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.

Paediatric vaccines in BRIC/emerging markets

Background and objectives

Lifescience Dynamics was invited to investigate opportunities for expansion of our client's paediatric vaccines in Brazil, Russia, India, China, Mexico and Turkey.

Objectives included market understanding, pricing points in the private market, concept testing and development of ideal product profiles.

Approach

Key opinion leaders, policy makers and influencers, front line doctors and parents were interviewed in the target market.

• Research was conducted in person and over the phone

Results delivered

• Burden of influenza disease and seriousness of influenza in young children
• How clinical trials should be set up
• Barriers to vaccination included
• Price points prophylaxis for national coverage via government initiatives
• Key decision makers for vaccinations: government guidelines, family practitioners, paediatricians, nursery entrance requirements, family elders and parents
  • Price points prophylaxis for where both parents work as well as where only one works

Merger and acquisition intelligence - Intelligence on target company as part of due diligence

Background and objectives

Our client, in association with a leading investment banker, was targeting a company that had a Low Molecular Weight Heparins (LMWH) in a late stage of development, with a view to a potential take-over, without alerting the target.

• Primary requirement was the assessment of the molecule for valuation
• Strength of their clinical trial and likelihood of successful registration and pricing potential
• Additional query to determine the realistic timeline for competing drugs' registration

Approach

Our approach focused on the clinical trial centres, lead investigators and CRAs:

• Multiple US and EU clinical and principal investigators were targeted
• Targets included limited number of personnel from the target company itself
• KOLs were approached to establish the status of competing compounds' development status

Results delivered

The output included all the priority 1 and 2 KITs

• Status of the clinical trial and early indication of end points
• Timelines for development
• Likely pricing scenarios
• Potential uptake scenario for valuation modelling

Conference intelligence - CI on clinical trials and emerging competitors

Background and objectives

Lifescience Dynamics was invited to undertake a competitive intelligence project in the area of hepatitis C, with a focus on clinical trials of our client's major competitors, as well as emerging competitors in their core product.

Approach

A conference for the American Association for the Study of Liver Diseases (AASLD) was the platform for gathering intelligence:

• Two analysts attended
• Our analysts utilised information from presentations and posters, as well as using both direct and indirect questioning to answer the KITs
• Follow-up telephone interviews were also used to fill holes in intelligence and corroborate findings

Results delivered

Robust findings provided the insight our client needed, including:

• Therapy was evolving; new oral small molecule classes of drugs were seen as products of the future
• New players and new products had resulted in intense industry and analyst interest; analysts believed that the client, perceived to be a laggard, could maintain its franchise in this area only through a robust programme of licensing or acquisition.
• Key competitor had an aggressive phase IV trial programme but there was no marketing threat perceived until at least 2009/2010

P&R market assessment of therapy for moderate to severe psoriasis

Background and objectives

The overall objective was to understand and describe the current and forward-looking market in moderate to severe psoriasis.

• Description of market landscape:
  • Treatment algorithms and patient characterisation
  • Biologic market realities
• Evaluation of clinical and economic positioning
  • To provide viable pricing range for launch
• Assessment of the US and EU5 market potential for entry into psoriasis
  • To provide forecast and forecast model
• To support client's decision-making processes for development of commercially optimal pivotal trials
  • To include recommendations for trial comparators

Approach

We designed a four phase approach with forecast modelling:

• Secondary research including qualitative and quantitative data on epidemiology, broad patient segments and pipeline analysis
• Primary market research with KOL's and front-line dermatologists, utilising a patient diary approach
• Evaluation of pricing and reimbursement aspects of the psoriasis market, including the potential for client's two internal compounds, leading to a strategic plan - price points in each market and launch order for EU5
• Integration of all materials into a forecasting model designed to evaluate market potential for our client

Results delivered

We provided a complete picture of the market place and market positioning for two products at two price points. We also provided a pricing and reimbursement strategy and recommended a comparator for head-to-head trial. And finally we provided market research, patient record form data and forecast model for the top US and EU5 markets.