Information management device and computer program

The information management device and computer program optimize cancer immunotherapy scheduling by predicting and managing cell processing times, facilitating early treatment for cancer patients.

JP7670273B2Active Publication Date: 2025-04-30PHC CORP +1
View PDF 3 Cites 0 Cited by

Patent Information

Application Number
JP2023511291
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-03-31
Filing Date
2022-03-28
Publication Date
2025-04-30
Estimated Expiration
2042-03-28

AI Technical Summary

Technical Problem

Cancer immunotherapy using modified immune cells requires significant time for mass-synthesizing and mass-culturing steps, which can delay treatment for severe cancer patients, necessitating efficient management to expedite treatment scheduling.

Method used

An information management device and computer program that predict and schedule treatment based on time information associated with obtaining and culturing cells from cancer patients, using attribute information to optimize treatment timelines.

Benefits of technology

Enables efficient management of personalized medicine by predicting and scheduling cancer treatments promptly, ensuring early treatment for patients and institutions.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure 0007670273000004
    Figure 0007670273000004
  • Figure 0007670273000005
    Figure 0007670273000005
  • Figure 0007670273000006
    Figure 0007670273000006
Patent Text Reader

Abstract

An information management device according to the present invention is equipped with at least one processor and causes the at least one processor to function so as to acquire, on the basis of a first cell acquired from a cancer patient, first time information pertaining to the time required to acquire a prescribed amount of at least one specific nucleic acid and second time information pertaining to the time required to culture second cells different from the first cell until a prescribed amount is reached, and so as to associate the first time information and the second time information with attribute information of the cancer patient and store the result as individual patient information.
Need to check novelty before this filing date? Find Prior Art

Description

[Technical field]

[0001] The present disclosure relates to an information management device and a computer program. [Background technology]

[0002] Recently, research on so-called personalized medicine, in which cancer patients suffering from cancer are given treatments tailored to each cancer patient based on sequence information of the cancer tissue, has been actively conducted. As an example of personalized medicine for cancer, a cancer immunotherapy using modified immune cells with partially modified base sequences (polynucleotide sequences) (hereinafter, sometimes referred to as "base sequence modified immune cells" or "modified immune cells") is known.

[0003] As an example of cancer immunotherapy using immune cells with modified base sequences, modified base sequence T cell therapy is known. In short, modified base sequence T cell therapy is a therapy in which T cells are obtained from a cancer patient, the base sequence of the T cells is modified by introducing the base sequence of a molecule (such as a T cell receptor) that recognizes a cancer antigen into the T cells, and the cells with modified base sequences are infused back into the cancer patient. As a specific modified base sequence T cell therapy, for example, the pamphlet of International Publication No. 2008 / 153029 discloses T cell receptor (T cell receptor: TCR)-T cell therapy (TCR-T cell therapy). Summary of the Invention [Problem to be solved by the invention]

[0004] However, cancer immunotherapy, an example of personalized medicine using immune cells with modified base sequences, requires at least a step of mass-synthesizing the base sequences of molecules (such as T cell receptors) that recognize cancer antigens, and a step of mass-culturing the cells to be modified, such as T cells. Although the time (number of days) required for each of these steps varies from person to person, it is generally on the level of several days or several weeks. Therefore, for cancer patients, particularly those with severe cancer, it is desirable to efficiently manage these steps in terms of time so that treatment can be administered as early as possible.

[0005] In addition to providing early treatment to cancer patients, it is preferable to clearly indicate a specific early treatment schedule to cancer patients (and their families). This also applies to medical institutions, cell manufacturing companies, cell manufacturing and sales companies, etc. that provide treatment to a large number of cancer patients.

[0006] Therefore, various embodiments provide an information management device and a computer program capable of efficiently managing personalized medicine. [Means for solving the problem]

[0007] The present disclosure provides the following aspects. An information management device according to an embodiment of the present disclosure includes: At least one processor; The processor: First time information on the time required for a first operation to be performed at a first institution, the first operation being to obtain a predetermined amount of at least one specific nucleic acid based on a first cell obtained from a cancer patient; second time information relating to a time required for a second operation performed in parallel with the first operation at a second institution, the second operation being to culture second cells obtained from the cancer patient and different from the first cells until a predetermined amount is reached; Get the first time information and the second time information are associated with attribute information of the cancer patient and stored as individual patient information; An information management device that causes the at least one processor to function as described above, The processor, predicting the first time information and the second time information regarding a new cancer patient based on a plurality of stored individual patient information; creating a treatment schedule for the new cancer patient based on the first time information and the second time information regarding the predicted new cancer patient; Present the created treatment schedule to the first institution and the second institution; and causing the at least one processor to do.

[0008] In addition, in one embodiment of the information management device, the first time information includes at least one of first detailed time information regarding the time required to culture the first cell until it reaches a predetermined amount, and second detailed time information regarding the time required to synthesize the specific nucleic acid contained in the first cell until it reaches a predetermined amount. In addition, in one embodiment of the information management device, the attribute information includes at least one selected from the group consisting of age information, cancer type information, information on the amount of the first cell obtained, immune information of the cancer patient, and cancer progression information. In the information management device according to one embodiment, the first cell is an immunocompetent cell contained in cancer tissue.

[0009] In the information management device according to one embodiment, the first cell is at least one selected from the group consisting of a T cell, a B cell, a dendritic cell, and a macrophage. In addition, in the information processing device according to one embodiment, the second cell is a cell obtained from the cancer patient. In the information management device according to one embodiment, the second cells are at least one selected from the group consisting of T cells, B cells, dendritic cells, and macrophages.

[0010] In addition, in one embodiment, the information management device causes the at least one processor to function to calculate at least one of first correlation information regarding the correlation between the first time information and the attribute information, and second correlation information regarding the correlation between the second time information and the attribute information, based on the stored plurality of individual patient information. In addition, in one embodiment of the information management device, the first correlation information includes at least one of first detailed correlation information regarding the correlation between first detailed time information regarding the time required to culture the first cell until it reaches a predetermined amount and the attribute information, and second detailed correlation information regarding the correlation between second detailed time information regarding the time required to synthesize the specific nucleic acid contained in the first cell until it reaches a predetermined amount and the attribute information. In addition, in one embodiment, the information management device causes the at least one processor to function to output a first prediction value regarding the first temporal information of the new cancer patient based on the attribute information of the new cancer patient and the first correlation information.

