PHUSE Annual CSS 2014
Presentations & Posters
The 2014 Annual Computational Science Symposium was a great sucess. Please see speaker presentations and posters from the event below:
Monday, March 17th
To listen to Monday's presentations click here
Fulfilling the Promise of Information Technology
- Taha A. Kass-Hout, M.D., M.S., FDA Chief Health Informatics Officer
TransCelerate Biopharma: Pre-Competitive Collaboration in Clinical Trials
- David Jordan, TransCelerate Boipharma
FDA Standards Strategy: Where are We and Where are We Going?
- Ron Fitzmartin, Ph.D., Office of Strategic Programs, CDER, FDA
CSC Update: A Demonstration of JumpStart, the New FDA Platform of Tools and Processes for Product Review - Lilliam Rosario, PhD., Director, Computational Science Center, CDER, FDA
Innovation through Collaboration: Why the CSS Working Groups are Important to FDA
- Steve Wilson, DrPH, CAPT., USPHS Director, Division of Biometrics III, CDER, FDA
Tuesday, March 18th
To listen to Tuesday's presentations click here
Summary of Working Group Progress
- Optimizing Data Standards Working Group
- Emerging Technologies Working Group
- Standard Scripts Working Group
- Non-Clinical Working Group
What you want to Know - An Open Discussion of Data Stanfdards Implementation
- FDA Expert Panel
PP01 - PHUSE CSS White Paper on Analyses and Displays Associated with Outliers/Shifts from Normal to Abnormal - Wei Wang & Mary Nillson, Eli Lilly & Company
PP02 - The PHUSE Therapeutic Area Wiki Page - Angelo Tinazzi, Cytel Inc., Sascha Ahrweiler & Oliver Wirtz, UCB BioSciences & Christian Mueller, F.Hoffman-La Roche
PP03 - PHUSE CSS White Paper on Analyses and Displays Associated with Central Tendancy - Mary Nilsson, Wei Wang & Qi Jiang, Eli Lilly & Co.
PP04 - SEND Architecture Facilitates Harmonization and Aggregation of Data from Different Organizations/LIM - Frederic Mura, Richard Buchanan & Michael Wasko, PDS Preclinical Data Systems Inc.
PP05 - Comparison of FDA and OpenCDISC SEND Validator Rules - Laura Kaufman, Maro Shuster, Richard Buchanan & Frederic Mura, PDS Preclinical Data Systems Inc.
PP06 - Legacy Data Meets CDISC - Experiences from Working with Evolving Standards in eSubmission Projects - Beate Hientzsch & Dirk Spruck, Accovion
PP07 - PHUSE CSS White Paper on Analyses and Displays Associated with Demographics, Dispositions and Medical History - Simin Baygani, Eli Lilly & Company
PP08 - Selecting a CRO for Creating and Integrating SEND Datasets from Multiple Organizations - Gerald Randolp, PDS Inc. & William Houser, Bristol-Myers Squibb on behalf of Interorganizational SEND Project Team for the Non-Clinical Road-map and Impacts on Implementation Working Group
PP09 - Recommendations on Use of the Clinical SDRG Model for Nonclinical Data Submission - Laura Kaufman & Sue Dehaven, PDS Inc. & Non-Clinical SDRG Working Group
PP11 - The Analysis Data Review Guide ADRG - Susan Kenny, Amgen
PP12 - Application of a Quality System to the Generation and Submission of SEND Files - Carolyn McGary & William Houser, Bristol-Myers Squibb
PP13 - SEND Datasets from Studies Conducted at Multiple Organizations: An Update Based on Current Practices - Jeffrey Foy, Celgene; Troy Simmons, Zoetis; Debra Oetzman, Covance; Kathryn Brown, Sanofi; William Houser, Bristol-Myers Squibb; Lynda Sands, Glaxo Smith Kline; Peggy Zorn, INDS Inc.; Gerald Randolf, Roche & Isaac Hatzell, Janssen
PP14 - Reduce Programming Time with Reusable Templates - Cathal Gallagher & Alistair Dootson, Dootsonic - Winning Industry Poster
PP15 - PHUSE CSS White Paper on Analyses and Displays Associated to Pharmacokinetics - with a Focus on Clin - Francois Vandenhende, Ingrid Burton & Sascha Ahrweiler, UCB BioSciences
PP16 - Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies - Jennifer Feldman, Instem; Megan Bausman, Covance; Paul Brown & Lauren Mihalcik, CDER, FDA; Nancy Everds, Amgen; Judith Henck, Eli Lilly & Co; Dan Potenta, Novartis; John Sims, Pfizer & Joyce Zandee INDs Inc.
