At Amgen, we apply four guiding principles to our R&D efforts. The first is to focus on grievous illness. Given the difficulty of successfully developing a new therapy, we focus our efforts on developing therapies to help patients suffering from the greatest unmet medical needs.
Our second guiding principle is to be modality independent – to fit the tool to the task. Small molecules and biotherapeutics (biologics) each have unique and inherent advantages and disadvantages. Our modality independent approach allows us to leverage the advantageous aspects of a particular approach that are best suited to interdict a disease. We are not driven to work in a disease area by our drug development capabilities. For us, the question is always: What’s the best therapeutic approach for a particular disease?
Our third major emphasis is to study disease in patients. All too often our industry has found that experimental models have little predictive value with respect to human disease, which often results in the failure of clinical trials and escalating drug development costs. While it is significantly more complicated to study disease in humans, we believe that this is the only way to successfully develop human therapeutics. Defining the key elements of disease in patient populations drives our R&D investment and the potential therapeutics we pursue. In addition, we are developing clinical trial approaches that allow key decisions earlier in the drug development process, ultimately reducing the overall cost of developing a drug.
Our fourth guiding principle, seamless integration, informs everything we do. We strive to integrate our organization, incorporating the perspectives from sales and marketing, clinical development and basic research into all of our drug development programs. There are important insights that come to basic research and clinical development from understanding the medical marketplace, and vice versa. Aligning our priorities across these functions ensures that we develop potential therapeutics in a manner that will address unmet medical needs and meet the changing demands of the marketplace.
These four guiding principles together are not enough to ensure our success as an organization. Hard work, intelligence, intuition, and some luck, are also essential. With all of those ingredients, we will achieve our aspiration to become the best human therapeutics company.