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东南亚和巴基斯坦:新兴的疫苗临床试验中心

医药生物2025-11-18-艾昆玮坚***
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东南亚和巴基斯坦:新兴的疫苗临床试验中心

SEA and Pakistan: EmergingHub for Vaccine Clinical Trials RAINA SINGH PAPLIKAR,Head, Marketing and Corporate Communications, R&D Solutions, IQVIA APACCECILIA WONG, Marketing Manager, R&D Solutions, IQVIA APAC A strategic perspective for clinical development in Southeast Asia and Pakistan. Table of contents Executive summary1SEA and Pakistan’s clinical trial emergence1SEA and Pakistan’s operational strengths and vaccine trial readiness2Country-level readiness and insights5Accelerating global vaccine access: SEA and Pakistan’s regulatorymodernisation and public health alignment6Why SEA and Pakistan is the next hotspot for vaccine development6WhatIQVIAOffers:Integratedsupport for vaccine clinical trial partners Conclusion9 AcknowledgmentReferencesAbout the authors Executive summary Southeast Asia (SEA) and Pakistan are quickly establishing themselves as acompetitive region for global vaccine clinical trials. Their strengths lie in theirdiverse patient populations, responsive regulatory systems, and alignmentwith global health priorities. The region offers access to genetically diverse, Indonesia, the Philippines, Pakistan, and Thailand.Their insights and commentary reinforced the SEA and Pakistan’s clinicaltrial emergence The urgency to shorten vaccine development timelineswithout compromising data quality has pushed globalorganizations developing new treatments to explore With over 900 million residents and endemic diseasessuch as tuberculosis, hepatitis, dengue, and RSV, The region has transitioned from being a cost-effective outsourcing destination to a hub of scientificand regulatory capability. National authorities have To highlight these developments, IQVIA hostedan expert panel in June 2025 featuring regulators,investigators, and clinical leaders from Vietnam, Vaccine pipeline trends shaping current trial activityinclude RSV, dengue, chikungunya, HPV, TB, malaria,and herpes zoster. Technological innovation is alsoaccelerating. Thermostable formulations, microarray SEA and Pakistan’soperational strengths and SEA and Pakistan span a diverse and rapidly maturingclinical research landscape, with countries across theregion increasingly contributing to global vaccinedevelopment pipelines. Diseases such as dengue, Pediatric applications of mRNA-based vaccines,which gained momentum during the COVID-19pandemic, continue to advance. Emerging constructslike self-amplifying RNA (saRNA) offer potential for Large pediatric birth cohorts, such as those found inIndonesia and Pakistan, provide strong feasibility forage-targeted vaccine trials. The region’s genetic and “Southeast Asia and Pakistan areno longer a support region. Itis becoming a strategic driverof vaccine innovation. We see One of the region’s most compelling shifts is regulatorymodernization. Countries like Indonesia have reduced Material transfer agreements are processed in aslittle as two to three weeks, and start-up timelinesare increasingly predictable across the region. Thisregulatory agility is complemented by infrastructure — Dr. Kevin O’Brien Vice President and Global Head of Infectious Disease “Trial partners are recognizingthe operational reliability thatSEA and Pakistan offer. From — Benjamin LavertyHead of R&D Operations for India, Australia and Enables customers access to key KOLs and provides a single regional solution Thailand – 5 sites The Drug Regulatory Authority of Pakistan (DRAP) hasmodernized its CTA review processes, contributing tomore predictable and efficient study initiation timelines. Country-level readiness and insights INDONESIA Indonesia is emerging as a high-potential geographyfor vaccine clinical trials, driven by population scale,regulatory modernization, and centralized governance.With an annual birth cohort exceeding five million, thecountry offers exceptional feasibility for pediatric andadolescent vaccine trials. Regulatory processes have “We are now capable of initiatingand completing pediatric trialswithin timelines that match — Dr. Asad Ali Pediatric Infectious Disease Specialist, Pakistan THAILAND “The scale of Indonesia’s pediatricpopulation, combined with asingle governance model for Thailand has established itself as a mature ecosystemfor vaccine research. National immunization coverageis high, and trial centers across the country areexperienced in running complex, multi-arm protocols. — Dr. Jereer PAKISTAN “We see Thailand as a sandbox fornext-generation vaccine platforms. Pakistan’s population profile presents a uniquedemographic advantage for vaccine trials, with nearly50% of its citizens under the age of 15. This allows for PHILIPPINES VIETNAM Vietnam supports decentralized but highly coordinatedtrial execution through a robust tiered public healthinfrastructure. The country has an established trackrecord in global clinical partnerships, including long- The Philippines brings extensive trial experience,having conducted seven COVID-19 vaccine studies andmultiple p