6th Annual Clinical Performance Metrics & Benchmarking Summit

Day One  Monday, September 20th

8:00
Continental Breakfast & Conference Registration

9:00
CHAIRPERSON'S WELCOME & OPENING REMARKS

David Zuckerman
President
CUSTOMIZED IMPROVEMENT STRATEGIES

9:15
IDENTIFYING CLINICAL METRICS
Strategies for Selecting Clinical Development Metrics and Analyses to Ensure Optimal Performance

• Gaining knowledge of the different types of metrics used in clinical development
• Understanding specific performance evaluations: trial metrics, country metrics, site metrics
• Methods for ensuring the metrics chosen are both valid and relevant
• Evaluating their impact on clinical development performance
• Discussion on special metrics to improve processes: quality metrics, financial metrics

Speaker
Nancy Dynes
Consultant, Portfolio Management Systems
ELI LILLY

10:00
INTERNAL PERFORMANCE
Gaining Internal Buy-in of Your Clinical Metrics Program to Improve an Organization’s Processes

• Learn how to teach people what they need to do as an organization to help them understand how metrics will be used
• How to communicate metrics results effectively throughout the organization

Speaker
Randy Krauss
Associate Director, Therapeutic Portfolio Management
GENZYME CORPORATION

10:45
Networking & Refreshment Break

11:15
METRICS IMPLEMENTATION
Finding Value in Data Acquired through Previously Implemented Clinical Performance Measurements and Assessments, to Avoid Unnecessary and Costly New Initiatives

• Identify appropriate metrics for study performance
• Utilize metrics to accelerate timelines by decreasing bottlenecks
• Analyze metrics continuously for guiding future performance

Speaker
Karen Brooks, MS, CCRA
Associate Director, Therapeutic Operations
SANOFI-AVENTIS

12:00
Lunch

1:15
Understanding How Performance Metrics Can Contribute to Improved Business Processes

• The use of metrics to help prioritize impact efforts when managing timelines and deliverables
• Comparing different metrics to identify which areas of improvement would garner the greatest revenue impact

Speaker
Sean Gharpurey
Principal Project Manager - Product Development Operations
GENENTECH

2:00
BENCHMARKING
How to Obtain and Utilize Benchmarking Data to Predict and Assess Clinical Trial Performance 

• Overview  of benchmarking and activities undertaken to participate in benchmarking surveys
• Where to go for the information to benchmark against    
• How to interpret benchmarking data and determine relevance to your business
• Incorporating bechmarking into clinical trial execution decisions
• Deriving meaningful conclusions from this data to measure productivity

Speaker
Otis Johnson
Manager, Global Clinical Trial Operations (GCTO)
MERCK & CO

Nancy Trewhella
Business Performance Management Head
MERCK & CO

3:00
Networking & Refreshment Break

3:30
CASE STUDY- INDUSTRY PERSPECTIVE
Understanding and Applying New Metrics for Measuring R&D Performance to Optimize Efficiency and Cost - a GSK Approach

• Examination of the current R&D practices
• Discussion of new metrics/ approaches used for optimum clinical performance
• The impact this has on cost optimization

Speaker
Dongzhou (Jeffery) Liu, PhD, MS , MBA
Medical Lead/Principle Clinical Investigator, Medical Affairs/Clinical Research
GLAXOSMITHKLINE

4:15
ROUNDTABLE DISCUSSIONS
Choose from one of the following tables discussing a specific clinical performance metric, and how they can indicate strong performance

1. Site Performance & Patient Recruitment Metrics: Identifying, applying and utilizing metrics to optimize site performance, productivity and quality
2. Protocol Metrics: Learn how to objectively score a protocol. How good is this document? How likely will people enroll in this? How is it written?
3. Quality Metrics: How to successfully define quality metrics, understanding what they are, and if the results of the quality metrics can be effectively used
4. Challenges Utilizing Metrics: Participants will present their own examples and scenarios of challenges faced when developing, implementing and/or utilizing metrics and the group will discuss potential recommendations and solutions.
5. Outsourcing Benefits and Challenges: Understanding the role of outsourcing in improving the sponsor-vendor relationship and best practices used in managing cost & increasing supplier productivity

