It is essential to remember that even with the best ideas, understanding technology is crucial to getting innovative drugs to the clinic. To achieve the goal of Personalized Medicines, industry and academia need to increase collaborative efforts to develop the necessary tools. 

 

Personalized Medicine is a branch of medical research that attempts to more directly connect basic research to patient care. It refers to using information about a person's genetic marker to tailor strategies for the detection, treatment and prevention of diseases. Though this may sound  a straightforward task, in actuality, it poses major scientific challenges when one considers that there are approximately 3 billion base pairs in the human genome. For any 2 people, 99.9% of those nucleotides are the same. However, 0.1% differences or 3 million nucleotides are different causing inter-individual differences with different responses to the environment, food , drugs and susceptibility to diseases. The real problem is how to analyze the 0.1% differences that hold clues to the variations among humans in susceptibility to diseases. Data on human genetic variation are useful to pinpoint genes responsible for the wide variability in people's responses to different types of drugs - a field that is now referred as pharmacogenomics.

 

Biomarker Strategy forms the basis for Personalized Medicine and the industry/regulatory focus for improving the success rate and reducing the high attrition rate often encountered in clinical research. The depth and breadth of knowledge required to successfully implement Biomarkers into Personalized Medicine is generating company collaborations and inclusion of professionals in the process of drug products development. Players like BBCR will play a critical role here in such collaborations.

 

Data on human genetic variation can be used to pinpoint genes responsible for the wide variability in people's response to many common drugs. Traditionally, basic research and clinical practice of medicine have been secluded in silos hardly communicating with each other. In the past, drugs were developed independently of the clinic, and often thrown over the fence to be tested for safety and efficacy in clinical trails. The recent move towards Personalized Medicine is focused to remove these silos and stimulate exchange of ideas and understanding of the possibilities of the basic research in clinical practice and the unmet medical needs.

 

The increasing demand for Personalized Medicine, prevention trials dependent on markers of disease progression, and drug development strategies targeting complex biological systems are powerful drivers for increased use of these multifactorial Biomarkers in all therapeutic areas. However, interpretation of multifactorial Biomarkers in development decisions remains a challenge and their full potential role has yet to be realized.

 

Personalized Medicine has the potential to be useful in early clinical drug development; it can assist in compound selection and in demonstrating early clinical proof of concept. However, the real issue is the time required to understand and characterize new Biomarkers. By the time a Personalized Medicine strategy and a Biomarker or a panel of Biomarkers gets validated, it can be too late in the process for them to be influential in decision making. The real questions then are

• Does Personalized medicine change the way we develop drug and practice medicine? 
• Do Biomarkers really measure something that is relevant to the disease or drug effects?
• Can we find sooner rather than later whether they can be useful for decision making?