allow workers to add data by simple drag-and-drop, or preferably by automatic agents that capture key information and transfer it to the system without extra effort. Ultimately, these workers have to recognize that depositing information into the system is part of their job, like using a lab notebook. But systems can be designed to offer lab workers added value to encourage use of the system. For example, a comprehensive listing of hyperlinks to all available databases and application tools is helpful, but this can be extended by providing online discussion groups and training manuals. A lab protocol repository covering standard and company lab methods and procedures may also be attractive to lab workers, while also serving corporate goals. This would include being able to find methods used by other workers in the company to accomplish specific experimental tasks, and ways to search for recognized experts across the company.

Finally, the most important challenge is user acceptance of a knowledge management system. If pharmaceutical companies are going to have a uniform, regulatory compliant system for managing information, they must succeed with user acceptance and it starts at the top.

IBM System Journal

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