2014 Archived Content


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.

Day 1 | Day 2 | Track Brochure | Full Event Brochure 


Bridging Luncheon Presentation between Forecasting and Aggregate Spend 

CFS Clinical12:15 pm Luncheon Presentation: Navigating the Challenges of Global Investigator Site Payments

Thiede_StuartStuart Thiede, Senior Vice-President & General Manager, Global Payment Services, CFS Clinical (CFS)

Investigator grant payments are the single greatest expense in a clinical trial, accounting for 40-60% of the total trial budget, and yet slow payments continue to be the most common complaint and challenge for sites. While the investigator payment process is quite challenging in the U.S. due to the multitude of compliance requirements including the Sunshine Act, the complexity multiplies exponentially in global trials. Challenges in the global environment are many and include but are not limited to working with multiple currencies and CRO’s, financial reporting across borders, contracting party issues, VAT taxes,  and transparency compliance.  

Review the complexities of global trials 

Reduce administrative work by centralizing systems and improving workflow 

Learn how to improve the bottom line by managing taxes 

Improving Strategic Planning To
Improve Outcomes

1:20 Chairperson’s Opening Remarks

ChrisChanChris 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

ManfredStapffManfred 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

JoePopowiczJoe 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?IMS Health 

Kannan_SureshSuresh 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

DeborahManzoDeborah Manzo, Senior Director, Clinical Business Operations & Transformation, Clinical Operations, AbbVie

3:10 Refreshment Break in the Exhibit Hall

Optimizing Clinical Project
Management And Partnerships

4:00 Chairperson’s Remarks
ChrisChanChris Chan, Director, R&D Financial Planning and Analysis, Onyx Pharmaceuticals 

4:05 Breaking the Stereotypes:  An Analysis of Outsourcing Strategies for Global Trial Planning (Niche CRO vs. Global CRO)

Lisa SergasLisa Sergas, Manager, Clinical Outsourcing, Medivation

There are many stereotypes or assumptions that exist in the industry regarding the advantages and disadvantages of working with a Niche/Regional CRO vs. a Global CRO for outsourced clinical trial services.  This presentation will evaluate the pros and cons of both models for consideration and provide an analysis of the costs, resources, and risks to incorporate into your study planning and vendor outsourcing strategy.   

4:30 Importance of Project Controls, Above and Beyond Project Management

Vanessa KempVanessa 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 BenottiRhonda Benotti, Business Manager, Strategic Outsourcing, Genentech, Inc.







WeiLiWei 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 

Signature Sponsor

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Premier Sponsors





PRA Health Sciences


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