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:

Speaker Presentations

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



Poster Presentations 

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.





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