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


ENSURING ACCURATE TRIAL BUDGETING AND FORECASTING

10:45 Chairperson’s Remarks

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

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 Financial Intelligence for Investigator Payments

KyleCunninghamKyle Cunningham, Vice President, Product Development, Greenphire, Inc.

This presentation will cover: 1. The important of Financial Intelligence, 2. Challenges to Producing Accurate FI, 3. Technology Driven Analytics as a Solution, 4. Benefits of Centralized Data, 5. Turning Data into Executable Ideas


NOVEL METHODS TO MINIMIZING STUDY COSTS

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 Interactive Discussion and Q&A with Speakers

Topics to be discussed include:

  • Accuracy of trial budgeting
  • Financial accruals
  • Methods to minimize study costs
  • Clinical trial payments

HALL BREAK AND BREAKOUT DISCUSSION GROUPS

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, DrugDev Payments

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


MANAGING BUDGET ISSUES ACROSS PROJECT TEAMS

10:45 Chairperson’s Remarks

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

10:50 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.

11:15 PANEL DISCUSSION: Mastering Budget Negotiations and Achieving Cost Savings

Moderator:

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

Panelists:

Teresa Piperno, Associate Director, Clinical Trial Management, Novartis Vaccines and Diagnostics

Sondra Smyrnios, Vice President, Clinical Operations, Alkermes

Julie Ross, Executive Vice President, CRO, Advanced Clinical

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
  • CRO and sponsor perspective on cost management
  • Taking a closer look at planning, budgeting and communication and their effect on change orders

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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