# US 2006/0167637 A1 · System and methods for optimized drug delivery and progression of diseased and normal cells

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- Number: US 2006/0167637 A1
- Document ID: US20060167637A1
- Status: Published application
- Kind: A1
- Application number: 11/390,250
- Filed: 2006-03-28
- Published: 2006-07-27
- Earliest claimed: 2000-10-19
- Assignees: Optimata Ltd.
- Inventors: Zvia Agur; Sarel Fleishmann; Kirill Skomorovski; Moshe Vardi
- Web page: https://patentgrep.com/patent/US20060167637A1

## CPC

- G16H 50/50: for simulation or modelling of medical disorders
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Systems for recommending an optimal treatment protocol for a specific individual are disclosed. The systems comprise generally a system model, a plurality of treatment protocols, a system model modifier, wherein said system model is modified by the system model modifier based on parameters specific to the individual; and a selector to select an optimal treatment protocol from said plurality of treatment protocols based on the modified system model. Systems embodying the above techniques but for a general patient are also disclosed. Systems for a general patient and an individual for various specific diseases are disclosed. Methods and computer program products embodying the above techniques are also disclosed.

## Claims

### Claim 1

A computer system for recommending an optimal treatment protocol for an individual, said system interfacing with the computer and said system further comprising:
a system model;
a treatment protocol generator adapted to generate a plurality of treatment protocols;
a system model modifier, wherein said system model modifier is adapted to modify said system model based on parameters specific to the individual; and
a selector adapted to select an optimal treatment protocol from said plurality of treatment protocols based on the modified system model.

### Claim 2 (depends on 1)

The system of claim 1 wherein the system model further comprises:
a biological process model; and
a treatment model that is adapted to model effects of a treatment on said biological process.

### Claim 3 (depends on 2)

The system of claim 2, wherein said biological process model comprises mathematical models for biological processes affecting healthy cell populations and biological processes affecting diseased cell populations with at least one disease.

### Claim 4 (depends on 3)

The system of claim 3 wherein said healthy cell populations include bone-marrow cells and host tissue cells that are affected by said treatment model.

### Claim 5 (depends on 3)

The system of claim 3 wherein said diseased cell populations is one of cancer cells, and diseased bone-marrow cells.

### Claim 6 (depends on 2)

The system of claim 2, wherein said treatment model comprises treatment specific processes that affect cell populations.

### Claim 7 (depends on 6)

The system of claim 6 wherein said treatment specific process comprises interactions and associated biological processes involving one of a group consisting of pharmacokinetic interactions and processes, pharmacodynamic interactions and processes, cytostatic interactions and processes, cytotoxic interactions and processes, and methods of affecting cell biology and causing cell death.

### Claim 8 (depends on 1)

The system of claim 1 wherein, said parameters specific to the individual includes one selected from a group consisting of parameters related to biological process dynamics, patient specific drug pharmacokinetics, pharmacodynamics, and dynamics of dose-limiting host tissues.

### Claim 9 (depends on 8)

The method of claim 8, wherein said parameters related to biological process' dynamics comprise age, weight, gender, blood picture, desired length of treatment protocol, previous reaction to treatment, molecular markers, genetic markers, pathologic specifics and cytologic specifics.

### Claim 10 (depends on 1)

The system of claim 1, wherein the selector is adapted to incorporate user-specific parameters in performing selection.

### Claim 11 (depends on 10)

The system of claim 10 wherein said selector is adapted to incorporate user-specific parameters by using a fitness function.

### Claim 12 (depends on 11)

The system of claim 11 wherein said fitness function adapted to incorporate at least one parameter selected from a group consisting of patient survival, time to death, time to reach a specified disease stage, tumor load, pathogen load, cytotoxicity, side effects, quality of life, cost of treatment, and pain.

### Claim 13 (depends on 12)

The system of claim 12, wherein the system is adapted to receive user input for specific coefficients for said at least one parameter and the system is further adapted to adjust the fitness function to satisfy the user's goals.

### Claim 14 (depends on 10)

The system of claim 10, wherein the user-specific parameters are based on a user, said user being a medical doctor.

### Claim 15 (depends on 10)

The system of claim 10, wherein the user-specific parameters are based on a user, said user being a scientist.

### Claim 16 (depends on 10)

The system of claim 10, wherein the user-specific parameters are based on a user, said user being a drug developer.

### Claim 17 (depends on 1)

The system of claim 1 wherein said system is adapted to consider cytotoxic effects during selection of treatment protocols.

