Cambridge Healthtech Institute’s Fifth Annual

Clinical Trial Forecasting and Budgeting 

Creating Realistic Budgets and Minimizing Financial Risk
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL 

With the rise in clinical trial costs and industry pressure towards greater efficiency, the need for accurate trial forecasting and budgeting is vital. Better financial planning, budgeting and communication can reduce the burden of cost and resource pressures leading to more efficient trials. Cambridge Healthtech Institute’s Fifth Annual “Clinical Trial Forecasting and Budgeting” conference shares best practices and case studies on methods and tools to creating realistic budgets and minimizing financial risks.

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Project Management for Outsourced Trials 

Tuesday, February 24

7:30 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

10:50 The Application of Financial Engineering Principles to Improve the Fidelity and Accuracy of Clinical Trial Forecasting and Budgeting

Kailash SwarnaKailash Swarna, Senior Director, Global Development Operations, Takeda Pharmaceuticals

Even today, Clinical Trial Forecasting and Budgeting remains more an art than a science. Constrained budgets combined with the need to make every dollar count, have made it necessary to improve our capabilities in trial forecasting and budgeting. We describe a novel approach based on the application of financial engineering principles and portfolio theory to significantly improve the fidelity and accuracy of trial forecasting, trial budgeting, cost hedging, and alternative opportunity assessment.

11:15 Financial Accruals: What It Is, Why It’s Essential for Accurate Budgeting, and How to Do It

Chris ChanChris Chan, Senior Director, R&D Finance, Finance, FibroGen, Inc.

Financial accruals is a challenging task for biopharmaceuticals of all sizes. It is essential for all clinical operations personnel to understand the underlying concepts of what it is, why it’s so important, why the endeavor is so challenging, and how to enhance and simplify the process in their respective companies.


11:40 Simplifying Accruals for Clinical Trials: Bayer Case Study

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

The clinical trials industry is special compared with other industries: We are ‘assembling’ relatively unique products (i.e. clinical study reports) by working with diverse, globally distributed suppliers (i.e. clinical sites). Global accounting standards require sponsors to report “service rendered” as R&D expenses, when the actual invoices from sites tend to come late and the contracts with service providers (e.g. CROs) are high-volume but with tricky payment milestones and depending on study progress. Bayer is implementing a simplified approach to help the clinical organization to plan and apply financial accruals more efficiently.

12:05 pm Sponsored Presentation (Opportunity Available)

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Session Break

1:25 Chairperson’s Remarks

Chris ChanChris Chan, Senior Director, R&D Finance, Finance, FibroGen, Inc.


1:30 Clinical Trial Financial Planning in a Dynamic Portfolio

Daniel Matarazzo, Head of Finance, Clinical Development & Regulatory Affairs, Regeneron Pharmaceuticals

Creating realistic operating budgets is a challenge for all companies; Financial budgets in drug development are particularly complex and need to provide Project teams with clarity as well as mirroring the timelines and complexity in a environment which protects patients while preserving data quality and delivering outcomes. This, coupled with increasingly stringent financial regulations can wreck havoc on financial planning and operational execution. Discussion will focus in experience in a growing biotech as well as aspects of portfolio management and collaboration dynamics.


1:55 Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution

Marina MalikovaMarina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center

This presentation will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity. The ability to develop comprehensive budgets and ensure billing compliance for clinical trials is challenging for many clinical sites. Poor financial planning/forecasting and undefined billing compliance practices are associated with increased risk leading to deficits and OIG investigations. Strategies for covering true costs related to protocol design will be discussed.

2:20 Mitigating and Managing Cost Variables in Clinical Trial Budgeting

Speaker to be Announced

2:45 Sponsored Presentation (Opportunity Available)


3:00 Refreshment Break in the Exhibit Hall

4:00 Find Your Table and Meet Your Moderator

4:05 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 key issues presented earlier in the day’s sessions. Delegates will join a table of interest 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.

View Detailed Interactive Breakout Discussion Groups 

5:00 Welcome Reception in the Exhibit Hall

6:15 Close of Day

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Project Management for Outsourced Trials 

Wednesday, February 25

7:30 am BREAKFAST PRESENTATION: Evaluating the ROI of Outsourcing Investigator Payments 

CStuart (Stu) ThiedeStuart (Stu) Thiede, President, Global Payment Services, DrugDev

Everyone knows the # 1 complaint of Investigators is slow payments to the sites. Pharmaceutical companies often outsource investigator payments to improve efficiencies, provide costs savings and build better investigator relationships. But how do you quantify whether or not you made the right decision to outsource? Do you go with anecdotal evidence and assume your goals are being realized or can you prove it with real metrics? This program will review a model that enables you to assess the ROI of outsourcing your investigator payments. See how this model measures benefits such as increased operational efficiencies, enhanced investigator relationships, improved budget management and increased compliance to determine whether or not you’re accomplishing your business objectives.

8:25 Plenary Keynote Session

9:45 Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

10:50 Changing the Change Order Paradigm

John Hogan, Director, Project Management, Harvard Clinical Research Institute

Change Orders are an inevitability during a clinical trial. Lack of communication regarding the impact of the requested change, to the operation of the project as well as the budget, can lead to tremendous discord between sponsor and CRO/ARO. The time has come for a closer look at how better planning, budgeting and communication can reduce the burden that change orders place on project teams.

11:15 Building and Negotiating Fixed Cost Contracts with the Intent of Minimizing Changes in Scope

KenWilsonKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer

Building a fixed cost contract with a CRO can be a difficult process, especially when poor planning occurs, either on part of the CRO or the Sponsor. I will discuss a stepwise process for building a fixed cost contract, with involvement and agreement by all parties involved. The intent of building a fixed cost agreement is to minimize changes in scope and hold the CRO accountable for performance metrics to which they have agreed. Key elements discussed and emphasized will be country/site/patient feasibility and project specifications/key cost drivers with the end result being a fixed cost contract with a small list of parameters that would justify a change in scope.


11:40 PANEL DISCUSSION: Mastering Budget Negotiations and Achieving Cost Savings

Moderator to be Announced

Stalled contract negotiation can result in significant delays in the clinical trial process. Mastering negotiations from site to sponsor and site to CRO can lead to cost reduction and more efficient clinical trials.

Topics discussed in this session Include:

  • Effective CRO management to achieve substantial cost performance
  • Optimizing CRO/outside vendor budget negotiation and cost reduction

12:05 pm Sponsored Presentation (Opportunity Available)

12:35 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Session Break/Close of Conference

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Project Management for Outsourced Trials 

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