Archived Content

Forecasting Budgeting 

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Wednesday, February 6

11:30 am Conference Registration

Shared Luncheon Presentation between Forecasting and Strategic Alliances

CFS Clinical12:05 pm Bridging Luncheon Co-Presentation: A Systematic Approach to Study Start-Up

Jim DiCesareJim DiCesare, Vice President, General Manager, Contract & Regulatory Services, CFS Clinical - Biography

Kevin WilliamsKevin Williams, Vice President, Corporate Development & Marketing, CFS Clinical - Biography 

Starting up a clinical trial is a complex and protracted process with many facets, including labor intensive regulatory document review, contract negotiations, and budget development. Leveraging sound business processes and technology can alleviate the administrative burden on sites and sponsors and accelerate the process of initiating a study. In this session the following will be discussed: 1. Best practices to expedite essential regulatory document completion and contract negotiations; 2. Enhancing clinical business processes with technology to improve compliance and mitigate risk; and 3. Improving investigator relationships with efficient business and financial practices.



1:25 Chairperson's Remarks

Marina MalikovaMarina Malikova, Ph.D., PMP, Executive Director, Surgical Translational Research: Operations and Compliance, Adjunct Professor, Biomedical and Clinical Sciences, Boston University Medical Center - Biography 

» 1:30 Keynote Presentation: How to Develop an Effective System of Financial Management during the Course of Your Clinical Trials 

Chris ChanChris Chan, MBA, Senior Director, Clinical Finance, Finance, FibroGen, Inc. - Biography 

An effective system of trial financial management isn't just simply looking at numbers. Managers must understand the actual and budget numbers (what system of accruals were used for actual numbers? what were the budget assumptions?) and have confidence that proper controls are in place to ensure integrity of those numbers. Managers should also understand how numbers relate to actual underlying progress of the clinical trials

1:55 Seeing Details in the Big Picture: How Careful Planning and Detailed Forecasting Can Lead To Reduced Budget Variance for Clinical Trial Programs

Allison Burmeister, Manager, Clinical Contracts & Finance, Gilead Sciences - Biography 

This presentation provides a detailed look at the true cost drivers in clinical trials. With the increasing costs of conducting clinical trials and the heightened scrutiny placed on cost containment, through a detailed case study, this presentation will address the following topics: 1. The current state of clinical trial costs 2. Major cost drivers in clinical trial costs 3. Tools and methods for accurate forecasting 4. Managing budget variance

2:20 Forecasting Techniques during the Commissioning / Kick Off Phases of a Study

Yan CardineauYan Cardineau, Program Director, R&D & Clinical Research, Medtronic CardioVascular - Biography 

The ability to forecast effectively and to manage variances continues to be the strategy employed by most to hit key milestones. Unlocking the full potential of these project management techniques requires art, skill and experience. This presentation discusses proven techniques, tools and tactics used to forecast and track variances in trials of different degrees of difficulty, uncertainty and complexity.

DSP Clinical2:45 Improving Outsourced Project Management for the Neglected Market of Small to Mid-Size Pharmaceutical and Medical Device Companies

Darlene PanzittaDarlene Panzitta, Founder & President, DSP Clinical - Biography 

Avoiding fire drills, enrollment issues, overspending and delayed timelines is impossible for PMs at small to mid-size pharmaceutical and device companies. Even with limited time and resources, PMs managing multimillion dollar studies can anticipate and resolve these problems quickly by making just a few strategic changes to the study plan and budget.

Langland3:00 Refreshment Break in the Exhibit Hall

3:40 Implementing a Capacity Planning Process in Development Operations

Todd JohnsonTodd Johnson, Global Head, Business Information Systems Management (BISM), Global Development Operations, Astellas Pharma Global Development, Inc. - Biography 

A key challenge in industry is the ability to forecast your internal capacity based on your future book of work. This has ramifications for possible outsourcing opportunities and headcount concerns. This presentation will be a case study on the development of a new process to forecast and manage internal resources within Astellas.

Oracle Health Sciences 4:05 Resource Estimation Practices and Strategies for Continuous Improvement

Molly Blake-MichaelsMolly Blake-Michaels, Consulting Solutions Expert, Oracle Health Sciences - Biography 

Clinical Research is a dynamic, constantly evolving field that requires a highly skilled workforce, and over or underestimating headcount requirements can be a very expensive proposition for both sponsors and service providers. This presentation will survey a variety of strategies currently in use to ensure that headcount estimates continue to remain accurate over time.

4:30 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest and become an active part of the discussion at hand. 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 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: Finance is from Mars, Clinical Development is from Venus: How to Improve Communications between the Respective Groups to Enhance Budgeting and Forecasting Efforts

Moderator: Chris Chan, MBA, Senior Director, Clinical Finance, Finance, FibroGen, Inc.

• Discuss common challenges encountered between the two groups in terms of generating reasonable clinical study budgets/forecasts.
• Discuss ways different people and companies have dealt with those challenges.
• Discuss new and innovative ideas that may alleviate those challenges.

TABLE: Improving Processes and Systems: Integrating Clinical Trial Operations, Resource Planning, Project Management and Finance

Moderator: Kelly Willenberg, President, Kelly Willenberg, LLC, Research Compliance Advocates

• Identifying risk in your operations
• Workload assessment
• Project management as a science
• What are the key elements in finance for clinical trials

TABLE: Assessing Trial Execution Risk via the Trial Protocol Design

Moderator: Igor Altman, Product Manager, Study Planning, Medidata Solutions

• Explore the factors in study design most important for risk assessment purposes
• Identify best practices for risk factor tracking and management
• Define the role technology and analytics can play in better risk management in study design development

TABLE: Continuous Improvement in Resource Estimation Practices in Clinical Research: Barriers and Best Practices

Moderator: Molly Blake-Michaels, Consulting Solutions Expert, Oracle Health Sciences

• Barriers to change: technological, organizational, human
• Best practices: technological, organizational, human

TABLE: Clinical Trial Finances: Challenges and Approaches

Moderator: Piet Theisohn, Director, Resource Management & Business Support, Global Clinical Development, Bayer Healthcare Pharmaceuticals 

• “Early estimating clinical trials’ cost is easy or not so easy because we use the approach / the tool….”
• “I think most important for managing the cost of running clinical trial monitored internally is…”
• “With a CRO we have learned to focus on ….”

Langland5:30 Networking Reception in the Exhibit Hall

6:30 End of Day

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