Vol. pp. Success is not necessarily automaticdownloads.hindawi.com/journals/jamc/1998/526193.pdf · AlastairB. Selkirk Success is not necessarily automatic tional. Thegreatest opportunities

Journal of Automatic Chemistry, Vol. 20, No. 4 (July-August 1998) pp. 109-110

Success is not necessarily automatic

Alastair B. SelkirkPharmaceutical and Analytical Research and Development, Abbott Laboratories,1401 Sheridan Road, Vorth Chicago, [L 60064-4000, USA

There are a number offactors (planning, process optimization,organizational structure, people development and the need to see thetotal picture) that must be in placefor automation to be as effectiveas possible. This paper discusses these factors and their relation-ship with automation. It evaluates less obvious areas associatedwith automation, as well as the more established ones, anddiscusses the premise that it is the integration of all these aspectsthat truly offers the biggest opportunities.

Introduction

Over the last few years, the pharmaceutical industry hassteadily become more competitive. Clear evidence of thisis seen in the number of mergers and takeovers that haveoccurred in the last five to seven years. There is no reasonto assume that this state of affairs will get anything butworse as we approach the next millennium. For com-panies to be successful, they need a source of break-through molecular entities, and a development processthat permits the drug to move effectively from discoverythrough IND to NDA or equivalent.

Thus, many companies are re-engineering their develop-ment processes to achieve the latter and give them a

competitive edge. These processes must be able to sig-nificantly reduce the development time, for example by25-30%, while, at the very least, maintaining quality.They must be achieved without a burnout of staff, anevent which unfortunately is becoming steadily morecommon in the industry.

To further exacerbate the problems, the complexity ofthe development process significantly increases each year,as do the registration requirements around the world. Inthe Chemistry, Manufacturing and Controls (CMC)area, the advent of ICH, SUPAC, PAIs, etc. havesignificantly changed the ways things are done, with farmore planning and internal controls being applied. Inthe author’s department, the concept of ’Good ScientificPractices’ has been introduced to define all work outsideGMP and GLP.

Finally, global integration is now essential for companiesto be successful.

Processes

The processes involved in developing a medicine from theglint in a chemist’s eye through to launch are extremelycomplicated. Even restricting these to the CMC areas,they are still immensely complex. Partly as a result ofthat, and partly as a result of the way many of theprocesses have evolved, they are generally very ineffi-cient.

A number of years ago, the author’s previous companywent through a major re-engineering exercise to reducethe time from IND to NDA. It was quickly decided thatdevelopment time could be reduced by 50%. While thismay not be possible across the board, it is likely thatsavings of 25-30% should be readily realized. So how doyou achieve such process improvements?

First, question everything. There must be no sacred cows,and re-engineering is not for the faint-hearted. Then,prepare a flow diagram ofhow things really happen. Thisis often a real eye-opener with many processes goinground and round in never-ending loops. Finally, get a

completely clean piece of paper and design it fromscratch as if you were a start-up company. This thenbrings you to the hardest part, implementation. The onlyadvice here is do not give up. You will be very temptedto, as the revamped processes will probably be worse inthe beginning and you will be surrounded by a lot ofunhappy staff. Perservere, it will take time. Most of there-engineering exercises that fail are because they werenot seen through to completion.

Planning

Planning is very important. For plans to work, they mustinclude key performance indicators so that it can bedetermined whether a company is on plan or not. It alsorequires training. Training should be taken into teams ona just-in-time basis and should ask and answer thequestions:

Is the team on track?How do they know they are on track?How do they stay on track?How do they get back on track?

This kind of training has been shown to significantlyincrease work without any staff burnout.

In many instances, it has been assumed that automationand computerization, the ’magic black box’, can solvethese problems. This paper proposes the hypothesis thatautomation alone will not provide the necessary improve-ments: indeed, such an approach may result in a de-creased efficiency. It then reviews some of the factorscontributing to the successful acceleration of the devel-opment process and evaluates the role of automation asan integral part of that accelerated process.

