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The Differences Between Discovery and Development Project &
Portfolio Management Come Down to the Level of Risk
Joint Session with Portfoliio Management
8:00 Chairperson’s Remarks
Carlos Nunes, Director, Portfolio Management & Analytics, Pfizer Inc.
8:05 Breakfast Presentation Sponsored by
Tufts CSDD Research: Trends in Assessing Internal and Outsourced Clinical Trial Costs and Resource Demand
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development
Under the current global operating environment, biopharmaceutical companies face far more limited financial resources while time-to-market pressures are intensifying and worldwide clinical research activity is rising steadily. In response, companies are becoming more demanding of their planning and forecasting capabilities and setting lower tolerances for variance between planned and actual performance. Accurately gauging costs and resource demand for a clinical trial – both internal and outsourced – remains one of the most important challenges for biopharmaceutical companies. This session presents findings from the Tufts Center for the Study of Drug Development on this critical topic, examining current industry practices and emerging trends.
8:45 What Senior Management Needs and Expects from Portfolio and Resource Management
Richard Heaslip, Ph.D., President, Programmatic Sciences; Associated Faculty, Organizational Dynamics, University of Pennsylvania; former Vice President, Project Management, Wyeth Research
Senior Management from pharmaceutical and biopharmaceutical companies have differing opinions about the specific roles that Portfolio and Resource Management Professionals should have in the decision making processes of their respective companies. However, most Senior Managers can easily identify what they need and expect from those highly trained professionals. In this talk, we will explore the types of relationships between the Senior, Portfolio, and Resource Management roles, and organizational constructs for optimizing interactions between these three important groups.
9:15 Co-Presentation: The Clinical Research Organization of the Future: Managing High Performance Outsourced Projects
Eric Morfin, Ph.D., VP, Project Management and Founder BioPharmaPM; DCTD Project Management, SAIC
Tim Krupa, Independent Consultant, former Executive Director, Project Management, Quintiles
The Clinical Research Organization of the Future will have to enable the pharmaceutical companies to pursue two seemingly incompatible goals: maintaining or increasing quality products while dramatically reducing costs and development lead times. During this presentation, the attendees will learn all the necessary practices for identifying and selecting the right CRO. Tim will discuss the techniques required for successfully managing CROs and the shared responsibilities required for the sponsor and the service provider.
10:00 What is more Important to Manage Risk and Uncertainties:
Process or Tools?
Ulrike M. Grimm, Ph.D., former Vice President, Program Management, Fresenius Biotech GmbH
Pharma companies tend to rely on the outcome of tools in portfolio management and decision analysis. However, the more complex the supporting software, the harder to check the consistency and plausibility of the data and underlying assumptions. The new tools suggest a high degree of precision, but does this hold true? My experience from a small biotech company shows that you can also achieve good results in managing uncertainties and risk by a more process-driven approach. The audience will understand that a transparent process of managing the data and assumptions that make up the business case is to my understanding more important than a highly sophisticated tool. Portfolio management should spend a rather large proportion of their available time to set the process right and align the organization to it (pay attention to comparability and review / consistency checks of the data by a transparent and communicaton-focused approach). Examples will be given.
10:30 Networking Coffee Break
11:15 “Software, Tools, and People - Oh my!” How to Reach the Land of Portfolio Management Dick Piehl, Project Manager, Integrated Project Management Company, Inc. (IPM)More and more companies are seeing the value of PPM and are using tools to help them determine how to invest their limited resources in the right projects. A wide variety of tools, ranging from simple spreadsheets to complex software packages, exist to evaluate a portfolio from several perspectives Once you have picked the tools the challenge is in how to integrate them to produce optimal results. How do you get everyone in your company to consistently use the tools? The answer is that dreaded word “process”. Portfolio management goes beyond tools. A sustainable, cost-effective development program depends upon well-defined operational processes that draw upon the positive aspects of a wide range of tools. This session will use a real case study to explore practical lessons learned to design and implement a development process that leads to successful portfolio management.11:45 Keys to Success for an Enterprise-wide Portfolio Management CapabilityJames Down, Vice President and Process Executive / Product Lifecycle Management, Becton DickinsonIn 2007 Becton Dickinson implemented a Global Product Development System (GPDS) organized around the PRTM PACETM methodology. The PACE model predicts evolution of a business from informal business processes (Stage 0) through “functional excellence”, “project excellence”, “portfolio excellence” to finally “cross-enterprise excellence”. Each stage accompanies enhanced business performance. Achievement of portfolio excellence requires the full alignment of project and portfolio management across the enterprise and implementation of a global portfolio management system. In this presentation we will describe the implementation of the Becton Dickinson GPDS how it transformed the product development processes including the successful implementation of a global portfolio management process that spans all business units within Becton Dickinson.
12:15 Sponsored Luncheon PresentationSponsored by
What Your Executive Really Wants in a Portfolio Review
Daniel Smith, Vice President Consulting, Enrich Consulting
1:55 Chairperson’s Remarks
Richard Heaslip, Ph.D., Associated Faculty, Organizational Dynamics, University of Pennsylvania; former Vice President, Project Management, Wyeth Research
2:00 Innovation in Delivering Positive Clinical Proof of Concept
Richard K. Harrison, Scientific Director, Thomson Reuters
Phase II is the weakest link in the R&D continuum. R&D productivity is at an unsustainably low level for the industry. However, there are strategies that can successfully navigate these challenges to deliver a positive clinical proof of concept and deliver new drugs in areas of high unmet medical need. This presentation will focus on how improving Phase II (PoC) survival will have the single biggest impact on R&D productivity. The audience will gain practical insights on how to assess risk in pre-proof of concept portfolios.