[0011] Moreover, in one embodiment of the information management device, the first prediction value includes at least one of a first detailed prediction value for the first detailed time information of the new cancer patient, which is calculated based on the attribute information of the new cancer patient and first detailed correlation information regarding the correlation between the attribute information and first detailed time information regarding the time required to culture the first cell until it reaches a predetermined amount, and the attribute information, and a second detailed prediction value for the second detailed time information of the new cancer patient, which is calculated based on the attribute information of the new cancer patient and second detailed correlation information regarding the correlation between the attribute information and second detailed time information regarding the time required to synthesize the specific nucleic acid contained in the first cell until it reaches the predetermined amount. In addition, in one embodiment, the information management device causes the at least one processor to function to output a second prediction value regarding the second temporal information of the new cancer patient based on the attribute information of the new cancer patient and the second correlation information. In addition, in one embodiment, the information management device causes the at least one processor to function to output at least a portion of a treatment schedule for the new cancer patient based on at least one of the first predicted value and the second predicted value.

[0012] In addition, in one embodiment, the information management device causes the at least one processor to function to transmit at least one of the first predicted value and the second predicted value via a communication line to at least one of a terminal device of the new cancer patient and a terminal device of a medical institution treating the new cancer patient. In addition, in one embodiment, the information management device causes at least one processor to function to transmit at least a portion of the treatment schedule via a communication line to at least one of a terminal device of the new cancer patient and a terminal device of a medical institution treating the new cancer patient. In addition, in the information management device according to one aspect, the at least one processor may be caused to function so that at least one of the pieces of attribute information is anonymized and then stored. In addition, in the information management device of one embodiment, the at least one processor may be caused to function so that the cancer patients and the new cancer patients can refer to their own attribute information from which the anonymization processing has been removed. The attribute information of the cancer patient is mutually anonymized in a group and multiple groups composed of the attribute information of the cancer patient, and is stored in a memory unit as anonymized information that does not identify the individual cancer patient in a comparative analysis of the attribute information of the cancer patient and the group; on the other hand, the attribute information of the cancer patient labeled with the consent information of the cancer patient, the doctor, and the cancer patient's family can be viewed by the doctor, the cancer patient, or their family members by the processor, which confirms the match between the information decoding unit and the consent information in the memory unit, and the attribute information of cancer patients other than the doctor, cannot be viewed, ensuring anonymity.

[0013] A computer program according to an embodiment of the present disclosure includes: At least one processor is executed to First time information on the time required for a first operation to be performed at a first institution, the first operation being to obtain a predetermined amount of at least one specific nucleic acid based on a first cell obtained from a cancer patient; second time information relating to a time required for a second operation performed in parallel with the first operation at a second institution, the second operation being to culture second cells obtained from the cancer patient and different from the first cells until a predetermined amount is reached; Get storing the first time information and the second time information as individual patient information in association with attribute information of the cancer patient; predicting the first time information and the second time information regarding a new cancer patient based on a plurality of stored individual patient information; creating a treatment schedule for the new cancer patient based on the first time information and the second time information regarding the predicted new cancer patient; Present the created treatment schedule to the first institution and the second institution; The at least one processor is configured to: Effect of the Invention

[0014] According to the present disclosure, it is possible to provide an information management device and a computer program capable of efficiently managing personalized medicine. [Brief description of the drawings]

[0015] [Figure 1] 1 is a block diagram showing an example of a configuration of an information management system including an information management device according to an embodiment. [Diagram 2] 1 is a block diagram showing an example of a configuration of an information management system including an information management device according to an embodiment. [Diagram 3] 2 is a diagram showing an example of an analysis result obtained in an analysis step in the information management system shown in FIG. 1. [Figure 4] 2 is a block diagram illustrating an example of a function of the information management device illustrated in FIG. 1. [Diagram 5] 2 is a schematic diagram showing an example of individual patient information for each cancer patient stored by the information management device 100 shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] In this disclosure, a numerical range indicated using "~" indicates a range including the numerical values ​​before and after "~" as the minimum and maximum values, respectively. In this disclosure, the content of each component in various substances means the total amount of the multiple components present in the substance when multiple components corresponding to each component are present in the substance, unless otherwise specified. In this disclosure, the term "process" includes not only an independent process, but also a process that cannot be clearly distinguished from other processes as long as the desired effect of the process is achieved.

[0017] Various embodiments will be described below with reference to the accompanying drawings. The same reference numerals are used to designate components common to the drawings. It should also be noted that components depicted in one drawing may be omitted in another drawing for ease of explanation. It should also be noted that the accompanying drawings are not necessarily drawn to scale. In this disclosure, the term application may be referred to as software or a program, and may be instructions for a computer that are combined to achieve a certain result.

[0018] 1. Configuration of information management device and information management system including said information management device An information management device according to an embodiment of the present disclosure and an information management system including the information management device will be described in detail with reference to Figs. 1 to 5. Figs. 1 and 2 are block diagrams showing an example of a configuration of an information management system 1 including an information management device 100 according to an embodiment. Fig. 3 is a diagram showing an example of an analysis result obtained in an analysis process in the information management system 1 shown in Fig. 1. Fig. 4 is a block diagram showing an example of a function of the information management device 100 shown in Fig. 1. Fig. 5 is a schematic diagram showing an example of individual patient information for each cancer patient stored by the information management device 100 shown in Fig. 1.

[0019] The information management system 1 and the information management device 100 can be applied to, but are not limited to, TCR-T cell therapy, which is an example of a therapy using immune cells with modified base sequences, and can be applied to other personalized medicines such as CAR (Chimeric Antigen Receptor)-T cell therapy. The information management system 1 and the information management device 100 shown in Fig. 1 can be applied without limitation to a therapy that includes two or more processes (steps) for culturing cells.

[0020] The information management system 1 and the information management device 100 disclosed in the present disclosure will be described below for convenience in association with TCR-T cell therapy as an example of personalized medicine. Note that the series of TCR-T cell therapies shown in FIG. 1 and the like are merely examples. In other words, it should be noted that the information management system 1 and the information management device 100 disclosed in the present disclosure can also be applied to personalized medicine in a case where the first cell described later is a cell other than the cancer tissue of the cancer patient P1, personalized medicine in a case where the second cell described later is a cell of a person other than the cancer patient P1, and the like.

[0021] 1-1. As an example, regarding the work, treatment, etc. performed at the first medical institution 10 (regarding information stored in the terminal device 11) In the TCR-T cell therapy, first, T cells (first cells) contained in a part of the cancer tissue (all of the cancer tissue when the cancer is completely removed) from a cancer patient P1 are obtained, for example, at a first medical institution 10. Next, the cancer tissue is subjected to, for example, a fluorescence activated cell sorting method using a FACS (Fluorescence Activated Cell Sorter) (registered trademark), to select T cells from various cell types contained in the cancer tissue. An antigen receptor molecule, TCR, capable of recognizing a cancer antigen is expressed on the cell membrane of the selected T cells. However, not all of the TCRs obtained from the cancer patient P1 can recognize the cancer antigen. For this reason, a separate analysis is required for each cancer patient to clarify which TCR can recognize the cancer antigen (whether it is effective in cancer treatment).

