| 8:00am Morning Coffee
8:30 Chairperson’s Opening Remarks & Review of Day One
8:45 Cutting Product Development Time
Time is money - BIG money - when it comes to pharmaceutical development. Getting to market quicker can translate literally into millions of dollars per day in additional revenue, and quality problems that stall approved products can hit the bottom line hard. While PhRMA reported that the industry invested nearly $40 billion in R&D last year - almost five times that of 1990 - high clinical development costs, coupled with declining discovery success rates, have caused productivity levels to fall. The looming patent expiry of several major blockbuster drugs and the related rise of cheaper generic alternatives aggravate the situation. In such an environment, project managers must be nimble and adept at change. Project schedules, risk assessments and mitigation plans must be robust and provide a catalyst for heroic results. This session will guide the participants through practical insights into how to achieve and even accelerate complex pharmaceutical R&D schedules by:
• Relating current drug development PM practices to general industry performance
• Creating an aggressive baseline development schedule
• Creatively compressing the baseline
• Analyzing and proactively managing risks and opportunities
• Reviewing case studies illustrating good schedule management techniques
Chad Nikel, MBA, PMP, Manager, Project Planning and Execution, Integrated Project Management Company, Inc.
9:30
Managing Successful Collaborations
Product development collaborations between large Pharma/ Biotech companies and smaller start up companies are common. For these to be successful, effective project management is needed to:
• Manage expectations between the two companies
• Create team chemistry between the two organizations
• Defining best practices
This talk will outline some processes that can be implemented to help in creating a successful collaboration.
John Connelly, Associate Director, Program Management, Genzyme Corporation
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10:15 Networking Refreshment Break
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CASE
STUDY |
10:45 Implementation of a Global Cross-Functional Project and Resource Planning Tool
Between mid 2003 and mid 2005, Merck designed and rolled-out a global project- and resource planning and tracking tool to improve data collection and reporting. Key observations and experiences of this period will be shared including the challenges of putting this system to optimal use, improving the quality of the data, and fully exploiting the potential of such a tool. In addition, the talk will address some ‘soft issues’ like planning uncertainty and how to deal with it, and the quantum leap in transparency caused by such a system and how that is linked to corporate culture issues.
Martin Heinrich, PhD, Senior Director, Head of Global Clinical Development Support, Merck KGaA
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CASE
STUDY |
11:30 Managing Project Resources in Research vs. Development: Variations on a Theme or Distinct Disciplines?
The increased focus on resource management over the last number of years in the pharmaceutical industry has led many companies to implement “one-size-fits-all” resource management processes and tools that extend from idea to approval. As these implementations progress there often is a realization that there is a need to tailor project resource management for discovery, early research and development. In this talk, we will:
• Describe why different approaches to resource management may be warranted
depending on where you are in the drug development process
• Clarify “fit for purpose” project resource management processes and tools that
address different needs of the business.
• Describe project management resource related roles and responsibilities in the
development continuum
Patrick Grogan, Senior Director, Analysis, Performance and Metrics, WWW Project Management, Pfizer, Inc.
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12:15pm Networking Luncheon (Sponsorship Available)
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CASE
STUDY |
1:45 Resource Modeling for Large Molecule Process Development
Large molecule process development is a multi year, cross discipline endeavor. In order to advance a full product pipeline, the resource capacities of process development must be aligned with both that of pre-clinical and clinical development as well as with that of clinical manufacturing and quality. Lack of fungibility both within scientific disciplines as well as between them makes this type of modeling challenging. One successful approach will be presented that addresses this challenge.
• Understanding one possible approach to planning process development resources
• Making links between budgets, resource models and long range plans
• Ways to communicate scientific functionality to your finance representative
Maureen Halligan, Associate Director, Process Development, Amgen
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CASE
STUDY |
2:30 Critical Chain Project Management: Concept and Application in the Pharmaceutical Industry
Critical Chain Project Management could form the platform through which project management can transform itself into the driving force for successful delivery of an organization's critical milestones. Applied properly, Critical Chain Project Management enables the management and project team to identify and execute the optimum path for successful planning and implementation of the projects in the pipeline. It also significantly increases project management's impact on the performance of the organization and the measurement and communication of this value addition. In this presentation we will cover the concept, application, necessary conditions for success, and management's buy-in and active role in the implementation of Critical Chain.
Bijan Bayat, Associate Director, Global Project Management, Pfizer, Inc.
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4:00 pm Close of Conference
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