IDEC has supported over 100 client projects, and has collaborated with clients in North America, Europe, the Middle East and Asia Pacific.
Clarify the Opportunity / Risks
Over 60 projects implemented, including 21 tailored spot consultation projects.
Confirm the Strategy
14 projects implemented
Implement the Strategy
11 projects implemented
15 projects implemented
IDEC is currently engaged by a global biopharmaceutical company to support the Japan development of a product being developed globally.
The client engaged IDEC's virtual R&D team to assess and prioritize various potential indications for the product in Japan, and has since worked closely with various local constituents in Japan (KOLs, PMDA, CROs and other vendors) to implement the program for Japan.
IDEC has been involved from the design of the Japanese development program (in 2010), and has ever since been a strategic partner of the client across a broad spectrum of activities for multiple indications.
|IDEC prepared an initial assessment report for the program across multiple indications, summarizing the opportunities and risks, including a prioritization of the various indications under consideration. The client has since initiated the development of the product across several indications in Japan.||IDEC led the implementation of PMDA consultations to confirm the development plan and complete data package for the relevant indications in Japan.||IDEC collaborated with the client to select and manage CROs to implement the clinical trials for Japan, and led the selection and management of Key Opinion Leaders (including the formation of an Advisory Board) in the target diseases area||IDEC is leveraging its in-house and external resources to prepare the eCTD for Japanese submission. IDEC and the client will collaborate closely to manage the queries from the PMDA across all areas (CMC, Non-clinical, Clinical)|
IDEC was engaged by a mid-size Japanese pharmaceutical company to support the development of a product in-licensed from the US.
The client engaged IDEC to help fill a major gap in their R&D organization due to other project commitments, as well as a need for specific expertise to support the development of the target compound.
IDEC was involved from the design of the Japanese development program (in 2009), and has ever since been a strategic partner of the client across a broad spectrum of activities, until the program was approved in January 2016.
|IDEC prepared an initial assessment report for the program, which had not been in-licenced by the client at the time. The report outlined the possible development scenarios for Japan for decision making by the client. The client ultimately in-licensed the program.||IDEC led the implementation of a PMDA consultation to confirm the development plan for the program in Japan. Given the available data package overseas, minimal additional clinical and non-clinical data were agreed for implementation for Japan||IDEC collaborated with the client to select and manage CROs and testing sites to implement the additional studies for Japan, and led the selection and management of Key Opinion Leaders in the disease area||IDEC leveraged in-house and external resources to prepare the eCTD for Japanese submission. IDEC and the client collaborated closely to manage the queries from the PMDA across all areas (CMC, Non-clinical, Clinical). The product was approved in January 2016.|