[0022] For such an analysis, it is necessary to prepare a sufficient amount of T cells (i.e., polynucleotides encoding TCR). Therefore, in TCR-T cell therapy, as shown in FIG. 1, T cells obtained from a cancer patient P1 and selected by FACS are cultured until they increase to a sufficient amount for the analysis. If a sufficient amount of T cells has already been prepared (in advance), the culture is not necessary. In FIG. 1, T cells are selected from a cancer tissue obtained from a cancer patient P1 by FACS15, and a specific amount of the selected T cells (state "X1") are cultured to obtain (proliferate) more T cells, resulting in a state "X2." The culture process for increasing the T cells from the state "X1" to the state "X2" is represented as "Process A." For the T cells that have increased to a predetermined amount by culturing, for example, mRNA is extracted from the T cells, and sequence information of the obtained mRNA is analyzed by a base sequence analyzer to extract sequence information related to the TCR. FIG. 3 is an example of an analysis result showing what type and to what extent TCRs are contained in T cells in state X2, as determined by subjecting the cells to a fluorescence activated cell sorting method using FACS (Fluorescence Activated Cell Sorter) (registered trademark). The polynucleotide encoding the target TCR may be extracted based only on the polynucleotide sequence information based on sequence information analysis, may be extracted based on the obtained polynucleotide, or may be extracted based on both the sequence information and the obtained polynucleotide. The polynucleotide encoding the TCR is not limited to mRNA, and may be DNA.

[0023] Next, among the polynucleotides (hereinafter referred to as TCR polynucleotides) encoding TCRs identified by the analysis using the base sequence analyzer, the TCR polynucleotides effective in cancer treatment for the cancer patient P1 (capable of recognizing a cancer antigen in the cancer tissue of the cancer patient P1) can be identified as those with a high TCR expression level, for example. The TCR polynucleotides identified by this identification need not necessarily be one type, but may be multiple types. The TCR polynucleotides that can be identified may be those with the highest expression level, or may not be those with the highest expression level. With regard to the above-mentioned analysis and a series of work states up to the work of identifying the TCR polynucleotides effective in cancer treatment for the cancer patient P1, in FIG. 1, the state in which mRNA is extracted from the cultured T cells is represented as "X3". In addition, in FIG. 1, the process related to this analysis and the work process of identifying the TCR polynucleotide or the TCR base sequence encoding it are collectively represented as "process D".

[0024] Here, in step A, the "predetermined amount" when culturing T cells to a predetermined amount is not particularly limited as long as the above-mentioned analytical operation regarding the TCR base sequence can be performed using a base sequence analyzer, and may be appropriately changed depending on the analytical device used for the analytical operation, etc.

[0025] Next, when a TCR polynucleotide effective for cancer treatment of cancer patient P1 is identified, the identified TCR polynucleotide is increased to a predetermined amount. In this case, the "predetermined amount" is appropriately set in consideration of an amount sufficient for generating T cells with modified nucleotide sequences (an amount sufficient for generating T cells with modified nucleotide sequences required for administration to cancer patient P1) as described below.

[0026] As a method for increasing the identified TCR polynucleotide to a predetermined amount, in the case shown in Figure 1, a method of separately synthesizing the identified TCR polynucleotide at the first medical institution 10 or another location can be used as an example. In Figure 1, the state of increasing the identified TCR polynucleotide in the above-mentioned "X3" state to a predetermined amount is shown as "X4", and the process of increasing only the specific TCR polynucleotide to the "X4" state is shown as "Process B".

[0027] Regarding TCR-T cell therapy, a series of operations including "Step A", "Step B", and "Step D" and managing the states of "X1" to "X4" regarding T cells and TCR polynucleotides may be performed, as an example, at the first medical institution 10 in Fig. 1, but is not limited to this. In other words, at least one of "Step A", "Step B", and "Step D" may be performed at a location other than the first medical institution 10, and, for example, an operation of identifying a TCR base sequence or TCR polynucleotide related to the state of "X3" may be performed at a location other than the first medical institution 10.

[0028] In the information management system 1 according to an embodiment shown in Fig. 1, it is assumed that a terminal device 11 is installed in a first medical institution 10. Attribute information of a cancer patient P1, information related to the above-mentioned "Process A", "Process B", and "Process D" performed in the first medical institution 10, etc. can be input and stored in the terminal device 11. The hardware configuration of the terminal device 11 is basically the same as the hardware configuration of the information management device 100 described later.

[0029] The attribute information of the cancer patient P1 may include at least one of various information related to the name, age, cancer type, amount of T cells acquired (amount of T cells acquired in the above-mentioned "X1" state), immune information of the cancer patient P1, cancer progression (cancer stage), and the like, without limitation. The immune information may be determined, for example, based on the number of lymphocytes. In this case, for example, if the number of lymphocytes is below a predetermined number, it may be determined that the immune state is poor, etc. Information related to "Process A", "Process B", and "Process D" that may be input to the terminal device 11 includes information (first time information) related to the total time (total number of days) required for each process. Furthermore, the first time information may include information (first detailed time information) related to the time required for "Process A" and information (second detailed time information) related to the time required for "Process B". Information regarding the time required for "Step D" (third detailed time information) is basically not information that changes depending on the cancer patient, and therefore does not necessarily have to be input (stored) in terminal device 11 (the third detailed time information does not necessarily have to be included in the first time information).

[0030] The terminal device 11 does not necessarily need to be physically installed in the first medical institution 10, and may be a cloud server (server device) in an environment in which electromagnetic communication is possible via a communication line. The terminal device 11 is also connectable to an information management device 100, the details of which will be described later, via a communication line.

[0031] Regarding "Step A", existing methods can be appropriately used for the culture conditions, culture apparatus, specific culture process, etc. for culturing T cells. Regarding "Step B", existing methods can be appropriately used for the specific synthesis method, synthesis apparatus, specific synthesis process, etc. for synthesizing TCR polynucleotides.

[0032] Incidentally, with regard to the work, treatment, etc., performed in the first medical institution 10 shown in Fig. 1 as an example, a case as shown in Fig. 2 may also be assumed. In short, the work, treatment, etc., performed in the first medical institution 10 shown in Fig. 2 as an example, omits "Step B" shown in Fig. 1.

