Breast cancer

Background and objectives

Our client, a major player in the oncology area, wanted to influence treatment protocols of breast cancer treatment with the key objective of "What will it take to change the current practice?"

Approach

We set up two advisory boards, one in the US and one in the EU, with eight oncologists in each, moderated by an expert of PhD level in cancers. There were two meetings per year, each lasting two days, where the clients could observe and table further questions.
The participants were given the following points to discuss:

• Novel approaches
• Selectively targeting a specific abnormality of the disease process
• Low toxicity
• Ease of administration
• Wide applicability
• Meaningful efficacy impact
• Potential for cure

Results delivered

A report and recommendations helped to expand the standard of care for breast cancer in each of top six markets and what the major factors will help drive changes the in current practice.

Alzheimer's disease and dementia

Background and objectives

Our client, a major player in the CNS area, wanted to obtain an accurate, current assessment of Alzheimer's disease product development and clinical trials.

We were presented with six companies and 19 products to assess, by focusing on:

• Safety profiles of products in trials
• Clinical development plans
• Clinical end points
• The plans and intentions
• The plan for interim data analysis
• Whether the Phase 3 trial design would be a randomised withdrawal or standard parallel arms

Approach

We set up two advisory boards, one in the US and one in the EU, with KOLs (principal investigators and lead investigators) and each group was moderated by a PhD level expert in Alzheimer's disease. We set up a two-day meeting in each continent, where the clients could observe and table further questions.
The participants were given the following points to discuss:

• Exploration of future treatment/management scenarios
• Clinical trial strategy and design - end points, development plans and data
• Issues regarding registration procedures
• Exploration of target product profiles (TPPs)
• Reaction to major clinical trial results
• Product development strategy

Results delivered

The proceedings were content analysed in great detail, and the results presented in the form of a written report as well as a personal presentation and discussion.