2019 SCIENTIFIC COMPUTING DAYS

BOOTH SESSION
Featuring 42 vendors, FDA groups & affiliates

		ANSYS Every time you deliver a product to a customer, you are promising them that it will work as advertised and make their life easier in some way. Using ANSYS engineering simulation software to design your products ensures that you can keep that promise, with every product and every order for every customer.				FDA Innovation Lab offers a collaborative community of experienced professionals, seasoned subject matter experts, and budding technologists. We are always looking to research and test out new innovative ideas that can foster innovation throughout FDA.
		ARA pairs innovation with in-depth knowledge of physical, chemical, physiological and biological processes to solve complex health problems. Our team is at the forefront of research into inhalation dosimetry of tobacco products and inhaled drugs				Internet2 operates the nation’s largest and fastest research and education network built to support big data scientific collaborations and secured by a community-developed trust and identity framework.
		Analysis Studio is a standalone R Shiny application built for the analysis of clinical trial data. Analysis Studio leverages the interactivity of R Shiny to deliver intuitive analyses in real-time.				The KickStart service uses Standards for Exchange of Nonclinical Data (SEND) data submitted by sponsors to increase the efficiency of the regulatory review process by providing reviewers with a data fitness assessment and training on the Janus Nonclinical system.
		Amazon Web Services (AWS) has been the world’s most comprehensive and broadly adopted cloud platform for 13 years. AWS offers over 165 fully featured services for compute, storage, databases, networking, analytics, robotics, machine learning and artificial intelligence, Internet of Things (IoT), mobile, security, hybrid, virtual and augmented reality, media and application development, deployment, and management.				Leadscope is a scientific leader in computational toxicology and develops in silico toxicology solutions; many built through research collaborations with the US FDA. . This technology supports submissions and review for ICH M7 and other guidance.
		Booz Allen Hamilton is demonstrating leading tools and technologies for supporting scientists and advancing the scientific mission, including: blockchain technology, machine learning, natural language processing, and cloud-based big data platforms.				Lhasa Limited is a pioneer in developing high-quality toxicology, metabolism, and degradation software and databases which deliver scientifically robust and trusted results.
		The Center for Devices and Radiological Health (CDRH) High Performance Computing (HPC) team will demonstrate: Leading edge techniques for scaling applications on massively parallel supercomputers/clusters.The CDRH HPC team will also share success stories of HPC users who have accomplished impossible tasks using the techniques and the HPC clusters.				Leidos offers health services, solutions and High-Performance Computing technical support for several federal agencies including: analysis, evaluation, and reporting of scientific and technical information such as technical findings, trends, forecasts, capabilities, and limitations.
		Center for Drug Evaluation and Research (CDER) Research Governance Council (RGC) serves as CDER’s executive board for oversight of research programs, policy, communication and resource allocations with a forward-looking perspective on factors that will affect CDER’s research programs and priorities.				Linguamatics, an IQVIA company, delivers market-leading I2E, a Natural Language Processing (NLP) based Artificial Intelligence (AI) solutions for high-value knowledge discovery and decision support from a wide variety of text. Example I2E use cases range from mining and extracting data from FDA internal documents (ie Submissions, Letters, Adverse Event Reports), external literature sources (FDA Drug Labels, Medline, PubMed Central) to EHR data and social media.
		Center for Food Safety and Applied Nutrition (CFSAN) Office of Analytics and Outreach (OAO)/Division of Risk and Decision Analysis develops quantitative and data-driven semi-quantitative public health risk models that provide decision makers with accurate nuanced information to make informed decisions.				MathWorks is the leading developer of mathematical computing software for engineers and scientists. Our goal is to change the world by accelerating the pace of discovery, innovation, development, and learning in engineering and science.
		CFSAN AWS HPC FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Division of Information Management and Technology (DIMT) Scientific Innovation and Infrastructure (SII) Branch continues to evolve and provide advanced, flexible, scalable, and available high-performance computing (HPC) capabilities to help our scientists, and the larger public health community, better understand and solve complex problems necessary to fulfill the food safety mission. SII will be demonstrating how broadening CFSAN’s AWS HPC services and use of serverless technology has led to discoveries of improved efficiency, collaboration with internal and external partners, and new capabilities that previously seemed out of reach when using the resources of their on-premise data center.				FDA’s Modeling and Simulation Working Group aims to advance the use of computational modeling and simulation (M&S) at FDA, by bringing together M&S scientists across the Agency and raising awareness about M&S at FDA.
		Chenega an innovative public health partner dedicated to solving critical client problems in various disciplines: biochemical toxicology, bioinformatics and biostatistics, genetic and molecular toxicology, microbiology, nanotechnology and system biology. Chenega’s expertise is in HPC modeling and analysis supports Next Generation Sequencing and image analysis.				MultiCASE develops state-of-the-art predictive toxicology software to complete in silico toxicity evaluation of drug candidates, impurities, metabolites, and reagents in accordance with ICH M7 and REACH legislation.
