Clinical Trials Forecasting for Finance Professionals

July 20, 2011
11:30 – 1:00 pm EST

In 2003, health economists in the US estimated the average cost of bringing a drug to market at US$802 million. Today, those costs are forecasted in the range of   $1.3 to - $1.7 billion.  Clinical trials cost is one of the biggest expense categories for biopharmaceutical companies.

The Industry Challenge: 

• More than 80% of clinical trials experience delay from one to six months costing pharmaceutical companies upwards of $35,000 per day, per trial.
• Only 10% of trials are completed on time.

Finance Challenge:

• Time delays in clinical trials are costly and generate significant variability in clinical development budgets.  Detailed understanding of the cost drivers of clinical trials could improve clinical trial cost forecasting, prevent unnecessary costs (aka CRO change orders) and reduce the corporation’s financial exposure.

This short course will discuss in detail the key drivers of clinical trial costs, methods for estimating the cost implications of changes in protocols and ways for R&D finance executives to help better forecast and manage trial expenditures.

Learning Objectives:

• Review the key drivers of clinical trial costs
• Examples of “hidden” costs of clinical trials
• Discuss strategies for minimizing the financial impact of clinical trial changes
• Provide practical recommendations to avoid costly amendments

Who Should Attend: 

• Finance Manager – Director Level: Pharma responsible for clinical development budgets and clinical trial costing
• Clinical Development Manager – Director Level Pharma: responsible for clinical trial forecasting
• Finance VPs/CFO of small to mid size biopharmaceutical company responsible for R&D budgets

Instructor Information: 
Marisa Co – PharmD, MBA: Managing Director Atheln, Inc. life science consulting firm which provides a broad range of drug development capabilities to the biopharmaceutical industry.
Harriet Oberman, MBA, CPA:  Principal at TF Oberman & Associates. Former Finance Director of Clinical Development at Amgen, responsible for clinical trial forecasting and accounting. 

Instructor Biography:

 Marisa Co – PharmD, MBA
Marisa has over 24 years experience in biotechnology and pharmaceutical industries with expertise in manufacturing, international and US sales, regulatory affairs, global strategic marketing, new product introductions, corporate finance, financial planning and corporate strategy.

Marisa is the Managing Director of Atheln, Inc. a multi-disciplinary life science consulting firm which provides a broad set of technical and commercial solutions to biotechnology companies. Marisa is the former Executive Director Global Development and Medical Affairs at Amgen where she was responsible for providing strategic, financial and operational leadership to the Global Drug Development Organization. In her role, Marisa led the implementation of a disciplined process for financial management of clinical trials which resulted in a reduction of quarterly variances from ~25% to 1-3% and the creation of the Clinical Development Feasibility and Global Capacity Management function.   Prior to joining Amgen in 1997,

Marisa was a Pharmaceutical Brand Manager in the Ophthalmic Division at Allergan, Inc.

Marisa has a degree in Pharmacy from University of Pharmacy and Biochemistry in Buenos Aires, an MBA from The Anderson School of Management at UCLA and is completing her masters in Media from Touro University Worldwide
Marisa is a board member of Medical Care Corporation, a company that provides web-based, patented diagnostic scoring for early detection of Alzheimer's Disease and other causes of dementia.

 Harriet Oberman - MBA, CPA
Harriet Oberman, a Certified Public Accountant, brings a global perspective on financial management to her role as co-principal of TF Oberman & Associates. Before joining the firm in 2009, Harriet served as Director of Finance, R&D, at the publicly traded biotechnology giant, Amgen, Inc. As such, she provided strategic, financial and operational leadership to its Global Development organization and implemented initiatives for a $1.4 billion annual budget.

She began working at Amgen in 1996, after receiving a Bachelors of Science from Southwestern University in Georgetown, Texas, with a major in biology and minor in mathematics. She also has an MBA from the Anderson School of Management at UCLA. Harriet’s executive assignments at Amgen included heading the European R&D Finance team, where she was responsible for managing an operating budget in 16 countries.