Catalyzing Solutions to Develop
Pharmaceuticals and Diagnostics in the
Era of Precision Medicine

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New platform technologies, biomarkers, analytical methods, wearable devices and other tools are changing
the landscape of medicine. Interventions are becoming more precise, outcomes more predictable.

Meanwhile, the integration of these new tools in drug and diagnostic development is complex and often pushing
existing regulatory policies and guidelines. New markets need to be found, existing ones redefined.

Opus Three operates at the nexus where innovative science meets regulatory challenges and is confronted
with a dynamic, rapidly changing market. We can help you integrate new technologies in your product programs and align
them with your development goals, assess market opportunities, help you maneuver the regulatory process, and design
strategies to generate data to successfully position your products in the market.

SOLUTIONS

Our team has several decades of experience in startup, small and large corporations. We have started companies ourselves and helped others create successful organizations.

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We can help you identify the right technologies and platforms, find novel or alternative ways to generate critical data, or design research studies and ensure a focused product development.

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The conundrum of a precision-based approach to medical product development is that it often starts with the opposite: the analysis of heterogeneous data.

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The depth of knowledge our regulatory experts have is vast working at the FDA as well as in the pharmaceutical and diagnostic industries developing products regulated by the FDA.

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Opus Three – Who we are

At Opus Three you will find scientists and practitioners. We love technology and tools aimed at better serving individual patients: precision medicine is our passion.

Our goal is to increase the number of effective personalized medicines and valuable diagnostic tests, and to accelerate the pace at which they reach the market.

Our scientific background mixed with our tenures at the FDA, diagnostic and pharmaceutical companies as well as frontline market access experience in pharmacy benefit management allows us to support our clients with a unique and holistic view on data analytics, product development, and corporate strategies.

Customers Testimonials