Presentations & Posters



Office of Computational Science Symposium: Applying he Right Tools, at the Right Time to Regulatory Review

Lilliam Rosario, PhD., Director, Computational Science Centre, CDER, FDA

JumpStarting the Regulatory Review Process: The Reviewer Perspective - An Overview

Steve Lemery & Peter Miele, FDA

JumpStarting the Regulatory Review Process: An Oncology Reviewer's Take

Steve Lemery, M.D., M.H.S,
Lead Medical Officer and Scientific Liaison, FDA

Jump Starting the Regulatory Review Process: Clinical Reviewer's Perspective

Peter Miele, MD, Medical Officer, FDA

Janus CTR: At the Heart of Integrating Data for Regulatory Review

Armando Oliva, Associate Director of Informatics, CDER Office of Computational Science, FDA

The PHUSE CSS Collaboration - Getting Involved and Getting it Done: A Regulatory Perspective

Steve Wilson, Dr.PH, CAPT.,
USPHS Director, Division of Biometrics III, CDER, FDA

Summary of the Working Group Success and Projects Moving Forward

CSS Steering Committee

Electronic Submissions - The Requirements for Standardized Study Data

Ron Fitzmartin, PhD.
Office of Strategic Programs, CDER, FDA




Poster No.Poster TitleAuthors
PP01 Adding in Vivo Mammalian Cytogentics Data to SEND andToxML                               Mohammed Ashfaq, Lhasa Ltd;
Gitte Frausing, Data Standards Decisions Aps & David Bower, Leadscope
PP02 An Analysis of Data De-Identification Practices in Use at Leading Biopharmaceutical Companies Dave Handelsman, d-Wise
PP03 CSS PHUSE White Paper Update on Analyses and Displays Associated with Outliers or Shifts from Natural to Abnormal Wei Wang & Mary Nilsson,
Eli Lilly & Company
PP05 Enhancing the Productivity of Analysis and Reporting through Collaborative Innovation Stephen Matterson, Chris Fenaughty & Unnat Patel, Pfizer
PP06 Resampling Methods as Applied to Significance Tests: A Case Study Veronica Powell & Carrie Caswell,
Theorem Clinical Research
PP07 Legacy Data Conversion Issues for Topical Product Studies Aijun Qiu, FDA, CDER & Hon-Sum Ko, FDA
PP08 Adapting to Adaptive Angelo Tinazzi, Ashish Aggarwal&
Steve Wong, Cytel
PP11 SEND (and SDTM) Implementation Guide Web-Based EASY Search Tool Bob Friedman& Wenxian Wang, Xybion Corporation & Michael Wasko, PDS Life Sciences
PP12 Template to Facilitate Creation Pharmacokinetics Concentrations SEND Datasets (PC Domain) William Houser, Bristol-Myers Squibb; Richard Buchannon, PDS Preclinical Data Systems & Christy Kubin, Brian Argo and other iSEND Team Members
PP13 SEND Data from Small/Medium Service Providers: How Prepared are they to Supply Data in SEND Format? Richard Buchannon, PDS Preclinical Data Systems & William Houser, Bristol-Myers Squibb
PP14 PHUSE CSS White Paper on Analyses Associated with Hepatotoxcity Terry Walsh, Astellas Pharma Global Development
PP15 Creating CDISC Test Data Sets - A Worthwhile Concept? Peter Schaefer, Independent
PP16 How Can CDISC Help CDRH? Kit Howard, CDISC; Carey Smoak, InClin &
Rajesh Nair, FDA, CDRH
PP17 Beyond Submission: Business Rules in Legacy Data Conversion for better CTR Integration Helena Sviglin, Eileen Navarro, Bobbie Witczak &
Lilliam Rosario, FDA
