Issues & Trends

Today’s healthcare system was built over many decades on traditional understandings of disease and treatment. The rapid advance of Molecular Medicine is overturning every part of the healthcare system, from research and clinical development through clinical practice and reimbursement, led by the new paradigm emerging from postgenomic biomedical science.

Where is the science leading us?

Traditional medicine is organized around specialties tied to organ systems or disease states, e.g., cardiovascular, gastroenterology, oncology, infectious disease, etc. Genomic science is challenging those traditional divisions. Diseases that are treated today by different medical specialties — such as some forms of retinal degeneration and colon cancer — are in fact more closely related at the level of genetics than they are to other diseases of the same organ.

The implications of this shift in understanding are profound for all the participants in our healthcare system:

  • Drug discovery and development must focus on the molecular causes or “mechanisms” of diseases, rather than symptoms
  • Disease mechanisms must be paired with rigorous clinically validated biomarkers for diagnosis and testing treatment efficacy
  • Diagnostics based on biomarkers must be effective and easy to deploy, and they must be reimbursed based on their value in preventing disease progression or improving treatment
  • Traditional regulatory guidelines must shift to encompass more focused and faster testing of compounds and diagnostics aimed at smaller mechanism-based patient populations
  • The deluge of data from the “omics” and from clinical medicine must be standardized, interoperable, and accessible
  • Patients must gain a in-depth understanding of their own genetic profiles and disease predispositions to be active partners in their own healthcare management
  • Personal information about genetic-based disease risk must have appropriate privacy protection

These issues, and many others related to them, cannot be solved in isolation: the full potential of Molecular Medicine can only be realized if all stakeholders identify common challenges and work together to identify solutions.