[0033] Specifically, in the work, treatment, etc. shown in FIG. 2, T cells obtained from a cancer patient P1 and selected by FACS15 are cultured and increased in advance in large quantities to an extent that it is possible to directly obtain a sufficient amount of TCR polynucleotides not only for the above-mentioned analysis work but also for generating T cells with modified base sequences (TCR-T cells). In FIG. 2, a state "X1" of a specific amount of T cells obtained from a cancer patient P1 and selected by FACS15 is cultured to generate (proliferate) a much larger amount of T cells than the amount of T cells in the state "X2" in FIG. 1, resulting in a state "X2a", and the culture step of increasing the T cells from the state "X1" to the state "X2a" is represented as "Step Aa". At the same time as the T cells are cultured, TCR polynucleotides are biosynthesized in the T cells. By subjecting a large amount of T cells obtained by mass culture to the above-mentioned base sequence analyzer, it is possible to analyze what kind and how much of the TCR is contained in the large amount of T cells obtained, as in the case described with reference to FIG. 1.

[0034] Next, among the TCR polynucleotides identified by the analysis using the base sequence analyzer, TCR base sequences effective for cancer treatment of the cancer patient P1 (capable of recognizing a cancer antigen in the cancer tissue of the cancer patient P1) are identified, for example, in the order of the expression level of TCR, as described above. When a TCR base sequence effective for cancer treatment of the cancer patient P1 is identified, only the TCR polynucleotide of the identified TCR base sequence is extracted. Here, in the case of FIG. 2, as described above, a large amount of T cells are cultured in step Aa, and TCR polynucleotides are also biosynthesized in a large amount of T cells. Therefore, in the case of FIG. 2, since a considerable amount of the identified TCR polynucleotide is extracted as described above, unlike the case of FIG. 1, it is not necessary to separately synthesize the identified TCR polynucleotide until it reaches a predetermined amount, and "step B" in FIG. 1 is not necessary. In FIG. 2, the steps related to the analysis, the work step of identifying the TCR base sequence, and the step of extracting the identified TCR polynucleotide are collectively referred to as "step Da".

[0035] In the case shown in Fig. 2, attribute information of the cancer patient P1, information related to the above-mentioned "step Aa" and "step Da" performed in the first medical institution 10, etc. can be input and stored in the terminal device 11. Information related to "step Da" means information related to the time required for "step Da" (fourth detailed time information), and since the fourth detailed time information is not basically information that changes depending on the cancer patient, it does not necessarily have to be input (stored) in the terminal device 11 (the fourth detailed time information does not necessarily have to be included in the first time information). Also, in the case shown in Fig. 2, the above-mentioned second detailed time information is not input (stored) in the terminal device 11, and in some cases, only the first detailed time information is stored.

[0036] 1-2. As an example, regarding the work, treatment, etc. performed at the second medical institution 20 (regarding information stored in the terminal device 21) In TCR-T cell therapy, for example, in parallel with work, treatment, etc. performed at a first medical institution 10, a process of obtaining a large amount of T cells into which the nucleic acid described above, i.e., a specified TCR polynucleotide, is injected in order to generate T cells with modified base sequences required for administration to a cancer patient P1 is performed at a second medical institution 20, for example.

[0037] First, in the second medical institution 20 as an example, blood is collected from a cancer patient P1 to obtain a certain amount of cells (second cells) including T cells, which are target cells, and the obtained second cells are cultured until they reach a predetermined amount. In this case, the "predetermined amount" is appropriately set in consideration of an amount sufficient for generating T cells with modified base sequences, i.e., an amount sufficient for generating T cells with modified base sequences required for administration to the cancer patient P1. In FIG. 1, blood of the cancer patient P1 is obtained, and a small amount of second cells can be obtained from this blood. Next, the obtained small amount of second cells (second cells in the "Y1" state in FIG. 1) can be cultured to obtain a necessary and sufficient amount of second cells.

[0038] An example of the second cell is an immunocompetent cell. The origin of the immunocompetent cell is not particularly limited, and the immunocompetent cell may be obtained from any tissue such as blood, bone marrow, or spleen, or may be induced from a stem cell or a pluripotent stem cell. Examples of the immunocompetent cell include T cells, B cells, NK cells, dendritic cells, and macrophages. Examples of cells that can be used to induce an immunocompetent cell include hematopoietic stem cells, mesenchymal stem cells, embryonic stem cells, and induced pluripotent stem cells (iPS cells). Examples of the second cell include T cells obtained by sorting from peripheral blood mononuclear cells (PBMCs).

[0039] Here, with regard to a series of steps for obtaining a necessary and sufficient amount of T cells as second cells from the PBMC of cancer patient P1, for example, a method for selectively growing only T cells contained in the PBMC (for convenience, referred to as "first method") can be used. As a method for selectively growing only T cells in PBMC, any known technique can be applied, for example, a method of culturing in a medium containing a cytokine such as IL-2. On the other hand, a method for obtaining (generating) a necessary and sufficient amount of T cells by selecting only T cells in advance from a small amount of PBMC as the second cells using the above-mentioned FACS and culturing only the selected T cells (for convenience, referred to as "second method") may also be used.

[0040] In addition, Figures 1 and 2 show, as an example, a culture process ("Process C" in Figures 1 and 2) in which only T cells are selectively proliferated (state "Y2" in Figures 1 and 2) from a small number of T cells as second cells (state "Y1" in Figures 1 and 2) from PBMCs derived from blood containing a mixture of various cells, using the above-mentioned first method.

[0041] A large amount of TCR polynucleotide obtained as described above is introduced into the large amount of T cells obtained in the culturing step of "step C" to generate T cells with modified base sequences (TCR-T cells). In Figs. 1 and 2, the step of introducing the large amount of nucleic acid (specified TCR polynucleotide) obtained as described above into a necessary and sufficient amount of T cells obtained in "step C" is expressed as "step E". In Figs. 1 and 2, "step E" is expressed as being performed in the second medical institution 20, but is not limited to this. "Step E" may be performed in the first medical institution 10, or may be performed in another location other than the first medical institution 10 and the second medical institution 20.

[0042] In the information management system 1 according to an embodiment shown in FIG. 1, it is assumed that a terminal device 21 is installed in a second medical institution 20. The terminal device 21 can input and store attribute information of the cancer patient P1, information related to the above-mentioned "process C" performed in the second medical institution 20, and the like. As described above, the attribute information of the cancer patient P1 can include at least one of various information related to the name, age, amount of blood collected, amount of initial PBMC acquired, cancer type, cancer progression (cancer stage), and the like of the cancer patient P1 without any restrictions. The information related to the "process C" that can be input to the terminal device 21 means information related to the time required for the "process C" (second time information). Note that the second time information may include information related to the time required for the "process E".

[0043] The terminal device 21, like the terminal device 11, does not necessarily need to be physically installed in the second medical institution 20, and may be a cloud server (server device) in an environment in which electromagnetic communication is possible via a communication line. The terminal device 21 is also connectable to the information management device 100, the details of which will be described later, via a communication line. The hardware configuration of the terminal device 21 is basically the same as the hardware configuration of the information management device 100, which will be described later.

