When one contemplates the complexity of the future of personalized medicine, it becomes quite clear that existing discovery, development, regulatory, commercialization and reimbursement frameworks in the pharmaceutical industry are nowhere near prepared for the impending changes. It is imperative that pharmaceutical executives develop a common understanding of the changes ahead so a cohesive strategy and set of actions can be implemented across the enterprise.
If they do not prepare, pharmaceutical companies run the risk that each function and therapeutic business unit will develop its own unaligned set of strategies and actions to address personalized medicine.
To bring personalized medicine (also referred to as “genomics” and “targeted therapy,”) to market, scientists analyze genomic profiles from hundreds or thousands of patients with a particular disease and compare them with genomic profiles of healthy patients. The goal is to understand how genetic differences contribute to disease. If a certain gene is missing or is not producing a needed protein, that protein can be synthesized and administered. If a certain gene creates a “harmful” protein, that protein can be neutralized therapeutically and, if necessary, replaced with a “healthy” protein.
Because of how these drugs are developed, they are only likely to work for the subset of patients for whom they were designed. For example, the drug Herceptin is only effective for breast cancer patients with HER2 positive tumors.
Similar to how the Internet has transformed the retail, music and publishing industries, personalized medicine is going to change the entire health-care ecosystem. Pharmaceutical companies will experience the greatest amount of change because personalized medicine changes how drugs are discovered, developed, submitted, commercialized and reimbursed.