PP18 Implementing the SDRG: Reflections from the Reviewer Community Helena Sviglin, Eileen Navarro, Crystal Allard & Lilliam Rosario, FDA/CDER/OTS/CSC; Jeno Pizarro, IBM, Strategy and Analytics & Ryan Barraco, Booz Allen Hamilton
PP19 Outside the Box: Race and Ethnicity in NDA Submissions Mina Hohlen & Eileen Navarro, FDA, CDER/OTS/CSC; Austin Taylor, IBM, Strategy and Analytics & Sergiy Sirichecnko, Pinnacle 21
PP20 M*ssing Application Data - Impact on NDA and BLA Reviews Eileen Navarro & Lilliam Rosario, FDA OCS, OTS; Austin Taylor, Jeno Pizarro & Kathryn Matto, IBM; Ryan Barraco, Booz Allen Hamilton & Max Kanevsky, Pinnacle 21
PP21 JumpStarting Review: Highlights DeYett Law, Patricia Koussis, Crystal Allard, Helena Sviglin, John Ho, Joy Li, Timothy Kropp, Lilliam Rosario, Eileen Navarro, FDA, OCS, OTS; Mary Doi, FDA OND, CDER; Dave Epstein CNI; Ryan Barraco & Austin Taylor, Booz Allen Hamilton; Katherine Matto & Jeno Pizarro, IBM
PP22 A Framework for the Adoption of Cloud Services in the Life Science Industry Anders Vidstrup, NNIT
PP23 Development of Standardized SAS Macros for Demographic Subgroup Participation in NDAs and BLAs Submitted to FDA's Center for Drug Evaluation and Research Anne Pariser, Eileen Navarro Almario & Lilliam Rosario, FDA
PP24 Clinical Site Dataset in eSubmissions to the FDA Beate Hientzsch, Dirk Spruck & Stefanie Sturm, Accovion
PP25 SDTM can be Customized to Different Types of Nonclinical Data using a Streamlined Decision-Making Process Robert Dorsam, FDA; Gitte Frausing, Data Standards Decisions & Roadmap Team Members
PP26 Dynamic Display of Patient Profiles Rebeka Tabbey & Wei Wang, Eli Lilly & Company
PP27 Qualification Process for Standard Scripts Hosted in Open Source Repository Dante Di Tommaso, Roche; Hanming Tu, Accenture & PHUSE CS Working Group development of Standard Scripts for Analysis and Programming
PP28 Communication: So, We have a New Standard… Now What? Wenxian Wang, Xybion Medical Systems; Debra Oetzmann, Covance & Troy Smyrnios, Zoetis
PP29 Standard Scripts for Analysis and Reporting: A Vision within Reach Christopher Hurley, MMS Holdings & Frank Senk AstraZeneca
PP30 Ensuring USUBJID is Unique for an Individual within an Application Monica Mattson, celgene Corportation; Mark Sullivan, Parexel International & Gary Walker, Quintiles
PP31 Operationalizing Global Clinical Trial Disclosures Zach Weingarden & Joe Archer, MMS Holdings
PP32 Review and Analysis of SEND Standardized Data at the FDA Kristi Johnson, Jillian Sanford, Karen Porter, Jon Kimball & Shree Nath, PointCross Life Sciences
PP33 Steps and Slides of Implementing Global Standards Terek Peterson & Karin LaPann, Theorem Clinical Research
PP34 AskOCP: Semantically Enhanced Search Applied to Clinical Review Documents Eduard Porta Martin Moreno & Ider Peter Lee, FDA
PP35 Enabling Integrated Analyses for Hypoglycemic Agents through Standards and Technology Tejas Patel, Helena Sviglin, Bereket Tesfaldet, Bobbie Witczak, Lilliam Rosario & Eileen Navarro-Almario, FDA
PP36 Text Mining: Expanding into Drug Regulatory Submissions and Surveillance Tony Sheaffer & James Dixon, Linguamatics
PP37 Template and User Guide for Nonclinical Study data Reviewer's Guide (SDRG) Laura Kaufman, PDS Life Sciences; Susan DeHaven, Sanofi & Non-clinical SDRG FDA/PHUSE Working Group

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