[0044] Regarding "Step C," existing methods can be used as appropriate for the culture conditions, culture device, specific culture process, etc. for culturing the second cells. Regarding "Step E," existing methods can be used as appropriate for the specific method, device, specific process, etc. for introducing a nucleic acid (specified TCR polynucleotide) into a T cell.

[0045] As described above, with reference to FIG. 1 and FIG. 2, the case where T cells are used as the first cells has been described as an example of the work, treatment, etc. performed in the first medical institution 10, but is not limited thereto. The first cells may be, for example, immunocompetent cells, and may be at least one selected from the group consisting of T cells, B cells, dendritic cells, and macrophages. In addition, the nucleic acid (specified TCR polynucleotide) to be increased to a predetermined amount has been described as a nucleic acid of a T cell antigen receptor, but is not limited thereto. This specified nucleic acid may be a molecule that can be expected to have a cytotoxic effect on cancer cells, and may be appropriately selected depending on the type of the first cells.

[0046] 1-3. Information management device 100 The information management device 100 according to an embodiment of the present disclosure is, for example, a terminal device or a server device connected to the terminal device 11 and the terminal device 21 via a communication line. The information management device 100 may be one terminal device or server device, or may be configured to be composed of multiple terminal devices or server devices for the purpose of distributing the load. In addition, when the information management device 100 is a server device, the server device may be a cloud server arranged on a cloud. Furthermore, the information management device 100 may be integrated with either the terminal device 11 or the terminal device 21. The information management device 100 as a terminal device or a server device mainly includes, as hardware, a central processing unit, a main storage device, an input / output interface, an input device, an auxiliary storage device, an output device (none of which are shown), etc., which are mutually connected by a data bus and / or a control bus, and can execute various information processing described later.

[0047] The central processing unit is called a "CPU" and can perform calculations on instructions and data stored in the main memory device and store the results of the calculations in the main memory device. Furthermore, the central processing unit can control input devices, auxiliary storage devices, output devices, etc., via an input / output interface. The information management device 100 can include one or more central processing units. Note that the information management device 100 may include at least one of one or more microprocessors and a graphics processing unit (GPU) instead of or together with the central processing unit.

[0048] The main storage device is referred to as "memory" and can store instructions and data received via the input device, the auxiliary storage device, and the input / output interface, as well as the results of calculations by the central processing unit, etc. The main storage device can include, but is not limited to, a RAM (random access memory), a ROM (read only memory), and / or a flash memory, etc.

[0049] The auxiliary storage device is a storage device having a larger capacity than the main storage device. The auxiliary storage device can store instructions and data (computer programs) constituting a specific application, specifically, for example, an information management application for therapy using base sequence modified immune cells, a web browser application, etc. Furthermore, the auxiliary storage device can transmit these instructions and data (computer programs) to the main storage device via an input / output interface by being controlled by a central processing unit. The auxiliary storage device can include, but is not limited to, a magnetic disk device and / or an optical disk device.

[0050] The input device is a device that takes in data from the outside, and can include, but is not limited to, a touch panel, a button, a keyboard, a mouse, and / or a sensor.

[0051] The output device may include, but is not limited to, a display device, a touch panel, and / or a printer device.

[0052] In such a hardware configuration, the central processing unit can sequentially load commands and data (computer programs) constituting a specific application stored in the auxiliary storage device into the main storage device and operate the loaded commands and data. This allows the central processing unit to control the output device via the input / output interface, and also to transmit and receive various information to and from the terminal device 11, the terminal device 21, the terminal device 31 of the cancer patient P1 (see Figures 1 and 2) and the like via the input / output interface and communication line.

[0053] A specific application for acquiring various information related to therapy using immune cells with modified base sequences (for example, the above-mentioned information management application for therapy using immune cells with modified base sequences) is installed in the information management device 100. By executing the application, the information management device 100 can acquire various information related to TCR-T cell therapy, for example.

[0054] The information management device 100 having the above-mentioned hardware configuration can mainly include a communication unit 110, a storage unit 120, a calculation unit 130, a treatment schedule creation unit 140, and a user interface unit 150, as shown in FIG.

[0055] The communication unit 110 can receive the attribute information and the first time information of the cancer patient P1 from the terminal device 11, and the attribute information and the second time information of the cancer patient P1 from the terminal device 21 via the communication line. As described above, the first time information includes at least one of the first detailed time information and the second detailed time information. The communication unit 110 can transmit the information received from the terminal device 11 and the terminal device 21 to the storage unit 120. In the present disclosure, the "communication line" can include, but is not limited to, a wired network, a mobile phone network, a wireless network (WiFi, WiMax, cellular, etc.), a fixed telephone network, the Internet, a local area network (LAN), a wide area network (WAN), an intranet, and / or Ethernet (registered trademark), etc.

[0056] The communication unit 110 can also receive various instruction information related to the attribute information of the cancer patient P1, the will, requests, changes, etc. of the cancer patient P1 from the terminal device 31 of the cancer patient P1. That is, by installing a specific application (for example, the above-mentioned information management application for therapy using genetically modified immune cells) in the terminal device 31 of the cancer patient P1, it becomes possible to transmit and receive various information between the information management device 100 and the terminal device 31 of the cancer patient P1. The above-mentioned instruction information transmitted from the cancer patient P1 to the information management device 100 (the communication unit 110 thereof) can include, without limitation, information related to changes in the attribute information of the cancer patient P1 (for example, changes in age, etc.), information related to consent or non-conformity to the treatment schedule transmitted from the information management device 100 to the terminal device 31 of the cancer patient P1, information related to a request for changes to the treatment schedule, etc.

[0057] The storage unit 120 can store the information received from the communication unit 110. Here, as shown in Fig. 5, the storage unit 120 can associate the attribute information of the cancer patient P1 received from the communication unit 110 with the above-mentioned first time information and second time information, and store them as individual patient information for each cancer patient (individual patient information Q1 of the cancer patient P1, individual patient information Q2 of the cancer patient P2, individual patient information Q3 of the cancer patient P3, ... are expressed in Fig. 5). Note that the storage unit 120 can store various other information of each cancer patient, date information related to the date of treatment, etc., as individual patient information of the cancer patient, in association with the attribute information of each cancer patient.

[0058] When storing the attribute information of each cancer patient, the storage unit 120 may anonymize at least one of the attribute information. That is, among the attribute information, for example, at least one of the name, age, cancer type, amount of T cells acquired (amount of T cells acquired in the above-mentioned "X1" state), cancer progression (cancer stage), etc. of each cancer patient may be anonymized and then stored. As for the method of anonymization, a well-known technique for anonymizing data may be used.

