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Personalized Medicine - page 9

CISN Summary Of Personalized Medicine Section

Cancer researchers define the term 'personalized medicine' as:

"A process that analyzes a person's molecular information to determine the person's propensity for developing certain diseases, including a disease's potential onset and course. It also determines a person's propensity for responding to different drug therapies, by determining a patient's ability to metabolize drugs and/or likelihood of experiencing adverse drug reactions. The term personalized medicine is often used in place of the scientific term pharmacogenomics." - Quote from Jennifer Miller,PhD (Bioethicist)

Clinicians, healthcare specialists and advocates define the term more broadly and include all relevant clinical and environmental exposure information added to an individual's molecular profile.

Although personalized medicine is not yet ready for everyday use on a broad scale, research advances are rapid and the hope is that the science will move forward quickly so it can be in the clinic soon. Some examples are already in use and others will be as they move through clinical trials.

 

A. Personalized medicine offers a structural model for efficient healthcare.

  • It is preventive, coordinated, and evidence-based.
  • It relies on a network of electronic health records that link clinical and molecular information to help patients and physicians make optimal treatment decisions.
  • Bioinformatics becomes a critical part of this process. The mountains of genomic, proteomic and other OMIC data now being collected must be stored, analyzed and interpreted so it can be applied. To find out more about how bioinformatics fits into the practice of personalized medicine go to: http://cisncancer.org/research/what_we_know/omics/bioinformatics.html
  • It is proactive and participatory, engaging patients in lifestyle choices and active health maintenance to compensate for genetic susceptibilities.
  • Accurate predictions could be made about - susceptibility of developing a disease, the course of the disease, and its response to treatment.


 
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B. Personalized medicine covers all the bases

  • "Risk Assessment - What is my risk of developing cancer in my lifetime?
  • Screening - Do I have cancer cells in my body?
  • Differential Diagnostics - Are my cancer cells malignant and if so, what is the precise classification of my cancer?
  • Prognosis and Staging - Compared to other people with my classification, how aggressive is my case and what are the implications for treatment?
  • Treatment Selection - How do a range of possible therapies compare for me with respect to efficacy and safety?
  • Treatment Monitoring - Is my therapy having the desired effect, with acceptable toxicity?
  • Surveillance - Is my disease still in remission?" - Quote from: www.genomichealth.com

Cancer is a collection of more than 100 different diseases, and, for most cancers, the molecular characteristics have not been fully classified and there are no known or validated markers for early detection, treatment planning, or targeted therapy.

The diagnosis of cancers is still based largely on morphological examination of tumor biopsy specimens, as it has been for decades, but this approach has significant limitations for predicting a given tumor's potential for progression and response to treatment. Personalized medicine hopes to change this.

 

C. Important public policy issues around personalized medicine

Because personalized medicine relies on the collaboration of drug and device companies, new standards will be needed for the approval and reimbursement process of the newly created drug-device combinations.

     

 

  • New genetic tests need:
    • Validation
    • Reimbursement
    • Regulation
  • Consumer ethical issues:
    • Privacy concerns
    • Ownership
    • Allowed usage
    • Psychological impact
    • Access to testing
    • Access to results
    • Discrimination
  • Healthcare provider education needed
  • Public education needed
  • Bioinformatics and other structural changes needed
 
Image courtesy of National Human Research Institute    

 

D. Personalized medicine includes clinical, 'OMIC' and environmental information

Remember personalized medicine is 'about you'. That means all of your traditional clinical medical information, combined with your 'OMIC' information and influenced by your interaction with your environment.

 

E. Stakeholders:

It will be essential for diagnostics and pharmaceutical companies, payers, physicians, and patient groups to interact to create an environment that is favorable to both the basic research that is required for innovation of effective personalized medicine solutions, as well as their eventual commercialization.

     
 

Personalized medicine is often defined as "the right treatment for the right person at the right time."

Todays and tomorrows children will benefit from the research being conducted today.

     
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