Tuesday, April 10, 2007
Full Day Pre-Conference Symposia

8:00 Symposia Registration and Morning Coffee

9:00 Symposia Begins

10:30 30-Minute Break

12:30 – 1:30 Luncheon for Full-Day Symposia Participants

1:30 Symposia Resumes

3:00 15-Minute Break

4:30 Symposia Concludes

Followed by

The enormous pressure on the biotechnology and pharmaceutical industries today to increase new drug development while keeping prices in check has fueled a pervasive quest for cost reduction. Senior-level management is taking more interest than ever in project performance and results, and pharmaceutical companies are increasingly introducing metrics to evaluate time, cost and quality. Biotechnology and pharmaceutical companies who outsource to CROs and other service providers are continually seeking ways to improve operational efficiencies as well as benchmark provider performance – a top priority for clinical R&D outsourcing professionals. This full day symposium focuses on driving process improvement and operational excellence for sponsors and providers.

Part I: Overview and Update on Metrics Champion Consortium (MCC): A Collaborative Effort to Jointly Improve Performance

The mission of the Metrics Champion Consortium (MCC) is to develop and support service provider performance metrics within the biotechnology and pharmaceutical industry with the intent to jointly encourage performance improvement, effectiveness, efficiency, and appropriate levels of control. This session provides participants with an understanding of the initiatives undertaken by the MCC in meeting its mission as well as insight into the current status of the development of performance metrics for CRO, Central Laboratory, ECG and Imaging providers. Finally, participants will have an opportunity to engage the presenters in open discussion on how to become involved in the metrics development process.

Participants review:

• Collaborative industry effort to improve partner relationships and project performance
  
• Standardization, adoption, implementation and subsequent improvement of metrics
  
• Value of participating in a MCC metrics initiative work group: shared learning from the CRO, Central Labs and ECG working groups

Part II: Benchmarking Metrics: Utilizing Industry Best Practices to Measure and Improve Performance: An MCC Perspective

• How to use benchmarking data to identify gaps and evaluate performance relative to the industry
  
• Why it is important to look both internally and externally
  
• Benchmarking of the internal progress in the light of best industry practices
  
• What outsourcing strategies other companies are adopting to improve time, cost and quality

Part III: Sponsor Perspective: Measuring and Comparing Performance of Service Providers

The measurement of both internal and external process is increasingly important due to pressures inherent in today's drug development. Clinical R&D Outsourcing Managers are responsible for ensuring provider services are suitable for the sponsor's business needs. They place great emphasis on quality and costs, master service agreements, negotiations, relationship management, monitoring ongoing performance, audits, issue resolution, and possible deselection if the provider were to fall below standards. With so many trials being outsourced, it is essential for sponsors to track resources including people, time and money as they all impact productivity and efficiency metrics over time. Using effective key performance metrics to reduce clinical development times and improve deliverables is essential. This segment covers:

• Performance metrics for vendor selection
  
• Measuring outsourced studies and performance
  
• Metrics for a regional monitoring program
  
• How are combined Sponsor/CRO metrics developed to assess team performance?
  
• How do you compare a CRO to your own internal regional monitoring?
  
• Ensuring providers and sponsors are using the same metrics
  
• How do you measure CROs performance? Site performance?
  
• Considering the partner relationship to be a business set of performance metrics
  
• Best practices for metrics in outsourcing

Part IV: Service Provider Perspective: How the Use of Metrics Can Help Develop Solid Business Relationships with Sponsors

• How can the provider demonstrate the value of services and success in achieving agreed upon performance targets rendered through the use of metrics?
  