PP17 - PHUSE Computational Science Symposium (CSS) White Paper on Analyses and Displays Associated with Adverse Events - Sheryl McCoy & Qi Jiang, Amgen & Mary Nilsson, Eli Lilly & Co.
PP18 - Legacy Data from Topical Corticosteroid Clinical Trials: Issues in SDTM Conversion - Aijun Qiu & Hon-Sum Ko, CDER, FDA
PP19 - Industry Standard Good Programming Practices Guidance V1.0 Now Available - Beate Hientzsch, Art Collins & Mark Foxwell, Accovion on behalf of the GPP Steering Board
PP20 - PHUSE CSS White Paper on Analyses Associated with Hepatotoxicity - Terry Walsh, Astellas Pharma Global Development
PP21 - Representing CDISC Foundation Standards in RDF - Scott Bahlavooni, Biogen Idec; Frederik malfait, IMOS & Geoff Low, Medidata
PP22 - Specs in Analysis Out - The Automatic Way - Endri Endri, EE Analysis - ICRC Weyer GmbH
PP23 - Lessons Learned from SEND Implementations at the FDA and Sponsor Companies - Shree Nath & Fristi Johnson, PointCross Life Sciences
PP24 - Use of a Bioinformatics Tool, MASE (Molecular Analysis of Side Effects), Generates the Hypothesis of an Association between FGFR2 and Bone Fractures - Peter Schotland, Keith K. Burkhart & Darrell Abernethy, FDA/CDER/OTS/OCP/IO
PP25 - Time to Spectrum Culture Conversion as a Trial Endpoint: Re-Use and Cross Study Analysis of Standardized Tuberculosis Trial Data - Eileen Navarro, Bobbie Witzcak, Joy Li & Lilliam Rosario, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS & Xianbin Li, Office of Biostatistics, Office of Translational Science, CDER, FDA, HHS
PP26 - Interactive Data Visualization of Clinical Trials Data with D3.js - John Ho, Joy Li, Eileen Navarro, Mary Doi, Timothy Kropp & Lilliam Rosario, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS & Paul Schuette, Office of Biostatistics, Office of Translational Science, CDER, FDA, HHS
PP27 - Using Semantic Web Technologies to Manage FDA Electronic Submissions Policy Information - Mitra Rocca & Syed Haider, CDER Office of Translational Sciences & Armando Oliva, CDER Office of Computational Science
PP28 - Demographic Representation in Aggregated Diabetes Clinical Trials - Shondelle Wilson-Frederick, HHS, Office of Minority Health; Helena Sviglin, Lilliam Rosario & ShaAvhree Buckman-Garner, FDA Centre for Drug Evaluation and Research & Jonca Bull, FDA, Office of the Commissioner, Office of Minority Health- Winning FDA Poster
PP30 - Modernizing the Review Process through Technology - Janus Clinical Trials Repository - Bobbie Witczak & Mary Doi, FDA/CDER/OTS/Office of Computational Science
PP31 - How to Design a Custom SDTM Domain for Nonclinical Data Overview - Gitte Frausing, Novo Nordisk, Debra Oetzman, Covance; Kathy Powers, Pfizer; Lynda Sands Glaxo Smith Kline; Donna Danduone, Instem; Robert Dorsam, FDA, CDER; Sara Obbers & Anisa Scott
PP32 - The PPi Risk Explorer, It's Development and Application in Assessing the Interaction of Drugs to Treat Osteoporosis and Proton Pump Inhibitions (PPIs) Use in the Risk of Osteoporosis Related Adverse Events - Zhongjun Luo, Jing Yang, Zheng Zuo, Marcea Whitaker, Nancy Xu, Lan Huang, Ram Tiwari, Weida Tong, Lilliam Rosario, Susan McCune & ShaAvhree Buckman-Garner, FDA & Charles Cooper, Becton, Dickinson & Co.