In these examples, we show how our Integrated Scientific Platforms help with the introduction of a new type of product, or assist in differentiation from existing products.
A global company with a number of novel neuroscience products in early clinical development
Our client needed a platform for a new chemical entity (NCE) with an entirely new mechanism of action. As a treatment for an established neurodegenerative disease, the challenge included:
In developing an Integrated Scientific Platform, Syntropy medica:
The platform fully characterized and established the unique, new approach and new terminology. It delivered a clear exposition of the scientific rationale, related to the new disease biology. The result for the company was a position as pioneers of the new approach to treatment. This was uniquely associated with them, their well-planned research and development and, ultimately, their product.
A global company with a strong reputation in cardiovascular medicine
This company required Syntropy to prepare a platform for a new cardiovascular product in an area where they already had a class leader. Their new product, early in clinical development, would eventually be introduced in the same class. In today’s demanding environment, clinical success is not enough, customers – physicians, regulators and payors – also require strong underlying science.
Syntropy utilized the extensive and thorough nonclinical evidence for the new product to create a robust and compelling scientific rationale within the Integrated Scientific Platform.
A key benefit of a well-constructed Integrated Scientific Platform is guidance for the clinical development plan. In this case, it became evident that new, more meaningful endpoints were required for the Phase III program. The Integrated Scientific Platform informed discussions with investigators.
The product ultimately met the identified Phase III endpoints. The result is a well differentiated product, clinically and scientifically, with the potential to improve treatment outcomes and replace the class leader.
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