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An Integrated Development Plan in Rare & Orphan Medicinal Products (OMPs)

Introduction

 

The global pandemic has taken a heavy toll on the rare and orphan disease community and on drug development. As the industry’s only fully integrated biopharma development organization, Syneos Health® has a unique view into these challenges. We understand that novel and integrated approaches linking Clinical, Regulatory RWE and Commercialization, including early engagement of key stakeholders, are required to accelerate products to market and de-risk the development of critical patient therapies.

 

To help innovative companies determine and execute the best path forward, our asset development experts from Syneos One® have developed ADAPT (Accelerate timelines, Drive evidence generation, Anticipate risks, Partner with stakeholders, be Transparent) an integrated evidence-based diagnostic tool that optimizes clinical and regulatory strategy in order to accelerate products to market and build strong value propositions for market access and adoption.

 

Built from a robust evaluation of over 200 orphan assets launched since 2016 with 436 orphan drug designations granted in 40 therapeutic classes, creates a best-practice benchmark, specific to each customers’ opportunity, to maximize value for all stakeholders along the product development journey. This sophisticated and innovative product development approach – informed by our breadth of capabilities, depth of therapeutic expertise and integrated perspective – builds a comprehensive and informed strategy and roadmap to ensure asset success. 

 

Learn More

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