Methods and Systems for Providing Personalised Medicine to a Patient

Abstract

The present disclosure relates to methods and systems suitable for use in identifying and providing personalised medicine to a patient. In some aspects, systems and method generate a co-therapy regimen for a patient suffering from a disease or condition. An identification of a co-therapy suitable to treat the disease or condition is received. A desired patient endpoint and a patient position are received, wherein the patient position is defined relative to the desired patient endpoint. A dataset relating to the patient is stored. The dataset comprises one or more patient data based on patient-related measurements. The dataset, the patient position and the desired patient endpoint are processed to generate a regimen for the co-therapy. The regimen is stored in a database.

1 . A system for generating a co-therapy regimen for a patient suffering from a disease or condition, the system comprising at least one data processing device having at least one processor, wherein the system is configured to:
 a) receive an identification of a co-therapy suitable to treat the disease or condition;   b) receive a desired patient endpoint and a patient position, wherein the patient position is defined relative to the desired patient endpoint;   c) store a dataset relating to the patient, the dataset comprising one or more patient data based on patient-related measurements;   d) process the dataset, the patient position and the desired patient endpoint to generate a regimen for the co-therapy;   e) store the regimen in a database;   f) receive additional patient-related information;   g) update the dataset relating to the patient based on the additional patient-related information;   h) process the updated dataset, the patient position and the desired patient endpoint to generate an updated regimen for the co-therapy; and   i) store the updated regimen in the database;   wherein the co-therapy comprises a pharmacological therapy and one or more non-pharmacological therapies, wherein the one or more non-pharmacological therapies comprises cognitive behavioural therapy administered by an electronic device.   
     
     
         2 . (canceled) 
     
     
         3 . The system of  claim 1 , where the at least one data processing device is further configured to:
 process the updated dataset, the patient position and the desired patient endpoint to generate an updated regimen for the co-therapy if an elapsed time associate with the additional patient information exceeds a threshold value.   
     
     
         4 . The system of  claim 1 , wherein the system is further configured to:
 receive sensor data gathered by at least one sensor; and   determine at least one of the one or more patient data based at least in part on the received sensor data.   
     
     
         5 . The system of  claim 4 , wherein the at least one sensor is an environmental sensor and/or a physiological sensor. 
     
     
         6 . The system of  claim 5 , wherein the environmental sensor is any combination of a light sensor, a temperature sensor, an acoustic sensor, an accelerometer, an air pressure sensor, an airborne particulate sensor, a global positioning sensor, a humidity sensor, an electric field sensor, a magnetic field sensor, a moisture sensor, an air quality sensor, a sensor capable of detecting proximity to a WiFi transmitter and/or a cellular network base station, and a Geiger counter. 
     
     
         7 . The system of  claim 5 , wherein the physiological sensor is a biological or end-point based biomarker sensor. 
     
     
         8 . The system of  claim 1 , wherein the system further comprises a human interface device, and wherein the system is configured to output the regimen using the human interface device. 
     
     
         9 . The system of  claim 1 , wherein the system is configured to process the dataset, the patient position and the desired patient endpoint using a rule-based system to generate the regimen for the co-therapy. 
     
     
         10 . The system of  claim 1 , wherein the system is configured to process the dataset, the patient position and the desired patient endpoint using a machine learning algorithm to generate the regimen for the co-therapy. 
     
     
         11 . (canceled) 
     
     
         12 . The system of  claim 1 , wherein the disease or condition is selected from the group consisting of pre-diabetes; diabetes; cardiovascular disease; neurodegeneration diseases; atrial fibrillation; attention deficit hyperactivity disorder (ADHD); autoimmune diseases; chronic graft-versus-host disease; hepatitis; chronic kidney disease; arthritis and chronic osteoarticular diseases; cancer; obesity; asthma; sinusitis; cystic fibrosis; tuberculosis; chronic obstructive airways disease, bronchitis; bronchiolitis; pulmonary fibrosis; pain, including chronic pain syndromes; depression; eating disorders; polycystic ovary syndrome; epilepsy; fibromyalgia; viral diseases; Huntington's disease; hypotension; hypertension; allergic rhinitis; multiple sclerosis; fatigue states, including chronic fatigue syndrome; insomnia; narcolepsy; osteoporosis; periodontal disease; postural orthostatic tachycardia syndrome; sickle cell anaemia and other haemoglobin disorders; sleep apnoea; thyroid disease; reflux, including gastroesophageal reflux; vomiting; irritable bowel syndrome (IBS); inflammatory bowel disease (IBD); peptic ulcer; acute urticarial; atopic dermatitis; contact dermatitis; seborrheic dermatitis; headache, including migraine, cluster headache, and tension-type headache; addiction; thromboembolic disease; hair loss; hormone replacement therapy; psychiatric disorders; endocrine dysfunctions, including growth hormone deficiency, hypothyroidism; haematological disorders, including clotting factor deficiencies or low levels of white or red blood cells; neurodevelopmental delay (NDD) disorders, including Autistic Spectrum Disorder (ASD), Smith Magenis Syndrome and ADHD; parasomnias, including REM and NREM parasomnias and nightmare disorders; sleep movement disorders; chorea and tic disorders. 
     
