From PoC to Global: How Emerging Biotechs Can De-Risk Phase II/III
Discover a five-step blueprint for biotechs to scale from proof-of-concept to global success with smarter trial design and regulatory foresight.
Emerging biotechs are achieving scientific breakthroughs faster than ever—particularly across Asia—yet many stall after early proof-of-concept (PoC) success. Moving from Phase I agility to Phase II/III scalability requires more than funding; it demands strategic orchestration. As global regulators raise expectations for diversity, data quality and commercial readiness, the leap from local PoC to global credibility has become the industry’s most defining inflection point.
This paper outlines how emerging biotechs can de-risk late-phase development by integrating regulatory foresight, operational precision and commercial intelligence from the outset. It provides a five-pillar blueprint to guide successful scale-up, including:
- Early regulatory alignment with FDA, EMA, PMDA and other global agencies to prevent redesigns and delays.
- Globally powered trial designs that balance clinical rigor with scalability and payer relevance.
- Operational readiness built on multi-regional infrastructure, experienced sites and real-time data oversight.
- Commercial strategy integration to ensure trials generate evidence that supports approval and access.
- Strategic optionality that positions companies for partnerships, IPOs or independent launches.
Readers will learn how a strategic development model—one that integrates science, regulatory, and commercial disciplines—can accelerate timelines, enhance investor confidence and create lasting value for emerging biotechs.
Fill out the form to discover how Syneos Health helps biotechs bridge early success and global impact through integrated late-phase development.
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