IBM Intro - CDISC

IBM Intro - CDISC

German CDISC User Group Meeting IBM Intro September 22nd, 2009 2009 IBM Corporation IBMs R&D Team @German CDISC User Group DECK A L e t U es Servic s s e usin &D lobal B Sciences R G M IB fe a & Li Pharm mb H Group utschland G e IB M D

s STO u k r a M LL es Servic s s e usin &D lobal B Sciences R G M IB e a & Lif m r a h P mb H Group tschland G eu IBM D S

NTGE E I W s Jens ervice e ss S usin &D lobal B Sciences R G M IB fe a & Li Pharm mb H Group tschland G eu IBM D ER LEIST r e t ices e P s Serv s e in

s u lobal B Life IBM G Pharma & p of Head s R&D Grou bH m e Scienc utschland G e IBM D 2009 IBM Corporation Creating Pharmaceutical Break-Throughs: - We believe there is no one magic bullet It takes a variety of data sources, best of breed tools & technologies to really create break-throughs but one open & harmonized data-standard would help 3 IBM 2009 IBM Corporation A real life example taken from PoC on

Hepatotoxic AE & CYP450 Marker Clinical Data Management Lab Data Coding This now needs to be confirmed by a statistician in a compliant manner, but hopefully a marker was found SAS, PL/SQL Safety Study 4712 Pre-clin stud Query Management Clinical Research Organizations Study 4711 Study 4712 Study 0816 Clinical Trial Management

Oracle LSH Statistical Programming Registries Study 0815 Patient Diaries Electronic Data Capture DDQB Genomic data Combining the search with Genomic data of the patients finally led to signal 4 IBM Spotfire Med. Pub. As PDF-files 2009 IBM Corporation

Life Sciences Pharma R&D - Services Portfolio Focused R&D services R&D Strategy & Process Optimization Clinical Data Integration & Aggregation (CDA) Clinical Trial (CTMS) and Investigator Relationship Management (IRTM) Electronic Data Capture (EDC) Integrated Project Resource and Portfolio Management (IPRM) Solutions for Compliance in Regulated Environments (Score) (e.g. Submission management, content management, clinical portal, ) Chemsearch Patent Data-Base Biobank Support & Pharmacogenomics (PGx) Data Driven Drug discovery (4D) Modelling and Simulation Data Mining, Web Mining, Text Mining, Target finder Other services applicable to R&D Pervasive computing Petaflop and Grid Computing Process Analytical Technologies (PAT) Training & Knowledge Management Computer System Validation (CSV) 2009 IBM Corporation IBMs Deep Industry Knowledge the R&D Group Embedded in the Larger Picture IBMs consulting capabilities are built around specific strategic and operational challenges facing pharmaceutical companies in the evolving global marketplace. With more than 1000 pharmaceutical industry specialists around the world, IBM Life Sciences consulting practice is part of the worlds largest consultant services organization with significant depth and breadth of industry experience. World-Wide Industry Specialist Resources: Pharmaceutical Practice consists of > 2.000 industry specialists worldwide Manufacturing Operations

Materials & Product Flow Management New Product/Package Introductions in Operations Clinical Supply Chain Process Contract Manufacturing Regulatory Compliance & Validation Supply Chain Information Management Business Planning & Development Business Plan Development Strategy Valuation Strategy & Planning Competitive Positioning Due Diligence Mergers & Acquisitions Research & Development Discovery/Pre-Clinical Clinical Development Clinical Data Aggregation Regulatory Compliance Pharmacovigilance Process Optimization Sales Account Management Health Care & Government Contract Management Sales Operations Improvement Field Sales Management Sales Force Automation Information Management

Management Information Systems Knowledge & Information Management Structured Product Labeling Drug submission Marketing Product Marketing Reimbursement Strategy DTC Strategy Rx-to-OTC switching Strategic Pricing Financial Management Shared Services Performance Management Financial System Management & Reporting 2009 IBM Corporation In a Word, IBM Stands for PROGRESS IBM is a values-based enterprise of individuals who create and apply technology to make the world work better. Today, about 400,000 IBMers around the world invent and integrate hardware, software and services to help forward-thinking enterprises, institutions and people everywhere succeed on a smarter planet.

2009 IBM Corporation IBM - Major Businesses Global Business Services Provides professional services and application outsourcing services Software Provides middleware that enables clients to integrate systems, processes and applications, as well as computer operating systems Global Technology Services Provides outsourced IT infrastructure services and business process services Global Financing Provides financing solutions that can be customized to address specific IT needs, from competitive rates to flexible payment

plans and loans Systems and Technology Provides advanced computing, storage and semiconductor technology and products S&D and Research Our Sales and Research, Development and Intellectual Property organizations provide a wide spectrum of client support and additional value 2009 IBM Corporation A Leader in Technology IBM maintains the worlds largest private-sector research arm. In 2008, for the 16th consecutive year, IBM was issued more U.S. patents (4,186) than any other company. In the last six years IBM has aggressively complemented an investment of $35 billion in research and development with more than 100 acquisitions of hardware, services and software companies.

