Regulatory Insights and Applications

Context: A major Asian biopharmaceutical company contacted IPAV to evaluate the competitive risks and benefits of seeking EU adaptive licensing and/or US breakthrough status designations for an innovative phase two therapeutic candidate for a major unmet medical need. The client has limited experience of regulatory processes outside Asian jurisdictions and was concerned about data transferability.

Solution: IPAV conducted a review of all clinical and scientific data pertaining to the candidate product, verified by an independent expert scientific advisory board. IPAV then provided training and strategic advisory services for senior members of the organisation to ensure that they were fully abreast of the regulatory landscapes they were targeting. Thereafter, IPAV assisted the client in preparing formal enquiries and submissions to EU and US regulators.

Outcome: Meetings with international regulators continue to progress well, with IPAV intimately engaged for this initial and now subsequent products seeking overseas accelerated approvals. IPAV has also made high-impact introductions to EU and US clients now seeing joint venture agreements to introduce their products to Asian markets, including Japan, South Korea, Singapore, China and Hong Kong.