In this episode, host Jeremy Schrand welcomes Tim Schroeder, Founder & CEO of CTI, Jaqueline Aguiar, Managing Director of APAC/LATAM, and Dr. Ludwig Baumann, Global Regulatory Strategist, for an in-depth conversation about the Asia Pacific region’s growing impact on clinical research. Together, they explore how population diversity, regulatory innovation, and advanced therapies are shaping the future of clinical trials. The discussion highlights real-world examples, regional strategies, and the evolving role of technology and local expertise in bringing new therapies to patients worldwide. 01:33 Welcome to the guests and setting the stage for the discussion. 01:50 Key drivers behind Asia Pacific’s growth: globalization of research, population scale, rare disease focus, and the need for global market access. 03:04 Panelists discuss the region’s diversity, infrastructure maturation, and regulatory harmonization efforts (ASEAN guidelines, mutual recognition). 05:10 Addressing past concerns about research qualityin Asia Pacific and how they’ve been resolved. 06:15 CTI’s strategic expansion into Asia Pacific:doubling of work, global footprint, and real-world examples from COVID-19 vaccine trials in Singapore and Vietnam. 08:17 Operational hurdles: regulatory fragmentation, cultural and language diversity, and government investment in science and digital health. 10:10 Managing regulatory variability: importance of local expertise, adapting to evolving guidelines, and leveraging relationships with regulators. 12:10 Harmonization and efficiency: Singapore’s reliance model, Australia’s streamlined processes, and their influence as regional role models. 14:26 Decentralized and virtual trials post-COVID: remote monitoring, reasons for choosing Australia (speed, tax credits) vs. China (population, cost). 16:07 Executing complex, multi-country trials: pivotal registration studies, remote monitoring, and the importance of experienced investigators. 18:05 Readiness for advanced therapies: academic medical centers’ preparedness, regulatory interest in cell and gene therapy, and the need for in-depth preparation for combination products. 20:27 Regulatory flexibility: pre-meetings with authorities, addressing language barriers, and successful integration of Asia Pacific into global trials. 22:01 Talent acquisition and retention: strategies for building consistent, high-quality teams across diverse countries. 23:53 Patient recruitment: cultural nuances and ensuring data quality and patient retention. 26:09 Looking ahead: the impact of AI, harmonization, and infrastructure development on accelerating clinical trial execution in Asia Pacific. 28:13 Recent success story: FDA approval of a rare disease drug with global patient participation, highlighting Asia Pacific’s role. 29:05 Closing thoughts: Asia Pacific’s leadership in innovation, regulatory adaptation, and inclusion of rare patient populations.
