The potential of South East Asia and India as the hub for vaccine studies

The potential of South East Asia and India (SEAI) as the frontier for vaccine studies + Current landscape of vaccine studies Table of Contents + The next hub for vaccine studies + Potential of SEAI + Better Asia public health 1

Market Value (in Millions) Analysts and experts observed the shift Market forecast for global vaccines market 10,000.00 9,274.13 9,000.00 8,143.06 8,000.00 7,149.94 7,000.00 6,277.93 6,000.00 5,512.28 4,840.00 CAGR: 13.89% 5,000.00 4,000.00 3,000.00 2,000.00 1,000.00-2015 2016 2017 2018 2019 2020 The recent growth reports (such as that from Market Data Forecast Report and Global Research Market press release) shared that the vaccine market has a global growth of approximately 13% in which Asia region had been consistently reported as the fastest growing region in this segment at 20-30% year on year. 2

Over the past 4 years, Asia participated in 31% of the 1170 vaccine studies and contributed ~60% of subjects Source: Trialtrove database 3

Illustrative example of global regulators approved rotavirus vaccines availability in national immunization programs Source: http://www.path.org/vaccineresources/files/path-worldwide-rotavirus-vaccine-introduction-map-en-2016.05.01.pdf 4

Number of Clinical Studies Asia Emerging Biopharmas are the key players in the Infectious Disease and Vaccine (IDV) market contributing ~130 new IDV per year 160 140 120 100 80 60 40 20 Number of New IDV Studies 130 #Phase 3 #Phase 2 #Phase 1 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Type of sponsors running IDV studies 45% 55% 71% 16% 36.0% 8% 14% 23% 14% 7% 6% 5% Phase 1 Phase 2 Phase 3 0 2013 2014 2015 2016 IITs Established Expansion Emerging Source: Thomson Reuters Data Export MARS Dashboard 5

SEAI is the second largest contributor of subjects in studies involving Asia Middle East 4% Africa 5% Europe 28% Asia Pacific 31% OTHERS 21.3% SEAI 24.2% JAPAN 20.2% CHINA 34.3% Americas 32% Source: TrialTrove, IQVIA MARS Dashboard 6

Question: How is SEAI helpful to the vaccine development programs? 7

SEAI offers unique opportunities for vaccine studies Singapore, Malaysia Short clinical study startup timeline Established regulatory guidelines Stable city infrastructure Highly experienced Investigators Vietnam, Philippines, Thailand Large pool of healthy adults and pediatric volunteer Unique subject outreach structure High prevalence of tropical diseases Moderate national vaccination program coverage India Good commercial and R&D market Low national vaccination program coverage High subject acceptance to me-too and me-similar vaccines 8

There are FIVE success driving factors in SEAI 1 Large Patient Pool Genetically diverse and treatment/vaccine naive population High incidence of tropical disease South East Asia Population: 623M 2 Cost Effectiveness High cost effectiveness Cost of running trials in SEAI is 40-60% lower than the US/Canada region 3 Gateway to rest of Asia Establishing a foothold in SEAI can provide access and synergies with the rest of Asia India Population: 1.3B 4 Public Health Focused ASEAN committee made public health a priority since the 90s Poorer Public Health reimbursement program hence naïve subjects 5 Perception of Public Positive perception towards vaccines Harmonization of new vaccine regulations across region likely to happen in the next future 9

Question: How can we work together to improve public health in SEAI and also achieve the goal of your vaccine development program? 10

Think differently with real world data for better decision making Harness the power of data and analytics for a different kind of clinical studies Rethinking design Truly targeted Site and Patients More effective recruitment Discover a more precise path to product approval and increase vaccine uptakes appropriately. 11

Connecting with the right data sources becomes important for protocol designing Pharmacy EMR Discharge & case notes Prescriptions Claims Reference data Sales Wholesalers Claims Lab/ biomarkers Patients Registries Clinical studies Survey panel data Physicians Institutions/ Health Systems Countries Mortality Social media Devices & sensors Genomics Imaging PRO Chart review Reference data Research experience Research experience Sales/ consumption Trial registries/ databases >530M global anonymized patient records 12

An illustrative example of analytics output: Hospital Name Tier xxx 1 xxx 1 xxx 2 xxx 3 xxx 3 xxx 3

Conclusion Conducting studies within SEAI enables larger group of subjects immunized against common diseases SEAI government authorities are supportive of public health improvement programs SEAI local culture and beliefs fuel higher acceptance on vaccine studies Potential of real world data provides insights for better decisions to be made Lowest cost of clinical studies as compared to rest of the world 14