Cambridge Healthtech Institute’s Fourth Annual
Clinical Trial Forecasting, Budgeting and Project Management
Improving Resource Allocation, Decision Making and Outcomes
February 5-6, 2014 | Hyatt Regency Miami | Miami, FL
In order to improve strategic planning for long-term clinical research and commercial success companies and clinical execs must get the overall resource strategy right, structure a realistic budget, and be able to make decisions based on accurate forecasts. Beyond the strategy and the forecast is project execution, and the next step to achieving trials that are on time and on budget is to then deliver this knowledge up to the C-level office and down to project teams for implementation. Mastering outsourcing, partnerships, strategic alliances, and project management of global clinical trials, whether in North America, Europe or RoW, will allow clinical execs to effectively manage resources and decision making to improve outcomes. CHI’s 4th Annual “Clinical Trial Forecasting, Budgeting, and Project Management” will cover the topics one should consider when trying to accurately forecast, budget and manage trials.
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WEDNESDAY, FEBRUARY 5
Bridging Luncheon Presentation between Forecasting and Aggregate Spend
12:15 pm Luncheon Presentation
Kevin Williams, Vice President, Corporate Development & Marketing, CFS Clinical (CFS)
1:20 Chairperson’s Opening Remarks
Chris Chan, Director, R&D Financial Planning and Analysis, Onyx Pharmaceuticals
1:30 Overcoming the Unknown: Managing the Most Common Perils in the Study Planning Phase
Manfred Stapff, M.D., Executive Director, Global Medical Operations, Forest Laboratories
“Failing to plan is planning to fail.” This well-known proverb is quoted in theory as often as it is ignored in practice. Time pressure, management expectations, or improperly used study start-up metrics seduce us to not spending enough energy during the study planning phase on evaluating potential operational hazards. Complexity of protocols, initially overoptimistic timelines, and lack of pre-specified responsibilities belong to the major culprits why teams will find themselves later too often in “panic mode” instead of “routine mode.” The presentation will provide suggestions on how to convert these perils from surprises into predictables.
1:55 Start with the End: How to Differentiate Your Product in a Changing Healthcare Market through Advanced Planning
Joe Popowicz, Principal Consultant, Emergent Clinical Consulting; former Director, Clinical Operations, Stryker Orthobiologics
As the healthcare environment changes with the addition of the ACA, HTAs and CER, more evidence is expected from Sponsor organizations to differentiate their products. Performance and safety remain cornerstones; however, there has been an evolution to look at comparative effectiveness, economics and quality of life measurements over longer patient durations. In this session, best practices in clinical research and commercial operations will be explored.
2:20 Achieving Faster, Less Costly and More Predictable Trials: a Myth or Reality?
Suresh Kannan, Vice President Products, Clinical Trial Optimization Solutions, IMS Health
Clinical and R&D teams are under more pressure than ever to complete their trials on time and within budget. The industry is riddled with information on clinical trial time delays and the impact those delays have on budgets and revenues. While issues always arise that cannot be planned for, a large majority of delays can be reduced by simply creating a balanced and actionable plan before the study starts. More and more the industry is pushing for predictability and foresight in the planning process: at a study level, at an asset level, and across the portfolio. While an abundance of metrics exist – through internal analysis and external tools – what is often lacking is the view of these metrics in a broader context. By rounding out the planning process with standardized data from internal performance benchmarks, external industry benchmarks, predictive analytics and field based insight the industry can make huge strides in their ability to finish trials on time and within budget.
2:45 Talk Title to be Announced
Deborah Manzo, Senior Director, Clinical Business Operations & Transformation, Clinical Operations, AbbVie
3:10 Refreshment Break in the Exhibit Hall
4:00 Chairperson’s Remarks
4:05 Managing Global Project Teams across Cultures and Time Zones
Eric Morfin, Senior Director, Project Management, Allergan
When it comes to clinical excellence, and project management in life sciences and clinical research, appropriate behavior-based leadership skills coupled with a strong cultural awareness can give you a competitive advantage. One of the most popular questions asked in clinical trials excellence is: “What are the qualities of a great CPM or CTM leader.” Once the technical skills are mastered, appropriate behavior based leadership skills and a deep understanding of how culture impact estimating techniques as well as communication become critical. The presentation will feature real examples from several clients as well as several mini case studies.
4:30 Importance of Project Controls, Above and Beyond Project Management
Vanessa Kemp, Manager, Project Controls; Master Capital Planning, Engineering, Novartis
Project controls can effectively reduce the variances in projects, increase schedule deliveries, and maintain the budgets set. Effective controls not only puts into practice Lean and Six Sigma principles, it drastically improves stakeholder management and leadership communication. Done well, project controls dramatically changes project portfolios and programs, and increases leadership satisfaction ten-fold.
4:55 Co-Presentation: Strategic Partnership Models with CROs
Rhonda Benotti, Business Manager, Strategic Outsourcing, Genentech, Inc.
Wei Li, Functional Manager, Strategic Outsourcing, Genentech, Inc.
With oversight committees and strategic parternship teams in place, clinical trials are better managed and executed. These cross-functional teams provide oversight, governance, and a clear communication and escalation path as well as the consistency and committment required for success from both sponsor and CRO.
5:20 Networking Reception in the Exhibit Hall
6:20 End of Day
Day 1 | Day 2 | Track Brochure | Full Event Brochure