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International Clinical Trials

Thinking Allowed

ICT: How have medical device and drug-device combination trials evolved?

John Potthoff: Medical devices have evolved rapidly over the last few years due to the convergence of technology – changing the definition of medical device to complex medical device, and accelerating the introduction and acceptance of drug-device combinations.

Traditionally, devices were always the last choice of treatment compared to drug therapy. However, complex medical device trials have triggered a drug-device awareness that is providing novel routes for new treatment and improving patient outcomes, while at the same time offering a benefit by extending intellectual property projection for companies.

The functional service provider (FSP) outsourcing model seems to be the future – do you think the traditional full-service approach will survive?

The FSP model is very attractive for certain kinds of businesses and situations. For example, you can quickly acquire staff with frontline experience in trial administration, bioanalysis, data management, medical writing and drug safety, without adding to your head count or burdening your human resources. On the other hand, Theorem has certain high-level capabilities and expertise that we share only with our full-service partners. We think there is plenty of room for both full-service and FSP models to coexist.

Are true strategic collaborations between sponsors and contract research organisations (CROs) impossible because of their differing long-term aims?

Nothing could be further from the truth. Both sponsors and CROs share the goal of successfully guiding a product through the steps necessary to receive approval from the Food and Drug Administration so that the product can, theoretically, go into the world to help improve health and relieve suffering. The fact that a CRO’s business model is based on providing services and the sponsor’s is based on manufacturing a product makes them no different than a wide range of other business relationships.

What innovations are companies like Theorem looking at to help optimise trials?

Theorem has been developing a suite of data visualisation tools that allow real-time visualisation of information in ways that speed understanding. In an era of risk-based monitoring and continual fine-tuning of trial design, connecting data streams with these kinds of techniques provides a rapid way for scientists to see multiple levels of data as they are generated – leading to better choices and decisions.

Will small and mid-size CROs have to start consolidating to avoid financial trouble?

With the right mix of services, expertise and leadership, even small, niche CROs can prosper. I would not say that avoiding financial trouble drives Theorem’s growth plans so much as our desire to be a bigger, stronger, more global CRO. Our goal is to be competitive when large and complex trials are being considered. If that means consolidating with other companies, so be it.

How do you differentiate yourself from the competition?

Our position in the marketplace is as a specialist in complex global clinical trials such as those surrounding medical devices and drug-device combination products. We have selected our senior leadership from among the top tiers in their respective fields and therapeutic areas, and augmented our team with the most qualified and experienced staff at every level. We have developed our own global network of top-notch investigators and sites, and we tie it all together with advanced data analytics.

You recently formed an alliance to integrate health economics and outcomes research, predictive modelling and defi nitive analysis – tell us more.

The alliance allows Theorem the ability to increase value to our clients through early planning using real-life, predictive data and analysis methodologies. This provides greater return on investment for our customers. As trials become increasingly complex and costly, Theorem supports cost reductions through better strategic and innovative development effort.

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Dr John Potthoff is President and Chief Executive Officer of Theorem, responsible for global operations and long-term growth strategy. He previously worked at INC Research and PPD, as well as founding Tanistry Inc. John earned his Bachelor’s, Master’s and Doctoral degrees in Psychology from the University of Texas.
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