Personalised Medicine: great for patients, bad for business?

The concept of personalised medicine has always been at the heart of every physician's decision making process but the "one-treatment-fits-all-disease-phenotypes" is very often not satisfactory. The regularly used "trial-and-error" approach in treating many patients, often determined on cost factors, delays appropriate treatment.

Finding alternative ways of diagnosing patients by using biomarkers, however, can dramatically improve this. For some patients the use of molecular diagnostics can also mean increased safety because pharmaceutical drugs can be harmful for some patients but not for others. Rather than rejecting the treatment option altogether, these patients can be identified and excluded from the treatment population. It can also lead to the resurrection of drugs. For example, Vectibix from Amgen didn’t show improved efficacy until non-responders with a mutation in the K-RAS gene were identified and excluded from the treatment. This is a prime example of personalised medicine but uncovers a new issue. Amgen would most probably not have gone ahead with developing the drug for a market that is 60% smaller than expected. Vectibix sales are below expectations and far from a blockbuster drug. So who should pay for these in the future?

There is almost a moral obligation for pharmaceutical companies to bring these drugs to market but this is not a business model and not sustainable for future products. To ensure that innovative products like Vectibix get to market in the future, the high development costs of around €1.5 billion will have to be reimbursed.

In the UK a new program has been launched that will foster development of personalised medicine with a much needed cash injection. The program is called the Stratified Medicines Innovation Platform and will oversee an investment of over £50 million of government funding in innovative research and development in areas such as tumour profiling, drug biomarker discovery and testing new business models. The first competitions, worth up to £11 million, open in January 2011.

Collaboration is needed in personalised medicine and is a prime requirement for these competitions. Details on the 3 competitions can be found here:

• Strand A: Developing Business Models and Value Systems
• Strand B: Tumour Profiling and Data Capture to Improve Cancer Care Flyer
• Strand C: Developing Biomarkers for More Effective Drugs

I hope that all other European countries will follow suit, however, cash injections and grants are not the only thing that is missing to make personalised medicine a reality.


We need:

• Clear guidelines from the regulatory authorities and payers which will help companies to develop their business plans
• Increase collaboration and involvement of physicians to make sure that these pioneering developments will reach the front line and the patients
• Government funding for sound projects that are not commercially valuable but with a great potential to improve patients' lives
• Access to national biobanks and patient data to researchers to ensure that the samples that are used and data that is generated is of the highest standard. Bad samples in - bad data out
• Agreements on standards in bio-sampling to ensure long time usability of biological samples and biobanks