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2013 Bioscience Vision Summit - Kevin Hrusovsky: Inspiring a Global Health Revolution
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2013 Bioscience Vision Summit - Kevin Hrusovsky: Inspiring a Global Health Revolution

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Kevin Hrusovsky, Former CEO and President of Caliper Life Science and President of PerkinElmer's Life Sciences and Technology group will tackle the current global state of healthcare and will deliver …

Kevin Hrusovsky, Former CEO and President of Caliper Life Science and President of PerkinElmer's Life Sciences and Technology group will tackle the current global state of healthcare and will deliver a framework for inciting a global health revolution. He will also discuss how disruptive technologies are enabling personalized health - Cradle to Grave.

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  • Need to personalize specific theraptutics – lots of money wasted in the older pharma model – recent report described that adverse drug reactions are now the 4th leading cause of death – and in terms of efficacy – some of the best thereputics until recently were only 60% efficacious – some particularly cancer therapeutics much worse
  • With transition
  • Figure 1
  • Start off with an example of a collaboration we have with CMH where LST technologies are impacting some of the non-direct production costs …and this team NGS programs are in fact at the cusp of being a really clinically translational tool.Started working with Stephane Kingsmore 4 or 5 years ago when he was at NCGR – with Darrell Dinwiddie…implementing automation and uF to streamline Sample prep. Couple year ago – move to CMH ..implement some of the approaches they had developed in a clinical setting.Developed an NGS based test for 595 recessive monogenic diseases suing NGS …started to implement if clinically
  • N-of-One SAMPLE CASE STUDIES.

Transcript

  • 1. 11 © 2009 PerkinElmer© 2009 PerkinElmer© 2009 PerkinElmer© 2009 PerkinElmer Buckeye Growth Partners Solect Kevin Hrusovsky Managing Director BGP Ex - Caliper CEO / PerkinElmer President LST BioForward Vision Summit Cradle To Grave, Health is Personal
  • 2. 22 Buckeye Growth Partners Buckeye Growth PartnersAgenda Personalizing Global Health 1 2 3 State of Health Personalized Health – Molecular Revolution Inspiring Disruptive Innovation – Di5
  • 3. 33 Buckeye Growth Partners Buckeye Growth Partners Life Expectancy Gains are Slowing Lifestyle is Undermining Medical Progress First time in 200 years, children’s life expectancy is shorter than parents By 2030 1900 2000Birth Year LifeExpectancy 0 10 20 30 40 50 60 70 80 90 Gains are Plateauing Cancer kills ~8 m/yr: ~72% Diabetes 350M: double Autism 1/88: 57x Asthma / allergies: double
  • 4. 44 Buckeye Growth Partners Buckeye Growth Partners Jaring Timmerman, 100 World record for backstroke Jiroemon Kimura, 115 World’s Oldest Man Buster Martin, 101 Marathoner, Life Enthusiast Ruth Frith, 100 Shot-put gold medalist Fauja Singh, 100 World’s Oldest Marathon Runner "If you live to the age of a hundred you have it made, because very few people die past the age of a hundred.” - George Burns (1896-1996) Living Longer and Doing More Country 100 yrs + Per 100k China 17,800 1.3 Canada 3,795 11.5 UK 9,330 15 France 14,994 25 Japan 36,376 28 USA 95,548 31
  • 5. 55 Buckeye Growth Partners Buckeye Growth Partners US Healthcare: Poorer Outcomes - Greater Cost Forbes (March 2013) $3 trillion wasted / year
  • 6. 66 Buckeye Growth Partners How Safe is US Healthcare? CDC (2003); NHS National Patient Safety Agency & the Health Foundation (2008) 100,000 10,000 1,000 100 10 1 1 10 100 1,000 10,000 100K 1M 10M Number of encounters for each fatality Totalliveslostperyear How safe is Healthcare? Driving in US Chartered Flights Healthcare (1 in ~600) Dangerous (>1/1,000) Ultra Safe (<1/100K) Scheduled Commercial Airlines European Railroads Nuclear Power Chemical Manufacturing Bungee Jumping Mountain Climbing More Dangerous than Bungee Jumping!