     
         13 . The system of  claim 1 , wherein:
 a) the disease or condition is insomnia and the co-therapy comprises melatonin and cognitive behavioural therapy for insomnia (CBTi);   b) the disease or condition is diabetes and the co-therapy comprises metformin and cognitive behavioural therapy;   c) the disease or condition is hypertension and the co-therapy comprises amlodipine and cognitive behavioural therapy; or,   d) the disease or condition is opiate dependency and the co-therapy comprises:   (i) morphine and cognitive behavioural therapy; or,   (ii) morphine, an α 2  agonist and cognitive behavioural therapy.   
     
     
         14 . The system of  claim 1 , wherein the desired patient endpoint is amelioration of the disease or condition, amelioration of the symptoms associated with the disease or condition, amelioration of the side-effects of a pharmacological therapy, and/or amelioration of the side-effects of a non-pharmacological therapy. 
     
     
         15 . The system of  claim 1 , wherein the one or more patient-related measurements includes:
 a) one or more physiological measurements;   b) one or more patient-centred outcomes;   c) one or more environmental measurements; and/or,   d) one or more behavioural factor measurements.   
     
     
         16 . The system of  claim 15 , wherein the one or more patient-centred outcomes includes one or more patient-reported outcomes. 
     
     
         17 . The system of  claim 16 , wherein the system is further configured to map the one or more patient-reported outcomes onto a predefined scale to create mapped patient-reported outcomes, and wherein the one or more patient data stored in the dataset are based at least in part on the mapped patient-reported outcomes. 
     
     
         18 . The system of  claim 1 , wherein the system is configured to apply a weighting factor to each of the patient-related measurements in order to generate the patient data. 
     
     
         19 . A method of generating a co-therapy regimen for a patient suffering from a disease or condition, the method comprising the steps of:
 a) establishing a desired patient endpoint;   b) identifying the patient position relative to the desired patient endpoint;   c) generating or modifying a dataset relating to the patient, based on one or more patient-related measurements;   d) processing the dataset, the patient position and the desired patient endpoint to generate the co-therapy regimen;   e) receiving additional patient-related information;   f) updating the dataset relating to the patient based on the additional patient-related information;   g) processing the updated dataset, the patient position and the desired patient endpoint to generate an updated regimen for the co-therapy; and   i) storing the updated regimen in the database;   wherein the co-therapy comprises a pharmacological therapy and one or more non-pharmacological therapies, wherein the one or more non-pharmacological therapies comprises cognitive behavioural therapy administered by an electronic device.   
     
     
         20 . A method of treating a patient suffering from a disease or condition, the method comprising the steps of:
 a) selecting a co-therapy suitable to treat the disease or condition;   b) establishing a desired patient endpoint;   c) identifying the patient position relative to the desired patient endpoint;   d) generating or modifying a dataset relating to the patient, based on one or more patient-related measurements;   e) processing the dataset, the patient position and the desired patient endpoint to produce a regimen for the co-therapy; and,   f) administering the co-therapy to the patient according to the regimen;   wherein the co-therapy comprises a pharmacological therapy and one or more non-pharmacological therapies, wherein the one or more non-pharmacological therapies comprises cognitive behavioural therapy administered by an electronic device.   
     
     
         21 . The method of  claim 20 , wherein the method comprises a plurality of treatment cycles, wherein the treatment cycle comprises steps (c) to (f). 
     
