Developments in Personalised Medicine

A few weeks ago I travelled to Shanghai to participate in the 1st Annual Tetra-Congress of Molmed-2010 (http://www.bitlifesciences.com/ mdpm2010/default.asp) where I chaired a session and gave a presentation on development of Psynova Neurotech’s product VeriPsych™ (http://www.veripsych.com/); VeriPsych™ is the first and only blood test to aid a psychiatrist in the diagnosis of recent-onset schizophrenia.

This was an international congress with c. 200 participants including speakers from >30 countries. It was organised into three parallel events:
• 3rd Annual World Congress and Exposition of Molecular Diagnostics
• Annual World Congress of Biomarkers
• Annual World Congress of Personalised Medicine

I was particularly struck by the pace of developments in Personalised Medicine and thought I would share some highlights in this field.

Dr Songkai Liu of Qiagen (http://www.qiagen.com) summarised the key drivers for the adoption of personalised medicine:
• Political: the drive to improve the cost-effectiveness of drugs is leading to the development of companion diagnostics i.e. tests that will identify responders or non-responders to specific drugs
• Scientific: a move towards targeted therapies is being driven by the demand for more effective treatments
• Regulation: there is a move from passive to active regulation and the regulatory authorities have realised that companion diagnostics can bring significant benefits for patients

Dr Sean Xinghua Hu of Bionest Partners (http://www.bionest.com) summarised some of the trends in development of stratified medicines (‘SM’); a SM is a product that has a diagnostic test required or recommended on the product label. Usually the test is a companion diagnostic.
• Bionest has identified 29 SM molecules and 31 unique products (some contain a combination of molecules) that were in use in 2008 e.g. Herceptin and tamoxifen.
• The product split by indication area is: 22 oncology, 1 CNS, 1 cardiology, 2 immunology, 1 metabolic disease and 4 virology.
• Total world-wide sales in 2008 were c. $18B with a CAGR of c. 20% compared to a CAGR of 4-6% for the overall pharmaceuticals market.
• Many of the current SM products were forced into becoming SM products due to clinical trials failures of the stand-alone drug e.g. Herceptin, Gleevec, Erbitux and Vectibix. SM was not part of the original product development strategy.
• The leading pharma companies as regards internalisation of their diagnostics activities in relation to personalised medicine are: Novartis (has an internal oncology diagnostics division developing companion diagnostics); Roche (now has their first CEO to have come from their diagnostics business and his priority is to develop their personalised medicine business); Pfizer; AstraZeneca; Merck.

This all amounts to an impressive rate of progress as regards adoption of personalised medicine. However, Dr Ming Tai-Seale of the Palo Alto Medical Foundation Research Institute provided a reality check in his description of an investigation into the provision of primary care by physicians to patients suffering from depression. Effective treatments for depression are available but it may take multiple trials for find the right one for a particular patient and many patients discontinue treatment for various reasons including side-effects or non-response to the initial medication. There also need to be incentives in place for primary care physicians to successfully customise treatments for individual patients. The key take-home message was ‘in an era of rapid technical advances we mustn’t lose sight of the importance of mechanisms for translating evidence-based medicine into practice’.