Table I: Operating changes required to support personalized medicine
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Pharmaceutical companies are migrating away from a "one-size-fits-all" drug-development model to address crucial game-changing
realities that are affecting every part of the value chain. These realities include expiring patents, competition from generic
drugs, and more demanding regulations that expect new drug applications to focus on targeted therapeutics that rely on biomarkers
to identify likely responders. As a result, pharmaceutical companies are changing many aspects of their business model, including
how drugs are discovered, developed, manufactured, and sold (see Table I).
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,
alee@prtm.com
Ash Malik is a senior principal,
amalik@prtm.com
Mark A. Mynhier is a partner, all in the healthcare practice of the management consulting firm PRTM.mmynhier@prtm.com