2:30 Managing Uncertainty: Developing Organizational Peripheral Vision
Roch Parayre, Ph.D., Senior Partner, Decision Strategies International Inc.; Fellow, Aresty Institute of Executive Education, Wharton School, University of Pennsylvania
Managers are barraged by a growing stream of weak signals from the periphery. How do they know to which items they should respond and which they should ignore? The key is to spot and interpret the important weak signals – particularly around customer demands and technology – and act on opportunities ahead of the competition, or recognize the early signs of trouble before they escalate into major problems. This session introduces the concept of organizational peripheral vision in order to identify opportunities and threats faster.
3:00 R&D Pipeline Modeling: Does it Help Inform Expectations around Product Flow?
Suzanne Brown, Executive Director, Pipeline & Project Management, Merck & Co.
Product probability of success in Pharma has not improved noticeably over the last several years yet we continue to increase R&D spending. By using pipeline modeling, can we better understand the impact of POS on product flow and subsequent investment? This presentation will highlight an approach that has been piloted at Merck Research Laboratories.
3:30 Networking Refreshment Break
4:15 Interactive Breakout Discussions
Break-Out Discussion Groups and Afternoon Wrap Up:
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest to them and become an active part of the discussion at hand. To get the most out of this interactive session and 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.
TABLE 1: Project & Portfolio Management: Will it Survive the Vertical Disintegration of the Biopharmaceutical Industry?James Samanen, Ph.D., President, James Samanen Consulting; former Director, Drug Discovery Project & Portfolio Management, GlaxoSmithKline
• What are the biggest concerns about the future of project and portfolio management as Pharma continue to downsize and externalize?
• If every area of expertise needs to argue for its position among the core competencies, will project and portfolio management will be among the last competencies to be retained in the future?
TABLE 2: How to Incorporate Resource Planning Into Portfolio Decision MakingGrant A. Morgan, Ph.D., PMP, Leader of R&D Metrics and Clinical Capacity Planning, Director, Global Project Management, Allergan
• Are internal resource projections incorporated into Portfolio decision making?
• Does upper management consider both FTE resources and available dollars when evaluating the optimal portfolio blend?
• Does upper management use a bottom up or top down methodology for incorporating resource estimates in portfolio planning, what are the benefits of both options?
TABLE 3: In Light of the Evolving Business Trend: Rethinking Pipeline Shape & ManagementArun Kejariwal, Manager Portfolio & Decision Support, Research Planning & Integration, Merck & Co., Inc.
• How companies are changing the org structure to give much higher focus on "Execution". This could also including if the companies are rethinking the skills needed for right execution.
• Changing strategies in terms of ensuring some % of budget is dedicated to external collaboration. Morgan Stanley report to shift from "research" to "search" model
• How should one think of the pipeline shape? Has the traditional approach of FIFO failed us? Should there be "buffer of projects" at each stage -- pick the best to move forward rather than FIFO?
TABLE 4: Pitfalls in Project Portfolio Planning Dorene Lynch, Business Development Executive, Integrated Project Management Co., Inc.
• How do you create consistent “high resolution” project plans that accurately spell out, in vivid detail, the resources required to complete each task and activity?
• How do you capture the actual hours spent by all project players in completing project tasks and activities? Do you analyze planned and actual time spent by each person in your organization on every project to which he or she is assigned in order to demonstrate who’s overloaded?
• How do you handle incidents of resources that are “stolen” across projects, excessive overtime, large-effort-but-ultimately-useless projects, and so on?
TABLE 5: Managing and Communicating Uncertainty in your Projects and PortfoliosRichard Sonnenblick, President, Enrich Consulting
• Is Monte Carlo simulation always necessary or can multiplication of attrition probabilities sometimes suffice?
• How do you effectively communicate project and portfolio uncertainty to executives?
• Should you communicate uncertainty in resource planning forecasts, and how do you avoid going too far?
TABLE 6: How Do You Build a New Culture When you Merge Two Companies? Suzanne Brown, Executive Director, Pipeline & Project Management, Merck & Co.
• Many companies are merging today and have increasing pressure to become productive immediately - where do you focus first to gain that productivity?
• Each company brings different processes, product and cultures - which is the most difficult to integrate?
• What are good practices to create a new culture?
TABLE 7: Flexible Resourcing Models for Clinical DevelopmentFelix Steybe, Ph.D., PMP, Resource Manager, Deputy Director, Global R&D Project Management, Bayer Schering Pharma AG
• Different principles for Rolling Forecasts vs Mid-Term Planning (external and internal costs)
• How are algorithms and cost models developed (ramp up payments, recruitment based models, CRO fees)?
• How can you report and analyze resources and do they really guide decision making?
TABLE 8: How to Manage and Fill Pipeline GapsUlrike M. Grimm, Ph.D., former Vice President, Program Management, Fresenius Biotech GmbH
• Do you have a pipeline model that sets the criteria for the specifics of projects to be looked for and do you work according to the pipeline model?
• Who decides about new projects: business development & licensing (BD&L) or research department? Or both? An independent committee?
• How are the two departments BD&L and research integrated with portfolio management? How are these interfaces managed? What could be improved?
5:40 Close of Portfolio Management Executive Forum (Strategic Resource Management continues on through Wednesday, November 4th)
Monday, November 1 | Tuesday, November 2 | Wednesday, November 3Thursday, November 4
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