Getting Your Asset into the Global Market: Regulatory, Clinical and Commercial Considerations, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn the key considerations for developing strategic and optimized global multiregional clinical trials. Attendees will 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.

TORONTO, Oct. 12, 2022 /PRNewswire-PRWeb/ -- Despite recession risk, global biopharmaceutical markets continue to grow and remain a desirable option for APAC-based companies. However, a recent trend of Chinese asset rejections by the US FDA — 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.

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.

Join experts from Syneos Health, Joy Chen, PhD, EMBA, APAC Regulatory Lead & Head of China, Global Regulatory Affairs Solutions; Anthony Messina, PhD(c), MSc, CCRP, Director, Assessment & Insights, Learning Solutions; Khalil Ahmed, VP Medical Affairs, Europe; Rosanne Campbell, Senior Project Leader, Value, Access & HEOR, Syneos Health Consulting; Stacey Fergusson, Senior Director, Corporate Development, Illingworth Research Group; and Chris Wells, Senior Director, Patient Concierge, Illingworth Research Group, for the live webinar on Thursday, October 27, 2022, at 3pm CST China (9am CEST/EU-Central).

For more information, or to register for this event, visit Getting Your Asset into the Global Market: Regulatory, Clinical and Commercial Considerations.

ABOUT SYNEOS HEALTH

Syneos Health® SYNH is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities.

To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.

ABOUT XTALKS

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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

Media Contact

Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com

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