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Tuesday, February 8, 2011
11:00 am - 12:00 pm Conference Registration
Sponsored by
12:00 Luncheon Presentation
Enhance Site Recruitment and Financial Management with a Sound Grant Payment Process
Kevin T. Williams, M.B.A., M.S., Vice President, Client Services, Clinical Financial Services Understand the impact the clinical trial agreement and associated grant payment schedule can have on your ability to recruit sites as well as manage your trial budgets. A sound process to managing your investigator grant payments affects more than you may think. This discussion will show you how to not only gain a competitive advantage for recruiting sites but also lessen the pain of managing your accruals and financial reporting.
Sponsored by
1:25 Chairperson’s RemarksAndy Grygiel, Vice President, Marketing & Product Management, ClearTrial
1:30 Case Study-Based Session for Improving Financial Outcomes in a Biotech Company
Elizabeth Shewell, Director, Outsourcing, Incyte
This session will discuss how to improve clinical trial forecasting and manage resource predictions for biotech and small pharma companies. Lessons learned from the interplay of all variables will be provided in order to demonstrate what has worked for us in forecasting internal and external study spending.
1:55 Mapping the Global Utilization of Clinical Research Capacity in Oncology Trials
Fabio Thiers, M.D., M.Sc., Ph.D., CEO, VIS Research Institute; Co-Director, Global Clinical Trials Research Program, MIT/NBER
Oncology trial planners prospectively access patient recruitment potential of centers, which partly depends on the characteristics of locations in which these centers are situated. In this session, we will provide multidimensional comparisons across locations internationally, while discussing how some have become so attractive for clinical research. We will address to what extent these locations with high utilization might have become saturated and interactively identify other ones in which there are substantial, and relatively untapped, opportunities for high quality enrollment.
2:20 Co-Presentation: Forecasting Pharmacovigilance and Epidemiology Resources (People and Costs) as a Component of the Overall Clinical Portfolio Plan
Bobbi McDonough, Director, Resource Management & Communications, Bristol-Myers Squibb
Janet Mulheron, Director, Project Planning & Management, Bristol-Myers Squibb
How do you move beyond clinical trial resource planning to a more comprehensive product approach for areas such as global pharmacovigilance and epidemiology? This session will discuss using resource forecasting to build your budget when your portfolio spans Discovery through Post Launch and on through Mature Brand. It will also address how this ties into the Project Plan for R&D work.
2:45 Afternoon Refreshment Break in Exhibit Hall
Sponsored by
3:15 Standardization and Validation of Training through Online TechnologyDave Young, CEO, Trifecta Multimedical Delivery of consistent training to investigators, site personnel and CRO staff is critical for successful study start-up and execution. This presentation will address various online methodologies that can used by sponsors/CROs to effectively deliver consistent training from study start-up through completion. It will also address online tools that sponsors/CROs can offer to sites to enhance trial execution and improve site enrollment and retention of clinically appropriate subjects.
3:40 Optimizing Protocols from the Ground Up
Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc.
This interactive session will explore the importance and value of gaining patient and site perspectives when designing protocols. By addressing root causes of common execution failures and re-thinking the process of feasibility assessments to secure feedback from the end users, sponsors can significantly increase their likelihood of success.
4:05 INTERACTIVE PANEL
Re-Engaging Industry-AMC Relationships for Improved Study Execution
 Geri Pumper, RN, Program Manager, Mayo Clinic
 Richard Robinson, Assistant Director, Internal Medicine, Metabolism, and Diabetes Group, US-CRU, Clinical Development, sanofi-aventis
Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc.
Leveraging AMC expertise for intelligent protocol design
Achieving streamlined study start-up at AMCs through a collaborative spirit and improved dialogue
Proactive recruitment planning –understanding what both parties need for success
Sponsor and site “wish lists” for achieving efficient study execution
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4:30 Informal Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
TOPIC 20: Cost and Operational Advantages of Deliverable-Based Budgets and Contracts
Moderator: Leif Kuse, Managing Director, Cilique UG
• What are the advantages and disadvantages of common cost models?
• What are the practicalities of deliverable-based contracts?
• What is fair risk sharing in deliverable-based contracts?
• How do you achieve integration of earned value and deliverable costing?
TOPIC 21: Vendor Management at the Project Level: Strategies for Establishing and Maintaining Relationships Internally and Externally for Successful Clinical Trial Execution
Moderator: Rhonda Benotti, Business Manager, Contracts and Outsourcing, Genentech
• The importance of establishing good relationships and trust with service providers beginning at RFP/selection phase
• Critical skills and expertise required for managing internal and external partners for effective clinical trial execution
• Partnering and aligning with clinical operations and other internal team members to manage vendors most effectively at the project level and prevent issues from being escalated.
TOPIC 22: The Fully Outsourced Model in Early Development
Moderator: Susan Lubin, Outsourcing Manager, Phase I, Bristol-Myers Squibb
• Description of the model
• Pros and cons of working with alliance partners vs multiple vendors
• Sharing of successes within this model
TOPIC 23: Pharma and Coverage Analysis with Sites
Moderator: Kelly Willenberg, President, Sole Member, Synergism, LLC
• Coverage Analysis Basics
• CTP and Device Rules
• Challenges with Sites
TOPIC 24: Standardized Training Modules that are used Across Therapeutic AreasModerator: Eric Zudak, Director, Business Development, Trifecta MultiMedical
• Why use standard modules
• Strategies to track compliance
• Pros and Cons of developing a standardized library
TOPIC 25: Effective Resource Forecasting
Moderator: Kristin Mauri, Director, Clinical Services, ClearTrial• What techniques are study sponsors utilizing to forecast resource demand?
• Which methods provide the most accurate forecasts?
• Which methods allow for the greatest flexibility to shift resources as the situation changes?
TOPIC 26: Systematic Approach to Investigator Contracting
Moderators: Kevin T. Williams, M.B.A., M.S., Vice President, Client Services, Clinical Financial Services
James M. Di Cesare, Vice President, Contracts & Consulting, Clinical Financial Services • Strategies for streamlining the process
• How to manage business risk
• Leverage information to reduce cycle times
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5:30 - 6:30 Networking Cocktail Reception