Global regulatory trends: challenges and implications. Is Asia - PowerPoint PPT Presentation

Global regulatory trends: challenges and implications. Is Asia breaking out of the age of innocence? Chew Kweetat National Regulatory Conference May 8, 2013 1

Asia’s Renaissance 2

Asia in Historical Context in terms of GDP % Share of total world GDP (1 AD – 2009 AD) Industrial revolution French & US Oil revolutions Fall of Roman Marco Polo's Discovery crisis Empire trips to Asia of America 100 Rest of world Europe 80 Rest of Asia 60 Japan India 40 20 China 0 1 500 1000 1500 2009 3 Source: Angus Maddison’s “Historical Statistics for the World Economy: 1 - 2004 AD”; Deutsche Bank Global Market Research.

The World’s 10 Largest Economies (GDP in US $ Billions) 80,000 2050 2040 2030 2020 2010 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 China United States India Brazil Mexico Russia Indonesia Japan UK Germany “The dramatic modernization of the Asian economies ranks alongside the Renaissance and the Industrial Revolution as one of the most important developments in economic history.” – Larry Summers (former US Treasury Sec.) Goldman Sachs – BRICS and Beyond, 2007

Regulatory Landscape in Asia Pacific Asia Pacific characterized by • Healthcare policies • Regulatory framework POLITICAL DIVERSITY • Generics’ policies • Patent recognition • Costs of drugs • Medical insurance scheme ECONOMIC DIVERSITY • Pricing and reimbursement • Payor vs. payee • Religious beliefs • Ethnic differences SOCIAL DIVERSITY • Migration of workforce 5

Key Challenges & Reverse Innovation 6

Key Challenges in Pharmaceutical industry Increase in Cost of Drug Discovery & Development Increasing Time to Market Impending Patent Expirations of Blockbuster Molecules Pricing Pressure by Governments to Reduce Health Care Costs • * Vijay Govindarajan & Chris Trimble. “Reverse Innovation”. Harvard Business Review Press, 2012. • “CEO Insights On Emerging Market Biosimilar Production & Manufacturing Trends”. Life Science Leader. 01 Nov, 2012.

Hot off the Press

Key Challenges in Pharmaceutical industry Increase in Cost of Drug Discovery & Development Increasing Time to Market Reverse Innovation * Impending Patent Expirations of Blockbuster Simple, low cost products developed in the emerging Molecules market, and moved to the West** Pricing Pressure by Governments to Reduce Take the learnings from the “East” and apply them to the Health Care Costs West** • * Vijay Govindarajan & Chris Trimble. “Reverse Innovation”. Harvard Business Review Press, 2012. • “CEO Insights On Emerging Market Biosimilar Production & Manufacturing Trends”. Life Science Leader. 01 Nov, 2012.

Reverse Innovation

Key Challenges & Regulatory Science 11

Challenges to Medicines Regulatory Authorities (MRAs) & Key to Meeting the Challenges Balance health protection with health promotion Rapid advancement in science Regulatory Science Increased stakeholder expectation Translate emerging technologies Benefit-to-risk assessment (from into real-world regulatory decision-making tools, i.e. population-based to individual- regulatory guidelines based) Greater emphasis on long-term Scientists from government, industry, and academia clinical outcome Adapted from: (1). Lumpkin MM, Eichler HG et al. Advancing the Science of Medicines Regulation: the Role of the 21 st -Century 12 Medicines Regulator. Nature Publishing Group. Vol. 92, No. 4 Oct 2012. (2) Lumpkin MM. DIA Meeting, Singapore. Jan, 2013.

What lies ahead for Regulatory Experts? 3. Personalized 4. Growing Ability to 1. New Models of 2. Learning how to Medicine/ Tailored Make Meaningful Innovation Utilize Big Data Therapies and Benefit-Risk e.g. TransCelerate Companion Diagnostics Assessments 6. Continued rise of 7. Achieving Market Patient/Consumer 8. Regulatory 5. Focus on Unmet Access is the New Goal, Empowerment: the Cooperation and Medical Needs and Value is the Key importance of Patient/ Convergence Driver Consumer Engagement 9. An Explosion of 10. Continued 11. Clinical Trial Data 12. The Era of Data Mobile Health Importance of Global Transparency Standardization is Here Applications Markets Regulatory Science feature prominently * Ref: DIA Industry Report 2013. “What lies ahead for 2013”? 13

Examples of Regulatory Science Tools Biomarkers & pharmacogenomics Tailored Therapies and Companion Diagnostics Meta-analysis methodologies Patient-reported outcomes & other endpoint assessment tools Adaptive clinical trial methodologies Adaptive licensing strategies Adapted from: (1). Lumpkin MM, Eichler HG et al. Advancing the Science of Medicines Regulation: the Role of the 21 st -Century 14 Medicines Regulator. Nature Publishing Group. Vol. 92, No. 4 Oct 2012. (2) Lumpkin MM. DIA Meeting, Singapore. Jan, 2013.

