FDA/PHUSE Annual Computational Science Symposium


The FDA/PHUSE Annual Computational Science Symposium was a great success with 260 attendees and 20 exhibitors. During the two days, the working groups built on the work that commenced at last years meeting and explored new projects such as Emerging Technologies.

You can download the presentations below:


Monday, March 18th

Welcome to the 4th Annual Computational Science Symposium 

"Making Progress: The FDA/PHUSE Collaboration and Computational Science Symposium": Part 1 - Steve Wilson, FDA

"Making Progress: The FDA/PHUSE Collaboration and Computational Science Symposium": Part 2 - Chuck Cooper, FDA

"Modernizing the Review Process through Innovation" - Lilliam Rosario, FDA

"FDASIA and Standardized Electronic Data: Where are We?" - Mary Ann Slack, FDA

Working Group Updates

Optimizing the Use of Data Standards

Development of Standard Scripts for Analysis and Programming

Improving Data Quality  

Non-Clinical Roadmap and Impacts on Implementation


Tuesday, March 19th

Emerging Technologies Panel

"Semantic Models for CDSISC based Standards & Metadata Management" - Frederik Malfait, Roche

"Introduction to the HL7 Fast Healthcare Interoperability Resources (FHIR)" - Lloyd McKenzie, Gordan Point Informatics

"R&D IT and the Cloud" - Matteo di Tommaso, Pfizer


Poster Presentations 

PP01: Strategies for Preparing and Validating Submission Data - Sandeep Juneja & Frank Rodiger, SAS Institute Inc

PP02: Relating PC and PP Domains using RELREC Records - Peter Schaefer, Pharsight

PP03: Active PURLs for Clinical Study Aggregation - David Wood, 3 Round Stones & Tom Plasterer, AstraZeneca

PP05: Clinical Analysis and Reporting Environment (CARE) - The Industrialization of Clinical Trail Analysis and Reporting - Greg Fuller, Independent - Industry Poster Winner

PP06: "Specifications Like This" - A Framework for Automatic Generation of Program Code and Documentation - Marc Andersen, StatGroup APS

PP07: Conversion of Legacy Data from Topical Corticosteroid Clinical Studies to SDTM Format - Hon Sum Ko & Elizabeth Gaudio, FDA

PP08: Web-based Integrated Summary of Safety Exposure Response Analysis - Jens Stampe Soerensen & Ider Peter Lee, FDA

PP09: Bringing Non-CDISC Datasets into a CDISC World with Reproducible Output - Nasanel Freimark & Victor Falch, Theorem Clinical Research

PP10: Data Quality in Submissions: A Missing Link - Kit Howard, Kestrel Consultants   

PP11: A Collaborative, Cloud Hosted Environment for Simulating CDISC SEND Submissions between CROs, Sponsors - Shree Nath, Heather Williams & Jackson Zalki, PointCross Life Sciences

PP12: Quantitative Systems Pharmacology in Development of CNS Therapies. Failure Analysis of Dimebon in Alzheimer's Diseases - Hugo Gerts, InSilico Biosciences

PP13: JANUS CTR Data and Cross Study Analysis at FDA - Helena Sviglin, Iffat Chowdhury & Bobbie Witczak - FDA Poster Winner

PP14: FDA/CBER Biological Product Pharmacological Classification - Jack Zhang, Vada Perkins & Bill Hess, FDA

PP15: EZ-R4Excel: How to do Powerful Data Analysis Easily in an EXCEL Environment - Jyotsna Kasturi, Davit Sargsyan & Dhamm ika Amaratunga, Janssen Pharmaceuticals

PP16: Get Involved with the FDA/PHUSE Script Repository - Kevin Kanem Phastar, Hanming Tu, Accenture & Mary Nilson, Lilly 

PP17: MetaWise: Extraction and Normalisation of Toxicologic Pathology Terminology From the INHAND Project - Jennifer Feldman, Instem 

PP18: MAED Service: FDA Developed Tool for Clinical AE Data Signal Detection - Joy Li, Chuck Cooper & Zhongjun Luo, FDA 

PP19: Automation of ADaM Dataset Creation with a Prospective, Retrospective and Pragmatic Process - Karin LaPann & Terek Peterson, PRA International

PP20: Interconnectivity of Nonclinical Data Across Data Silos for Drug Discovery and Development - Jyotsna Kasturi, Janssen Pharmaceuticals, Paul Brown, CDER FDA, Suresh Madhaven, PointCross Life Sciences, Alan Brown, Donna Danduone, Instem, Jemery Wally, FDA & Latha Prabakar, PointCRoss Life Sciences

PP21: Study Data Reviewers Guide Template Sample - David Brega & John Brega, PharmaStat

PP23: Fitting Data from Observational Studies to the SDTM - Jane Diefenbach, PharmaStat 

PP24: Use Case Scenarios for Interorganizational Assembly and Exchange of CDISC SEND Datasets - Lynda Sands, GlaxoSmithKline, Shree nath, POintCross Life Sciences, William Houser, Bristol Myers Squibb, Debra Oetzman, Covance Laboratories Inc, Kathryn Brown & Susan DeHaven, Sanofi US Inc, Jeff Foy, Celgene Summit, Troy Smyrnios, MPI Research, Peggy Zorn, INDS Inc & Jyotsna Kasturi, Janssen Pharmaceuticals

PP25: Integrating and Converting Data Across Studies – IDBs - Natalie Reynolds

PP26: Priorities for a Nonclinical Standardization Roadmap - Debra Oetzman, Covance Laboratories Inc, Lynda Sands, GlaxoSmithKline, Bob Dorsam, FDA, Gitte Frausing, Novo Nordisk, Rick Thompson & Sara Obbers, Janssen R&D, Anisa Scott, JMP Life Sciences & Lou Ann Kramer, Eli Lilly 

PP27:Analytical Overview of the CDER Risk-based GCP Clinical Investigator Inspections Site Selection Tool - Paul Wesili, FDA



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