• Corporate culture: relationship-driven vs. data-driven
• Using operational metrics that match those of the sponsor
  
• Understanding differences in structure between provider and sponsor
  
• Setting a standardized approach for study reports
  
• Defining agreed upon targets for studies
  
• Creating a mutually beneficial scenario

Part V: Panel Discussion

• Panel Discussion with Symposium Presenters

Workshop Leaders:
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM (MCC)

Brian P. Schrock, MS, Manager, Diagnostic and Experimental Medicine, ELI LILLY & COMPANY

Dave Zuckerman, President, CUSTOMIZED IMPROVEMENT STRATEGIES

Holly Hankins, Manager, Medical Sourcing, ELI LILLY & CO

Badhri Srinivasan, Senior Director, Process Optimization Group, QUINTILES GLOBAL CLINICAL DEVELOPMENT SERVICES

Who Should Attend

• Clinical R&D
  
• R&D Outsourcing
  
• Clinical Operations
  
• Performance Measurement/Management
  
• Project Management
  
• Metrics and Benchmarkin

UPDATED AND EXPANDED FOR 2007!

This workshop addresses the basics of outsourcing from how to select vendors to send an RFP, to what the RFP should contain to how to conduct a face-to-face meeting. The workshop presenters also discuss how to select a vendor, build the relationship, manage effective project planning with the vendor, and oversight of the CRO. Also discussed are the unique challenges of small pharma and biotech in getting the right level of attention from the CRO.

Part I: How to Decide Who to Outsource To: Finding the Right Mix for Your Company's Needs

• Provider selection and the RFP process
  
• What is entailed in the process of the transfer of obligations?
  
• Choosing your model (full or functional) depending on budget and size of program
  
• How to best set up the team structure, monitoring functionality, data, etc.
  
• Working with investigative sites and SMOs—when it is good to use SMOs and when it is not

Part II: Relationship Management

When Big Pharma runs into problems with suppliers who are not delivering, they can pull business back in house. Small pharmas and biotechs don't have the same luxury. This session offers strategic and tactical advice for approaching problems prospectively, cultivating better relationships with vendors, and setting expectations and performance specifications clearly ahead of time.

• Project and control mechanisms with high staff turnover
  
• How to best set up team structure, monitoring functionality, data, etc
  
• Process of transfer of obligations
  
• How do you avoid micro-managing the CRO?
  
• How should the CRO manage the small biotech to maximize the relationship and build trust?

Part III: small Fish in a Big Pond: Strategies for Small Pharma and Biotech to Get the Right Level of Attention from Large CROs

Biotech companies usually do not have their own outsourcing or procurement groups and clinical staffs are burdened with trying to be experts in everything from protocol writing, budgeting, and selecting a CRO. They don't have the expertise in house and often make tragic mistakes, sometimes getting burned in the process, making it difficult to move forward. While the traditional CRO model does not lend itself to meeting smaller company challenges, the increasing Big Pharma trend toward functional outsourcing and unbundling services is forcing the tide of change. The industry has seen a re-emergence of special branches at large CROs focusing on biotech and catering to their different needs, personalities, and functions on full service outsourcing basis. Biotech is an extremely important piece of the market and grouping segment, far outpacing big pharma.

• How can biotechs "sell" themselves to the CRO partner to make their importance as a client known?
  
• Defining the scope of the work, expectations and responsibilities
  
• How to work more effectively in an outsource model
  
• How to outsource and at what level
  
• Dealing with high turnover on both sides/consistency of teams

Chairperson: Rikki Bouchard, President and CEO, RH BOUCHARD & ASSOCIATES, INC.

Workshop Leaders:
Kathleen Findlen, Executive Director, Clinical Operations, SYNDAX PHARMACEUTICALS, INC.

Nicholas Kenny, PhD., Senior Director, Oncology, INC RESEARCH

Lynn McGovern, Director of Clinical Planning and Outsourcing, SYNTA PHARMACEUTICALS

Karen Zuklie, Director of Planning and Outsource Management, PURDUE PHARMA LP

Who Should Attend

• Clinical R & D
  
• Product Development
  
• Clinical Operations
  
• New Product Planning
• CROs specializing in smaller company need

Don't Miss the Grand Opening of the Exhibit Hall
and
The CRO Partnerships Game with Bob Eubanks!