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Agenda At A Glance
Monday, September 20, 2010 | Workshops
| 8:15 | Registration and Morning Coffee | 12:00 | Luncheon |
| 9:00 | Sessions Begin | 1:15 | Sessions Continue |
| 10:30 | 30-Minute Morning Networking Break | 3:00 | 30-Minute Afternoon Networking Break |
| 5:00 | Session Concludes | ||
A | RFI University: Building a Clinical Core Lab RFI Request for Information |
The RFI University curriculum is filled with hands on information for developing an industry standard Request for Information (RFI) for clinical outsourcing and data managers. The lessons of the one day university are designed to make outsourcing to core labs a more standardized process. Discuss tips, tools and lessons learned to make your job easier during planning, execution and analysis of Core Lab Outsourcing.
Curriculum lessons:
Planning: Determine the Information you Need
- Building the RFI to find labs that have specific testing capabilities
- Prequalification and qualification criteria of central
labs, ECG, and Imaging labs to find labs that have specific testing capabilities - Evaluate the financial risk of central labs, ECG, and
Imaging Labs to mitigate decisions through financial and resource assessments - Therapeutic area specific studies – determine the standard tests that should be ordered and why
- Define the key elements of the request for information and contracting language
Execution: Checklists, Criteria and Timelines
- Vendor selection criteria checklist - questions to ask potential lab, ECG, or imaging partner
- Build an assessment grid to help study team make the selection decision
- Vendor assessment criteria
- Global lab industry scope of services grid to identify what facilities are available in emerging markets
Analysis: Advanced Strategies
- How to outsource to phase one units for early phase cardiac studies
- Define the financial repercussions of outsourcing decisions and how it can affect others including your data management teams
- How to incorporate data management early in outsourcing process for cost savings
University Professors:
Kristian Hubbard, Manager, Outsourcing, Discovery Medicine & Clinical Pharmacology, BRISTOL-MYERS SQUIBB
Steven Porzio, Clinical Data Specialist, Data Operations, BRISTOL-MYERS SQUIBB
B | Logistics Task Force: Best Practices in Transportation Logistics |
The Logistics Task Force is dedicated to open and inclusive discussion of logistics issues which affect clinical research and define best practices to address those issues. Each issue will be followed by a discussion on best practices which will include opportunities for the audience to contribute. The Logistics Task Force is an open forum. Our discussions can be found on the Clinical Trial Logistics forum on LinkedIn. Your contributions would be welcome. During this session, panelists discuss the following issues:
Courier Discount Policy & Global Rate Cards
- Volume-based vs Revenue-based discounts
- Application of discount milestones for both central lab and study sponsors
- Is it possible to establish reliable global rate cards?
Building a Sponsor-Lab-Logistics Specialist Partnership
- Opening communications and sharing information to improve performance
- Understanding the roles and responsibilities of each partner
- Working together to support objectives and growth
- Building for the future
Pass-through Fees and Invoicing Transparency
- Are administrative fees for pass-through reconciliation necessary?
- Would a logistics SOW improve invoicing transparency?
- Are couriers able to provide a clear reconciliation of the events to both labs and sponsors? (Payer & Non-payer account assignment to a specific project)
Evaluating Central Lab Financials
- How is the Central Lab project proposal evaluated?
- What is the advantage of a clear logistics scope of work document? Would this support a better evaluation of the pass-through charges?
- How can the couriers support this process?
- How does outsourcing balance regional and global priorities? Is cost really the deciding factor?
Doing More with Less
- Reducing biological specimen volumes
- Can we improve sample stability and reduce the use of dry ice or cold packs? What can be done with dried blood spots? Is point-of-care “Lab-on-a-Chip” technology the future of diagnostic testing?
- Can reusable low-eutectic freezer packs replace dry ice? What safeguards are required?
- Is it possible to reduce or eliminate paper for clinical lab results? Would a lab EDC solution create new value?
In addition, a 45 minute breakout session on of the following topics:
Case study: “Reducing the Use of Specialty Couriers in Clinical Trials”
Paula Russella, Procurement Manager, GSK
B: Specialty Courier Cost Drivers: Understanding the cost issues and quality issues
C: Logistics Scope of Work Document: Developing a logistics support tool which can produce value for today and tomorrow
Moderator:
Peter Colbourne, Managing Director, CONCENTRX CONSULTING
Panelists:
Karen Turner, Contract Manager, Global Outsourcing & Supplier Governance, GSK
Richard Polgar, Associate Director, Global Procurement, BMS
Julie DeBus-Levy, Manager, Outsourcing and Contracts, ABBOTT LABORATORIES
Scott Sawicki, MA US Head, Clinical Contracting & Category Management, NOVARTIS
John Monetti, VP Business Development, WORLDCOURIER
Kevin Smith, MBA, Director of Clinical Operations, EUROFINS-MEDINET
Bruce Guenter, Sr. Director, Global Materials Logistics, PFIZER
Elena Logan, VP Business Development, ACM GLOBAL LABS
