2014 Pilot Program High Quality Content

In 2014 a Pilot version of the complete EOE program will be offered. The content for the Pilot Program is listed below. The content is a eleven (11) topic subset of the same high quality lectures that comprise the complete program. The 2014 Pilot enables companies to sample the EOE program while making a smaller investment of time and money. Clinical Difference expects various firms to enroll 8-10 individuals or more in the 2014 Pilot. Customers have indicated that they expect to enroll either a mix of staff from sales, marketing and medical science to determine the best fit or instead focus on a particular area and select a core group from a department such as sales.

Content

Below are additional details on topics that are top-of-mind for many oncology clinicians today:

Hallmarks of Cancer

This section will address hallmarks which we define as the cellular and molecular changes that are associated with cancer development. As technology develops, it is understood that the number of hallmarks figure to increase over time. (and the content will be updated accordingly) Clinical breakthroughs in oncology are increasingly connected to the inhibition of identified targets. Emphasis will be placed on conveying the underlying principles of the core concepts and how each relates to the pathogenesis of cancer. The core concepts include:

1. increases in cell growth rate
2. alteration in cell metabolism
3. recruitment of tumor vascularization
4. altered host immune system mechanisms
5. activating invasion and metastasis
6. enabling replicative immortality

Examples of mutations in specific tumor types and approved products will be used to illustrate the core concepts in a real world context. While specific product examples are still being evaluated, examples of anti-angiogenic therapies would not only draw on an extensively studied treatment such as Avastin, but also touch on example targets such as MET and VEGFR2 to reflect the breadth of the process and underline common trends.

Clinical Trial Principals and Statistics

This section will address the goals, objectives, design and interpretation of clinical trials. The focus is to build a stronger understanding of the thought processes used both in constructing trials and determining the endpoints needed to demonstrate efficacy. Designing truly effective trials is critical, particularly in disease states where there are multiple therapeutic choices beyond the study drug. Meaningful clinical endpoints must be identified and met in order to demonstrate meaningful clinical benefits. Topics include:

1. Impact and limitations of trial design style (i.e. randomized discontinuation trial)
2. Translating statistics into absolute patient benefit
3. Comparability of efficacy data between distinct studies
4. Effects of patient crossover
5. Defining "changes in relative risk"
6. Defining target patient populations
7. Frequently seen limitations of clinical studies