A Workshop organised by The Biotechnology Information Strategic Forum, with support from DGXII of the Commission of the European Communities, and held at CAB International, Wallingford, Oxon, UK, October 1996
The need for validated information in biotechnology, an industrial viewpoint -- Elspeth Scott
The pharmaceutical industry is a heavy user of biotechnology information and will become increasingly dependent on access to such information in the future. The industry is extremely well regulated in the interests of patient safety, and companies are required to follow Good Laboratory, Good Clinical, and Good Marketing Practice Guidelines. They have to be able to prove that their systems and services and techniques are of the highest quality, and, as they spend huge amounts of money on research, development, and marketing, they must know that their services are secure and that they are operating within the copyright and IPR laws.
The pharmaceutical and biotechnology industry must also provide validated and authorised deliverables at every research and business stage. The information sources used in these processes must therefore be: traceable, reliable, of consistent quality, and be usable and secure. Industry is willing to pay for such quality guarantees, although cost must not be a barrier to access and use. Basically, the biotechnology industry has to use information as an essential element in the discovery, development, registration, and manufacture, and marketing of their product.
With the advent of electronic publishing, the roles of the different players in the information chain are changing. The library will no longer be the main collator and holder of information; there will be much more emphasis on direct user access to information, but users currently lack a stable environment in which to plan and work.
This is exacerbated by the fact that there is now probably too much information being provided in increasingly 'novel' forms. The new technologies of combinatorial chemistry, high throughput screening and genomics are creating huge quantities of data; the Internet is causing a revolution in scientific communication, and the traditional published information continues to increase. Information is copied and re-copied, stored and re-stored and is often even used and re-used as value is added to basic data obtained from research processes. Thus, it is increasingly difficult to find the 'needle in the haystack', or to check what "copy" one has obtained. The user needs better abstracts and locators, and better validation and guarantee services.
A further difficulty is the fact that in this emerging environment, information sources become unreliable - links between information 'vanish' as Internet servers are replaced or discontinued, and data is subject to change - sometimes continual - so that certain databases only present a "snap-shot" of a subject at that time; at least the printed journal kept its information in a static form. And, with the blurring of titles, editorial boards, and the traditional signs of validation and peer review, there are increasingly fewer recognised indications of quality and integrity. Technically, the problems of slow networks, coupled to high costs and copyright restrictions as producers anxiously try to protect themselves from use and then re-use, are causing concerns.
Increasingly, industrial companies are also seeking, and demanding, the right to manipulate different types of (published and unpublished) information in their own physical environments. R&D and drug monitoring, testing and registration processes are increasingly electronic and the trends to a totally electronic future, for instance with Computer Assisted New Drug Application - CANDAs, mean that "paper-less procedures" will soon be the order of the day. Then it will be no good referring to a paper copy of a journal article when all the other pieces of substantiating evidence in, say, a drug registration case, are placed on a CD ROM. Information must be obtainable in these new forms and new paradigms for doing this legally and cost effectively have to be found.
The user therefore still requires solutions to the continuing explosion of biotechnology information. Industry wishes to link data and information, it wishes to manipulate published information and integrate the broad base of data into knowledge management and decision making. Publishers must not sell half a product - information is to be used, modern technologies allow it to be used and re-used and this jump must be achieved by all those involved.