Organizational structure

Many companies make the mistake of designing theirorganizational structure and then designing the processto fit the organizational structure. The opposite is theway to efficiency. Since so much of the business in thepharmaceutical industry is cross-functional, then theorganizational structure should be primarily cross-func-

0142-0453/98 $12.00 (C) 1998 Taylor & Francis Ltd109

Alastair B. Selkirk Success is not necessarily automatic

tional. The greatest opportunities for improved efficiencyare often not in how well a chemist analyses a sample or aformulator formulates a product, but, rather, in how wellthey interact with each other.

Real progress can be made at cross-functional interfaces.In my present company, we organized by setting up anumber of project teams, which were essentially designedto be akin to small start-up companies. The teams wouldbe fully accountable for the running of that project. Suchan organization has two basic problems to overcome. Thefirst is how to avoid reinventing the wheel for each new

project. The second is how to stop the perception thatstaff will not have a job when the project finishes. Centresof Excellence were created which acted as ’homes’ forpeople waiting to be assigned or reassigned to projects. Inreality, these waiting periods were non-existent, but thecentres provided a perceived safety net. In addition, asmall core of people were kept in the centres. Their jobwas to set standards across the projects, define processimprovements to improve project team effectiveness, andprovide experts and mentors to the teams, i.e. to have thetime and focus to implement the improvements thateverybody knows need to be done, but nobody has thetime to do.

Technology

What has all this to do with automation? In far too manyinstances, there is a perception that there is a ’black box’answer to all our problems, a perception that we willdevelop a system and all that will be needed is to simplypress a button. Technology can do much to support andfacilitate improvement programmes, but, in itself, it doesnot solve them. Without good processes, well-designedand well-executed plans, supported by the correct organ-izational structure, it is simply the inefficient that isautomated.

In our organization, we include a number of activitiesunder the umbrella of automation. These include ro-botics, laboratory acquisition systems, laboratory man-agement systems, and document management systems.The primary product that research and developmentmanufactures is information, often in the form of docu-ments. If information and documentation are effectivelymanaged, then projects will also be effectively managed.

Thus, robotic systems, laboratory acqusition and man-agement systems, etc. must be integrated in a cross-functional manner with document management systemsto form an overall comprehensive system. Too often, theyexist as separate islands of technology. To achieve thisintegration, an overall strategic plan has to be developedand then peeled like an onion with increasing detail at

each stage. If the plan is not integrated, there is a realdanger of simply shifting the bottlenecks, rather thanachieving real progress.

The other major issue with technology development isthe ’creeping sophistication syndrome’. Here, the systemhas more and more refinements planned and developed.The result is that it is never finished and never becomesfully operational.

People

Since people are our most valuable resources, it isinteresting to consider the effects of automation on them.Automation properly developed undoubtedly improvesboth consistency and productivity. There is a perception,however, that it decreases flexibility and innovation. Theerrors in this perception should be pointed out to thepeople involved very early in the process. Technologyshould be used to automate the results of innovation.Receptor screening is a good example of this. We should,however, also innovate the results of automation. Com-binatorial chemistry is a classic example of this, where thecreation of huge numbers of new molecules greatlyincreases the innovative opportunities, both in the dis-covery of new drugs and in the improvement of existingdrugs. However, automation should not be allowed tostifle personal creativity--major discovery breakthroughsare still more likely to come from personal ideas. Suchfree thinking must be encouraged and automation usedto improve its implementation.

Automation should be used to reduce bureaucracy. Here,the machines can be regulated rather than the people;people can be freed from repetitive jobs, which they arenot usually very good at, to increase their innovativeabilities.

Conclusion

Automation can undoubtedly increase the efficiency of a

process, be it a simple single process or a complexinteraction of processes like those related to drug devel-opment. For automation to be fully effective, it needs tobe part of an overall integrated system that also includesprocess improvement, management systems, organiza-tional structure, and even a belief and culture thatoptimizes those opportunities provided by automation.Great strides have been made in the technology related toautomation. I believe the biggest challenge we now faceis in its integration. Automation improves efficiency, butwe need to ensure it also optimizes effectiveness.

110

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Vol. pp. Success is not necessarily automaticdownloads.hindawi.com/journals/jamc/1998/526193.pdf · AlastairB. Selkirk Success is not necessarily automatic tional. Thegreatest opportunities