### Claim 18 (depends on 1)

The system of claim 1 wherein said system is adapted to consider drug efficacy during selection of treatment protocols.

### Claim 19 (depends on 1)

The system of claim 1, wherein the selector is adapted to use operation research methods for the selection.

### Claim 20 (depends on 1)

The system of claim 1, wherein the selector further comprises heuristics, said selector being adapted to use the heuristics for searching and selection.

### Claim 21 (depends on 20)

The system of claim 20 wherein, said heuristics comprise computational feasibility.

### Claim 22 (depends on 1)

The system of claim 1 wherein said recommendation comprises a combination of disease and treatment strategy, wherein said treatment strategy includes at least one of types of treatment, device, drug combination, treatment schedule and dosage.

### Claim 23 (depends on 1)

The system of claim 1, wherein, said system is adapted to be implemented over a distributed computing system.

### Claim 24 (depends on 23)

The system of claim 23, wherein the distributed computing system is the Internet.

### Claim 25 (depends on 23)

The system of claim 23, wherein the system is adapted to be used remotely by a user.

### Claim 26

A computer system for recommending an optimal treatment protocol for a general patient, said system interfacing with the computer and said system further comprising:
a system model;
a treatment protocol generator adapted to generate a plurality of treatment protocols; and
a selector to select an optimal treatment protocol from said plurality of treatment protocols based on the system model.

### Claim 27 (depends on 26)

The system of claim 26 wherein the system model further comprises:
a biological process model; and
a treatment model that is adapted to model the effects of a treatment on said biological process.

### Claim 28 (depends on 27)

The system of claim 27, wherein said biological process model comprises mathematical models for biological processes affecting healthy cell populations and biological processes affecting diseased cell populations with at least one disease.

### Claim 29 (depends on 28)

The system of claim 28 wherein said healthy cell populations include bone-marrow cells and host tissue cells that are affected by said treatment model.

### Claim 30 (depends on 28)

The system of claim 28 wherein said diseased cell populations is one of cancer cells, and diseased bone-marrow cells.

### Claim 31 (depends on 27)

The system of claim 27, wherein said treatment model comprises treatment specific processes that affect cell populations.

### Claim 32 (depends on 31)

The system of claim 31 wherein said treatment specific process comprises interactions and associated biological processes involving one of a group consisting of pharmacokinetic interactions and processes, pharmacodynamic interactions and processes, cytostatic interactions and processes, cytotoxic interactions and processes, and methods of affecting cell biology and causing cell death.

### Claim 33 (depends on 26)

The system of claim 26, wherein the selector is adapted to incorporate user-specific parameters in performing selection.

### Claim 34 (depends on 33)

The system of claim 33 wherein said selector is adapted to incorporate user-specific parameters by using a fitness function.

### Claim 35 (depends on 34)

The system of claim 34 wherein said fitness function is a function of at least one parameter selected from a group consisting of patient survival, time to death, time to reach a specified disease stage, tumor load, pathogen load, cytotoxicity, side effects, quality of life, cost of treatment and pain.

### Claim 36 (depends on 35)

The system of claim 35, wherein the system is adapted to receive user input for specific coefficients for said at least one parameter and the system is further adapted to adjust the fitness function to satisfy the user's goals.

### Claim 37 (depends on 33)

The system of claim 33, wherein the user-specific parameters are based on a user, said user being a medical doctor.

### Claim 38 (depends on 33)

The system of claim 33, wherein the user-specific parameters are based on a user, said user being a scientist.

### Claim 39 (depends on 33)

The system of claim 33, wherein the user-specific parameters are based on a user, said user being a drug developer.

### Claim 40 (depends on 26)

The system of claim 26 wherein said system is adapted to consider cytotoxic effects during selection of treatment protocols.

### Claim 41 (depends on 26)

The system of claim 26 wherein said system is adapted to consider drug efficacy during selection of treatment protocols.

### Claim 42 (depends on 26)

The system of claim 26, wherein the selector is adapted to use operation research methods for the selection.

### Claim 43 (depends on 26)

The system of claim 26, wherein the selector further comprises heuristics, said selector being adapted to use the heuristics for searching and selection.

### Claim 44 (depends on 43)

The system of claim 43 wherein, said heuristics comprise computational feasibility.

