Yutaka DeSilvaGlobal Business
Management

Yutaka DeSilva, MBA is a business development and strategy advisor with more than 25 years of experience spanning clinical development, CRO leadership, and corporate development across the U.S., Japan, and Asia-Pacific. He advises sponsors on Japan-specific clinical development and regulatory strategy for therapeutics in rare diseases and oncology, with a focus on helping biotech companies execute practical, Japan-inclusive development plans that support global objectives.

His expertise covers end-to-end Japan entry planning, including regulatory pathway and PMDA engagement strategy, development plan localization, clinical operations feasibility, CRO and vendor partnering, and alliance development.
In addition to strategy development, Mr. DeSilva brings substantial execution oversight experience, working closely with Japan-based teams to ensure that development plans are operationally feasible, appropriately resourced, and effectively executed in alignment with sponsor expectations and broader global programs.

Before his current advisory work, Mr. DeSilva spent over 20 years at IQVIA/Quintiles in leadership roles across Clinical Operations, Business Development, Corporate Development, and Key Customer Management.
Over the course of his career, he has supported hundreds of clinical trials and contributed to innovative study execution strategies, business solutions, and growth initiatives.
Mr. DeSilva was positioned in Japan from 2008 to 2012 at a pivotal period when Japan began to participate more actively in global studies.
He started up a Global Study team and played a key part in building the operational capabilities and organizational readiness needed to support global study execution in Japan, eventually serving as the head of Japan Clinical Operations.
This hands-on experience continues to inform his work today, helping sponsors navigate Japan’s regulatory and clinical landscape while maintaining close alignment with global development teams.

Mr. DeSilva brings a practical, globally informed perspective that combines business development, strategic planning, and operational execution—helping sponsors reduce risk, compress timelines, and improve the probability of success in Japan.