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GEXVal´s Challenge
Japan-based biotech, a spin-out from Takeda, focusing on rare diseases looking for support to translate their lead asset to the clinic.
The Adnovate team functioned as an extension of the GEXVal Inc/GEXVal AU Pty Ltd internal team supporting not only the clinical study execution but strategic planning of the product and additions to the quality management system as needed. GEXVal and Adnovate foster an excellent team with partners in Australia, sharing the same goal to deliver innovative medicines to patients and families who live with rare diseases.
Juran Kato | CEO GEXVal Inc.
Adnovate Clinical’s Solution
Functional leadership through provision of an interim CMO, clinical operations and statistical staff to support clinical development activities. Adnovate Clinical designed and guided the development of the translational, clinical and operational plans for a phase 1 study, successfully transitioning it into the clinic and producing a high-quality protocol with a complex biomarker approach incorporating innovative trial and statistical methodology. Adnovate provided guidance for the selection of the CRO and oversaw the production of key study documents and processes, and the implementation of the study using a risk-based management approach. The study ran to time and the team helped manage the CRO budget, representing the sponsor’s interests to the highest level at all times.