  • 7. 77 Buckeye Growth Partners Buckeye Growth Partners“One Size Fits All” Does not work; $1 Trillion Wasted Adverse drug reactions 4th leading cause of death Toxicity Cancer (all types) 25% Alzheimer disease 30% Hepatitis C 47% Osteoporosis 48% Diabetes 57% Asthma 60% Cardiac arrhythmias 60% Schizophrenia 60% Depression 62% 0% 10% 20% 30% 40% 50% 60% 70% Efficacy Cost: $200B / yr Depression Schizophrenia Cardiac arrhythmia Asthma Diabetes Osteoporosis Hepatitis C AD Cancer 38 cancer drugs approved 2000 - 2010 Increased toxicity for targeted agents • GREATER MORTALITY • GREATER MORBIDITY • MORE SEVERE ADVERSE EVENTS
  • 8. 88 Buckeye Growth Partners Buckeye Growth PartnersDrugs’ Toxic Side Effects Warnings Users may be at a higher risk of  Ulcers  Amnesia  Heart Attack  Stroke  Enlarged breasts in men  Insomnia  Suicide  Loss of smell & taste  Internal Bleeding  Birth Defects  Loss of Libido  Weight Gain  Seizures
  • 9. 99 Buckeye Growth PartnersJapan is Living Longer than US Life Expectancy U.S. Health in International Perspective: Shorter Lives, Poorer Health (2013) Correlation Death from Noncommunicable Diseases Life Expectancy at Birth (Men, Women)
  • 10. 1010 Buckeye Growth Partners Buckeye Growth PartnersCancer: #1 Killer in the World and Japan http://www.jcancer.jp/english/cancerinjapan/ Japan
  • 11. 1111 Buckeye Growth PartnersJapan is Using Less Energy and Living Longer than US Life Expectancy at Birth (Men, Women) U.S. Health in International Perspective: Shorter Lives, Poorer Health (2013) World Bank (2011) Energy Consumption per Capita (kg of oil equivalent per capita) Inverse Correlation Life Expectancy Energy Consummption
  • 12. 1212 Buckeye Growth Partners Buckeye Growth PartnersJapan has one of the lowest levels of obesity http://steadfastfinances.com/blog/2010/09/23/global-obesity-rates-making-money-on-the-obesity-epidemic/ Japan has 8x lower rates of obesity than the USA and consumes 10x less sugar 0 5 10 15 20 25 30 India China Japan South Korea Italy Sweden France Netherlands Poland Brazil Turkey Finland Germany Russia Spain Greece Iceland South Africa Chile Canada Britain Australia New Zealand United States Mexico
  • 13. 1313 Buckeye Growth Partners Buckeye Growth PartnersJapan Public Health Centre Source: American Journal of Clinical Nutrition (October 2012) 21% higher risk of stroke if one soft drink per day Risk of ischemic stroke 83%. Strong evidence linking sweetened soft drinks to obesity, cardiovascular disease, diabetes and cancer. 20% of USA caloric intake
  • 14. 1414 Buckeye Growth Partners Buckeye Growth Partners2/3 of People are Overweight  Obesity is a global epidemic  Costs quadrupling; $400B (NEJM, 2005; AHRQ, 2006; CBO, 2008; CDC, 2009)
  • 15. 1515 Buckeye Growth Partners Buckeye Growth PartnersAchieving food addiction is a SCIENCE 70% consumed by Americans is processed food BLISS POINT = optimal sugar, fat & salt Use science (eg. brain scans) to achieve BLISS POINT Irony: Healthy food is not profitable
  • 16. 1616 Buckeye Growth Partners Buckeye Growth Partners Globally, We Use More Energy and Eat Bigger Meals
  • 17. 1717 Buckeye Growth Partners Buckeye Growth Partners Earth 4.5B years old Life 2B years old Industrial Revolution; 11:59:59 on Dec 31 Humans 150,000 years old 1800 1B Growth Assaulting Ecosystems - Earth is Fighting Back!
  • 18. 1818 Buckeye Growth Partners Buckeye Growth Partners Earth 4.5B years old Life 2B years old Industrial Revolution; 11:59:59 on Dec 31 Humans 150,000 years old 1800 1930 1B 2B Growth Assaulting Ecosystems - Earth is Fighting Back!
  • 19. 1919 Buckeye Growth Partners Buckeye Growth Partners Earth 4.5B years old Life 2B years old Industrial Revolution; 11:59:59 on Dec 31 Humans 150,000 years old 1800 1930 1960 1B 2B 3B Growth Assaulting Ecosystems - Earth is Fighting Back!
  • 20. 2020 Buckeye Growth Partners Buckeye Growth Partners Earth 4.5B years old Life 2B years old Industrial Revolution; 11:59:59 on Dec 31 Humans 150,000 years old 1800 1930 1960 2011 1B 2B 3B 7B Growth Assaulting Ecosystems - Earth is Fighting Back!
  • 21. 2121 Buckeye Growth Partners Buckeye Growth Partners Earth 4.5B years old Life 2B years old Industrial Revolution; 11:59:59 on Dec 31 Humans 150,000 years old 1800 1930 1960 2011 1B 2B 3B 7B Growth Assaulting Ecosystems - World is Fighting Back! 4.5B years of stored fossil fuel Greenhouse gas = 400 vs. 250ppm 25k species go extinct/year 80 countries no forest – 52k g w/tree 25 trucks of waste for 1 good Super storms
  • 22. 2222 Buckeye Growth Partners Buckeye Growth Partners Subsidies Sugarcane Corn $ Prices Lowered Subsidies lead to Unintended Consequences Buckeye Growth Partners
  • 23. 2323 Buckeye Growth Partners Buckeye Growth Partners Sugarcane Corn Cows Salmon Chicken Pesticides Growth Hormones Antibiotics Increased Productivity – Unintended Consequences on Health Buckeye Growth Partners
  • 24. 2424 Buckeye Growth Partners Buckeye Growth Partners Cows Salmon Chicken Cancer Heart Disease Diabetes Stroke Over-Stimulated Insulin Growth Hormone Omega 6 Overload Hormone Imbalance Increased Productivity – Unintended Consequences on Health Buckeye Growth Partners
  • 25. 2525 Buckeye Growth Partners Buckeye Growth Partners 69 year old truck driver Photoaging - Sun exposure
  • 26. 2626 Buckeye Growth Partners Buckeye Growth PartnersBreast Cancer - Rising Incidence on a Global Scale Obesity & exercise Early puberty Older pregnancies Hormones, & Pesticides Alcohol & Smoking
  • 27. 2727 Buckeye Growth Partners Buckeye Growth Partners Personalized Medicine
  • 28. 2828 Buckeye Growth Partners Buckeye Growth Partners Personalized Medicine Health INFORMATICS
  • 29. 2929 Buckeye Growth Partners Buckeye Growth PartnersAgenda Revolutionizing & Personalizing Global Health 1 2 3 State of Health Personalized Health – Molecular Revolution Inspiring Disruptive Innovation – Di5
  • 30. 3030 Buckeye Growth Partners Buckeye Growth PartnersPersonalized Health – Asymptomatic Medicine… Source: http://www.slideshare.net/jcanton/future-of-health-care-presentation Probability Of Disease Personalized Medical Intervention Personalized Lifestyle Modification Genes Biomarkers Proteomics SNPs Environmental Impacts Healthier Longer Lives Transform Sick Care into Healthcare
  • 31. 3131 Buckeye Growth Partners Buckeye Growth Partners GLOBAL HEALTH REVOLUTION Extend Productive Life Economically 77 100
  • 32. 3232 Buckeye Growth Partners Take Away Goes Here Translating Genomics into Precision Medicine Structure of genomes Biology of genomes Biology of disease Advancing medicine 1990-2003 Human Genome Project 2004-2010 2011-2020 Beyond 2020 Source: Nature v.470, p.204 (2011)
  • 33. 3333 Buckeye Growth Partners Buckeye Growth Partners Commercial Prospects for Genomic Sequencing Technologies Nature Reviews in Drug Discovery (May 2013)
  • 34. 3434 Buckeye Growth PartnersSuccessful Genomics – Marketed Drugs & in Clinical Trials DRUG TARGET COMPANY INDICATION STATUS Xalkori EML4-ALK NSCLC FDA Approved in 2011 Zalboraf BRAF kinase Melanoma FDA Approved in 2011 Benlysta BLYS Lupus FDA Approved in 2011 Odanacatib Cathepsin K Osteoporosis Stopped early due to success Atacicept BLYS Receptor Lupus PII/III AMG-785 Sclerostin Osteoporosis PIII LX4211 SGLT1 Diabetes Completed PII, showed POC LX1032 TPH1 Carcinoid Syndrome Completed PII, showed POC Mapatumumab TRAIL-R1 Cancer PII Apomab TRAIL-R2 Cancer PII Dulanermin TRAIL Cancer PII LX-2931 S1P Lyase Rheumatoid Arthritis PII LX-1033 TPH1 IBS PII OC-000459 CRTH2 R Asthma PII DG-041 Prostanoid EPR PAD PII Source: Nat. Rev. Drug Disc. (Jan, 2011) These drugs would not exist had it not been for genomic data This is the tip of the iceberg, since it takes 10-15 years to develop a drug
  • 35. 3535 Buckeye Growth Partners Buckeye Growth Partners Propelling personalized medicine through MDx Profound Growth of Molecular Test Scope and Availability Source: www.genetests.org Updated as of 9/4/2012 Genetic tests for 2748 diseases in 622 CLIA labs in the US
  • 36. 3636 Buckeye Growth Partners Biomarker Tests to Improving Efficacy / Safety $2B $4B $5B REQUIRES biomarker test for 26 approved drugs RECOMMENDS biomarker test for 90 approved drugs
  • 37. 3737 Buckeye Growth Partners “A major breakthrough in metastatic melanoma treatment.” NEJM Editorial, August 26, 2010 “We have never seen 80% response rate in melanoma. This is remarkable.” Paul Chapman, M.D., Memorial Sloan-Kettering Source: Flaherty et al., NEJM (2010) Genomics-Enabled Breakthrough for Melanoma 81% metastatic melanoma patients with BRAF (V600E) mutation responded to treatment Precision Medicine Breakthrough BRAF V600 Test BEFORE AFTER +
  • 38. 3838 Buckeye Growth Partners Buckeye Growth Partners Dumb Cancers • Single dominant mutation • Small mutation load • Monotherapy is effective • Resistance rare, late, same pathway Smart Cancers • Multiple mutational divers • Large mutational load • Multi-targeted therapy required • Resistance common, early Sledge, G. ASCO Presidential address, 2011 Stupid and Smart Cancers
  • 39. 3939 Buckeye Growth Partners Buckeye Growth Partners Gaddy Getz, Broad Institute 2011 Lung cancer has high rate of somatic point mutations
  • 40. 4040 Buckeye Growth Partners Epigenetics Only 20% of disease linked to germ line mutations Science (2010) Diet Drugs Infections Life-Style Stress Radiation Pollution Internal Chemical Environment Xenobiotics Inflammation Preexisting disease Lipid peroxidation Oxidative stress Gut flora Environment Linked to Explosion in Disease Epidemic of Chronic Disease Emerging as key link between environment & NCD epidemic
  • 41. 4141 Buckeye Growth Partners Buckeye Growth PartnersGene Expression in Monozygotic Twins Javier and Carlos 6 years old Anna Marie and Clotilde 66 years old Yellow = concordance http://www.pbs.org/wgbh/nova/body/epigenetics.html 50k Person Sister & Epi-Twin Studies 70+% of Health linked to Environment
  • 42. 4242 Buckeye Growth Partners Buckeye Growth Partners  WHO estimates 6m deaths from smoking and 0.6M deaths from SHS  ¼ of SHS deaths are children, ½ are women  Smoking alters methylation patterns in epigenome 20 year - 40,000 patient study to examine effects of direct and second hand smoking (SHS) One Billion Smokers Globally Epigenetic effects of Smoking seven automated systems
  • 43. 4343 Buckeye Growth PartnersEpigenetic changes in tumor progression Increased Histone-modification imbalance Increased frequency of hypermethylation Decrease in total DNA methylation content
  • 44. 4444 Buckeye Growth Partners Buckeye Growth Partners Human Microbiome - “The Second Human Genome” Our bodies contain >100x more unique bacterial genes than human genes Asthma Atopic dermatitis Colorectal cancer Kidney stones Periodontitis Psoriasis Obesity Irritable bowel disease Crohn’s disease healthy micobiome perturbed… Science Translational Medicine (June 2012) Trends in Genetics (January 2013) …immune and metabolic disease ensue Linked to Human Microbiome
  • 45. 4545 Buckeye Growth Partners Buckeye Growth Partners Microbiome Research is Rising Exponentially Explosive Growth in Microbiome Research Publications since 2003 Nature Biotechnology (April 2013)
  • 46. 4646 Buckeye Growth Partners Buckeye Growth Partners Fact or Fallacy
  • 47. 4747 Buckeye Growth Partners Buckeye Growth Partners ‘Needing’ forms the basis of addiction – you can’t turn it off anymore
  • 48. 4848 Buckeye Growth Partners Buckeye Growth PartnersFACT -- Defining food addiction Robert Lustig Food Provocateur
  • 49. 4949 Buckeye Growth Partners Buckeye Growth Partners7 Criteria of Addiction: 1 2 3 4 5 6 7 Tolerance – need more substance to get the same effect Withdrawal – anxiety, depression, tremors Bingeing Desire or attempts to cut down or quit Cravings or seeking Interference with life Use despite negative consequences Emotional Trigger Guilt Craving RitualUsing Addiction Cycle Addiction = 3+ of 7 criteria defined by the American Psychological Association
  • 50. 5050 Buckeye Growth Partners Buckeye Growth PartnersThe Key Players that Determine our Metabolic Fate DOPAMINE (neurotransmitter) LEPTIN …the result is metabolic disease Work well when in balance, BUT when things go wrong… RESISTANCE RESISTANCE ADDICTION INSULIN
  • 51. 5151 Buckeye Growth Partners Buckeye Growth Partners All Calories Are NOT Equal Food as a Hormone
  • 52. 5252 Buckeye Growth PartnersAll Calories are NOT Created Equal Proteins require 10-20 times as much energy to digest as fats Source: Science. (February 2013)
  • 53. 5353 Buckeye Growth Partners Buckeye Growth PartnersA Big Mac, Large French Fries & Large Coke The “typical” fast food meal is a recipe for cardiovascular mayhem 1360 Calories Total 520 Calories from Fat 89% Daily Total Fat (58g) 89% Daily Total Cholesterol (80g) 63% Daily Total Carbohydrate (190g) 24 teaspoons of sugar (95g) 1/4 the fat as a block of lard… …and 1/2 a cup of sugar
  • 54. 5454 Buckeye Growth PartnersAll Calories are NOT Created Equal More energy is needed to digest raw foods Source: Science. (February 2013)
  • 55. 5555 Buckeye Growth PartnersCooking increases Body Mass Index Source: PNAS (Npvember 2011) Changes in BMI on sweet potato diets Raw Whole Raw Pounded Cooked Whole Cooked Pounded { { Raw Cooked
  • 56. 5656 Buckeye Growth PartnersAll Calories are NOT Created Equal Fruit fiber mitigates most of the negative effects of sugar Source: Science. (February 2013)
  • 57. 5757 Buckeye Growth Partners Buckeye Growth PartnersOur Craving for Sugar has Consequences The craving for sugar has contributed to the diabetes epidemic Analysis of 175 countries shows: Extra 150 cal/day in sugar 1.1% boost in T2D Extra 150 cal/day in all food0.1% boost in T2D Implies sugar impacting diabetes more than obesity
  • 58. 5858 Buckeye Growth Partners The Mediterranean Diet the Evidence is In!
  • 59. 5959 The Mediterranean Diet – the Evidence is In! For the first time ever, the protective effect of the Mediterranean Diet was examined in a large, randomized trial.
  • 60. 6060 Confidential The Mediterranean Diet – the Evidence is In! 7,447 people with CVD risk (but no prior CVD) were split into three groups: Control Group: Low Fat diet Group 1 Mediterranean diet PLUS given free extra virgin olive oil Group 2 Mediterranean diet PLUS given free nuts
  • 61. 6161 Buckeye Growth PartnersThe Mediterranean Diet – the Evidence is In! Control Group Low Fat Diet Group 1 MD + Olive Oil Group 2 MD + Nuts 30% LESS LIKELY TO HAVE SUFFERED A CVD EVENT – AFTER 4 YEARS
  • 62. 6262 Buckeye Growth Partners Buckeye Growth PartnersHormones Determine Our Metabolic Fate When things are working “properly” we maintain a normal healthy weight David on a Mediterranean Diet I’m full Leptin (adipose tissue) • Level: LOW Dopamine (brain) • Level: LOW Insulin (pancreas) • Level: LOW
  • 63. 6363 Buckeye Growth Partners Buckeye Growth PartnersWhen Key Players Go Bad… Hormone resistance – and metabolic disease David on a High Sugar and Fat Diet Hungry & Lazy Keep Eating Leptin (adipose tissue) • Level: HIGH Dopamine (brain) • Level: HIGH Insulin (pancreas) • Level: HIGH
  • 64. 6464 Buckeye Growth Partners Buckeye Growth PartnersAgenda Revolutionizing & Personalizing Global Health 1 2 3 State of Health Personalized Health - Molecular Revolution Inspiring Disruptive Innovation – Di5
  • 65. 6565 Buckeye Growth Partners Buckeye Growth Partners Framework to Inspire Disruptive Innovation – Di5 Capital Transitions Greater Purpose & Vision Governance & Culture Market Immersion & Strategy Innovation & Commercialization
  • 66. 6666 Buckeye Growth Partners Revolutionize Global Health Innovation Asymptomatic Personalized Sustainability United Purpose: Eradicate Disease - Cancer
  • 67. 6767 Buckeye Growth Partners Chris Maki is ALL IN! For my three little girls …
  • 68. 6868 Buckeye Growth Partners Buckeye Growth Partners Chris, Allie and Tommy will never be forgotten Contributed photo
  • 69. 6969 Buckeye Growth Partners Buckeye Growth PartnersBridging The Technology Adoption Gap Win – Win Technology PatientD I S E A S E S TRANSLATION Government, Hospitals, Pharma and Tools
  • 70. 7070 Buckeye Growth Partners TECHNOLOGY THEMES Imaging & Pathology Biomarkers Mdx, Cdx Cellular Systems Molecular Analysis Biologics Vaccines Targeted Small Molecule INFORMATICS Personalized Health Solect Solar
  • 71. 7171 Buckeye Growth Partners Buckeye Growth Partners Need relevant predictive models Biomarkers are enabling translation Cancer, Cardiac, Stroke and Diabetes Current industry trends: 99%+ attrition $1B+ / 15 years Small AnimalCellDNA, RNA Protein HumanTissue The Challenge Facing Our Customers: In Vitro In Vivo TRANSLATION
  • 72. 7272 Buckeye Growth Partners Buckeye Growth Partners In Vitro In Vivo Small AnimalCellDNA, RNA Protein HumanTissue Top Challenge Facing Our Industry: TRANSLATION
  • 73. 7373 Buckeye Growth Partners Buckeye Growth Partners Pre-ClinicalClinical Goal COST OF TESTING DATAQUALITYDisruptive Innovation in vitro to in vivo to human Small Animal Cell DNA, RNA Protein Human Tissue Solect Solar
  • 74. 7474 Buckeye Growth Partners Buckeye Growth PartnersCapturing Value through Hybrid Model CONFIDENTIAL
  • 75. 7575 Confidential Unification of 25 Companies Life Sciences & Technology
  • 76. 7676 Buckeye Growth Partners Advances in Sequencing Technology Enable Clinical NGS Cost Prohibitive Cost Effective “Cancer will most likely be transformed by next generation sequencing.” Eric Topol, The Creative Destruction of Medicine
  • 77. 7777 Buckeye Growth Partners Key Bottlenecks in Next Generation Sequencing Source: The Global Outlook for Next Generation Sequencing: Usage, Platform Drivers & Workflow (2011) BioInformatics LLC. Survey asking 267 scientists currently using Next Generation Sequencing. Sample Prep Informatics
  • 78. 7878 Buckeye Growth PartnersMolecular Tools Creating Sea Change of New Applications Food ID Agrogenomics Human Genomics Infectious Disease Inherited Disease Epigenomics Transcriptomics Cancer Diagnostics Parental Testing Pathogen Detection Dating Consumer Genomics Food and Environment Neonatal Testing Livestock Breeding Fishery Mgmt
  • 79. 7979 Buckeye Growth Partners Geospiza LIMS and OmicsOffice Visualization NGS Sample Prep Workflow Solutions LabChip XT • Automated DNA Fractionation and Sizing NGS Workstation Post PCR Isolate Sample Fragment & Sizing Generate Library Quantify Sample Sequence Analyze LabChip GX • HT Bioanalyzer-like QC for DNA and RNA NGS Workstation • Automated High- throughput Sequencing Sample Preparation Molecular Biology Workstation • Nucleic Acid Extraction MBW DS XT GX NGS XT GX NGSW Geospiza LabChip DS • UV-Vis DNA/RNA Quantification Sequencing Service Benefits – Agnostic Protocols • Smaller samples - Better quality • Reduced bias - Higher throughput • Lower costs and Informatics linkages
  • 80. 8080 Buckeye Growth PartnersCustomers, Partners & Advocates AGBT 2012 AGBT 2011 *not a comprehensive list, over 500 NGS customers AGBT 2013
  • 81. 8181 Buckeye Growth PartnersMolecular Tools Creating Sea Change of New Applications Food ID Agrogenomics Human Genomics Infectious Disease Inherited Disease Epigenomics Transcriptomics Cancer Diagnostics Parental Testing Pathogen Detection Dating Consumer Genomics Food and Environment Neonatal Testing Livestock Breeding Fishery Mgmt
  • 82. 8282 Buckeye Growth PartnersCancer Treatment Trends at 2013 AACR Early Detection & Predisposition Heterogeneity & Resistance Combination and Immune therapies Non-invasive and frequent samples
  • 83. 8383 Buckeye Growth Partners More Testing with Smaller Samples NGS Multiplex Assays CTC Imaging Tumor Section Core Biopsy - FNA Single Cells More Testing Smaller Samples
  • 84. 8484 Buckeye Growth Partners Buckeye Growth Partners Next Gen Pathology Imperative to Embrace the Sequencing / Imaging Revolution
  • 85. 8585 Buckeye Growth Partners Buckeye Growth PartnersGenoptix: Advancing Precision Medicine AQUA avoids ~20% ER false negatives Conventional IHC: ER/PR ~20-40% disagr. Her2 ~20% disagr. ki67 no standards Her2 ER ki67 PR (4 slides) Vectra simulated H&EDAPIERPRki67Her2all markersfind tumormeasure proteins ER+ (23%) PR- (4%) Ki67+ (16%) Her2+ (100%) (1 slide)
  • 86. 8686 Buckeye Growth Partners Buckeye Growth Partnerski67 examples (4 patients w/ diff. morphologies) Pathology today Nearly Impossible to accurately determine % of tumor cells Error rates are 10 – 50%
  • 87. 8787 Buckeye Growth Partners Buckeye Growth PartnersWe add a tumor marker (red) to guide image analysis. Can’t be done visually Hides nuclei and weakly expressing brown stain But ENABLED with image analysis
  • 88. 8888 Buckeye Growth Partners Buckeye Growth PartnersinForm generates a tumor mask using pattern recognition
  • 89. 8989 Buckeye Growth Partners Buckeye Growth PartnersIndividual tumor nuclei are scored pos/neg (blue neg, brown pos)
  • 90. 9090 Buckeye Growth Partners Buckeye Growth PartnersReliable, automated, objective, accurate scores ki67 positivity: 0% ki67 positivity: 6.4% ki67 positivity: 29.5% ki67 positivity: 8.0%
  • 91. 9191 Buckeye Growth Partners Buckeye Growth Partners C BA D C A B High AQUALow AQUA Ki67 Heterogeneity Quantitation
  • 92. 9292 Buckeye Growth Partners Buckeye Growth Partners DAPI PhalloidinKi67 KeratinSignaling 1 Signaling 2 Circulating Tumor Cells: Detect 1 Cancer / 1B Normal cells MGH Chip Radiology: Takes weeks to detect Signaling reflects drug response in days 6-color signaling assay Vectra
  • 93. 9393 Buckeye Growth Partners Buckeye Growth PartnersFluorescence-guided surgery example Color Fluorescence Overlay • Nu/nu mouse with 4T1-luc2 tumor model • CatB-680 probe (2nmol/100mL i.v.) given on day 7 • Surgery 24 hrs post injection of probe • Fluorescence imaging reveals residual tumor after primary resection
  • 94. 9494 Buckeye Growth PartnersMolecular Tools Creating Sea Change of New Applications Food ID Agrogenomics Human Genomics Infectious Disease Inherited Disease Epigenomics Transcriptomics Cancer Diagnostics Parental Testing Pathogen Detection Dating Consumer Genomics Food and Environment Neonatal Testing Livestock Breeding Fishery Mgmt
  • 95. 9595 Buckeye Growth Partners Buckeye Growth Partners Tests 55 available tests Newborn screening global market opportunity Total 130M births North Americas Births 4M births $125M $750M* $1B$125M Market Opportunity 6 2 4M births Rest of World 122M births Western Europe 30 100%Screened 95% 45% *Assumes ~60% screened, Average 10 tests/child
  • 96. 9696 Buckeye Growth Partners Buckeye Growth Partners Why Autism?
  • 97. 9797 Buckeye Growth Partners Buckeye Growth PartnersAmong the last untapped Dx opportunities Clinically important, scientifically overlooked Current genetic tests fall short Opportunity to lead Opportunity to change the lives of children 97
  • 98. 9898 Buckeye Growth Partners Buckeye Growth Partners What is Autism? 98
  • 99. 9999 Buckeye Growth Partners Buckeye Growth PartnersWhat are Autism Spectrum Disorders (ASDs)? 99 Impaired Communication Impaired Social Interactions Repetitive Behaviors / Restricted Interests Autism Spectrum Disorders
  • 100. 100100 Buckeye Growth Partners Buckeye Growth PartnersNo Easy Answer to “What Causes Autism?” 100 5 – 20% Genetics • DNA • Single gene mutations 80% Unexplained • Environmental? • Age of the father? • Events during pregnancy? • Immune response? SynapDx Test • Expression of genes • Multiple sources of evidence
  • 101. 101101 Buckeye Growth Partners Buckeye Growth PartnersThe Journey is Long & Time Matters 101 19 months or earlier Parents’ First Concern ~4.5 years Average Age of ASD Diagnosis Get in line for Evaluation at Center ~3.5 years Source: www.cdc.gov, www.iancommunity.org; SynapDx Parent Survey Sept 2010  486,000 children suspected of developmental delay annually in US  A third of patients get diagnosed at autism centers  50,000 diagnosed with ASD annually  Lifetime costs per ASD patient $3.2M
  • 102. 102102 Buckeye Growth Partners Buckeye Growth PartnersEarly Detection Improves Outcomes “20% of children have the autism label removed when behavioral therapy is begun early.” Geri Dawson, PhD, Chief Science Officer, Autism Speaks, Speaking at an NIH-sponsored biomarker meeting 2011 Every dollar spent on SynapDx testing could save $70 102
  • 103. 103103 Buckeye Growth Partners Buckeye Growth Partners 80% of children with autism are missed before age three Visit Pediatrician Diagnosed before age 3 (2) = Suspected of Autism Spectrum Disorder (ASD) = Autism Spectrum Disorder Diagnosis Missed before age 3 (8) No evaluation before age 3 Referred and evaluated by age 3
  • 104. 104104 Buckeye Growth Partners Buckeye Growth Partners SynapDx test could identify 90% of children by age three Get SynapDx Test Missed before Age 3 (1) Diagnosed before age 3 (9) Lower Risk test result Elevated Risk test result
  • 105. 105105 Buckeye Growth Partners Buckeye Growth Partners SynapDx: Accelerate Time to Diagnosis 105 Autism CenterPediatrician Suspected Patient Other Specialists / Therapists Wait until high index of suspicion Precious Time Lost Today With SynapDx Test Autism CenterPediatrician Suspected Patient ASD Dx ASD Dx 4.5 yrs old 2 yrs old
  • 106. 106106 Neonatal Diagnosis in Two Days: STAT-Seq “A lot of people are going to realize that this is the future.” Richard Gibbs, Baylor College of Medicine 50 hours to diagnosis for $13,500 One test – 600 rare diseases CONFIDENTIAL
  • 107. 107107 Buckeye Growth Partners Buckeye Growth Partners We are building ridiculously small, and elegantly simple purpose-built products based on remarkable mass spectrometry technology. From security and defense to life science research and environmental monitoring, bringing MS capability from the centralized lab to the point of need. Answers whenever and wherever you need them.
  • 108. 108108 Buckeye Growth Partners// Buckeye Growth Partners Centralized Model of Scientific Research Strategic Research Routine Analysis “Core Facility” Routine Analysis
  • 109. 109109 Buckeye Growth Partners// Buckeye Growth Partners The „Personal Mass Spec‟ Disrupts Scientific Workflows “Core Facility” Strategic Research  Small Footprint  Simple Operation  Robust  Adequate Performance  Affordable  Broadest Application Platform Legacy Mass Spec  Large Size  Expert Operation  Maintenance  Excess Performance  $150K- $1M+ price  Expansive $2.4Bn/yr Market Biotechnology & Medical Research Pharmaceuticals DiagnosticsAgriculture
  • 110. 110110 Buckeye Growth Partners Human Health Environmental Health Side Effects Dosage Medicine Symptoms Biomarkers Food Pathogens Chemicals Water Safety Air Quality Pollution Exercise Nutrition My LifePad – Integrating Information for Personalized Health
  • 111. 111111 Buckeye Growth Partners Buckeye Growth Partners N-of-One’s Solutions: Timely  Succinct  Transparent  Clinically actionable  Non-prescriptive N-of-One® Realizing Precision Medicine 12 yo M: Glioblastoma • NGS identified BRAFV600E mutation, more commonly associated with melanoma • Impact: Oncologist petition for vemurafenib (FDA: melanoma) 25 yo F: Breast Cancer • arrayCGH detected high-level Her2 gain in recurrent tumor • Status post mastectomy: disease free • Impact: N-of-One TrialMatchTM identified Her2 vaccine trial 61 yo F: Lung Cancer • Her2/neu mutation detected by DNA MassARRAY • Impact: Successful petition by oncologist for off-label use of Herceptin; patient in remission nearly 2 years 79 yo M: Pancreatic • High-level c-Met expression detected • Impact: N-of-One TrialMatchTM identified cabozantinib trial (FDA approved: thyroid cancer) N-of-One material confidential. Do not distribute
  • 112. 112112 Buckeye Growth Partners Buckeye Growth PartnersPKI Technology was Instrumental in these Discoveries Pfizer, Sutent (sunitinib) (kidney and stomach cancer) Pfizer, Lyrica (pregabalin) (HIV) Pfizer, Celsentri (maraviroc) (neuropathic pain) Genentech, Zelboraf (vemurafenib) (melanoma, BRAF V600E mutation) Novartis, Tasigna (nilotinib) (CML, chronic myeloid leukemia, Gleveec resistance) Novartis, Zometa (zoledronic acid) (metastasis of breast, lung, prostate and multiple myeloma) Takeda, Rozerem (ramelteon) (sleep disorders) BMS, Sprycel (dasatinib) (CML, chronic myeloid leukemia, Gleveec resistance) SIRTex, SIR-Spheres (yttrium-90) (liver cancer) Cubist Pharma, Cubicin (daptomycin) (S. aureus infections – MRSA treatment) Phase I: Cell Genesys, CG0070 (Bladder and multiple indications) Nereus Pharma, NPI-0052 (multiple myeloma) Cephalon, CEP-26401 (Alzheimer’s & schizophrenia) Millennium, PS-341 (combo) (Non-Hodgkin’s Lymphoma, others) Insert Therapeutics, IT101 (solid tumors) Novartis, CHIR-258 (Metastatic melanoma) Novartis, AEE788 (Advanced Cancers) Phase II,III: Sanofi-Aventis, Aflibercept (Multiple indications) Boehringer Ingelheim, Oldodaterol (COPD) Xencor, XmAb2513 (Hodgkin’s Lymphoma) Neurogen, DAB-452 (Parkinson) EntreMed, Panzem (Recurrent Glioblastoma) FDA Approved In Clinical Trials
  • 113. 113113 Buckeye Growth Partners Buckeye Growth PartnersAgenda Personalizing Global Health 1 2 3 State of Health Personalized Health – Molecular Revolution Inspiring Disruptive Innovation – Di5
  • 114. 114114 Buckeye Growth Partners Buckeye Growth PartnersThank You BioForward Vision Team and… Dr. David Rimm - Yale Dr. Laura Macconaill – Dana Farber Dr. Dan Haber, Dr. Long Le, Dr. Mehmet Toner – MGH Dr. Jay Flatly – Illumina Dr. Kevin Knopp, Dr. Chris Petty – 908 Devices Dr. Stan Lapedis - SynapDx Dr. Andrew Barry, Dr. Nate Cosper, Dr. Mark Roskey Dr. Cliff Hoyt, Dr. Brad Rice, Dr. Josh Moho – PKI Dr. Irene Rombel – Biotech Analyst Google Ventures, NorthBridge Partners, General Catalyst, Arch Ventures Buckeye Growth Partners Solect Solar