Tuesday, November 3, 2009— Optional Pre-conference Workshops
(Open to Customers Only)
  9:00-12:00pm Efficiently Transforming Clinical Data Collected With InForm™ into SDTM Format

Advanced Features of Empirica™ Signal: Topic Tracking and Logistic Regression
  1:00-4:00pm Pushing the Boundaries: Novel Applications of a Combined IRT/EDC Solution

Report Distribution and Advanced Reporting Using Empirica™ Trace
  7:00-8:30pm Welcome Reception
Wednesday, November 4, 2009— IUC Day One
  8:00-8:45am Registration and Breakfast
  9:00-9:45am Welcome and Opening Remarks
Bob Weiler, Chairman, President and CEO
Phase Forward
  9:45-10:30am

Industry Keynote
John F. Crowley, Former CEO of Novazyme Pharmaceuticals, Inc.
and presently the President & CEO of
Amicus Therapeutics
  10:30-11:00am Break
  11:00-11:30am Solutions Update
Steve Rosenberg, Senior Vice President, Products and Services
Phase Forward
  11:30-12:00pm What's New At Phase Forward
Himanshu Oberoi, Vice President, Waban Software Group
Scott Dixon, Vice President, Outcome Logix Group
Phase Forward
  12:00-1:15pm Lunch
 
eClinical Track A:
eClinical Track B:
 Safety Track C:
  1:15-2:15pm
Product and Solutions Update - Clinical Product and Solution Update – Safety
  2:15-2:45pm
Integrating InForm into the research data stream at Children’s Hospital
 Jason Rightmyer, Children’s Hospital		 Leveraging Data Warehousing and Service Oriented Architecture to Increase R&D Productivity
Paulette Roper, Allergan		 Safety Management in Clinical Trials: Technical Lessons Learned
Esther King, Momentum Research

Empirica Trace session
  2:45-3:15pm
Megatrials Session
Thurman Hamlet, Parexel
Smita Mehta, Parexel
Debra Tolsma, DCRI
Patrick Burns, Phase Forward
 Challenges When Designing Oncology Trials
Marina Nillni, Marina Varshavsky
Dana-Farber Cancer Institute
 Stepping Outside the Box: Alcon's Implementation of PSURs with CCSI Look-up Functionality
Stephen Schmidt, Alcon Labs
  3:15-3:45pm
Break Break Break
  3:45-4:45pm
Filling the black box void of the clinical data lifecycle
Daniel Boisvert, Genzyme
Michael Bartlett, Lundbeck
 Transitioning to Central Designer and Use of Standards
Stacy Dabin, Celgene
Mary Evanchick, Celgene

Utilizing Operational Metrics from a Safety Database
Doug Hill, Drug Safety Alliance
Scott Fonseca, Phase Forward

Risk Management between the Regulatory Rock (FDA REMS, EU RMP) and the Litigation Hardplace
Uwe Trinks, Foresight Group

  4:45-5:30pm
The Phase Forward Design Labs
Paul Boyd, Phase Forward
 Healthcare Data Mining for Safety Update
David Fram, Lincoln Safety Group, Phase Forward
  7:00pm Cocktails  
  7:30pm Networking Dinner and Entertainment  
Thursday, November 5, 2009— IUC Day Two
  8:00-8:45am Breakfast
  9:00-9:05am Welcome
Martin Young, Senior Vice President, Integration and Product Strategy
Phase Forward		  
  9:05-9:45am Customer Keynote
P. K. Tandon, Ph.D., Senior Vice President, Global Biomedical Data Sciences & Informatics
Genzyme Corporation, Inc.		  
  9:45-10:30am Computational Science in CDER: Challenges and Future Directions
Charles Cooper, Medical Officer, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER), FDA 		 
  10:30-11:00am Break  
 
eClinical Track A:
eClinical Track B:
 Safety Track C:
  11:00-11:30am
Use of Interactive Response Technology in Clinical Trials
Margaret Hsu, Abbott Laboratories
 Using a standard library to efficiently build a trial
Michael Eyre, sanofi-pasteur
 A Case Study of Using Phase Forward analytical Systems to Improve the Review of Safety Data
Ana Szarfman, FDA

 
  11:30-12:00pm
Integration of Data Between Clarix and InForm and Efficiencies Gained Across Trials Within a Single Clinical Program
Sue Matias, Vertex
Greg Adkins, Vertex

 Implementation and Execution of Long Term Registries
Heather Fitzpatrick,
PRA International

 Implementation of a new lifecycle safety/risk management process at Purdue Pharma
Denis Keohane, Purdue Pharma

 
  12:00-12:30pm
Using the Right Metrics to Manage EDC Trials
Cassie Newell, ICON
 Managing Increased Protocol Complexities
Cheryl Schliessman, Celgene
 Integrating EDC and SAE Reporting Processes
Michael Gorman, Sentrx
  12:30-1:30pm Lunch  
  1:30-2:15pm
Using Central Coding: Experiences and Best Practices
Narcisa Cuceanu, Novartis Vaccines
Elaine Luscombe, Celgene
Mo Lam, Phase Forward
 A Case Study in Synchronizing Electronic Images and Metadata in a GMP Compliant Format
Dave Clark, Aurum Institute
Tim Crowe, Cleveland Clinic
Abraham Gutman, AG Mednet
Rob Quinn, Phase Forward
 Approaches to discover and evaluate drug-drug event combinations in Empirica Signal and examples of hypothesis testing
Patrick DeLisle, Eli Lilly
  2:15-2:45pm
Data Integrations: Use of Adapters
Ankur Jain, Quintiles
 Employing a risk-based approach to streamline User Acceptance Testing
George Keller, Vertex
Lauren Ryder, Vertex
 Empirica Signal Management System Implementation and Learnings at AstraZeneca
Peter Bogetti, AstraZeneca
  2:45-3:15pm
Break Break Break
  3:15-3:45pm
Migrating Data to Central Repositories – Strategies, Challenges and Benefits
Manish Dave, Merck & Co
 Taking EDC to the Suite Spot
Ross Rothmeier, Covance
 Empirica Suite Concepts from Focus Groups
Marianne Savage, Phase Forward
Michael Johnston, Phase Forward
Paul Boyd
  3:45-4:15pm
Efficient and Effective EDC Support Services
Andrew Mackelfresh, DCRI
Cherie Barnes, DCRI
 Innovative Technology: Pragmatism, Efficiency and Effectiveness using Phase ForwardTM IRT
Greg Ettorre, Cephalon
  
  4:15-4:45pm
Converting Clinical Data into SDTM Format
Jim Nigrelli, Veristat
 Trends in Global Drug Supply Management: Leveraging IRT to Streamline Supply Chain Logistics
Chris Ellis, Aptuit
  
  5:00pm Conference Adjourns  
  To register for the conference

*Please note: Time slots and track topics are tentative