		Core DataFitness (Core DF) Under the Core DataFitness (Core DF) program, the Office of Computational Science (OCS) has been focused on modernizing its processes with the goal of providing data quality information to all CDER reviewers early in the review process. We will showcase several reports and services developed in this program that address the data quality assessment needs of nonclinical and clinical reviewers, including specialized needs for reviewers in the Office of Clinical Pharmacology (OCP).				The National Center for Toxicological Research conducts research in both bioinformatics and cheminformatics. The Center also develops and coordinates bioinformatics capabilities within NCTR, across FDA Centers and in the toxicology community.
		CTP Integrated Research and Data Systems (CIRDS)- CIRDs is an integrated platform that provides an advanced & customized search engine to retrieve structured & unstructured data from multiple data sources. Users can search through UCSF, TCKB, RTS (projects and documents) and iDAT (coming) data sources via an intuitive and modern interface. MITRE and MarkLogic developed CIRDs in collaboration with CTP (Informatics Research Staff). For more information and to use the tool please visit http://cirds.fda.gov				Center for Drug Evaluation and Research (CDER)/Office of Computational Science (OCS) Service Desk is a reviewer’s single source of information for all OCS supported tools and services; OCS offers 24 fully integrated tools and services; including Scientific Computing, Shared Workstations, and HPC Governance. We are a centralized hub that assists CDER reviewers and the Scientific Computing community by providing information, analytical support, installation assistance, and troubleshooting steps to support the regulatory review process.
		Dassault Systèmes, the 3DEXPERIENCE Company, provides businesses and people with virtual universes to imagine sustainable innovations. Dassault Systèmes' Life Sciences industry solutions aim to improve patient experience and organizational business excellence.				Janus is an application that leverages Study Data Tabulation Model (SDTM)/ Analysis Dataset Model (ADaM)/ Integrated Summary of Safety (ISS) and Standards for Exchange of Nonclinical Data (SEND) data for the clinical and nonclinical review processes, respectively.
		Dovel Technologies, LLC (Dovel) advances Federal agency missions by blending deep domain expertise and advanced technologies to improve lives.				FDA Recruitment employs a team of individuals to protect and advance the Food and Drug Administration’s (FDA) mission by helping to speed innovations that provide our nation with safe and effective medical products, and that keep our food safe and reduce harm from all regulated tobacco products.
		Data Dashboard increases transparency and accountability by displaying and allowing the analysis of public FDA data through easy to use, visually accessible, customizable, and understandable graphics.				Perspecta, partnered with the Food and Drug Administration (FDA), to support the agency’s mission by providing a secure and reliable IT environment enabling swift and appropriate responses by the agency.
		FDALabel is a National Center for Toxicological Research (NCTR) developed web-based application that allows users to conduct full-text and customized searches of a database of over 100,000 labeling documents.				Pharm3r is a leader in scaled, post-market analytics solutions. Pharm3r uses its patented natural language processing technology (Boomerang NLP™) and innovative software to offer clients a 360-degree view of companies, products and key individuals across the life science eco-system.
		General Dynamics Information Technology is an industry leader providing biomedical informatics, scientific computing, and High-Performance Computing (HPC) expertise and professional services to the Federal Government.				PointCross Life Sciences serves the BioPharma industry and FDA with tools such as Xbiom, a regulatory platform solution for study packaging into eData; RMST, a stochastic simulation-based review solution for assessing cancer risk; and MySEND, a desktop tool used to review SEND data sets.
		Genohm develops and maintains software solutions such as Laboratory Information Management System (SLIMS), which is the foundation of the Genomic Information Management System (GIMS) application at the Center for Food Safety and Applied Nutrition (CFSAN) and uses next generation sequencing technology to analyze samples related to foodborne illnesses.				SAIC® is redefining ingenuity by helping FDA Scientists find the right intersection of HPC Modernization and Data Analytics to support scientific and regulatory discovery.
		Google Cloud Platform is a trusted technology partner who understands how to help agencies transition from legacy architectures and utilize their data to fuel true mission success. Google Cloud Platform provides cloud-native infrastructure with layered security, machine learning and analytics at web-scale to rapidly innovate and advance agency goals.				SAS partners with the FDA to power the application of artificial intelligence and machine learning to drive new and important insights, transforming the way the FDA protects the health of Americans.
		The FDA, Office of Health Informatics supports the agency’s need in fulfilling regulatory objectives and statutory responsibilities related to the exchange of information and data-sets between FDA, and regulated industry; researchers and scientists with engagement of external experts, public health support for international harmonization and safety of the global marketplace; empowers patients with information about their care; and collaborates with other government agencies to solve common problems.				Office of Acquisitions and Grant ServicesOAGS awards contracts, interagency agreements and grants, and administers the purchase card program. Our office can assist you with acquisition planning, performance issues, the scientific computing IDIQ, and certification of Contracting Officer’s Representatives (CORs).
		The Center for Biologics Evaluation and Research (CBER)High-performance Integrated Virtual Environment (HIVE) team works with FDA researchers and reviewers to perform complex data analysis on next-generation sequencing experiments, adding custom analytics and pipelines to the HIVE platform. CBER HIVE also trains and supports users, by assisting with big data transfer and storage.				WiseDesign supports the Center for Tobacco Products (CTP) in developing business and data architecture, using proven methodology. WiseWorks is MATLIST-approved software for building real-time, graphical, collaborative models as a single repository of stakeholder knowledge. Models encompass people, process, data, and technology, accessible through a graphical reader or reporting.

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