Personalized/Precision Medicine at New Liberty Proteomics
Consider a common instance in which a given drug works for Patient A but not Patient B. Several possibilities present themselves, among them: misdiagnosis, disease differentiation within a given diagnosis, differential metabolism of the drug, or differential availability of the drug. Of this abbreviated list, the first two possibilities are potentially addressed by improved diagnostic tools. The latter two, however, could vary considerably for a given patient over time, or from patient to patient as a function of, e.g., age, weight, gender, diet, periodic physiological changes, or prior exposure to similar drugs. Indeed, this latter possiblity is embedded in clinical trial mandates by the USFDA, having seen that many drugs work better in some nations (India, China e.g.) than in others (US, Western Europe). Personalized Medicine must differentiate drug-resistant disease, and drug-resistant patients.
Does the treatment match the disease? Is the treatment effective for the Patient? These are the key questions for Personalized/Precision Medicine. Answering the first question certainly requires access to robust Diagnostics/Companion Diagnostics tools - tools that, for the most part, do not currently exist. The second question is likely the more challenging of the two, requiring drug activity assessments at a Personal level, preferably prior to administration of the drug. Answers for either question rely heavily on a thorough determination of Mechanism(s) of Action expressed by a drug under conditions relevant to human biology. Further, assessment methods must be employed that simultaneously reflect those Mechanisms and modulations of those Mechanisms on a patient to patient basis. The methods receiving the most attention for Personalized/Precision Medicine cannot meet these criteria (see “Pre-FALCON Personalized/Precision Medicine” below) and must be considered high-risk options. Only FALCON maintains biological relevance and generality from Screening through determination of Mechanisms of Action through development of Diagnostics/Companion Diagnostics. For the first time in the history of drug administration, powerful tools exist – RAPTOR AND RAVEN – to assess drug effectiveness against disease as manifest in a single patient.
FALCON achieves this game-changing status through the ability to assess disease and drug-related activity in samples of any complexity and/or derived from any source. Fundamental biological events – protein-anything interactions and/or degradation - can be quantitatively evaluated in Lysates, Extracts and Sera; in Intact Cells; or any desired tissue of interest from Patients: Blood, liver, lungs, muscle, CNS; . . . and even the Microbiome.
Pre-FALCON Personalized/Precision Medicine
Many voices praise the benefits of Personalized/Precision Medicine - without mentioning or realizing that it does not yet exist. Despite the clear need to match treatment to patient, drug selection is still largely hit-or-miss (see companion document, “Diagnostics/Companion Diagnostics at New Liberty Proteomics”). Two approaches dominate research efforts to match patient to treatment: genomics and protein identification/quantification. The use of genomics to diagnose disease per se does not appear promising in recent reports (misses 2/3 of previously diagnosed patients or adds one patient to 318 diagnosed by other methods). The need for alternative metrics is obvious. Identification and quantitation of proteins is still in the early stages, and methodology issues exist. In brief, the massive, potential payoff for full implementation of Personalized/Precision Medicine largely depends on only two approaches, both focused on extremely narrow aspects of human biology. How, for example, does either deal with the apparent profound influence of the Microbiome on disease and drug metabolism?
FALCON and Personalized/Precision Medicine
The heart of FALCON is quantitative detection of drug modulation of bio-activity via RAPTOR and RAVEN. This modulation establishes MOA’s and drives development of DX/CDx. The same approach applies to drug/disease effectiveness at the level of individual patients. Inter-patient testing can, as one example, establish elevated (or suppressed) drug metabolism in the gut. Other tests can point to preferential drug accumulation in, e.g., the liver or components of the bloodstream. Observations such as these, taken collectively, not only speak to the effectiveness of the drug within the individual, but can also suggest alternative delivery of the drug and/or suggest co-treatments. Finally, NLP recognizes the potential of alternate metrics and has established collaborative relationships in epigenetics, DNA/RNA sequencing, protein identification/quantitation, and the Microbiome. Taken in composite, the odds go up by orders of magnitude.
Personalized/Precision Medicine Cost-Effectiveness
The groundwork for implementation of Personalized/Precision Medicine begins on day one. Knowledge gained at each step of Drug Screening and Evaluation connects directly to subsequent assessments of drug performance in relevant, human tissues. Clinical application of FALCON integrates with existing clinical processes and the incremental cost is relatively minor – especially if clinically useful Diagnostics are forthcoming as an independent source of revenue.
The FALCON platform, built on the unique capabilities of RAPTOR and RAVEN, ushers in unexpected changes in drug development. NLP scientists are available to meet with your scientists (and managers with your managers) to devise a customized and cost-effective roadmap from day one through clinical trials – and, perhaps, beyond.
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