### Claim 45 (depends on 26)

The system of claim 26 wherein said recommendation is a combination of disease and treatment strategy, wherein said treatment strategy includes at least one of types of treatment, device, drug combination, treatment schedule and dosage.

### Claim 46 (depends on 26)

The system of claim 26, wherein, said system is adapted to be implemented over a distributed computing system.

### Claim 47 (depends on 46)

The system of claim 46, wherein the distributed computing system is the Internet.

### Claim 48 (depends on 46)

The system of claim 46, wherein the system is adapted to be used remotely by a user.

### Claim 49 (depends on 48)

The system of claim 48, wherein the remote system is a telephone

### Claim 50

A computer-implemented method of recommending an optimal treatment protocol for an individual comprising:
creating a system model;
enumerating a plurality of treatment protocols;
modifying the system model based on parameters specific to the individual;
selecting an optimal treatment protocol from said plurality of treatment protocols based on the modified system model and recommending said optimal treatment.

### Claim 51 (depends on 50)

The method of claim 50 wherein the step of creating the system model further comprises:
modelling a biological process; and
modelling effects of a treatment on said biological process.

### Claim 52 (depends on 51)

The method of claim 51, wherein said modelling of biological processes is done by mathematically modelling biological processes affecting healthy cell populations and mathematically modelling biological processes affecting diseased cell populations with at least one disease.

### Claim 53 (depends on 52)

The method of claim 52 wherein said healthy cell populations include bone-marrow cells and host tissue cells that are affected by said treatment model.

### Claim 54 (depends on 52)

The method of claim 52 wherein said diseased cell populations is one of cancer cells, and diseased bone-marrow cells.

### Claim 55 (depends on 51)

The method of claim 51, wherein said treatment models comprise treatment specific processes that affect cell populations.

### Claim 56 (depends on 55)

The method of claim 55 wherein said treatment specific process is interactions and associated biological processes involving one of a group consisting of pharmacokinetic interactions and processes, pharmacodynamic interactions and processes, cytostatic interactions and processes, cytotoxic interactions and processes, and methods of affecting cell biology and causing cell death.

### Claim 57 (depends on 50)

The method of claim 50 wherein, said parameters specific to the individual include one or more selected from a group consisting of parameters related to biological process dynamics, patient specific drug pharmacokinetics, pharmacodynamics and dynamics of dose-limiting host tissues.

### Claim 58 (depends on 57)

The method of claim 57, wherein said parameters related to biological process' dynamics comprise age, weight, gender, blood picture, desired length of treatment protocol, previous reaction to treatment, molecular markers, genetic markers, pathologic specifics and cytologic specifics.

### Claim 59 (depends on 50)

The method of claim 50, wherein user-specific parameters are used in selecting the optimal treatment.

### Claim 60 (depends on 59)

The method of claim 59 wherein a fitness function is used to perform the selection.

### Claim 61 (depends on 60)

The method of claim 60 wherein said fitness function incorporates at least one parameter selected from a group consisting patient survival, time to death, time to reach a specified disease stage, tumor load, pathogen load, cytotoxicity, side effects, quality of life, cost of treatment and pain.

### Claim 62 (depends on 61)

The method of claim 61, wherein a user can input specific coefficients for said at least one parameter to adjust the fitness function to satisfy the user's goals.

### Claim 63 (depends on 59)

The method of claim 59, wherein the user-specific parameters are based on a user, said user being a medical doctor.

### Claim 64 (depends on 59)

The method of claim 59, wherein the user-specific parameters are based on a user, said user being a scientist.

### Claim 65 (depends on 59)

The method of claim 59, wherein the user-specific parameters are based on a user, said user being a drug developer.

### Claim 66 (depends on 50)

The method of claim 50 wherein said system is adapted to consider cytotoxic effects during selection of treatment protocols.

### Claim 67 (depends on 50)

The method of claim 50 wherein said system is adapted to consider drug efficacy during selection of treatment protocols.

### Claim 68 (depends on 50)

The method of claim 50, wherein operation research techniques are used in performing the selection.

### Claim 69 (depends on 50)

The method of claim 50, wherein heuristics are used to perform searching and selection.

### Claim 70 (depends on 69)

The method of claim 69 wherein, said heuristics comprise computational feasibility.

### Claim 71 (depends on 50)

The method of claim 50 wherein said recommendation is a combination of disease and treatment strategy, wherein said treatment strategy includes at least one of types of treatment, device, drug combination, treatment schedule and dosage.

