3:30 Break-out Discussion Groups:
Attendees will join a table with their peers and a moderator to discuss some of the more poignant questions facing the industry. 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 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: Modeling the Portfolio of the Future: Will Today’s Cycle Time, Attrition, and Cost Models Remain Valid?
James F. Resch, Ph.D., Director, Strategic Intelligence, Discovery Strategy and Performance, AstraZeneca Pharmaceuticals, Inc.
How will changing expectations of regulators affect future industry investments? What new evidence will be required to support pricing and reimbursement decisions? Which therapy areas are poised for the biggest changes in clinical trials of the future?
TABLE 2: Building Partnerships between Project Management, Resource Management, Functional Management, and Finance
Eric Morfin, PMP, Ph.D., Executive Director, Project Management, Amylin Pharmaceuticals, Inc.
What are the pitfalls to avoid when trying to develop partnerships internally, between Project Management and other departments? What is an “engagement model” that Project Management can use to establish trust, uncover real resource needs, and maintain a strong relationship with each department?
TABLE 3: Visualization of Management Information
Anders Persson, Ph.D., Director, Capacity Management, AstraZeneca
How to efficiently visualise volatile early development project data to support portfolio governance? Is it possible to create a more agile R&D organization through smarter but still user-friendly visualization of project and portfolio data? How to visualize risk?
TABLE 4: Modeling Base Business to Enhance Your Drug Development Trade-off Options
Melquiades de Jesus, Associate Director, Research & Development Operations, Resource Management, Capability Stewards, Bristol-Myers Squibb Co.
How do you assure the "climb is worth the view", when setting a process to forecast base business work? What is the importance of creating a "feedback loop" between the forecast and time actual system (timecard)?
TABLE 5: End-to End R&D Resource Capacity Planning
Shannon Diehl, MBA, PMP, Associate Director, Resource Planning, Johnson & Johnson
What scope and levels of detail are considered value-added? How do you approach early Research modeling? How do you plan for Extensions (line, safety, compassionate use, etc.) and Medical Affairs Studies?
TABLE 6: Incorporating a “Globalized” Workforce and Other Resourcing Options into Capacity Management
Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Head of India Operations, Bristol-Myers Squibb
Mohan Pandey, MBA, PMP, Head, Operations and Project Management, Biocon BMS R&D Center, Bristol-Myers Squibb India
TABLE 7: Aligning Portfolio & Productivity with Corporate Strategy
Mellor Hennessy, Ph.D., Global Portfolio Strategist, Business Performance & Continuous Improvement, Global Development, AstraZeneca
How do you use quality, cycle time and cost targets to drive performance in your R&D organizations? What impact do these Corporate/R&D level targets have on project teams and portfolio governance at gates? How do you recognize/manage tradeoffs between quality, cycle time, and cost metrics?
TABLE 8: Pursuing Operational Excellence: Competitive Advantages, New Operating Models, a New Lean Industry, and Learning from Resource Process Development beyond just Clinical
James Kirwin, MBA, Assistant Vice President, Clinical Resources and Process Development, Clinical Development Operations, Wyeth Research
What Pharma organizational model(s) would best promote Productivity/Innovation? How can a Pharma organization implement Lean resource management? What do you believe leads to competitive advantage in R&D?
TABLE 9: Giving Drug Development the Stage-Gate® Treatment
Jean-Claude Le Duc, Manager, Enrich Consulting, Inc.
What are the challenges associated with applying the Stage-Gate process (as formalized by Cooper and Edgett) to drug development? What are the effective implementation strategies that have worked in your organization?
TABLE 10: Controlling Bias in Portfolio Management
Robin G. Foldesy, Ph.D., Vice President, Portfolio Management, Wyeth Research
The use of opinion and bias to make decisions is rooted in human nature. Despite the availability and use of sophisticated portfolio management tools, the introduction of bias is inevitable when building or restructuring a drug development portfolio. No Pharma company, large or small, is completely immune to the risk of decision-making based on opinion and bias. This round table will be an interactive discussion of:
Examples of different types of bias observed in portfolio discussions The unwillingness to “let go” of a Loser and its consequences The difficulty in overcoming “business as usual” Processes or techniques successively used to avoid bias and promote objectivity
TABLE 11: Evaluating Benefit-Risk throughout Development as part of Portfolio Planning
Bonnie J. Goldmann, M.D., President, Goldmann Consulting, LLC, former Senior Vice President at Merck and Johnson & Johnson
More in-depth of specific issues which affect timing and success of a product Detailed examples of REMS to provide the spectrum, detail and cost for maintaining a product on the market How this information can be incorporated in portfolio decision-making
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