8:00 Morning Coffee
8:40 Chairperson’s Remarks
Mindy Davis, Director, Clinical Services, ClearTrial
8:45 Capacity Planning and Resource Allocation for Portfolio of Clinical Trials
Vladimir Shnaydman, Ph.D., President, ORBee Consulting
Efficient strategic capacity planning and resource allocation is becoming a hot topic for biopharmaceutical companies and Clinical Research Organizations (CRO) due to increasing pressure to reduce cost of drug development. It is critical for many clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for portfolio of clinical trials.
9:15 Resource Can be Tracked in Biopharmaceutical Drug Discovery
James Samanen, Ph.D., President, James Samanen Consulting; former Director, Drug Discovery Project & Portfolio Management, GlaxoSmithKline
In contrast to Biopharmaceutical Drug Development, Resource for Discovery Projects is not dedicated to projects typically, but held in the line departments and applied to projects on an as-needed basis. Resource tracking in Biopharmaceutical Drug Discovery is typically established for Line Department accounting, not for Project Tracking. But by ensuring that a few formalisms are embedded in the Resource Tracking system, Biopharmaceutical Drug Discovery project and portfolio managers can collect valuable resource information that shows when line resource was applied to a particular project. This presentation will outline both the benefits and challenges to Biopharmaceutical Drug Discovery Project Resource Tracking.
9:45 Networking Coffee Break
10:30 Co-Presentation: Sterile Product Clinical Production Demands and Capacity Planning
Part 1: Modeling Demand for Clinical Portfolio Needs (Phase 1-3 Programs)
Carol Kirchhoff, Ph.D., Senior Principal Scientist & Group Leader, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Part 2: Assessing, Optimizing and Ensuring Capacity
Gretchen Peck, Principal Scientist, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
11:30 Dynamic Resource Allocation in Mid-size Pharma Discovery
Eberhard Raemisch, Senior Manager, Strategic Planning & Business Support Discovery to PoC, RDP/SB, Nycomed GmbH
This presentation is about a process steering allocation of FTE’S and resources to projects according to clear defined goals in order to maximize the value of the portfolio and to ensure timelines and overall productivity in a mid size pharma enterprise. It will describe selection criterias for new projects. In addition, a discussion about pro’s and con’s of in-house discovery at mid-size pharma/is there a right mix of in-house and external acquisition projects. The entire industry is looking for new business models. A lean and flexible model might be the way out of the current productivity crisis. This presentation offers Insights how mid-size pharma can manage the challenge of a vivid pipeline. Insights about risk management in mid-size pharma will be provided.
12:00 Lunch on Your Own
1:25 Chairperson’s Remarks
Mindy Davis, Director, Clinical Services, ClearTrial
1:30 Productivity Can Drive Strategic Clinical Resource Planning & Capacity Management
Grant A. Morgan, Ph.D., PMP, Leader of R&D Metrics and Clinical Capacity Planning, Director, Global Project Management, Allergan
Productivity metrics of Clinical functions are being used to accurately predict clinical resource requirements across Allergan’s portfolio of Clinical studies. Allergan has developed a clinical capacity resource tool (SPEAR Tool) that calculates projected patient enrollment and clinical resource type specific headcount estimates for individual studies. This talk will update the audience on the expansion of this tool to be a fully integrated global resource management system. Implementation and user acceptance key learning’s will be shared as will examples of utilization of the SPEAR Tool resource data for portfolio management.
2:00 Implementing a High-Level R&D Portfolio Resource Management Tool (PoRT) at Bayer Schering Pharma AG
Felix Steybe, Ph.D., PMP, Resource Manager, Deputy Director, Global R&D Project Management, Bayer Schering Pharma AG
This contribution reports on the successful implementation of a prototype Portfolio Resource Management tool and further development towards a successor at Bayer Schering Pharma AG (BSP). With this system, standard FTEs and costs are estimated on portfolio level based on high-level parametric models and reference values. In addition, the system consolidates detailed functional resource plan data from all main R&D functions. Plan and standard data are combined, linked with management information and aggregated to portfolio views. This enables BSP’s Portfolio Office with the capability to provide flexible ‘what-if’ project and portfolio scenario analysis and supports sound portfolio decision making at management level.
2:30 Working the Matrix: The Role of Project Management in Building Partnerships with Functional Management and Finance to Achieve Effective Resource Management
Mark Christodoulou, Programme Manager, Project Management, Norgine Ltd.
The talk will be in the form of a case history on how we tackled (and continue to tackle) the issues around matrix management that enabled the organisation to understand the resource needs of the business to plan resourses across the portfolio more efficiently and effectively. The talk will cover aspects of resource management, project & portfolio management and matrix management and will highlight how a small pharma company with ambitions to be a bigger pharma company has had to deal with the growing pains of needing to ensure the right resources are allocated to the right projects at the right time to enable us to meet our business objectives.
3:00 CLOSING KEYNOTE PRESENTATION:
Pipeline Risk and Project Prioritization in Clinical Development
Jeffrey Handen, Director, Project & Pipeline Management, Merck & Co., Inc.
Discovery and development of drugs inherently have many uncertainties. A good understanding of these uncertainties and their impact, both real and potential, is essential to optimizing pipeline execution. Strategic resource management accordingly requires a platform to quantify such risk and its implications.
|
3:30 Chairperson’s Closing Remarks
3:45 Close of Conference
Monday, November 1 | Tuesday, November 2 | Wednesday, November 3
Thursday, November 4