Case Study 6

Case Study 06: Leveraging Collaborations in Asia for Preclinical Evaluation of Drug-Device Combination Product Development

Project Objectives

Identification of high-quality, but cost-effective contract resources for the preclinical evaluation of the client’s drug-device combination product prototype

Execution of Project

In executing on the project objectives, Enable Life Sciences:

·      Led the search in Asia for high-quality but cost-effective contract resources for the preclinical testing – primarily in Taiwan and India

·      Created Requests for Proposals (RFPs) for the preclinical evaluation, and based on the response to RFPs and site visits, made a final recommendation to the client (which was accepted)

·      Facilitated the formal site visit to the chosen contract lab in India by the client’s preclinical organization head

·      Created the legal agreement framework for the testing to be initiated (in coordination with the client’s legal resources)

·      Led the project management efforts for the preclinical testing carried out by the chosen contract lab, in coordination with the client’s R&D leadership. This project-management effort included site visits in India every 8-12 weeks during the course of the project execution

·      Led the documentation (comprehensive reports) of the preclinical results for the client

Concrete Project Outcomes

The efforts by Enable Life Sciences resulted in (a) the successful identification of a global resource for its medical devices client, resulting in ~70% cost savings as well as the yield of high-quality and well-documented preclinical results (b) the communication of the obtained preclinical results at international scientific conferences by the client, and (c) the internal approval and funding (at the client end) for the R&D efforts advancing the combination product development