People who have participated in important activities within an organization have valuable experiences that should become part of the institutional memory. These experiences may be collected on audio or videotapes/DVDs using structured interviews conducted by professional interviewers. Topics that should be discussed include (a) the problems faced by these individuals, (b) how those problems were addressed, (c) how the organizational structure and company operations assisted or hindered their efforts, (d) what lessons they learned at the time of the event(s), and (e) what lessons they currently see as emanating from their experiences that they would want to pass on to newer employees. They should be asked what they would have done at the time that is different from what they did and, also, how they would approach the same or similar problem today.

It is possible for a professional writer to conduct interviews and to prepare a written document on a subject of particular interest, such as the discovery and development of a specific drug that is important to the company. It must be stressed that honesty in reporting is mandatory if this information is to have any lasting value. Attempting to gloss over problems or to present a more polished view of events than what really occurred does not contribute any real value and benefit to the institutional memory. Moreover, the information may be counter-productive if people are led to draw the wrong conclusions and lessons from the information, and then possibly use the “lessons” inappropriately.

Experiences of employees, their families, and others who participate in company-sponsored events also become part of the institutional memory. Traditions carried on for numerous years, such as picnics, retreats, annual awards, and special staff meetings, are valuable events in this regard.

Companies with significant turnover may rapidly lose part of their institutional memory if the lessons learned are not captured in some way for the benefit of current and future staff. When one considers the enormous financial investment made by a company in the ongoing training of staff, it makes little sense for a company not to obtain the full benefits of its investment through the relatively inexpensive means of collecting lessons that can be passed on to current and future staff. Employees who have been at a company for a long time often serve as a repository for various types of information and act as internal consultants as well as mentors for newer and also for younger employees. A company with rapid turnover risks losing important people who retain part of the company’s identity and can help train new employees in many cultural, as well as policy and political aspects of the company.

Although there are several components of an institution’s memory, the most important is probably the lessons learned that can help current employees perform their jobs more effectively. These lessons may come from the experiences collected, documents available for review, and other information, but to extract and identify important lessons a company should pursue one or more steps beyond simply gathering these items and information.

The first step in this process is to have one or more people review the information gathered in an attempt to elicit the lessons of current or potentially future value. A second step is to ask those people interviewed to discuss the lessons they learned from their experiences. A third step is to contact important individuals at the company, such as project leaders and product managers, identify both specific and general lessons learned from their projects, and write those down in a suitable format for future use. These could be collected from project leaders after a project is terminated as a result of success or failure to achieve its goals. Product managers also could be interviewed at important product milestones. Alternatively, the lessons they learned could be solicited from both groups on a periodic basis (e.g., every two years).

A description of the lessons collected could be placed in a loose-leaf binder and as PDF files on the company’s internal computer system for use. The information should be categorized as well as cross-indexed by all relevant terms [e.g., regulatory affairs, Phase 1, drug X, and department(s) involved].

Lessons and experience are what one has remaining when a drug fails. It is essential to learn from one’s mistakes because, as Santayana wrote, “Those who cannot remember the past are condemned to repeat it.” Although lessons should be learned as they occur, it is sometimes necessary to conduct a systematic evaluation of some drugs’ histories to extract lessons. The lessons learned may then be widely disseminated within the company.

One approach to evaluating one’s products to identify the lessons of value is mentioned. The history of a drug’s discovery, development and marketing can be divided into five parts: discovery, preclinical evaluation, clinical testing, technical development, and marketing. Once an acceptable group of categories is chosen, it is necessary to choose the drugs to be examined. This examination exercise may be limited to a specific group of drugs where there is interest in identifying lessons, or the exercise may address a specific question or issue (e.g., have unsuccessful drugs been terminated more rapidly in the past three years than in a three-year period that occurred 10 years ago?). In choosing drugs to evaluate, it is usually important to pick those with the highest likelihood of providing worthwhile lessons that may be extrapolated to other situations. This is important because the same circumstances are unlikely to ever occur again for most drugs that failed or even for those that were successful. It is important to evaluate both successful and unsuccessful drugs.

The most relevant part of this activity is determining how the lessons learned from the exercise will assist the future development of other drugs. This requires identifying how the lessons may be applied to drug discovery and/or development activities, plus attaining management support for any recommendations that result from this exercise. Recommendations may be in the form of changes in the (a) organization, (b) responsibilities of individuals or groups within the organization, (c) sign-off procedures, (d) use of check lists at appropriate places and times, or (e) other means of preventing similar problems from occurring again.

Companies generate, as well as collect, a great amount of information every day. This information varies in its relevance for a company’s institutional memory, primarily depending on the breadth of the company’s definition of this term, as well as its interest in creating and preserving its institutional memory. Some or all of the material published by company employees may be chosen to be part of the institutional memory. Examples of out-of-date regulatory applications, adverse event reports, plus letters to and from regulatory authorities about the company’s products may also have value. Of course, a great deal of this information will be stored in off-site regulatory affairs data warehouses. Some or all published information about a company’s products may also be of interest. Relevant published information may be saved and indexed on the internal website or other database, based on the specific product, the author(s) of the article, the year of publication, and cross indexed by other factors. The information would be collected, coded, and stored in an electronic database as well as in a facility with ability for rapid retrieval. This historical database could also be stored on hard copy (i.e., paper) or in a deep-freeze facility (i.e., warehouse), where it would be less accessible for rapid retrieval.

There is generally a lack of documentation by a company of a major issue that has affected a product, either positively or negatively. Few companies will invest the people-time to create essentially a case study of the episode/issue once it is settled. There are often many lessons to be captured and conveyed to others, in the short and long term, and it is not sufficient to rely on memory and verbal transfer. The people involved retire, die, move to other places, etc., and the facts and wisdom are lost. And history repeats itself with the same or similar mistakes made.

Every company generates and collects many tangible items that relate to its own activities over the years. Most of those items are eventually discarded but some become collector’s items and increase in value. Items with the company’s name are particularly important to save, and include samples of their products. All companies would be wise to set apart and store some of these items. Even a small company can place some of the more interesting items in a small cabinet or case in their lobby for their employees and visitors to view.

If the company has been in business for a long period or is fairly large, it may have sufficient material to justify dedicating an entire room for this purpose. If the number and nature of the items collected warrant, an entire museum of a few rooms may be created.

The types of items that should be saved include: