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A Research and Innovation Center
.com .gov .org First assigned domain names First telerobotic surgical system New drug for lymphoma R Computer mouse Ultrasound for medical diagnostics First ARPANET and internetworking nodes U.S. Dept. of Education 2010 technology plan Treatment for d rug-resistant malaria Emmy Awards for HDTV and more Created Siri (acquired by Apple) A Research and Innovation Center © 2016 SRI International 1
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making people safer, healthier, and
SRI’s Mission: create world changing solutions making people safer, healthier, and more productive Not-for-profit : Return on investment is measured by impact, not dollars Multidisciplinary: Breadth and depth to solve the hardest problems Perspective: Located in the heart of silicon valley, 100s of partners around the globe Science-focused: Build on technology platforms to fill gaps in customer needs 2 © 2016 SRI International
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SRI – Who We Are Founded by Stanford in 1946 2,100 staff members
A world-leading independent R&D organization • Founded by Stanford in 1946 − Located in heart of Silicon Valley − More than 10 locations worldwide − Not-for-profit corporation − Independent in 1970 Headquarters — Menlo Park, California 2,100 staff members − More than half with advanced degrees Consolidated 2015 revenue ~$550M • Princeton, New Jersey 3 © 2016 SRI International
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Bridging Basic Research to Commercialization
Easy to describe, very challenging to do! “Valley of Death” Universities and National Laboratories Corporations Basic Research Applied Research Product Development Discovery Production © 2012 SRI International © 2016 SRI International
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Bridging Basic Research to Commercialization
Easy to describe, very challenging to do ! SRI Universities and National Laboratories Corporations Basic Research Applied Research Product Development Discovery Production © 2016 SRI International
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Our legacy of world-changing innovations
.com .gov .org First computer mouse Created Siri (acquired by Apple) First ARPANET and internetworking nodes First assigned domain names First telerobotic surgical system Ultrasound for medical diagnostics U.S. Dept. of Education 2010 technology plan New drug for lymphoma Vision technologies (HDTV, Color TV, etc.) Emmy Awards for HDTV and more Developed SWOT analysis 1 st Disneyland theme park © 2016 SRI International
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Converting government investment to market impact
Products Scale Up & Licenses Non-Profit Retain IP Ventures SRI Global Partnerships © 2016 SRI International
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SRI Technology Spin-off Ventures
Publicly Traded Robotics DNA testing services* Surgical robotics Speech recognition for customer service Electroadhesion for materials handling Innovative robots for manufacturing/service* Soft robotics for Medical rehabilitation Information Technology Virtual personal travel guide Real-time web video streaming and sharing Artificial intelligence for web personalization Intelligent banking Artificial intelligence for calendar integration Iris biometric identification* Virtual personal assistant for smart phones* Customer service tools* Enterprise social media technology* Digital TV technologies* Stray voltage detection services Panoramic image editing software* Electronic and digital signature solutions Technology for K-12 and higher education Materials Bio/Medical (formerly Rosedale Medical) Glucose monitoring system Electroactive polymers* Digital color printing applications* Anti-counterfeiting systems* Super-bright LED light engines* Drug dispensing system* Drug discovery Environmentally friendly light products* Metal “print and plate” manufacturing process Optical network components Disposable hearing aid* Bed bug detection devices *Acquired or merged © 2016 SRI International
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100+ industry projects annually
• S/W stabilization for mobile chat - - - Google Medical device for continuous blood pressure measurement - Omron Activity monitoring algorithms - Client private Automotive lane sensing - Volvo Scientific digital imagers - Perkin-Elmer Pharmaceutical development - Roche Electro-adhesion Floor Cleaner - Client Private (Japan) • Mobile Banking assistant - BBVA (Spain) Long-range Iris Biometrics - Client private Vehicle-to-vehicle communications - - GM Dioxin abatement - Mitsui Heavy Industries (Japan) Content summarization - Yahoo Underwater Mass Spectromete - Chevron Educational Products - Microsoft And many more … © 2016 SRI International
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Key Success Factor = How We Work
5 Disciplines of Innovation enable success 1 2 3 4 5 Important customer or market needs High value creation Innovation champions Innovation teams Organizational alignment Top 10 book 10 © 2016 SRI International
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SRI technology platforms in computing, robotics,
sensors, materials, biomedical science and health. A.I. & Computer Speech & Vision Science Technology Robotics & Automation Sensing & Devices Energy & Materials Biomedical Science & Health • Machine learning • Virtual Assistants • Structured analysis • Knowledge representation • Workflow automation • Activity recognition • Cyber & security • Trusted systems • Data analytics • Speech recognition • Translation • Language analytics • Emotion and state • Speaker ID • Natural language • Image processing • Perception • Visual search • Augmented/Virt • Manipulation • Mobility • Actuators • Automation systems • Machine learning • Perception • SLAM • Micro-robots • Electro-active materials • Multi-spectral imagers • Medical devices • RF, Radars • Chemical • Optics and Lasers • Molecular/DNA • Input and gesture • Physiological monitoring • Custom polymers • Low cost silicon • Carbon capture • Biofuels • Gas separations • Water purification • Bioinformatics • Efficient energy transfer • Sustainable materials • Drug Discovery • Preclinical Development • Early Clinical Trials • Neuroscience • Infectious Disease • Oncology • Biomarkers • Proteomics • Glycomics • Diagnostics • Circulating Tumor Cells • Automated reasoning • Cyberphysical systems ual reality • Object and activity recognition • Biometrics • Biomedical Imaging • Medicinal Chemistry • HTS/HCS • Aging Research Initiative • Computational imaging SRI Technology Platforms Combine and Customize Unique Client Solution © 2016 SRI International
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Lab to Market Ideation Process
Strategic Landscape Customer Need Statement Ideation Workshop Selection Identify major market trends & the business context of our customers Learn customer business and technical challenges and use cases Create technical solution concept, scope and timeline Prioritize and determine phased implementation strategy © 2016 SRI International
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SRI’s innovation acceleration model
Engage Ideation Workshop Identify internal and external technology / market baseline. Generate use case scenarios & product / service offerings linked to innovative use of Execute Phased Development Program Rapid & Iterative Lab-to-Market Model Prototype Proof of Concept Transition to Client Discover SRI technology platforms. Build short and longer term roadmaps Ideation 1 - 3 months Client Review SRI Technology Platforms months Client Review Custom Solution Innovation Programs Applying SRI’s value creation process to identify, evaluate and transform organizational innovation practices. Impact © 2016 SRI International 13
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Case Study: SRI Lab to Market
2003 to 2008 – DARPA initiates new R&D program called Cognitive Assistant that Learns and Organizes (CALO). SRI selected to lead team of 20+ research organizations. $150M funding over 5 years. 2007 – Several industrial projects with computing and mobile electronics companies. SRI hires Dag Kittlaus, former Motorola executive, as an EIR (entrepreneur-in-residence) to explore market opportunities for CALO technologies. 2008 – SRI scientist Adam Cheyer joins Dag Kittlaus and Tom Gruber to found Siri as an SRI spin-off venture. Siri raises $8.5M series A financing, followed by $15M series B. Late 2009 – Siri launches in app store May 2010 – Siri acquired by Apple Oct 2011 – Siri integrated in iPhone 4s © 2016 SRI International 14
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Case Study: SRI Lab to Prototype Strategic Ideation Statement Design
Landscape Customer Need Statement Ideation Workshop Concept Design • We want to build safer motorcycles We want to increase our market share We want to be known as technology leaders Motorcycle Fatalities Automobile © 2016 SRI International
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First trials -> less than 7 months after workshop
© 2016 SRI International 16
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Case Study: SRI Lab to License
Enhancing security and privacy for mobile devices Samsung sought a robust biometric experience that was fast and simple to use. Utilizing SRI’s Iris On-the Move (IOM™) technology, Samsung and SRI were able to develop a compact, low- cost H/W and S/W module that was safe, secure, and easy-to-use. Result: • x smaller • x lower-cost • 10x faster Samsung entered into a license for technology and continues to work with SRI to develop both industrial and consumer applications of mobile IOM™. © 2016 SRI International 17
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Biosciences discovery development Basic biomedical research
Drug and diagnostics discovery Preclinical and clinical development © 2016 SRI International
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Our Impact on World Health
More than six decades of breakthroughs Halofantrine SRI-discovered halofantrine, marketed as Halfan® by GlaxoSmithKline and distributed by the World Ultrasound SRI made ultrasound practical for medical diagnostics. Health Organization, has saved countless lives as a treatment for drug-resistant malaria. Pralatrexate Bexarotene For treatment of T-cell lymphoma, the FDA approved pralatrexate, co-discovered by SRI and marketed as Folotyn® by Allos SRI discovered Bexarotene, a retinoid receptor ligand marketed as Targretin® by Eisai for treatment of Telerobotic Surgery Bioinformatics SRI technology allows surgeons to remotely perform minimally invasive surgical procedures. SRI ’ s genomic databases combine with artificial intelligence and symbolic computing techniques to accelerate research. cutaneous T-cell lymphoma © 2016 SRI International
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Real drugs Halfan® halofantrine Antimalarial GSK Targretin® bexarotene
Anticancer Eisai Folotyn® pralatrexate Allos © 2016 SRI International 20
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SRI Biosciences Pharmaceutical Focus 300 person R&D division
• 300 person R&D division − $50M annual base of gov’t-funded R&D − $20M annual non-gov’t support In typical years we team with approx.: − 10 foundations & other nonprofits − 20 gov’t agencies − 30 universities − 70 companies © 2016 SRI International 21
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SRI Biosciences Our team © 2016 SRI International 22
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Millions of Lives Saved
100s of Novel Drugs $100s of Millions in R&D Millions of Lives Saved With Help from Many Friends © 2016 SRI International 23
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Basic Research in Disease Mechanisms
Infectious Disease Cancer • Tropical & neglected diseases • Influenza, TB • Drug resistance • Vector biology • Biodefense • Akt, survivin, estrogen pathway inhibitors Low oxygen, ischemia Angiogenesis Rare cell technology Radiobiology research Tumor glycomics CNS Disease Autoimmunity & Inflammation • Aging Cognition • Inflammatory & autoimmune diseases • Innate responses • Sleep, circadian rhythms • Adaptive responses: • Neurodegeneration Pain Addiction Antigen-specific responses, T cell and B cell functions © 2016 SRI International
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From Idea to IND & Beyond
SRI Biosciences Basic Research “Institute” Drug Discovery “Biotech Venture” Drug Development Services “CRO” © 2016 SRI International 25
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PharmaceuticalSciences
SRI Biosciences Capabilities Wide range of experience Basic Research Drug Discovery Preclinical Development Biomarkers& Diagnostics NCE & NBE Therapeutics PharmaceuticalSciences CRO Services HCS & HTS PK/DM & Predictive ADMET Proteomics Medicinal Chemistry DrugDelivery & Formulations Systems Biology Small Molecules Safety Toxicology Drug Repurposing Novel Peptides ClinicalChemistry Bioimaging Polyclonal Antibodies CMC & QA/QC Pharmacology Vaccines GLP & GMP Radiolabeling Project Management Clinical & Regulatory 26 © 2016 SRI International
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Integrated Pharmaceutical Discovery & Development
Provides seamless transition from idea through the IND and into the clinic SRI Capabilities © 2016 SRI International
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Biosimilar Capabilities
Genome Biology 2004, Volume 6, Issue 1, Article R2 Romero et al. R2.9 H. sapiens Pathway: oxidative ethanol degradation I alcohol dehydrogenase 2: ADH1B comment • BioInformatics/ Computational Biology ethanol NAD Locations of Mapped Genes: NADH aldehyde dehydrogenase 2 NAD NADH acetaldehyde acetate acetyl coenzyme-A synthetase: ACAS2 acetyl-CoA phosphate coenzyme A ATP ADP reviews reports Superclasses: Pathways Created by: wagg on 16-Sep-2003 Comment: dehydrogenase. The resulting acetaldehyde passes into the mitochondrial compartment where it is converted to This ethanol degradation pathway begins with conversion of ethanol to acetaldehyde by cytosolic alcohol acetate (by mitochondrial aldehyde dehydrogenase). Should acetate be activated to acetyl-CoA within the liver, it metabolised by extra-hepatic tissues [ Salway ] . Extrahepatic tissues take up acetate where it is converted to liver mitochondrial matrix. Consequently, acetate leaves the mitochondrial compartment and the hepatocyte to be would not be oxidized by the Krebs cycle because of the prevailing high ratio of NADH + H / NAD+ within the Four distinct human ethanol degradation pathways have been described - three oxidative pathways and one acetyl-CoA [ Yamashita01 ] . oxidized to acetate for subsequent extra-hepatic activation to acetyl-CoA [ Yamashita01 ] . Oxidative pathways nonoxidative pathway. All oxidative pathways mediate the oxidation of ethanol to acetaldehye which is then are differentiated based on the enzyme/mechanism by which ethanol is oxidized to acetaldehyde. The present pathway utilizes cytoplasmic alcohol dehydrogenase with the other two oxidative pathways utilizing endoplasmic ethyl esters (FAEEs) as primary end products [ Best03 ] . known as Cytochrome P450 2E1. The nonoxidative pathway is less well characterized but produces fatty acid reticulum Microsomal Ethanol Oxidizing System (MEOS) and peroxisomal catalase, respectively. MEOS is also Oxidative and nonoxidative pathways have been demonstrated in a range of tissues including gastric, pancreatic, hepatic and lung. Inhibition of oxidative ethanol degradation pathways raises both hepatic and pancreatic FAEE acetaldehyde have also been demonstrated in the pancreas - the cytochrome P450 2E1 & alcohol dehydrogenase Pancreatic ethanol metabolism occurs predominantly by the nonoxidative pathway but oxidative routes to levels demonstrating that oxidative and nonoxidative pathways are alternative metabolically linked pathways. References pathways [ Chrostek03 ] . intake." Front Biosci 8;e PMID: Best03 : Best CA, Laposata M (2003). "Fatty acid ethyl esters: toxic non-oxidative metabolites of ethanol and markers of ethanol Chrostek03 : Chrostek L, Jelski W, Szmitkowski M, Puchalski Z (2003). "Alcohol dehydrogenase (ADH) isoenzymes and aldehyde dehydrogenase (ALDH) activity in the human pancreas." Dig Dis Sci 48(7); PMID: tissues." Biochim Biophys Acta 1532(1-2); PMID: Yamashita01 : Yamashita H, Kaneyuki T, Tagawa K (2001). "Production of acetate in the liver and its utilization in peripheral Salway : Salway, J.G. "Metabolism at a Glance, Second Edition." p.90. Figure 3 (see legend on next page) Genome Biology 2004, 6: R2 deposited research Drug Discovery & Development Capabilities • Fermentation /Production Technologies • OMICS refereed research interactions information © 2016 SRI International
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SRI Drug Development Pipeline – Track Record of Success
halofantrine vidarabine bexarotene pralatrexate tirapazamine TAS-108 SR13668 Oral Vancomycin IND • IND • IND • IND • IND • IND • IND • IND NDA • NDA • NDA • NDA • NDA • NDA • NDA Oral DTPA SR16157 SR16388 SR13654 BH-0492 Early Discovery SRI Drugs available for licensing © 2016 SRI International
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Bloomberg Global Innovation Index
© 2016 SRI International
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Top Global Trends in BioPharma
Pharmacoeconomics / Outcomes Personalized Medicine Prevention Patient Centric Access AND Affordability Generics Chronic Disease Digital Pharma Biosimilars • © 2016 SRI International
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Innovation Case Study examples
Oral DTPA (agent to counter radiation exposure) Innovation of Diagnostics and Medical Devices (FastCell) Continuous Drug Manufacturing process (SynFini) • © 2016 SRI International 32
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Case Study: New Drug Formulation for Radiation Exposure
Reformulation of Zn-DTPA into an oral formulation from an IV medication Zinc diethylenetriaminepentaacetate (Zn-DTPA) has been the chemical compound commonly used to treat radionuclide exposure delivered through an IV. Many attempts to re-formulate Zn-DTPA into an oral medication has failed. In 2005, SRI took on the project and was able to successfully develop and manufacture a novel, oral formulation of Zn-DTPA that has proven efficacy in animal studies. SRI identified promising enhancers by using their “IVtoPO Platform Technology” program to perform high-throughput solubility and intra-intestinal permeation screening. © 2016 SRI International
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Case Study: FAST cell ™-CTC Technology
Customized Liquid Biopsy 2 x 10 7 cells scanned in a minute FAST CTC Analysis HER2 / CEP17 Morphology/ Pathology Nano-PCR Peripheral blood from a cancer patient is collected for multiple endpoint analysis ̶ FAST cell ™ locates CTCs, enables precision analysis, pathological review & confirmation of CTCs – Staining for protein markers, FISH for genomic amplification and translocation – Sequencing, nano-PCR and expression analysis in development © 2016 SRI International
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Proprietary FAST cell ™ Cytometer
Automated Imaging at High Resolution Scanning laser spot focuses on top of transparent substrate FAST – Fiber Array Scanning Technology FAST Substrate Motion Rotating Mirror Light Collector Fiber Optic Bundle ADM Multiplex biomarker imaging CTC • Cytokeratin (Red)+ • DAPI (Blue)+ • CD45 (Green)- WBC • Cytokeratin (Red)- • CD45 (Green)+ Collimating, Bandpass, collection Filters/Lens Photomultiplier Tubes (PMT ) Laser speed = 10m sec -1 ~ 1 cm 2 sec -1 F-Theta linearity ~ 0.1% Spot size ~ 8 µ m Location accuracy = 40 µ m Scan Width = 76 mm © 2016 SRI International
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Continuous Manufacturing in Pharmaceutical Research
1800s – 1900s 2000s The Future Streamlining the small molecule drug discovery progress… …By creating an end to end automated chemical synthesis platform Synthetic Chemistry – Status Quo Batch process methodology hasn’t changed in two centuries © 2016 SRI International
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SynFini - Revolutionizing Drug Design/Manufacturing
• Potential Economic Impact − Save $Bs in drug discovery and development Reduce time from lab to market Decrease discovery synthesis time ~80% Decrease transfer to pilot scale time by ~85% • Stage of Project − Received SBT funding DARPA Make-It • Four year, multimillion dollar program Technology and know how proposed by SRI • Next Steps − Engage one or more strategic partners Build industry consortium © 2016 SRI International Revolutionizing drug manufacturing for increased efficiency and reduced costs.
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Conclusion Thoughts on Future Innovations in BioPharma
• Pharmacoeconomics / Outcomes − − Personalized Medicine − Prevention − Patient Centric − Access AND Affordability − Generics − Chronic Disease − Digital Pharma − Biosimilars Interface of traditional and emerging disciplines © 2016 SRI International •
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working together on important problems to change the world… repeatedly
Ted Ira Executive Director of Business Development, Global Partnerships © 2016 SRI International 39
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