Interviewed by Andrew Smith
Keywords
Contract Research Organisation (CRO), Globalisation, Innovation, Outsourcing, Strategic partnership
Dr Robert Davie is Vice President and General Manager, Europe, for Clinical Development at Covance. We are very grateful to him for making time to talk to us.
To set the ball rolling, could you tell me a little about the activities and challenges that you face on a day-to-day basis?
One of the great positives about my job is the fascinating variety of opportunities and challenges that turn up every single day. Truly, every day is different. Typically, my day consists of activities at both the tactical and strategic level and usually both internal and external to Covance. Obviously, my first priority is always client-related activities.
Covance has been involved with several innovative outsourcing arrangements. What would you say has been the most important idea in this period of sector-wide creativity?
We are all aware that the pharmaceutical industry has been struggling to cut their costs and increase R&D productivity. Trends we see from this are threefold:
- The need to take time and cost from the development cycle
- The ability to shorten time to peak market sales
- To move from fixed to variable costs
To my mind, there have been two central aspects to this period of sector-wide creativity. The first is the recognition of the need to be flexible and offer our clients a broad choice of partnering and innovative outsourcing arrangements as opposed to insisting that outsourcing means one thing and one thing only. The second and perhaps most important aspect is how we add value and remove waste or duplication for our clients. So, we are seeing a continued shift to a greater bundle of services, program (as opposed to single study) outsourcing and much greater interest in the move from fixed to variable costs.
What are the challenges involved in moving from individual outsourced studies to sustaining long-term, global outsourcing partnerships?
From a CRO perspective, long-term, global outsourcing partnerships truly enable us to leverage our cross-functional expertise and capability, and to grown, learn and integrate with our sponsor partners for innovation and success. Individual outsourced studies are by definition of a shorter-term nature and carry with them different terms for us to satisfy. From a client perspective, many sponsors are in the process of evaluating core versus non-core activities and this often very complex process cuts to the heart of their organisations and cultures. It’s not difficult to understand why the sponsors are at very different stages moving towards partnering, and choose different paths. As above, our challenge, as a CRO, is to accommodate this range of needs and interests, and always strive to delight our customers.
When planning the future of your personnel and your organisation, what have you learned from studying companies in other industries?
Other industries have adopted, for example, project management principles long before the CRO industry, or more comprehensive process and organisational theories such as Total Quality Management, Six Sigma and Lean. While Covance is in a leadership position among CROs with regard to eg, Six Sigma deployment, we too have plenty of opportunity to observe and learn. Evident lessons learned include the paramount importance of risk management, proactive problem solving and prediction, and careful coordination across processes and services, to ensure consistent and streamlined delivery.
The top CROs had been tipped to be well placed to ride out the current recession, but the sector has suffered in the past few months. How important will operational innovation be, as distinct from commercial innovation, over the coming year?
At Covance, operational and commercial innovation goes hand in hand. However, if the services we deliver aren’t based on a foundation of operational excellence, any amount of commercial innovation won’t do us, never mind our clients, any good what so ever. Hence, we have put in place a multiple-year program to promote consistent excellence and quality as well as drive strategic investments in people, processes and new technologies.
A complementary strategy is centered on integration. What can we do to simplify and shorten the multiple handover points in outsourced clinical development? We also have a much greater emphasis on up-front planning, helping to ensure consistency through the entire development cycle. As costs become increasingly important to our clients, we view innovation as essential in delivering value and increasing our market share.
With a pan-European remit, how much difference do you really see between professionals and systems in ‘old’ and ‘new’ Europe?
The so-called ‘emerging’ markets represent an exciting opportunity for the industry to leverage the tremendous potential across Central and Eastern Europe, Russia and further East. Of course, this raw power and the investigator and patient enthusiasm have to be harnessed in ways that produce ethical and approvable clinical trial performance. Evidently, the emerging markets are much less saturated with trials, but this is changing, just like more investigators are generating more experience. It’s clear the emerging markets can perform with the same quality as the established markets, but often faster and frequently with significant cost savings too. The biggest difference likely is our understanding of how to generate success on a country-by-country basis and from this perspective, it’s important for sponsors to partner with CROs who understand not only local conditions but also are able to integrate emerging market performance into an international framework of expectations and standards.
Site start-up and patient recruitment are often highlighted as key areas where projects can go off-plan. Are new tools and techniques improving these areas, or do sponsors need to have more modest expectations?
Tools and technologies aside, realistic expectations are a key driver of success in any clinical trial. Without realistic expectations, the trial planning is off base, and the trial is set on a path to disappointment.
In the UK, the mCTA, the integrated IRAS application system and the recent introduction of the Clinical Research Network are all examples of positive measures to address start up complexity and reduce cycle time. In the area of patient recruitment, investments by CROs and sponsors in improved feasibility, data mining and recruitment forecasting techniques, and a greater emphasis on emerging clinical research locations are paying dividends.
In addition to ever more sophisticated tools and techniques, it is key to consistently execute trial basics such as carefully and proactively listening to the sites and making their contribution to trial conduct as minimally invasive and optimally rewarding as possible.
At a conference last year, I heard you ask panellists what would be the next steps in the ‘flattening’ of the pharma/CRO world; what are your thoughts on this question? How important is it to have a presence in every country?
The ‘flattening’ of the pharma/CRO world is a sign of industry maturation, and this development mirrors events seen earlier in other industries. The ‘flattening’ enriches pharmas and CROs alike: pharmas by enabling them to focus on the activities that are truly core to their business, and CROs by evolving into true strategic clinical development partners. As a CRO, to be a true, effective partner in today’s drug development market, size, stability, scalability and global reach are vital, and Covance continues to invest in this area. Five years ago, Covance Clinical Development operated in 18 countries worldwide; now we have a presence in 31 countries in Europe alone and we intend to continue to invest in this area. Our premise is why should our clients need to invest in “new” regions and build their own infrastructure? We believe it makes more sense for Covance to do so, also considering that we operate with greater efficiency based on our ability to offer services in these countries to multiple clients.
Finally, if you could change one thing about the wider world of medicine, beyond the scope of your current role, what would it be?
The wider world of medicine doesn’t perform its miracles in a vacuum but often relies upon, and indeed is limited by, shortcomings in infrastructure and education. If those two basic yet vital resources are addressed with more urgency especially in developing countries, the true power of the world of medicine, even as it exists today, will be unleashed in an even more impactful fashion to truly transform the quality of living regardless of borders and income differences.
Enhanced levels of education might also go some way to helping the wider public understand the concept of the risk:benefit ratio and that all drugs have some degree of inherent risk attached. This may address the challenges of the litigation culture, which feeds on the belief that all drugs should be risk-free.
Robert Davie PhD MICR, is Vice President and General Manager, Europe, for Clinical Development at Covance. Andrew Smith is Editor of Clinical Research focus.
