Why Are We Going to Move to Another CRO?
Antonio Llamas, Regional Head of Operations in Spain and Portugal for Wyeth Research, joins Pharma IQ, to discuss global clinical outsourcing. To listen to the podcast go to Strategies for Selecting CROs and Keeping Partnerships on Track.
Pharma IQ: Now, to start us off, could you just tell us, from your perspective, what changes or progression has been made within the market in recent years?
A Llamas: Well, there have been several changes within the market that occur in parallel, and of course, the analysis is complex due to the multiple assets that those changes bring into the business. Let me summarise two of them that I think are the most relevant ones and that could be an interesting item for discussion. The first one, of course, is the merging process that we are facing, and the second one could be the evolution between consolidated markets and emerging markets.
The first one: during the last year we have seen two major big pharma mergers and some people say that this could be the trigger for other movements. Moreover, this merging process is not exclusive for big pharma, but also happens frequently at many other different levels like shareholders and other vendors involved in the clinical trial process. This is not new. We have suffered mergers and things within the last year but the numbers are clear and significant. The value of the acquisitions and the new firms are spectacular.
It is said that this is the end of the current business model and, although the pharmaceutical industry investment in R&D has doubled in the last ten years, fewer than half new products actually make it into the market. So the business model is to create a handful of robust products is no longer sustainable and the change is necessary. So this is the first thing that has happened, and the effects of this will be seen in the next few years. The effects on guidelines, on investments and new company models will have a [unclear] on the clinical trial as well in the next coming years, on the CROs and all the other partners.
Rather than relying on primarily possible new blockbuster drugs, the industry will shift into other developing... of a wider range of medicines. I don’t know, does it mean more investment? I think that is not necessarily the case. The pharmaceutical industry will become increasingly dislocated with some companies become niche players, developing fewer and more targeted drugs, and others will go to the generic route and focus on the volume and the sales for revenue. So we will see which is the best way and we will see how these new models will affect all the other partners in the clinical trials.
Pharma IQ: We will indeed. I’d just like to ask, Antonio, how do you at Wyeth set about selecting the right clinical research organisation to partner with?
A Llamas: Well, we as many other big companies, have developed new models to select the right road. We have to take into consideration which kind of trials and which kind of tasks are going to be delegated, so depending on the niche, the selection will go through different pathways. First of all, we have to think about global outsourcing models against local outsourcing. [Unclear] codes have advantages and disadvantages. If the global outsourcing model has been selected, a few key elements must be considered. First resources; second quality; and the third, of course, price.
For the first one, for the resources: in a global market, in a multiple country selection, the process is not possible in some cases, so we have to think about maybe not [unclear] contracting in some other areas or countries. For the quality – there is some analysis that must be done in advance due to previous experience and a learning process, because all the vendors have a learning process to increase quality with big companies. In this case, joint ventures and preferred providers could increase the quality, and the knowledge of each other will be increased in the future. And for the local outsourcing models – well, the items are the same but the weight of each of these will not be the same for the final decision. I mean, usually for the local contracting models, we usually have better bids and better prices, so we can focus on quality and resources on the market, on the local market.
Pharma IQ: Okay. So what obstacles have Wyeth faced when dealing with outsourcing clinical trials, and what solutions or strategies were subsequently employed to deal with those?
A Llamas: Well, I would say that we can divide the obstacles into two different categories or levels – the first is quality and the second is the performance, and the performance levels of the outsourcing models. Even more, I would say that the main obstacle is how to measure the quality and the performance. The definition of good metrics to prevent obstacles is the best strategy and the best solution for the future. So the better we define, the better we prevent and the better we solve any problems.
It is not new that issues highlighted by internal audits or inspections have finished on outsourcing agreements in the past, so the key again is how to prevent, how to set up quality controls and set up performance metrics that alert both parties, not only the contractor but also the shareholder, alert problems in safety or information throughout the trials, whatever. That occurs during the clinical trial.
But in some ways we have to learn that we must set up our alternative plans or emergency plans in collaboration with the CRO to prevent negative impact of these events on the relationship that we have. So again, it’s a matter of be prepared and think in advance what will be the obstacles and to try to solve in advance.
Pharma IQ: So just coming off from that, how can the sort of success of a relationship with a CRO be accurately measured, and how, if needed, can it be improved?
A Llamas: Well, this leads to thousands of possible options because the key is a clear definition of metrics. The sooner that we define our metrics, the better because both companies are in the same line and we have to talk with the same information and the same language. This sounds magic but in my experience it’s the key of success for a collaboration between the CRO and the company. In this case, if you have extensive collaboration agreements, or massive agreements within companies, that will help to re-define metrics and to improve metrics little by little, because at the beginning it will be a mess but after a few months or a few years you get used to accurately measure the relationships and input.
Again, I would say that we can classify metrics into different levels. First quality, and second performance. And how quickly we do the trial, which is the efficiency of the collaboration. We have to think about different metrics depending on the clinical trial that we are facing, and depending on the CRO that we have contracted.
Pharma IQ: What would you say would be the key things that companies should be aware of when looking to make a smooth transition from one CRO to another?
A Llamas: Well, I could answer with another question – why are we going to move to another CRO? And depending on the answer to this question of why, we will have the key for a smooth transition. If the answer is due to quality issues that we have had, then we have to think about what the problem was and how could we avoid a repetition of the issue. For example, if we have had a quality issue because of high turnover of general staff, then it’s clear that we have to discuss, to evaluate resources and to set up measures to avoid these with a new CRO.
If the answer is because we are moving to another organisational model, or we are thinking about investment analysis or new agreements to reduce costs, or whatever other consideration, once the transition will be completely different, and the key thing to keep in mind will be also completely different. A balance between the effective times to do the transition and the co-existence of the two models is a key thing here. A good communication plan is also essential because all the parties must be aware of the next steps and the next things to keep in mind. So particularly, I think, we have to answer why are we moving to another CRO, and then with a good communication plan we will see the key things that all people must be aware of for a smooth transition.
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