[0059] Calculation unit 130 calculates information (first correlation information) regarding the correlation between the first time information described above and each attribute information (information regarding age, cancer type, amount of T cells acquired, cancer stage, etc.) based on a large number of individual patient information (Q1, Q2, Q3, ... in FIG. 5) regarding a large number of cancer patients (cancer patients P1, P2, P3, P4, P5, P6, P7, P8, ... in FIG. 5) stored in storage unit 120. Furthermore, calculation unit 130 calculates information (second correlation information) regarding the correlation between the second time information described above and each attribute information (information regarding age, cancer type, amount of blood collected, cancer stage, etc.) based on a large number of individual patient information regarding a large number of cancer patients stored in storage unit 120.

[0060] In addition, the first correlation information may include at least one of information regarding the correlation between the first detailed time information and the above-mentioned attribute information (first detailed correlation information) and information regarding the correlation between the second detailed time information and the above-mentioned attribute information (second detailed correlation information).

[0061] As an example, the calculation unit 130 can refer to a large number of individual patient information stored in the memory unit 120, generate a multiple regression equation, and calculate the above-mentioned first correlation information (first detailed correlation information and second detailed correlation information) and second correlation information.

[0062] Specifically, the calculation unit 130 generates (calculates) a multiple regression equation in which attribute information (e.g., information on age, cancer type, amount of acquired T cells, and cancer stage) corresponding to an arbitrary cancer patient is used as an explanatory variable as the first detailed correlation information, and the first detailed time information corresponding to the arbitrary cancer patient is used as an objective variable. For example, the multiple regression equation corresponding to the first detailed correlation information is as shown in the following Equation 1.

[0063]

number

[0064] In formula 1, A is an intercept in the multiple regression equation, and B to E are coefficients of each explanatory variable. In the multiple regression equation of formula 1, four explanatory variables are used: age, cancer type, amount of T cells acquired, and stage. However, this is not necessarily limited to this, and only one of these four may be used as an explanatory variable, or any two or three may be used as explanatory variables. Furthermore, attribute information other than these four, for example, immune information of cancer patients, may be added as an explanatory variable.

[0065] Similarly to the first detailed correlation information, the calculation unit 130 generates (calculates) a multiple regression equation as the second detailed correlation information, in which attribute information (e.g., information on age, cancer type, amount of acquired T cells, and cancer stage) corresponding to an arbitrary cancer patient is used as an explanatory variable, and second detailed time information corresponding to the arbitrary cancer patient is used as an objective variable. For example, the multiple regression equation corresponding to the second detailed correlation information is as shown in the following equation 2. Note that F in equation 2 is an intercept in the multiple regression equation, and G to J are coefficients of each explanatory variable. Note that in the multiple regression equation of equation 2, only one of the four explanatory variables in equation 2 below may be used as an explanatory variable, or any two or three of them may be used as explanatory variables. Furthermore, attribute information other than the following four, for example, immune information of the cancer patient, may be further added as an explanatory variable.

[0066]

number

[0067] Furthermore, the calculation unit 130 generates (calculates) a multiple regression equation in which attribute information (e.g., age, amount of blood drawn) corresponding to an arbitrary cancer patient is used as an explanatory variable as the second correlation time information, and the second time information corresponding to the arbitrary cancer patient is used as a target variable. For example, the multiple regression equation corresponding to the second correlation information is as shown in the following equation 3. Note that K in equation 3 is an intercept in the multiple regression equation, and L and M are coefficients of each explanatory variable. Note that in the multiple regression equation of equation 3, only one of the two explanatory variables in equation 3 below may be used as an explanatory variable, or attribute information other than the following two may be added as an explanatory variable.

[0068]

number

[0069] The calculation unit 130 may generate (calculate) the first correlation information (the first detailed correlation information and the second detailed correlation information) and the second correlation information by machine learning a neural network instead of the above-mentioned multiple regression equation (or together with the multiple regression equation). Specifically, a first data set that is a lump of various attribute information corresponding to an arbitrary cancer patient (for example, cancer patient P3) and a second data set that is the first detailed time information corresponding to the arbitrary cancer patient (the cancer patient P3) are generated, and these are prepared for a large number of cancer patients to generate first teacher data in which the first data set is an input value and the second data set is an output value. By machine learning the neural network using this first teacher data, a machine-learned neural network corresponding to the first detailed correlation information can be generated.

[0070] Similarly, a third data set that is a collection of various attribute information corresponding to an arbitrary cancer patient and a fourth data set that is the second detailed time information corresponding to the arbitrary cancer patient are generated, and these are prepared for a large number of cancer patients to generate second training data that uses the third data set as an input value and the fourth data set as an output value. By machine-learning a neural network using this second training data, a machine-learned neural network corresponding to the second detailed correlation information can be generated.

[0071] Furthermore, a fifth data set that is a collection of various attribute information corresponding to an arbitrary cancer patient and a sixth data set that is the second time information corresponding to the arbitrary cancer patient are generated, and these are prepared for a large number of cancer patients to generate third training data that uses the fifth data set as an input value and the sixth data set as an output value. By machine-learning a neural network using this third training data, a machine-learned neural network corresponding to the second correlation information can be generated.

[0072] Furthermore, the calculation unit 130 can output at least one of a predicted value for the first time information (first predicted value) and a predicted value for the second time information (second predicted value) in the TCR-T cell therapy, as an example, to be provided to the new cancer patient, based on the multiple regression equation (the above-mentioned equations 1 to 3) or the machine-learned neural network generated (calculated) as described above, and attribute information of the new cancer patient (a patient who will soon receive treatment related to TCR-T cell therapy, as an example). Note that the first predicted value can include at least one of a first detailed predicted value based on the first detailed correlation information (for example, the above-mentioned equation 1) and a second detailed predicted value based on the second detailed correlation information (for example, the above-mentioned equation 2). For example, for a new cancer patient, the following can be output: "77 years old," "stomach cancer," "10 7 When the attribute information, such as "number of patients," "Stage 1," and "Volume of blood drawn: 400 mL," is transmitted to the information management device 100 (communication unit 110) via terminal device 11 and terminal device 21, the calculation unit 130 can calculate a first detailed prediction value (e.g., "14 days"), a second detailed prediction value (e.g., "5 days"), and a second prediction value (e.g., "10 days") by substituting the attribute information of these new cancer patients into, for example, each of the explanatory variables in the above-mentioned equations 1 to 3.

[0073] The calculation unit 130 transmits the first predicted value (first detailed predicted value and second detailed predicted value) and the second predicted value calculated as described above to the communication unit 110, and the communication unit 110 can transmit these predicted values ​​to the terminal device 11, the terminal device 21, and the terminal device 31 of the new cancer patient. This allows the first medical institution 10, the second medical institution 20, and the new cancer patient to grasp an overview of the treatment schedule for TCR-T cell therapy, as an example, for the new cancer patient.