John Byerley, VP Business Development, CLINICAL REFERENCE LABORATORY-GLOBAL SERVICES
Ralph Venturini, VP Business Development, MARKEN
Tuesday, September 21, 2010 | Morning Plenary
| 8:00 | Registration and Morning Coffee |
| 8:45 | Chairperson’s Welcome Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 9:00 | Prediction, Prevention and Detection – How the Patient will be the Game Changer in Personalized Medicine, Diagnostics and Clinical Drug Development Thomas Goetz, MPH, Executive Editor, WIRED MAGAZINE Author, The Decision Tree |
| 9:45 | Future of Central Labs – Autumn Update Kenneth I Kaitin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, TUFTS UNIVERSITY |
| 10:30 | 45-Minute Morning Networking Break in the Exhibit Hall |
| 11:15 | Technology in Action Jim Sowash, Manager, OverRead Department, ERT |
| 11:30 | Keynote Presentation Stephan Schuster, Professor of Biochemistry and Molecular Biology, PENN STATE UNIVERSITY CENTER FOR COMPARATIVE GENOMICS AND BIOINFORMATICS |
| 12:00 | Case Study Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 12:30 | Networking Luncheon |
Tuesday, September 21, 2010 | Afternoon Tracks
| A Best Practices in Outsourcing to Central Labs, ECG, and Imaging Labs | B Strategies to Achieve Quality Data and Seamless Integration | |
| 1:30 | Track Chair: Sarah Martin-Munley, PhD, Biotech and Pharmaceutical Consultant and former Chair of the MCC CENTRAL LABS STEERING COMMITTEE | Track Chair: Jennifer Duff, Associate Director, Clinical Data Management, ACCENTURE AT PFIZER |
| 1:35 | Cost, Quality and Time Management Strategies When Outsourcing to Central Labs, ECG and Imaging Labs Panelists: | Adopt Process Efficiencies to Reduce Internal Overhead and Improve Biomarker Data Management Daru Sharp, BA, MS, DMCP Team Lead, External Data Operations, BRISTOL-MYERS SQUIBB |
| 2:15 | Case Study Beverly Armstrong, Outsourcing Manager, BRISTOL-MYERS SQUIBB | Real-Time Data Transfer Between Sponsors and Vendors to Improve First-Time Data Quality Jennifer Duff, Associate Director, Clinical Data Management, ACCENTURE AT PFIZER |
| 2:45 | Reduce Costs and Maintain Quality at Investigator Sites through Process Improvement | Standardization of Lab and Imaging Data Transfers Specifications Greg Burgess, External Data Acquisition Operations, SCHERING PLOUGH |
| 3:15 | 30-minute Afternoon Networking Break | |
| 3:45 | Optimal Lab Selection for Oncology Studies to Improve Patient Care and Data Quality Panelists: | Technical Data Management: Local Lab Data Harmonization, Collection of Repeat PK Data and Strategies for Faster Data Loading Collection of Repeat PK Data Strategies for Faster Data Loading and Faster Database Lock Panelists: |
| 4:30 | TEAM APPROACH! How to Ensure that Lab Partnering Doesn’t Stop at the Outsourcing Transaction Dr. Marietta Henry, Vice President, Medical Affairs and Global Laboratory Medical Director, COVANCE CENTRAL LABORATORY | Local Lab Data Solutions Jim Wagner, Vice President of Technical Services, ICON CENTRAL LABORATORIES |
| 5:00 -6:15 | Networking Reception in the Exhibit Hall | |
Wednesday, September 22, 2010 | Morning Plenary
| 8:00 | Morning Coffee |
| 8:30 | Chairperson’s Recap of Day One Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 8:45 | New Pharma Business Models: Effect on Budgets, Timelines and Relationships Analys Distinguished Panelists: |
| 9:30 | Virtual Site Tour-Central Lab Kevin Smith, MBA, Director Clinical Operations, EUROFINS MEDINET |
| 9:45 | Panel Discussion Norman Mustafa, Global Outsourcing & Supplier Governance, Center for Clinical Study Excellence, GSK |
| 10:30 | 30 Minute Networking Break in Exhibit Hall |
| 11:00 | Virtual Site Tour- ECG Acquisition and Site training Jim Sowash, Manager, OverRead Department, ERT |
| 11:15 | Performance Metrics Adoption and Integration Lessons from MCC Members to Improve Trial Operations Guy Mascaro, President, METRICS CHAMPION CONSORTIUM (MCC) |
| 12:00 | Technology in Action Lawrence Satin, MD, FACC, Chief Medical Officer, CARDIOCORE |
| 12:15 | Networking Luncheon |
Wednesday, September 22, 2010 | Afternoon Tracks
| A Strategies to Improve Partnerships with Central Labs | B Best Practices in Partnering with ECG and Imaging Labs | |
| 1:35 | Track Chair: Donna Saligan, MBA, MT (ASCP), Contracts & Outsourcing Manager, RH BOUCHARD AND ASSOCIATES Track Reporter: Scott Harris, Global Category Manager, Clinical Purchasing, SANOFI AVENTIS | Track Chair: Lawrence Satin, MD, FACC, Chief Medical Officer, CARDIOCORE |
| 1:35 | Is the Decentralized Central Lab the New Model? Rajani Prasad, Vice President, CLINICAL REFERENCE LABORATORY GLOBAL SERVICES | Standardization and Process Efficiencies for Studies that Incorporate Clinical Endpoint Committees (CECs) or Data Safety Monitoring Boards (DSMBs) Rafael Escandon, Vice President, Clinical Outcomes, ICON MEDICAL IMAGING |
| 2:15 | Identify Process Bottlenecks and Solutions to Save Everyone Moderator: Rajani Prasad, Vice President, CLINICAL REFERENCE LABORATORY GLOBAL SERVICES Panelists: | Standardization of Imaging Lab Processes in Oncology Studies Neeta Fahey, Associate Director, Clinical Imaging and Technologies, PFIZER |
| 3:00 | Spotlight on Quality: Improve Vendor Quality Standardization for Global Regulatory Compliance Moderator: Members: | Strategies to Efficiently Integrate Accurate ECG and Lab Data Jay W. Mason, MD, Chief Medical Officer, SPAULDING CLINICAL RESEARCH |
| 3:45 | Conference Concludes | |
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