The Background
Early clinical-stage US dermatology biotech Botanix Pharmaceuticals was keen to accelerate the clinical development of its dermatology lead acne product and looked to the Asia-Pacific region to take advantage of the Australia’s supportive regulatory environment and R&D tax rebate scheme and vast patient pool.
Acne is one of the most common skin diseases in the world, with approximately 85% of people between the ages of 12 to 24 experiencing at least minor acne.
Early clinical-stage US dermatology biotech Botanix Pharmaceuticals was keen to accelerate the clinical development of its lead acne product and looked to Australia to take advantage of the country’s supportive regulatory environment and Australian R&D 43.5% cash refund scheme.
Challenge
Working with the company, Novotech was able to reduce potential patient consent challenges from the initial trial protocol.
Our Actions
In collaboration with the clinical trial site and clinical investigators using Novotech recruitment solutions, Novotech was able to exceed patient recruitment targets at the four sites in Australia thanks to its experience in provide Dermatology CRO services to biotechnology companies
Novotech’s Botanix team managed the trial from start to finish, providing clinical trial and project management, medical monitoring, data management and statistical analysis, medical writing, patient recruitment strategies and drug safety surveillance. Novotech deployed several leading IT platforms, such as SharePoint, VieDoc and its own Clinical Trial Management System (CTMS), as part of its clinical trial and data management for Botanix.
Results
Armed with positive data from the trial, Botanix was able to start planning phase II trial activity from its lead acne product.
“Novotech was in key helping us work with the ethics committees involved and navigate this potential clinical trial hurdle. Also having worked with the CRO before, we were comfortable and confident in their clinical trial and project management processes. We appreciate their approach of being a research partner, rather than just a service provider.”
Botanix Pharmaceuticals
Vice President of Clinical Research and Regulatory Affairs
Mark Davis