     
         22 . The method of  claim 19 , wherein, in the processing step, the dataset, the patient position and the desired patient endpoint are processed using a rule-based system to produce the regimen for the co-therapy. 
     
     
         23 . The method of  claim 19 , wherein, in the processing step, the dataset, the patient position and the desired patient endpoint are processed using a machine learning algorithm to produce the regimen for the co-therapy. 
     
     
         24 . (canceled) 
     
     
         25 . The method of  claim 19 , wherein the disease or condition is selected from the group consisting of pre-diabetes; diabetes; cardiovascular disease; neurodegeneration diseases; atrial fibrillation; attention deficit hyperactivity disorder (ADHD); autoimmune diseases; chronic graft-versus-host disease; hepatitis; chronic kidney disease; arthritis and chronic osteoarticular diseases; cancer; obesity; asthma; sinusitis; cystic fibrosis; tuberculosis; chronic obstructive airways disease, bronchitis; bronchiolitis; pulmonary fibrosis; pain, including chronic pain syndromes; depression; eating disorders; polycystic ovary syndrome; epilepsy; fibromyalgia; viral diseases; Huntington's disease; hypotension; hypertension; allergic rhinitis; multiple sclerosis; fatigue states, including chronic fatigue syndrome; insomnia; narcolepsy; osteoporosis; periodontal disease; postural orthostatic tachycardia syndrome; sickle cell anaemia and other haemoglobin disorders; sleep apnoea; thyroid disease; reflux, including gastroesophageal reflux; vomiting; irritable bowel syndrome (IBS); inflammatory bowel disease (IBD); peptic ulcer; acute urticarial; atopic dermatitis; contact dermatitis; seborrheic dermatitis; headache, including migraine, cluster headache, and tension-type headache; addiction; thromboembolic disease; hair loss; hormone replacement therapy; psychiatric disorders; endocrine dysfunctions, including growth hormone deficiency, hypothyroidism; haematological disorders, including clotting factor deficiencies or low levels of white or red blood cells; neurodevelopmental delay (NDD) disorders, including Autistic Spectrum Disorder (ASD), Smith Magenis Syndrome and ADHD; parasomnias, including REM and NREM parasomnias and nightmare disorders; sleep movement disorders; chorea and tic disorders. 
     
     
         26 . The method of  claim 19 , wherein:
 a) the disease or condition is insomnia and the co-therapy comprises melatonin and cognitive behavioural therapy for insomnia (CBTi);   b) the disease or condition is diabetes and the co-therapy comprises metformin and cognitive behavioural therapy;   c) the disease or condition is diabetes or obesity and the co-therapy comprises a GLP1-agonist and cognitive behavioural therapy;   d) the disease or condition is diabetes or obesity and the co-therapy comprises a GLP1-agonis, metformin and cognitive behavioural therapy;   e) the disease or condition is hypertension and the co-therapy comprises amlodipine and cognitive behavioural therapy; or,   f) the disease or condition is opiate dependency and the co-therapy comprises:   (i) morphine and cognitive behavioural therapy; or,   (ii) morphine, an α 2  agonist and cognitive behavioural therapy.   
     
     
         27 . The method of  claim 19 , wherein the desired patient endpoint is amelioration of the disease or condition, amelioration of the symptoms associated with the disease or condition, amelioration of the side-effects of a pharmacological therapy, and/or amelioration of the side-effects of a non-pharmacological therapy. 
     
     
         28 . The method of  claim 19 , wherein the one or more patient-related measurements includes:
 a) one or more physiological measurements;   b) one or more patient-centred outcomes;   c) one or more environmental measurements; and/or,   d) one or more behavioural factor measurements.   
     
     
         29 . The method of  claim 28 , wherein the one or more patient-centred outcomes includes one or more patient-reported outcomes. 
     
     
         30 . The method of  claim 29 , further comprising:
 mapping the one or more patient-reported outcomes onto a predefined scale to create mapped patient-reported outcomes, and wherein the step of generating or modifying a dataset, based on one or more patient-related measurements comprises generating or modifying the dataset based on the mapped patient-reported outcomes.   
     
     
         31 . The method of  claim 19 , wherein the step of generating or modifying a dataset relating to the patient, based on one or more patient-related measurements, comprises applying a weighting factor to each of the one or more patient-related measurements.