The Evolving Pharma Landscape Critical Considerations in Precision

The Evolving Pharma Landscape: Critical Considerations in Precision Medicine Gani Padolina Director R&D/QA/Business Development idpadolina@adp-ppc. com +63 920 988 2517 10/3/2020 PGC Nov 2016

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Waters LC MS/MS 10/3/2020 PGC Nov 2016

Harvested Material Extraction, Isolation, Characterization Refining the Research Process: Fail -Fast; Fail Cheaper Gx. P/Data Traceability Refinement Loop • Primary Pharmacology • ADME • Safety/Tox • Modulation/Potentiation Studies • -omics Clinical Trials and Product Development 10/3/2020 PGC Nov 2016 Drug Product

Outline • Local Market Overview • Precision Medicine: Challenges and Solutions • Collaborative Opportunities 10/3/2020 PGC Nov 2016

Philippine Healthcare Market • 2015 Pharma: 150. 44 Bn PHP • 2015 Healthcare: 656. 11 Bn PHP • 2016 Pharma Forecast: 156. 19 Bn PHP • 2016 Healthcare Forecast: 722. 42 Bn PHP ~200 Bn PHP in 2020 10/3/2020 PGC Nov 2016 Source: Global. Info and Global. Data

Evolving Patient Behavior • 1980’s – Dominance of brand name prescription • 1990’s – Emergence of Branded Generics • 2000’s – Availability of Uni-branded Generics vs Branded Generics • 2010’s – Accessibility/Patient Preferences on Retail Channels 10/3/2020 PGC Nov 2016

Spending Pattern for Patented Molecules and Generics Expenditure/Profit sensitivity in manufacture and marketing of generics Source: Business Monitor International and PWC 10/3/2020 PGC Nov 2016

Top 10 Drugs Help Between 4% to 25% 10/3/2020 PGC Nov 2016 Schork, N. J. Nature. 520, 609 -611 (2015)

Ethnicity as biggest predictor of drug response (GALA Study) 10/3/2020 PGC Nov 2016 Burchard, E. G. Nature. 513, 301 -302 (2014)

150 out 10, 000 10/3/2020 PGC Nov 2016

Challenges Clinical Studies <4% of genetic association studies are non-Euro 10/3/2020 Funding Agencies Focus on ease of data analysis= homogenous data Publications Require samples from two independent banked samples PGC Nov 2016 Research Community Limited minority scientists and partnerships w minority communities

N-of-1 Trials Focus on the individual Aggregation of N-of-1 Trials Basket Trials Gen Pop 10/3/2020 PGC Nov 2016

Collaboration Pathways PGC Disease Taxonomy 10/3/2020 Regulatory Agencies Review and Approval of New Tools and Products from gene sequencing technology NIH • Clinical study design including n-of-1 • Volunteer recruitme nt (1 M++) PGC Nov 2016 Patient Privacy Responsible approach to study design and data gathering

Ecosystem Benefits 140$ return for Patient Access every 1$ Invested 10/3/2020 PGC Nov 2016

“Basic research, by definition, will sometimes lead us down blind alleys, but it will also tell us what we don’t know, which then helps us figure out new pathways. And when things do pay off, then they create economic opportunities in ways that we could never imagine. ” - US President Barack Obama, 2015 Launch of Precision Medicine Initiative 10/3/2020 PGC Nov 2016

Thank You • • • USAID-STRIDE DOST/PCHRD University of the Philippines Ateneo de Manila University PCARI IPO-ITSO Centers idpadolina@adp-ppc. com +63 920 988 2517 10/3/2020 PGC Nov 2016

GLP: Logistics and Traceability Source: TG Mc. Cloud, NCI; Molecules 2010, 15, 4526 -4563 10/3/2020 PGC Nov 2016

Classic vs Network • One Gene • One Drug • One Disease • Multiple Genes • Combinations • Modulation/Multiple Pathway Interaction 10/3/2020 PGC Nov 2016

Evolving Market Landscape • Business Growth Derived from higher consumption of mature products from the middle demography • End Patient/Customer Retail flow mutated with very cheap generic drug stores exceeding the number of MDC branches within 3 years 10/3/2020 PGC Nov 2016