Full Day Symposia
Tuesday, April 10, 2007
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
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.
Part II: Benchmarking Metrics: Utilizing Industry Best Practices to Measure and Improve Performance: An MCC Perspective
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:
Part IV: Service Provider Perspective: How the Use of Metrics Can Help Develop Solid Business Relationships with Sponsors
Part V: Panel Discussion
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
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
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.
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.
Chairperson: Rikki Bouchard, President and CEO, RH BOUCHARD & ASSOCIATES, 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
Don't Miss the Grand Opening of the Exhibit Hall