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Unicyte´s Challenge
A small Swiss-based biotech developing a stem-cell-derived product, requesting strategic and medical leadership and clinical development support.
The Adnovate Clinical team were crucial in the successful transition of Unicyte’s lead stem cell therapy to the clinic. Over a 2-year period, their functional experts contributed significantly to overcome a number of technical and strategic challenges and enable regulatory approvals. Adnovate Clinical have also been a key part of the exosome-based platform team developing the translational strategy and executing the operational aspects in preparation for the FiH study.
Colin Buck | Unicyte COO.
Adnovate Clinical’s Solution
Function leadership through provision of an external strategic lead and functional experts. Using scientific and medical support, assessments were carried out in a variety of clinical indications, with extensive KOL interaction. With the help of Adnovate Clinical’s expert statisticians, clinical development plans were put forward incorporating a variety of simple and complex trial designs, before development of a full Phase I synopsis. Adnovate Clinical’s scientific, medical and medical writing expertise were leveraged to author both the Phase I synopsis and an investigator brochure. Our hands-on clinical operations specialists provided guidance on CRO selection and management.
