The result is a sweeping shift toward personalized medicines that rely on disease-profiling technologies and retooled pharmaceutical capabilities. Research and development (R&D) and product development will need to adapt more quickly to new disease-profiling techniques (e.g., genomics, proteomics, and metabolomics) and technologies (e.g., microarrays, genotyping platforms, disease models, and dynamic-system pharmacokinetic and pharmacodynamic analysis) by integrating an ecosystem of R&D partners. These new R&D practices will need to validate and characterize hypotheses around novel disease pathways and mechanisms of action rather than rely as heavily on hypothesis-free, high-throughput target analysis. By using the latest profiling technologies to identify likely responders, researchers will be able to conduct smaller, shorter, more focused, and less expensive clinical trials.
Development teams will need to integrate a group of experts, including molecular biologists, geneticists, informaticists, process scientists, instrument software/hardware engineers, sales and marketers, medical-affairs specialists, and regulatory experts to synchronize drug and companion diagnostic development and launch. Effective orchestration of these experts, practices, and technologies will require advanced product-development capabilities.Manufacturing organizations will need to coordinate the production of drug products and companion diagnostic kits. Given smaller patient populations for each targeted molecule, drug manufacturers will adapt their high-volume operations to smaller volume operations that entail more frequent equipment changeovers, cleaning, and product-line clearances. Drug manufacturers will need to partner with and manage outsourced companion diagnostic kit manufacturers, which involves ensuring high-quality internal drug-manufacturing operations and outsourced diagnostic kit manufacturing. With more operating complexity, greater controls will be required of manufacturing, operations, including production controls, material handling, environmental monitoring, drug and kit storage and handling, and drug–device batch-record review.
The path to personalized medicine will require a capability to manage a complex, integrated set of capabilities across a broad ecosystem of partners; however, the clinical outcomes and lower overall development costs will justify the means.
Albert S. Lee is an associate,