2022 - Getting Your Asset into the Global Market: Regulatory, Clinical and Commercial Considerations

Despite recession risk, global biopharmaceutical markets continue to grow and remain a desirable option for APAC-based companies. However, recent examples of Chinese asset rejections by the US Food & Drug Administration — largely due to insufficient patients in the US as well as lack of diversity of patients — underscores the need for companies to plan for global multiregional clinical trials. Meanwhile, increasing use of health technology assessments (HTA) across key markets including Europe and Japan suggests that proving a significant level of efficacy against existing comparators, rather than placebo, is becoming more important. Furthermore, as therapy areas become increasingly more crowded and commoditized, having a broad clinical and commercial strategy is unlikely to pay off.
Thus, companies increasingly face difficulties designing their global multiregional clinical trials in a way that corresponds to the needs of global regulators and optimizes the overall commercial success of products in global biopharmaceutical markets — all while minimizing costs associated with their clinical trial programs. There is therefore a growing need to re-evaluate trial design strategies to not only meet approval requirements, but also drive product market uptake and overall commercial success. This requires early engagement with regulatory bodies addressing important topics such as endpoints and standard of care for control arms, as well as making accommodations for payer preferences through levers like more precise exclusion and inclusion criteria.
This webinar will cover key considerations for developing strategic and optimized global multiregional clinical trials. Register to learn how addressing regulatory, pricing, market access and commercial strategy considerations early in the clinical development planning and design process can help support future commercial success for APAC-developed assets on the global stage.