Adaptive licensing Brainchild NEW Drug Development ParadIGmS • Massachusetts Institute of Technology (NEWDIGS) (MIT) Authorities • US FDA • European Medicines Agency (EMA) • Health Canada • Health Sciences Authority (HSA) of Singapore Academia • Harvard Medical School • National University of Singapore (NUS) • Mayo Clinic Private & Public Partnerships Adaptive Licensing 15

Adaptive licensing Accelerated Approval for orphan drugs, high unmet medical needs Pre-approval Post-approval Optional or mandatory PMS Traditional Approval Optional Pre-approval Post-approval PMS Adaptive licensing*: prospectively planned, adaptive approach, iterative gathering of evidence Mandatory Optional Pre-market Post-approval PMS PMS * Ref: Eichler et al. Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval. Nature Publishing Group. VOLUME 91 NUMBER 3 | 16 March 2012

Evolution of MRAs 17

Change and Evolution of Asian MRAs Asian MRAs Asian Challenges Reverse Regulatory will change renaissance to MRAs Innovation Science and evolve further 18

Evolutionary ages of MRAs Regional collaboration Generator of new, scientific data Protector & Promoter of Public Nationally-focused Health Help develop new scientific tools & methodologies How to make better decisions? How to explain them better? Protector of Public Health Coalitions of like-minded & like- challenged regulators More active assessors of data Poor at documenting, Age of explaining, communicating Wisdom Age of Tinkering Passive, retrospective assessors of data More innovation – Implement development and Age of local clinical adoption of regulatory Innocence trials science tools “Deferential” assessment Local Regulatory Clinical Science trial CPP Adapted from: (1). Lumpkin MM, Eichler HG et al. Advancing the Science of Medicines Regulation: the Role of the 21 st -Century 19 Medicines Regulator. Nature Publishing Group. Vol. 92, No. 4 Oct 2012. (2) Lumpkin MM. DIA Meeting, Singapore. Jan, 2013.

Asia – What age is it in? 20

Evolution of Asian MRAs Legend To explore status of Regulatory Age of Age of Age of Science in Asia Innocence Tinkering Wisdom COUNTRY ASEAN CHINA INDIA KOREA TAIWAN SINGAPORE CPP CPP CPP CPP CPP not CPP not CPP mandatory mandatory mandatory mandatory mandatory mandatory Local CT Local CT CT CT CT mostly CT mostly Local CT not not mandatory mandatory mandatory mandatory mandatory mandatory 21

Regulatory Science USA & OTHERS NEW Drug Development ParaDIGmS (NEWDIGS) EUROPE ASIA • Adaptive licensing Innovative Medicines Let’s explore Critical Path Initiative Initiative (IMI) • 6 modules e.g. Predictive • ASEAN, CHINA, KOREA, Safety Testing Consortium • Projects on Improving drug TAIWAN, INDIA & (PSTC) SINGAPORE development (>40) 22

China & India India China China 12th 5-year Plan (2011-2015: (Reassessment of previous Major New Drug Creation Plan aggressive strategies) Independent Expert The Chinese 30 kinds of innovative drugs committees: Feb 2013 to Academy of formulate guidelines: Sciences: • approval of new drugs World’s • clinical trials • banning of drugs largest Transform 200 categories of drug • approval of fixed dose combinations science and technology research 150 kinds of diagnostic reagents organization Committee to investigate approval of four drugs/ clinical trials by CDSCO: Mar 10 new vaccines into clinical trials 2013 World’s top • A fixed dose combination producer of • An appetite stimulant for children 40 biological drugs with doctorates •An oncology drug “without Phase II studies”, and independent intellectual property • Additional indications right 23

ASEAN, Taiwan, Korea & Singapore ASEAN Taiwan Korea Singapore World's first approved stem-cell medication for AMI (Jul 2010) Hearticellgram Center for ASEAN Pharmaceutical Stability Adaptive Regulatory World’s first “true” Guidelines licensing Science biosimilar antibody 2004 (Mar 2013) (in line with global guidelines) (June 2012) Remsima ~ Remicade 24

Is Asia breaking out of the Age of Innocence? 25