[0074] Moreover, the calculation unit 130 transmits to the treatment schedule creation unit 140 the first predicted value (the first detailed predicted value and the second detailed predicted value) and the second predicted value calculated as described above.

[0075] The treatment schedule creation unit 140 can output at least a part of the treatment schedule to be performed on the new cancer patient based on at least one of the first predicted value and the second predicted value received from the calculation unit 130. Specifically, for example, assume that T cells are obtained from a new cancer patient on "December 9, 2020". In this case, on the same day, various attribute information of the new cancer patient is transmitted to the information management device 100 via the terminal device 11, and the calculation unit 130 calculates the first predicted value (assumed to be, for example, "14 days" in this case) and the second predicted value (assumed to be, for example, "7 days" in this case), and these predicted values ​​are transmitted from the calculation unit 130 to the treatment schedule creation unit 140. Based on the first predicted value of "14 days" and the second predicted value of "7 days" received from the calculation unit 130, the treatment schedule creation unit 140 can output, for example, the date on which the state of "X4" in FIG. 1 will occur as "December 23, 2020", 14 days after "December 9, 2020", and then output the date and time on which the new cancer patient will have blood drawn as "December 16, 2020" (i.e., 7 days before December 23, 2020) in order to make the PBMCs in the state of "Y2" on "December 23, 2020". This makes it possible to output a treatment schedule that synchronizes the date on which the state of "X4" in FIG. 1 will occur with the date on which the state will become "Y2".

[0076] The treatment schedule creation unit 140 transmits the treatment schedule output as described above to the communication unit 110, and the communication unit 110 can transmit this treatment schedule to the terminal device 11, the terminal device 21, and the terminal device 31 of the new cancer patient. This not only enables the first medical institution 10, the second medical institution 20, and the new cancer patient to instantly grasp details of the treatment schedule for TCR-T cell therapy, which is an example of the new cancer patient, but also enables the new cancer patient to be efficiently and quickly provided with treatment.

[0077] The user interface unit 150 can execute operations such as changing various settings and directly inputting various information to the information management device 100 without using a communication line, in response to operations by a user using the information management device 100 .

[0078] The information management device 100 according to the embodiment described above can efficiently manage therapies using immune cells with modified base sequences, such as TCR-T cell therapy, and can provide efficient and rapid treatment to new cancer patients.

[0079] Incidentally, in the embodiment described above, it has been assumed that certain specific values ​​are stored or calculated for the first time information, the first detailed time information, the second detailed time information, the second time information, the first predicted value, the first detailed predicted value, the second detailed predicted value, and the second predicted value. However, it should be noted that certain exceptional cases are also assumed in which some or all of these are 0 or incalculable (infinity). As a first exceptional case, for example, when the immune condition of a certain cancer patient is extremely poor and it is practically impossible to obtain a predetermined amount of a specific nucleic acid based on a first cell obtained from the certain cancer patient, the first time information may be stored as 0 or incalculable (infinity), or a predetermined value, for example, 1 (day), may be automatically stored. Similarly, as a second exceptional case, for example, when the immune condition of a certain cancer patient is extremely poor and it is practically impossible to culture a second cell obtained from the certain cancer patient until it reaches a predetermined amount, the second time information may be stored as 0 or incalculable (infinity), or a predetermined value, for example, 1 (day), may be automatically stored.

[0080] Furthermore, as a third exceptional case, for example, when the immune status of a new cancer patient is extremely poor and at least one of the first and second predicted values ​​described above is output as 0 or incalculable (infinity), at least one of the first and second predicted values ​​output as 0 or incalculable (infinity) may be set to automatically rewrite to a predetermined numerical value, for example 1 (day).

[0081] In the first exceptional case, personalized medicine may be adopted in which cells obtained from a person other than the cancer patient who satisfies certain conditions are substituted for the first cell, and a specific amount of a specific nucleic acid is obtained based on the substituted cells. In the second exceptional case, personalized medicine may be adopted in which cells obtained from a person other than the cancer patient who satisfies certain conditions are substituted for the second cell, and the substituted cells are cultured until a predetermined amount is reached. In the third exceptional case, personalized medicine may be adopted in which cells obtained from a person other than the new cancer patient who satisfies certain conditions are substituted for the first cell or the second cell (and in some cases, both).

[0082] 2. Variations In the information management system 1 including the information management device 100 of the embodiment described above, other additional functions may be provided separately.

[0083] Specifically, for example, an apparatus for synthesizing a TCR polynucleotide used in "step B" in Fig. 1 may be linked to the terminal device 11 via a communication line so that a signal indicating that "step B" has been completed may be transmitted to the terminal device 11. In this way, when the terminal device 11 receives the data, it can transmit alert information indicating that the work of "step E" will soon be performed to the terminal device 31 of the new cancer patient. In this way, in the case where the new cancer patient is to receive treatment related to TCR-T cell therapy, for example, the new cancer patient can timely know that TCR-T will soon be administered.

[0084] 1 and the terminal device 21 via a communication line, a signal indicating that "step C" has been completed may be transmitted to the terminal device 21. Thus, when the terminal device 21 receives the data, it can transmit alert information indicating that the work of "step E" will soon be performed to the terminal device 31 of the new cancer patient. Thus, in the case where the new cancer patient receives treatment related to TCR-T cell therapy, for example, the new cancer patient can timely know that TCR-T will soon be administered.

[0085] 2, the culture device used in "step Aa" may be linked to the terminal device 11 via a communication line so that a signal indicating that "step Aa" has been completed is transmitted to the terminal device 11. As a result, when the terminal device 11 receives the data, it can transmit alert information indicating that the work of "step E" will soon be performed to the terminal device 31 of the new cancer patient. As a result, in the case where the new cancer patient receives treatment related to TCR-T cell therapy, for example, the new cancer patient can timely know that TCR-T will soon be administered.

[0086] Incidentally, in the information management system 1 including the information management device 100 of the embodiment described above, it is basically assumed that various information is transmitted from the information management device 100 to the terminal device 31 of the cancer patient, but this is not limited thereto. Specifically, the attribute information, first time information, second time information, individual patient information, various predicted values, etc. of each cancer patient described above are all stored in the information management device 100, so each cancer patient may access (view) various information by accessing the information management device 100 from the terminal device 31 via a communication line. In this case, while it is required that all the attribute information of each cancer patient is anonymized as described above, each cancer patient (and his / her family) may be configured to be able to refer to various information of himself / herself by taking a necessary authentication step or the like.

[0087] 3. Various Aspects The information management device 100 according to one embodiment described above has the following computer program installed therein. That is, the computer program according to one aspect of the present disclosure "causes at least one processor to function so as to acquire, based on a first cell acquired from a cancer patient, first time information on the time required to acquire a predetermined amount of at least one specific nucleic acid, and second time information on the time required to culture a second cell different from the first cell until the second cell reaches a predetermined amount, and to associate the first time information and the second time information with attribute information of the cancer patient and store them as individual patient information."

