From Protocol To Pill: A Roadmap For Early Planning

By Angela Gong, Director of Global Regulatory Affairs, IQVIA

Asia Pacific’s drug development landscape is accelerating more than ever before. Emerging biotech companies now face multiple hurdles – from compressed timelines, choosing the right biomarkers, to transparency throughout the Investigational New Drug (IND) application.

It is critical to engage an experienced Contract Research Organisation (CRO). Partners with global knowledge and extensive experience in Asia Pacific including Japan, have a competitive advantage as they can help implement the best strategies in an efficient and cost-effective manner.

From considerations to achieve a successful IND to the critical role of biomarkers and leveraging regional trends, this article provides insights to tackle the challenges that a biotech company may encounter during the clinical trial process.