What do they bring to the table?
We are all familiar with the expression ‘those that can do, those that can’t consult’ but is this really fair? In this article I plan to explore what it is that consultants bring, both positive and negative, when they’re engaged, based on my own experiences of using consultants, working within a CRO where my clients used consultants to challenge my proposals and most latterly, working as a consultant to support chemical development programmes for my clients.
In this article I will cover the following key questions;
- When do you need consultancy input?
- What value does it add?
- Who is appropriate?
- Threats to internal staff?
In order to answer these questions and focus the discussion points, I will use examples from chemical process development and scale-up to illustrate where and how Scientific Update has positively contributed to the success of many projects for numerous clients.
More often than not, we are contacted at Scientific Update by potential clients when they have a problem and the standard battery of internal solutions has failed to reach a satisfactory conclusion. This brings me to my first point; obviously you will argue that consultants would like to be engaged early to ensure a longer collaboration for increased revenue, but in fact it is often so the very expertise you are paying for can be brought to bare on the issues early and likely help stave off the very issues we are subsequently asked to solve through not having been contacted sooner! So, this brings me to troubleshooting.
As an example, I recollect when I was heading a project within a CRO and we had moved a classical resolution from the laboratory to pilot plant. We experienced issues with poor diatereoisomeric excess of the salt owing to poor control over the extent of crystallisation on extending operating durations at scale in comparison with the laboratory. We had spent significant time in the laboratory to develop the resolution, but failed to adequately address the issues around extended durations. On experiencing a very poor performance on plant, we had to establish a re-work procedure to recover the batch and be able to complete the project, albeit later than expected and at higher cost (and loss to our bottom line). We contacted Trevor Laird at Scientific Update who quickly diagnosed the problem and provided a series of experimental conditions to test using straight forwards Simplex- based experimental design. We interacted very closely with Trevor, sharing data and agreeing the next series of experiments. Within 2 weeks we had identified a much-improved process that resulted in retention of diastereoisomeric purity even after a 24h hold period and were able to apply this in subsequent plant campaigns. This example may not be typical of all encounters with a consultant, but illustrates how bringing on board the right experience can help resolve an issue very rapidly. In fact, with hind-sight, had I contacted Trevor several weeks earlier, we will probably have anticipated more effectively the operational problem and implemented a more appropriate development effort, avoiding the initial failure on plant altogether.Another area where consultants can be particularly beneficial is in the development of your staff and maintaining their scientific knowledge base. A key aspect of working as a consultant is maintaining a keen awareness of the current chemical literature, trends in the industry and related regulatory aspects (both GMP and SHE issues). Clients can use a consultant to bring their technical staff up to date with latest technologies, perhaps asking the consultant to brief a group on a particular area or topic in readiness for some key project activities. For instance, when working in a CRO where we were to embark on our first process validation campaign, we used consultants not only to ensure our quality systems were of the correct standard, but also to give training to those involved (from managers to plant operators), thereby reducing the risk of campaign-limiting errors. It can be difficult to measure the benefit of this type of consultancy, since if effective, the outcome is that you did not have a costly failure, but you did have the cost of the training! In this instance, the consultancy input was used on the basis of a risk vs benefit assessment.
One area where many CROs and CMOs who undertake process validation and commercial manufacture of API’s for a third party might benefit from specific consultancy input an training would be the application of Quality by Design (QbD) as we move forwards. This is a developing area in the regulatory arena and one that appears set to gather momentum, so those with a clear view of how and when to apply the principles stand to be at the cutting edge and reap the benefits of speedier NDA approval, greater regulatory flexibility and lower cost base for manufacture owing to improved process understanding resulting in less failed batches/need for re-processing.
