Personalised Medicine

Personalised Medicine (or “the right drug and dosage at the right time for the right patient”) has frequently been touted as a potential cure for the troubled blockbuster business model. Initially, expectations were high, if not outright unrealistic. After a few initial success stories such as Herceptin and HIV viral resistance testing, many industry observers have been waiting for the next round of drug plus diagnostic test combos to come to the market that would substantially modify pharma and diagnostics business, and pricing models. But the road has proven to be a rocky one, illustrated by the case of the EGFR drugs (Erbitux, Tarceva, Iressa) where promising leads (receptor polymorphisms) have not yet translated into clinically relevant applications.

The technical difficulties remain enormous: be it marker statistics, or the challenge of differentiating a truly predictive marker for a given drug’s efficacy from a prognostic marker for disease progression. At many pharmaceutical companies the grand business model visions around Personalised Medicine have been downscaled to biobanking initiatives and using biomarkers in early development for picking up early signs of activity (the new buzzword is “translational medicine”). Many of the diagnostics companies that have tried to position themselves as Personalised Medicine players have come to realise that most value capture will remain with the drug. Dx prices are essentially being locked-in at a level that is far below drugs and most deals between Dx and Rx have been fee-for-service.

At Catenion, we believe that new platform technologies tend to go through different stages in their adoption. After the initial euphoria had worn off, Personalised Medicine has been in a state of depression for the last few years. Following the path of other technologies (e.g. monoclonal antibodies), Personalised Medicine is now entering into a phase of pragmatic acceptance as biomarkers and diagnostic tests are slowly but steadily penetrating drug development and clinical practice with the regulatory frameworks being developed. Business model challenges are still manyfold — from the impact that a Personalised Medicine approach has on the traditional R&D process, to the pricing and distribution of drug plus test combos; in many cases new ground will have to be broken.

Catenion has helped leading and emerging players in the pharmaceutical and diagnostics industries establish strategies that take into account the technical issues as well as business model aspects.

Personalised Medicine Readiness Assessment

Our “Personalised Medicine Readiness Assessment” reviews both the suitability of a portfolio and the degree of penetration of Personalised Medicine into established R&D processes as well as the technological infrastructure ultimately required to develop an actionable strategy.

The “Personalised Medicine Readiness Assessment” has been developed to help companies quickly establish a competitive position and strategy in the field of personalised medicine by answering a few essential questions in three steps:

Step one contains a thorough review of a company’s current position in the Personalised Medicine space:

  • Is there an overall strategic intent with respect to Personalised Medicine beyond R&D?
  • What is the potential impact of Personalised Medicine on company’s portfolio – based on indications and selected individual projects?
  • To what extent have processes and checkpoints for biomarkers been established?
  • What internal capabilities for biomarkers have been established?
  • What types of partnering activities have been started in Personalised Medicine?

In a second step we define the optimal position of a company in the Personalised Medicine space and define the activities required to close the gaps:

  • What strategy would be optimal with a given impact of Personalised Medicine on company’s portfolio?
  • What are the lessons learnt and best practices from other companies in similar positions?
  • What role should Personalised Medicine play in company strategy?
  • What are the required internal capabilities?
    • Skills and technologies
    • Processes and organisation
    • Partnering strategy
  • Which development projects would benefit most from a biomarker strategy?

In a last step we assess the feasibility of Personalised Medicine concepts at the portfolio level and define concrete action plans for individual projects:

  • How attractive is the Personalised Medicine value proposition for a particular project (NPV with and without Personalised Medicine)?
  • Is a Personalised Medicine strategy technically feasible based on sample availability, marker statistics, diagnostics platform, etc.?
  • What would a commercialisation concept look like (timelines, costs, partnering requirements, distribution strategy, pricing, etc.)?

In addition, we have developed specific project evaluation tools to review any R&D project with and without biomarkers based on an in–depth assessment of the statistical and commercial requirements. Our R&D Risk Assessment contains many criteria assessing the risk profile associated with biomarkers.