[0088] Furthermore, the information management method executed by the information management device 100 according to one embodiment of the present disclosure is "an information management method executed by at least one processor that executes computer-readable instructions, wherein the processor executes the instructions to obtain first time information regarding the time required to obtain a predetermined amount of at least one specific nucleic acid based on a first cell obtained from a cancer patient, obtain second time information regarding the time required to culture a second cell different from the first cell until it reaches a predetermined amount, and associate the first time information and the second time information with attribute information of the cancer patient and store them as individual patient information."

[0089] Furthermore, an information management system 1 including an information management device 100 according to one embodiment of the present disclosure is an information management system having: "a first terminal device that acquires first time information regarding the time required to acquire a predetermined amount of at least one specific nucleic acid based on a first cell acquired from a cancer patient; a second terminal device that acquires second time information regarding the time required to culture a second cell different from the first cell until it reaches a predetermined amount; and a third terminal device that is connected to the first terminal device and the second terminal device via a communication line, and associates the first time information and the second time information with attribute information of the cancer patient and stores them as individual patient information."

[0090] This disclosure is based on the following Japanese patent applications and enjoys the benefit of priority from said Japanese patent applications, the entire contents of which are incorporated herein by reference: (1) Japanese Patent Application No. 2021-59960, entitled "Information Management Apparatus and Computer Program" filed on March 31, 2021

[0091] All publications, patent applications, and technical standards mentioned in this disclosure are incorporated by reference in their entirety into this disclosure.

Claims

1. At least one processor; The processor: First time information on the time required for a first operation to be performed at a first institution, the first operation being to obtain a predetermined amount of at least one specific nucleic acid based on a first cell obtained from a cancer patient; and second time information relating to a time required for a second operation performed in parallel with the first operation at a second institution, the second operation being to culture second cells obtained from the cancer patient and different from the first cells until a predetermined amount is reached; Get the first time information and the second time information are associated with attribute information of the cancer patient and stored as individual patient information; An information management device that causes the at least one processor to function as described above, The processor, predicting the first time information and the second time information regarding a new cancer patient based on a plurality of stored individual patient information; creating a treatment schedule for the new cancer patient based on the first time information and the second time information regarding the predicted new cancer patient; Present the created treatment schedule to the first institution and the second institution; The information management device causes the at least one processor to function as described above.

2. The information management device of claim 1, wherein the first time information includes at least one of first detailed time information regarding the time required to culture the first cell until it reaches a predetermined amount, and second detailed time information regarding the time required to synthesize the specific nucleic acid contained in the first cell until it reaches a predetermined amount.

3. The information management device according to claim 1 or 2, wherein the attribute information includes at least one selected from the group consisting of age information, cancer type information, information on the amount of the first cells obtained, immune information of the cancer patient, and cancer progression information.

4. The information management device according to claim 1 , wherein the first cell is an immunocompetent cell contained in a cancer tissue.

5. The information management device according to claim 4 , wherein the first cell is at least one selected from the group consisting of a T cell, a B cell, a dendritic cell, and a macrophage.

6. The information management device according to claim 1 , wherein the second cell is at least one selected from the group consisting of a T cell, a B cell, a dendritic cell, and a macrophage.

7. The information management device according to any one of claims 1 to 6, wherein the at least one processor is caused to function so as to calculate, based on the stored plurality of pieces of individual patient information, first correlation information regarding a correlation between the first time information and the attribute information and second correlation information regarding a correlation between the second time information and the attribute information, which are used to predict the first time information and the second time information.

8. The information management device of claim 7, wherein the first correlation information includes at least one of: first detailed correlation information regarding the correlation between first detailed time information regarding the time required to culture the first cell until it reaches a predetermined amount and the attribute information; and second detailed correlation information regarding the correlation between second detailed time information regarding the time required to synthesize the specific nucleic acid contained in the first cell until it reaches a predetermined amount and the attribute information.

9. The information management device according to claim 7 or 8, wherein the at least one processor is caused to function to output a first predicted value regarding the first temporal information of the new cancer patient based on the attribute information of the new cancer patient and the first correlation information.

10. The first predicted value is A first detailed prediction value regarding the first detailed time information of the new cancer patient, which is calculated based on the attribute information of the new cancer patient and first detailed correlation information regarding a correlation between first detailed time information regarding a time required to culture the first cell until it reaches a predetermined amount and the attribute information; and a second detailed predicted value regarding the second detailed time information of the new cancer patient, calculated based on the attribute information of the new cancer patient and second detailed correlation information regarding a correlation between second detailed time information regarding a time required for synthesizing the specific nucleic acid contained in the first cell until the specific amount is reached and the attribute information; The information management device according to claim 9 , further comprising at least one of the following:

11. The information management device of claim 9 or 10, wherein the at least one processor is configured to function to output a second prediction value regarding the second temporal information of the new cancer patient based on the attribute information of the new cancer patient and the second correlation information.

12. The information management apparatus of claim 11 , further configured to: output at least a portion of a treatment schedule for the new cancer patient based on the first predicted value and the second predicted value.

13. The information management device of claim 11 or 12, wherein the at least one processor is caused to function to transmit the first predicted value and the second predicted value via a communication line to at least one of a terminal device of the new cancer patient and a terminal device of a medical institution treating the new cancer patient.

14. The information management device of claim 12, wherein the at least one processor is caused to function to further transmit at least a portion of the treatment schedule via a communication line to at least one of a terminal device of the new cancer patient and a terminal device of a medical institution treating the new cancer patient.

15. At least one processor is running to: First time information on the time required for a first operation to be performed at a first institution, the first operation being to obtain a predetermined amount of at least one specific nucleic acid based on a first cell obtained from a cancer patient; and second time information relating to a time required for a second operation performed in parallel with the first operation at a second institution, the second operation being to culture second cells obtained from the cancer patient and different from the first cells until a predetermined amount is reached; Get storing the first time information and the second time information as individual patient information in association with attribute information of the cancer patient; predicting the first time information and the second time information regarding a new cancer patient based on a plurality of stored individual patient information; creating a treatment schedule for the new cancer patient based on the first time information and the second time information regarding the predicted new cancer patient; Present the created treatment schedule to the first institution and the second institution; A computer program product that causes the at least one processor to function in accordance with the present invention.

Citation Information

Patent Citations

  • The Use of Bioinformatic Data in Autologous Cell Therapies

    US20180181709A1

  • Methods and systems for performing a patient-specific immunotherapy procedure with chain-of-custody and chain-of-identity biological sample tracking

    US20200268860A1

  • Centralized and decentralized individualized medicine platform

    WO2020113098A1