Nuala Murphy, president, Clinical Research Services, ICON discusses outsourcing in today’s market, overcoming challenges and delays associated with the growing volume of data in clinical trials, and what is and isn’t working well in partnership models. For Contract Pharma’s comprehensive analysis of the CRO Industry, see the Annual CRO Industry Update: Big Data Drives Drug Development Efforts. 
 
Contract Pharma: What do you see as the greatest motivators for outsourcing in today’s market?
 
Nuala Murphy: Improving the productivity of sponsors’ clinical development processes will continue to be the primary driver of outsourcing in 2018 and beyond. Sponsors will persist in their drive for new ways to help them improve cycle times and reduce costs. We expect this will increase interest in specialist capabilities such as risk-based monitoring, adaptive trial designs and flexible delivery models.

Innovation is playing an increasingly important role in helping to support more efficient drug development. Sponsors and CROs are engaging in discussions in how new approaches coupled with existing, tested technologies and sophisticated analytics can substantially reduce the risk and cost of clinical drug development.  

Sponsors are also looking leverage the investments that CROs have made in areas that address development challenges such as site identification, patient recruitment, health economics and outcomes research.  For example, patient recruitment persists as the key driver of cost in clinical development and will remain a focus for the years to come. CROs will continue to look for new ways to approach this challenge, whether it’s by decreasing the burden on patients to make clinical trials a care option, putting site networks in place to make the process and outcomes more predictable, supporting sites more fully in the training and tools they need, or the automated data collection and analytics of electronic medical records (EMR).

We expect there will also be demand for services in the areas of orphan and rare disease drug development as sponsors look for therapeutic knowledge and global site relationships to help them in smarter trial design and to recruit patients faster based on previous experience, in these complex areas.

CP: How do you help overcome challenges and delays associated with the growing volume of data in clinical trials and expanded use of real world evidence? 

NM: With the advances in computing power available today it is not the amount of data per se that creates the challenge. The challenge is analysing the types of data, both structured and unstructured and doing it in a way that yields scientifically relevant insights. Organizations require access to the right mix of specialist analytic tools and resources, together with a data strategy which supports interoperability standards in order to integrate the disparate data sources.
 
CP: Are you seeing any new collaboration models with the potential to disrupt traditional outsourcing?
 
NM: ICON provides the full continuum of clinical development services and has the flexibility to adapt to a collaboration model based on specific client requirements. 

One innovative model we have been operating over the past four years was developed and implemented based on the need of small biotechs, venture capital, and private equity organizations through to mid-size pharma that secure funding to develop an asset to a pre-defined stage of development or to marketing submission.  This model offers these clients a broader based service which integrates strategic drug development expertise with execution and operational excellence.  The model has greatest utility where the sponsor does not plan to build infrastructure or deploy resources and hence it avoids duplication of roles between the organizations, focusing on efficient delivery. ICON is also able to utilize established relationships with various investment groups to find approaches to finance development of some of these programs.

In this model, ICON operates as the full drug development team for the asset and works as an autonomous entity with little or no-sponsor involvement, executing work to the overall pre-agreed brief of the client. The team designs an integrated development program, usually with the client or their consultants, based on a target product profile. The principle is to develop an asset-centric approach which focuses on de-risking the program. The development plan is then fully costed and when approved the team work within the defined boundaries, executing against the agreed parameters of the plan. Allowing the ICON team to develop the strategy and then implement with minimal sponsor involvement means that ICON can look to take on some of the operational and financial risk through fixed price-fixed outcome contracts.
 
CP: What is and isn’t working well in partnership models?
 
NM: Sponsor-CRO partnerships continue to mature and we have definitely experienced the model moving from ‘execution’ to ‘design & execution’.  As in any partnership, trust is the important bedrock and we work with our clients to understand their biggest challenges and develop solutions that deliver real value to their business. Having trusted partnerships in place enables us to engage our clients at an earlier stage so that we can proactively meet their clinical development requirements with optimal results.

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Dr. Murphy has executive responsibility for driving excellence in global operational performance and delivering industry leading metrics that support pharma, biotech and medical device companies to bring drugs to market faster, for the benefit of patients. In the last 12 months alone, ICON has conducted over 500 clinical studies, involving 68,000 patients. Dr. Murphy, member of the executive team at ICON, leads a leadership team of international experts, members of which have been recognized among the industry’s best. Clinical Research Services has just under 7000 employees and has contributed to the development of 40 approved drugs since 2015.