Agenda – 16th Clinical Performance Metrics & Analytics Summit

  • Day One
  • Day Two

Day One

 Monday, December 2

8:30 – 9:45

Chairperson’s Opening Remarks
Tim Koch, Global Head, Key Account Management – Trial Mgmt., Transformative Business Operations (TBO) within Global Development Operations, Novartis

9:45 – 10:30

Measure Metrics That Matter: Understand What to Measure for Optimal Success
Alec Vardy, Executive Director, Clinical Data Management, Jazz Pharmaceuticals

10:30 – 11:00

Networking Break

11:00 – 12:00

Case Study: Monitor Data and Analyze Trends Across Multiple Clinical Trials
Jennifer Hill, Associate Director Clinical Data Informatics and Analytics, ENDO PHARMACEUTICAL

12:00 – 1:00

Networking Lunch

1:00 – 2:00

ICH E6 R2 Interpretation and Implementation: Case Study of Practical and Advanced Application of GCP Risk Management
Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Quality Performance and Risk Management, Pfizer
Sheri Kuss, Clinical Quality Lead, Pfizer

2:00 – 2:45

Best Practices for Measuring the Patient Experience in Clinical Trials
Faye O’Brien, Director, Performance and Metrics, AstraZeneca
Michele Teufel, Feasibility and Recruitment Partner, AstraZeneca
Kathy Cole, Director of Feasibility, PMG Research

2:45 – 3:15

Networking Break

3:15 – 4:00

Expanding RBM Capabilities With Automated Anomaly Detection
Chandi Kodthiwada, Director, Product Management, Saama Technologies

4:00 – 4:45

Focus KPIs and Monitor Centralized Goals When Launching Quality Improvement Projects
Sharon Brower, CQA, Director, Clinical Training, Process and Continuous Improvement, Global Clinical Operations, Bristol-Myers Squibb


Day Two

 Tuesday, December 3

8:30 – 8:45

Chairperson’s Recap of Day One
Tim Koch, Global Head, Key Account Management – Trial Mgmt., Transformative Business Operations (TBO) within Global Development Operations, Novartis

8:45 – 9:30

Roundtable Discussion: Utilize Metrics to Improve Dashboards, Set Clear Goals, and Engage Stakeholders
Tim Koch, Global Head, Key Account Management – Trial Mgmt., Transformative Business Operations (TBO) within Global Development Operations, Novartis
David Hamilton, Associate Director, Clinical Development and Analytics, Strategy and Operations, Novartis

9:30 – 10:15

Improve Inefficient Reporting Systems and Produce Reliable, Relevant, Timely Data With Advanced Analytics and Dashboards
Kristine Koontz, Head of U.S. Clinical Operations, GlaxoSmithKline

10:15 – 10:45

Networking Break

10:45 – 11:30

Predictive Mining of Clinical Trials using Machine Intelligence Techniques
Shameer Khader, Ph.D., Senior Director, Advanced Analytics, Data Science and Bioinformatics, AstraZeneca

11:30 – 12:15

Measuring Success of a Quality Risk Management Approach
Kristin Stallcup, Senior Director, Xcellerate Customer Success, Covance

12:15 – 1:15

Networking Lunch

1:15 – 2:00

Selecting and Leveraging Metrics for Emerging Clinical Trial Strategies
Priya Chaturvedi, Ph.D., Executive Director, TA Head Vaccines and ID, MRL Quality Assurance, Merck

2:00 – 2:45

Panel: Manage Vendor Oversight Approaches and for Healthy Sponsor/Vendor Engagements
Leesa Gentry, Senior Vice President, Global Clinical Operations and Program Management, Evotec
Mayuri Trehan, PMP, Certified Lean Six Sigma Black Belt, Director, Global Regulatory Compliance, CELGENE

2:45 – 3:15

Chairperson’s Closing Remarks
Tim Koch, Global Head, Key Account Management – Trial Mgmt., Transformative Business Operations (TBO) within Global Development Operations, Novartis