2009 IBM Corporation http://www.research.ibm.com/FunGen/FGDownloads.htm Gene expression analysis [email protected] A software environment for gene expression analysis and machine learning Njk(j,k,Ne,Ng,) ~ Ng k Ne k Ng-k Ne-j [1-(1+j-1 )k k ] (1j ( )( ) = j j-1-(j-1)j p = 1-exp{-Njk} Lepre, Rice, Tu, and Stolovitzky, [email protected]: an efficient algorithm for pattern discovery and multivariate feature selection in gene expression data, Bioinformatics 20(7):1033-44 (2004). Other Selected Relevant Papers: Mateos, Dopazo, Jansen, Tu, Gerstein and Stolovitzky, Systematic learning of gene functional classes from DNA array expression data by using multilayer perceptrons, Genome Research 12, 1703-15 (2002). Califano, Stolovitzky and Tu, Analysis of Gene Expression Microarrays for Phenotype Classification , Proceedings of the 8th Annual Intelligent Systems in Molecular Biology (ISMB) 2000; 8:75-85 (2000). 2009 IBM Corporation

Functional Genomics & Systems Biology Group The DREAM Project DREAM (Dialogue on Reverse Engineering Analysis and Methods) aspires to collect data and techniques that researchers can use to understand how well their reverse engineering methods can infer the nature of the underlying biochemical networks in the cell. Ideally, researchers would like to test their techniques on a "gold standard" biological network, where interactions are perfectly known. Such networks are often artificial, may lack features found in real biological networks, and may include wrong and missing interactions. Unlike most current approaches, the deepest biological insight will come from combining different types of information, including data on gene expression, proteins, and small molecules, among others. Robustness, sparceness Reverse Engineering Acetyl-CoA Malate CoA Oxaloacetate MDH2 MLS1

Citrate CIT2 ICL2 Glyoxylate Fumarate Isocitrate CoA Acetyl-CoA Data Mining Fumarate Succinate Tricarboxylic Acid Cycle Prediction and experimental design Succinyl-CoA Ketoglutarate Glyoxylate Cycle Simulation

2009 IBM Corporation 2009 IBM Corporation Computational Chemistry and applications in Biochemistry IBM help enhance your modeling & simulation framework for design of pharmaceutical products: simulates complex enzymatic reactions (ADMET projects or enzyme engineering in general); model ligand-protein interaction at the stage of lead identification and optimization. Examples of systems under investigation are: metal-activated enzymatic reactions and design of novel materials for organic electronics ligand-protein interaction, such as HIV-protease inhibitors and simulating how progesterone interacts with its receptor in the human body; identifying molecules responsible for the degradation of flavor in foods. Method used: combined quantum mechanics/molecular mechanics (QM/MM), classical molecular dynamics using quantum-refined force-fields. This activity involves diverse technical steps: development of new algorithms code optimization, particularly for massive parallel computing, eg CPMD (Power, PowerLinux and Blue Gene/L. data analysis selected applications aimed at unraveling the physics and chemistry of the system virtual design of novel materials for advanced technologies development of interfaces for Grid computing. During the past 10 years IBM established scientific collaborations with a number of industrial labs.

Contact: Wanda Andreoni & Alessandro Curioni, IBM Zurich Research Labs 2009 IBM Corporation 2009 IBM Corporation Fighting AIDS virus IBM and University of Edinburgh use World's most advanced supercomputer combined with lab experiments to speed the design of drugs aimed at inhibiting infection by the HIV virus. The project is focused on how the human HIV-1 virus attaches to cells in the body and injects its genetic material and to speed the design of inhibitors for the part of the virus responsible for allowing the virus' genetic material to enter the human cell In 2007, IBM's Haifa Research Laboratories and some European partners developed an integrated system for anti-HIV treatment called EuResist. Enabled by the integration of comprehensive databases, advanced data analytics and prediction tools, the system can forecast how genetic HIV variants will respond to specific antiretroviral treatments. It can therefore help doctors to choose the most effective drugs and drug combinations for their HIV patients 2009 IBM Corporation Scripps Research Institute and IBM Partner Tackle the Global Pandemic Challenge Conduct advanced research on pandemic

viruses Goals Include 1. Develop a means to anticipate, manage and contain infectious diseases 2. Leverage Scripps world class research and IBMs expertise in computational biology and supercomputing 3. Attract advanced research talent to the state of Florida through collaborations associated with the pandemic work Components of Collaboration 1. Exploit an IBM Blue Gene supercomputer to conduct advanced disease modeling 2. Provide access to talent and resources of IBMs Computational Biology Center Have a look at www.ibm.com/avianflu 2009 IBM Corporation Building Multiscale Heart Models (1/2) Heart disease is the leading killer in the developed world Heart will allow better therapies for heart disease ...but will require bridging between organ level and molecular level Organ level Reconstruction of whole heart by Peter Hunter, U. of Auckland Cell level

In each cell of heart, a lattice of sarcomeres produce contraction on every heart beat. Molecular level Sarcomere contracts by cyclical interactions of myosin on thick filament (red) and actin in thin filament (green). Collaborators - University of Auckland, JHU, Loyola, UCSD, UIC, Oxford, others 2009 IBM Corporation FDAs JANUS Submission Data Repository Model by IBM Current Clinical Study Past Clinical Studies JANUS Grew out of CDISC and HL7 data standardization efforts FDA and IBM designed the JANUS clinical data submission repository Worked under a Cooperative R&D Agreement (CRADA), completed in 2004

JANUS logical data model published: http://www.fda.gov/oc/datacouncil/ IBM implemented a JANUS prototype for FDA and NCI FDA and NCI cooperating through an Interagency Operational Task Force (IOTF) Testing completed in January 2006 IBM is currently implementing a JANUS Operational Prototype for FDA and NCI 2009 IBM Corporation Leading the Transition to a Smarter Planet Today, IBM is helping our clients to change the way the world literally works and to make the planet not just smaller and flatter, but smarter. IBM is applying its expertise, global scope and creativity to build the backbone of 21st century industries and public institutions. Our world is becoming INSTRUMENTED Our world is becoming INTERCONNECTED Virtually all things, processes and ways of working are becoming INTELLIGENT

2009 IBM Corporation Building a Smarter Planet Smarter R&D + Intelligent + Instrumented = Interconnected An opportunity for life sciences organizations to think and act in new ways. 2009 IBM Corporation

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