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International Clinical Trials

Better Together

ICT: How would you describe your business philosophy?

Craig Lipset: I am not sure that I subscribe to a proper defi ned business philosophy, but my approach to challenges in our field is to test solutions based on their value to patients. If we begin by doing right by patients, many solutions become self-evident. I am extremely passionate about the incredible opportunities to transform medical product development. Sharing that passion often empowers others to express their own passion, which in turn brings out their best ideas.

How has the industry evolved in the past 12 months?

Among the most significant trends in the industry is the spirit of collaboration: an unprecedented willingness among organisations to share, redefi ne areas of competition, and appreciate the value in pooling efforts. This may be driven by the highly resource-constrained environment in which we all operate. We are seeing sharing of operational as well as scientific data; and industry working with companies typically considered competitors, as well as other stakeholders. The need for communication and coordination is vital. Just as we can no longer afford redundant non-competitive efforts within our companies, likewise we cannot afford redundant consortia or supporting multiple groups attempting to address the same challenge. Coordinating and linking of capabilities avoids overlap and creates hand-offs that move the field further down a desired path.

What do you think the clinical trials sector needs to focus on in 2013?

We have made incredible strides in gaining access to diverse data in an increasingly timely manner. We can see study progress and other research data, and we can access rich clinical data from healthcare – in many cases, in near real time. However, all too often we are still making decisions using instinct and beliefs. We need to adapt how we are planning, designing, executing and interpreting our studies to be able to leverage these rich data resources.

The industry has good data access, but our analytic tools – in particular, predictive analytics – are still immature. But the primary area of need is around our people – improving culture and training. Only then will we realise the true potential of big data analytics to enhance and accelerate smarter drug development.

Pfizer is a worldwide company, but which parts of the world will make their mark in the next year?

For many years, we have seen trends in the global marketplace, as trials and energy would shift to Latin America, Eastern Europe, India, China and beyond. Today, our efforts are truly global. While we must still develop appropriately robust GCP trained investigator communities, and ensure patients are informed and their interests protected, I no longer believe in one region being ‘it’ geographically.

We must come full circle as an industry and ensure a robust clinical trials infrastructure in the US. Research participation rates among healthcare providers are poor, which in turn impacts participation rates among patients. For many years, we have rushed to other corners of the globe, rather than invest in addressing these challenges in the US and potentially the EU.

What advice would you give a start-up company?

In my role at Pfizer, I greatly enjoy spending time with start-up companies, as a mentor for health tech incubator Blueprint Health, or as an individual entrepreneur. Young start-ups often gravitate towards the consumer opportunities in healthcare, but I enjoy helping them appreciate some of the business-to-business opportunities and needs in clinical research. When I see the exciting tools and solutions being developed today by healthcare start-ups, I look to harness and redirect some of that energy to address the many challenges in our space. Or even better, look for convergence between research and healthcare, and attempt to monetise their product or solution from both ends.

How do you feel companies can maintain R&D innovation in 2013?

Our industry has a long history of maintaining innovation in research – new mechanisms, new targets, new delivery platforms, and so on. We are much less mature at applying innovation in our development efforts, often perceiving regulations and processes as a barrier. We must develop innovative new capabilities that can simultaneously bring impact to our current development programmes while also helping the desired future state of a robust and sustainable clinical research ecosystem.

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Craig Lipset is Head of Clinical Innovation within Worldwide Research and Development at Pfizer. He was listed among PharmaVOICE’s 2010 most inspiring people in the life sciences, and among Pharmaceutical Executive’s 2011 Emerging Leaders.
Craig Lipset
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