Global Readiness for the Next Wave of Biotech Innovation: How Development Economics and Regulatory Context Predict Whether North America, Europe, or Asia Will Lead

Moderator

William V Padula, PhD, University of Southern California, Rancho Palos Verdes, CA, United States

Speakers

Natalie Reid, MBA, MPH, PhD, Stage Analytics, Severna Park, MD, United States; Andrew Lee, PhD, BridgeBio, San Francisco, CA, United States; Michael Duffy, PhD, OrgaNova, Philadelphia, PA, United States

Purpose: Concerns about where biotech innovation will originate, scale, and mature are intensifying as global R&D activity expands. North America continues to dominate investment dollars and capital markets, but Asia has rapidly increased clinical trial activity and developer participation at a fraction of the cost, suggesting gains in development efficiency. Europe occupies an intermediate position shaped by regulatory harmonization, public financing, and evolving innovation incentives. These divergent trajectories raise important questions for HEOR and policy. From an HEOR perspective, it remains unclear whether lower-cost development environments translate into comparable regulatory success and clinical value. Specifically, to what extent do development economics and regulatory context predict a region’s ability to efficiently generate evidence, sustain innovative pipelines, and deliver long-term value to health systems? Addressing these questions is critical as governments, investors, and manufacturers seek to allocate resources efficiently while balancing innovation, quality, and access. Overview: This multi-perspective panel will debate global readiness for the next wave of biotech innovation, grounded in HEOR principles. Padula will moderate the session and open with an overview of global biotech development trends, highlighting differences in investment intensity, evidence generation, and regulatory pathways across North America, Europe, and Asia (10 minutes). Panelists will each present for 10 minutes, offering data-driven, industry perspectives on regional strengths and limitations, and discuss whether lower-cost development environments translate into durable innovation and value creation, how cross-regional partnerships shape efficiency and risk, and whether these ecosystems retain advantages in regulatory success, market access, and reimbursement. The session will conclude with moderated exchange and audience discussion (20 minutes). This panel will benefit HEOR researchers, industry leaders, investors, and policymakers seeking to understand how development economics and regulatory environments shape the evolving geography of biotech innovation.

Topic

Health Policy & Regulatory, Health Technology Assessment, Medical Technologies

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