Other areas where using a consultant can bring advantages include the following:
- Using the consultant's extensive literature knowledge - eg in designing a better route etc, new ideas, for brainstorming route selections
- As an arbiter between options or to provide an objective opinion to help in client/contractor interactions
- Using the consultant's wide experience in choice of starting material for a synthesis, handling a difficult reagent, who to contract to, a better isolation method, choice of specification, regulatory issues etc
- Suggesting ways to optimise yield, reduce cost, get more in vessel (space time yield) etc), better reagent, catalyst ligand, methodology, continuous vs batch, new equipment
- Facilities/equipment, what to buy etc
- Overseeing contract work
- Sanity checks/reality checks
I am sure most people have encountered problems or issues outside the scope of their experience or knowledge and the easiest thing to do is to ask someone for help and guidance. Within large organisations there is often someone (somewhere) that can help and is in effect acting as a consultant, albeit without making a direct charge for their services. For smaller organisations without the luxury of a range of internal expertise, they may turn to independent external consultants. Before doing so, it is important to do some research into the area to help guide your selection of consultant or indeed determine if sufficient information is readily to hand and you have the time to assimilate it and manage the issue internally. In short, consultancy input is used when you either do not have the expertise in-house or your internal people do not have the time to spare to deal with certain issues, as they are busy on more pressing areas of the business. Aside from this rather obvious use of consultants to fill a knowledge or experience gap, their engagement is also often used in order to gain a second ‘external’ opinion which encourages people to look closer and harder at problems. Derek Walker comments in his book ‘The Management of Chemical Process Development in the Pharmaceutical Industry’ that in his view, it was not simply the direct input to solving problems, but it was ‘also the stimulus that outside minds, with none of the inside “baggage,” provided which uplifted [the team] to contribute at a higher level.’
Having established some notion as to when consultants can make a positive impact, what value do they add? This can be difficult to quantify. In cases where a consultant is engaged to fill a specific knowledge gap, then it is easier to gauge the benefit, but where a consultant is engaged to review or challenge internal opinion, it may sometimes be less clear. I feel it is important that the management and structure of the organisation challenge the very decision to engage a consultant so as to ensure that the objectives are clear and the consultant has a clear remit for the expectation, otherwise costs can start to escalate. In cases where cost escalates, this is of little long-term benefit to the consultant, as the organisation is likely to look closely at the cost vs benefit and may well consider the cost outweighs the benefit and this is in turn of little long-term benefit to the organisation. Clarity of the scope and expectation is crucial to my mind such that there is something to measure against and determine the added value. It is understood that not all the added value is tangible; for instance it may be that the consultant is someone known and revered in his or her field, so their engagement adds kudos to the status of the organisation and the decisions it is making. Also, bringing in a consultant can provide motivation to key staff to ‘raise their game’ as they look forward to the opportunity to pit their wits against a recognised expert.
For instance, when working within a CRO my team and I were invited to our client’s offices to present an update of our work to key client team members and their consultant, a very well known academic professor of international standing. The prospect of close examination of our chemistry and strategy certainly influenced our approach to the rigour with which we presented the update and resulted in an excellent meeting.
The selection of the correct consultant is a key point and is perhaps rather like finding a dentist you can trust not to hurt you, but if he/she does, then it’s for your benefit! The technical ability is an obvious requirement and can fairly readily be assessed by means of curriculum vitae and track record, but the suitability in terms of personality and belief in the project can only really be assessed by interaction, although personal recommendation is a good start. In my view, having the correct personality is a key attribute such that a level of trust and a rapport can be established between all members of the team with the consultant and vice versa. In a past role I was involved in an expansion project to build, commission and run a small chemical pilot plant and the engagement of a consultant engineer to manage the project was crucial. We rapidly established a healthy working relationship in which we challenged each-others’ views and delivered a successful project to both time and budget for mutual benefit. The consultant in this case filled a key knowledge gap in the (then) small organisation, but importantly was prepared to act both as consultant and mentor.
So, in the above few paragraphs I have outlined the positive impacts of enlisting the help of consultants, but what about the negatives? Aside from the obvious risk of feeling a lack of value for money, there is the risk that the consultant poses an underlying threat to staff already in the organisation, so this requires consideration and management. In my view, definition of a clear remit for the consultant is crucial and that this remit should also be made clear to your internal staff, so the scope is open. Where a member of staff feels threatened, the organisation management needs to be prepared to spend time to establish the basis for this and potentially can broaden the scope of the consultant to provide some mentoring and support the development of the individual, so as to avoid conflict and aim to build effective teamwork for the benefit of all. The organisation needs to be sure to challenge their consultant to ensure the guidance provided is appropriate for the needs of the organisation and/or project to avoid being taken down a route that could establish onerous requirements in the future.
In this article I have tried to present an unbiased view about technical consultants. There is little doubt that the benefits are not always easy to quantify and, indeed, there can be some negative impact also, but through the timely engagement of appropriate consultancy support, organisations can reap significant benefit. This benefit may be very clear in terms of achieving a goal which they would otherwise not have attained or less tangible in terms of the motivation and development of staff within the organisation to contribute to a higher level.