1. Figure 1.1

2. Industry Value Chain Problem to be solved Technology innovation Basic research Applied research Pilot phase (Prod dev) Application phase (Production) Introductory phase (Marketing) Operational phase (Distribution) Consumer INPUT VALUE CHAIN OUTPUT VALUE CHAIN Distributors Physicians/ Regulatory/ Insurance Exploratory/discovery research and development Product Development Manufacturing, Marketing and Sales/Distribution Idea Figure 1.2

3. Figure 1.3 MANUFACTURE MARKETING SALES CLINICAL TRIALS DISCOVERY & PRECLINICAL $ Target BiologyLead drug candidate Disc- overy Identi- fication Valid- ation preclinical Validation, Toxicology Phase I Phase II Phase III Manufacturing, Regulatory Phase IV study Distribution Channels, Marketing Early Manufacturing Physician Hospital Consumer Post-approval trials Years Value $$

4. Figure 1.4

5. Years Value $$ Product concept Animal testing Device Specs, design Production prototype Pilot trial Manufacturing production Physician Hospital Consumer Distribution Sales, Mktg MANUFACTURE MARKETING SALES CLINICAL TRIALS DISCOVERY & PRECLINICAL $ Pivotal trial Figure 1.5

6. Biomarker identification and validation Internal R&D In-licensing Manufacturing requirements Clinical Test Development Product specifications Technical platform Performance criteria Analytical performance optimization/assessment Scale up and manufacturing Retrospective clinical validation Commercialization Research Use Only (RUO), ASR Performance, Utility Criteria Performance, Utility Criteria Prospective clinical validation Registration & Commercialization PMA, CE Mark test Registration & Commercialization CE Mark, 510(k) tests Figure 1.6

7. Discoveries Inventions Better tools & techniques Information Curiosity/ research New applications, products Figure 1.7

8. Figure 1.8 part 1 Ferment Growth 1 2345 6 8 7

9. Figure 1.8 part 2 #KEY GROWTH STEPS FOR INDUSTRY 11953 - DNA structure solved Crick and Watson 21973 – Cohen and Boyer perfect recombinant DNA techniques 1975 – Kohler and Milstein produce mABs from hybridomas 31976 – Genentech founded – first commercial life sciences company 41980 – Diamond vs Chakrabarty – Supreme court case approves principle of patenting genetically modified organisms 51983 – PCR technique is developed 61990 – The International Human Genome Project is launched 71998 – RNA interference phenomenon published 82000 – Human Genome Project 1 st draft completed – genomics and technology stock markets spike and fall.

10. Figure 1.9

11. 1980 1990 2000 2010 MARKET SIZE (arbitrary units) Ferment Mature Molecular diagnostics (NAT) market 2004 Growth 1 23 4 Overall in vitro diagnostics market (IVD) 2004 5 6 Figure 1.10 part 1

12. Environment Ecosystem Organism Cells Macromolecules Genes Molecular Structure & function KNOWLEDGE and TECHNOLOGY Systems models Multiscale tools integration KNOW THYSELF Molecular manipulations Germ line control Figure 1.11

13. Industrial biotech Agricultural biotech Human Therapeutics Enabling Technologies Environmental bioengineering Materials Science Bioengineering Bioinformatics Bio-computing CONVERGENT BIOTECH Figure 1.12

14. Technology Network Effects Energy Breakthrough Biotech Breakthrough Infotech Deep Computing Nanotech Semicond Advanced Materials Figure 1.13