### Claim 72

A computer-implemented method of recommending an optimal treatment protocol for a general patient comprising:
creating a system model;
enumerating a plurality of treatment protocols;
selecting an optimal treatment protocol from said plurality of treatment protocols based on the modified system model; and
recommending said optimal treatment.

### Claim 73 (depends on 72)

The method of claim 72 wherein the step of creating the system model further comprises:
modelling a biological process; and
modelling effects of a treatment on said biological process.

### Claim 74 (depends on 73)

The method of claim 73, wherein said modelling of biological processes is done by mathematically modelling biological processes affecting healthy cell populations and mathematically modelling biological processes affecting diseased cell populations with at least one disease.

### Claim 75 (depends on 74)

The method of claim 74 wherein said healthy cell populations include bone-marrow cells and host tissue cells that are affected by said treatment model.

### Claim 76 (depends on 74)

The method of claim 74 wherein said diseased cell populations with at least one disease is one of cancer cells, and diseased bone-marrow cells.

### Claim 77 (depends on 73)

The method of claim 73, wherein said treatment models comprise treatment specific processes that affect cell populations.

### Claim 78 (depends on 77)

The method of claim 77 wherein said treatment specific process is interactions and associated biological processes involving one of a group consisting of pharmacokinetic interactions and processes, pharmacodynamic interactions and processes, cytostatic interactions and processes, cytotoxic interactions and processes, and methods of affecting cell biology and causing cell death.

### Claim 79 (depends on 72)

The method of claim 72, wherein user-specific parameters are used in selecting the optimal treatment.

### Claim 80 (depends on 79)

The method of claim 79 wherein a fitness function is used to perform the selection.

### Claim 81 (depends on 80)

The method of claim 80 wherein said fitness function incorporates at least one parameter selected from a group consisting of patient survival, time to death, time to reach a specified disease stage, tumor load, pathogen load, cytotoxicity, side effects, quality of life, cost of treatment and pain.

### Claim 82 (depends on 81)

The method of claim 81, wherein a user can input specific coefficients for said at least one parameter to adjust the fitness function to satisfy the user's goals.

### Claim 83 (depends on 79)

The method of claim 79, wherein the user-specific parameters are based on a user, said user being a medical doctor.

### Claim 84 (depends on 79)

The method of claim 79, wherein the user-specific parameters are based on a user, said user being a scientist.

### Claim 85 (depends on 79)

The method of claim 79, wherein the user-specific parameters are based on a user, said user being a drug developer.

### Claim 86 (depends on 72)

The method of claim 72 wherein said system is adapted to consider cytotoxic effects during selection of treatment protocols.

### Claim 87 (depends on 72)

The method of claim 72 wherein said system is adapted to consider drug efficacy during selection of treatment protocols.

### Claim 88 (depends on 72)

The method of claim 72, wherein operation research techniques are used in performing the selection.

### Claim 89 (depends on 72)

The method of claim 72, wherein heuristics are used to perform searching and selection.

### Claim 90 (depends on 89)

The method of claim 89 wherein, said heuristics comprise computational feasibility.

### Claim 91 (depends on 72)

The method of claim 72 wherein said recommendation is a combination of disease and treatment strategy, wherein said treatment strategy includes at least one of types of treatment, device, drug combination, treatment schedule and dosage.

### Claim 92

A computer program product, including a computer readable medium, said program product comprising a set of instruction to enable a computer system to aid in recommending an optimal treatment protocol for an individual comprising:
a system model code;
treatment protocol generator code for generating a plurality of treatment protocols;
a system model modifier code, wherein said system model code is adapted to modify the system model based on parameters specific to the individual to generate a modified system model code; and
a selector code to select an optimal treatment protocol from said plurality of treatment protocols based on the modified system model.

### Claim 93 (depends on 92)

The computer program product of claim 92 wherein the system model code further comprises:
a biological process model code; and
a treatment model code that enables a computer to model the effects of a treatment on the biological process.

### Claim 94

A computer program product, including a computer readable medium, said program product comprising a set of instructions to enable a computer system to aid in recommending an optimal treatment protocol for a general patient comprising:
a system model code;
treatment protocol generator code for a generating a plurality of treatment protocols; and
a selector code to select an optimal treatment protocol from said plurality of treatment protocols.

### Claim 95 (depends on 94)

The computer program product of claim 94 wherein the system model code further comprises:
a biological process model code; and
a treatment model code that enables a computer to model the effects of a treatment on the biological process.