Moderators
Maggie Ayers, B.Sc.
Director, Clinical Studies
ASTELLAS

Nancy Dynes
Consultant, Portfolio Management Systems
ELI LILLY

Lawrence Florin
Section Director, Clinical Outsourcing
ASTRAZENECA

Gretchen E. Goller, MSW
Patient Recruitment/Compliance Strategist-Operations
SANOFI-AVENTIS

Jan Matsson
Director Clinical Outsourcing
ASTRAZENECA R&D

5:15
Day 1 Concludes

Day Two  Tuesday, September 21st

 
8:00
Continental Breakfast

9:00
CHARIPERSON'S INTRODUCTION OF DAY TWO

David Zuckerman
President
CUSTOMIZED IMPROVEMENT STRATEGIES

9:05
MODERATOR’S SUMMARY OF ROUNDTABLE DISCUSSIONS
Brief overview and key points from roundtable discussions

9:30
CRO METRICS
Identifying Metrics and Tools to Measure CRO and Sponsor Performance and Continuous Improvement in Clinical Outsourcing Collaborations

• Identifying metrics and tools to measure the partnership and collaboration between pharmaceutical companies and CROs
• The Importance of relationship governance
• Case Study: The AstraZeneca/Quintiles Clinical Pharmacology Alliance

Speaker
Jeffrey A. Kueffer, MBA, PMP
Vice President, Operations Management
INC RESEARCH

Jan Matsson
Director Clinical Outsourcing
ASTRAZENECA

10:15
Networking & Refreshment Break

10:45
UPDATE FROM THE MCC
Understanding How Pharmaceutical, Biotechnology and CROs Develop Standardized Metrics to Drive Process Improvement and Boost Partnership Performance in Clinical Trials

• Developing and implementing standardized performance metrics with a goal of improving efficiency and delivery of clinical trial operations
• Building an industry benchmarking database for clinical trial metrics
• Piloting quality assessment tools for site selection and protocol development

Speaker
Linda Sullivan
Vice President of Operations
METRICS CHAMPION CONSORTIUM

11:15
PANEL DISCUSSION
Examining Available Technologies for Performance Metrics Data Collection and Analysis

• How are pharmaceutical companies deciding and prioritizing which types of performance data to obtain and analyze?
• Discussing the issues pharmaceutical companies have to address such as data standardization and how they are making the build or buy performance measurements technology decisions
• Understanding the challenges for implementation and adoption of these new systems and processes

Moderator
Scott Ballenger
President
TRIAL ACCELERATION INSTITUTE

Panelist
Alex Lancksweert
Business Lead, Simplifying Clinical Information Environment (SCIE)
GLAXOSMITHKLINE

Cheryl Fiedler, PharmD
Executive Director, Study Strategy & Planning
BRISTOL-MYERS SQUIBB

Edward Mannello
Director, Study Recruitment
ASTRAZENECA

12:15
Main Conference Concludes

Lunch for Workshop Participants

1:15
POST-CONFERENCE WORKSHOP
Using Metrics & Balanced Scorecards to Optimize Enrollment, Data Quality, and Pharma-CRO Relationships

As the amount of clinical R&D work continues to grow and the pressure to get to market quickly increases, we must answer the question, “How well are we doing and how can we do our work faster and better?” At the heart of that question are the problems of optimizing enrollment and data quality as well as maximizing the benefits of pharma-CRO relationships. During this workshop, we'll discuss how targeted metrics and Balanced Scorecards can be employed to do just that.

In this hands-on workshop you will learn:

• The basics of both performance metrics and the Balanced Scorecard - What types of metrics to include (and to not include)
• How to develop a useful and consistent set of metrics
• How to apply those metrics to the critical problems of CRO relationships, site selection, enrollment and data quality

David Zuckerman
President
CUSTOMIZED IMPROVEMENT STRATEGIES

4:15
Post-Conference Workshop Concludes