Centralized and decentralized individualized medicine platform
The subject disclosure relates to systems, devices, and methods for executing operations related to procurement of individualized medicine therapies. Also disclosed are embodiments systems, methods, and devices for accessing a wide range of individualized medicine platform modules. Furthermore, disclosed herein are individualized medicine platform systems, methods and devices communicatively coupled to blockchain computing systems comprising several nodes. The disclosed systems, methods, and devices also generate chain of custody and chain of identity event data.
1 . A computer-implemented method for monitoring chain of custody and chain of identity for a patient sample in a personalized medicine supply chain, the method comprising:
acquiring, by a server comprising one or more processors and configured to execute instructions for a personalized medicine supply chain platform, event data corresponding to the personalized medicine supply chain that is associated with the patient sample;
curating, by the server, the event data to determine one or more of (i) event identifier data associated with a task in a supply chain event, (ii) time data associated with when the task of the supply chain event occurred, (iii) identity data associated with an identity of an entity or custodian associated with the task of the supply chain event, (iv) description data including information about the task of the supply chain event, or (v) location data associated with where the task of the supply chain event occurred;
analyzing, by the server, the curated event data to determine transactional processes and identify custody transfer information and custodian identity information for the patient sample; and
generating, by the server, audit data representing an audit trail of the one or both of the chain of custody and the chain of identity based on the determined transactional processes and identified custody transfer information and custodian identity information, wherein the chain of custody tracks the patient sample from the time it leaves a patient body to infusion of a therapeutic comprising the patient sample into another patient body.
2 . The computer-implemented method of claim 1 wherein:
the chain of custody includes data associated with a custody transfer of the patient sample in a completed personalized therapy or an unfinished personalized therapy; and
the chain of identity includes data associated with a change of custodial identity of the patient sample in a completed personalized therapy or an unfinished personalized therapy.
3 . The computer-implemented method of claim 1 wherein the audit data representing an audit trail of one or both of the chain of custody and the chain of identity corresponds to each leg of a journey undertaken by the patient sample.
4 . The computer-implemented method of claim 1 wherein the description data includes information pertaining to the task comprising at least one of (i) a verification of a patient, (ii) a scanning of a label on the patient sample, (iii) a verification that a label matched an identifier number, (iv) a verification that an apheresis occurred, or (v) a transfer of a material from one entity to another entity.
5 . The computer-implemented method of claim 1 , further comprising:
receiving, by the server, a request for a personalized therapy order from a first computing device executing a personalized medicine application associated with the personalized medicine supply chain platform; and
authenticating identity information associated with a user of the personalized medicine application on the first computing device based on a set of user criteria including user identity permissions and user roles permissions.
6 . The computer-implemented method of claim 5 wherein the authenticating comprises:
employing an authentication federation scheme operable to authenticate user profiles associated with the personalized medicine application, and
generating an access token for access by authentication server devices different from the server configured to execute instructions for the personalized medicine supply chain platform.
7 . The computer-implemented method of claim 1 , further comprising: generating identity data corresponding to one or more user profiles of a personalized medicine application associated with the personalized medicine supply chain platform;
generating a role corresponding to the one or more user profiles, wherein the role comprises at least one regional requirement and at least one therapy type; and assigning a group of permissions to the role, wherein the group of permissions comprises a defined permitted action for execution by an authenticated user profile and a defined resource corresponding to the defined permitted action, wherein a data store, executing on the server, stores at least one of the identity data, the role, the group of permissions, or grant data, and wherein the grant data represents an effective date associated with a grant of the defined permission.
8 . The computer-implemented method of claim 1 , further comprising: generating identity data corresponding to one or more user profiles of a personalized medicine application associated with the personalized medicine supply chain platform; generating a role corresponding to the one or more user profiles, wherein the role comprises at least one regional requirement and at least one therapy type; and assigning a group of permissions to the role, wherein the group of permissions comprises a defined permitted action for execution by an authenticated user profile and a defined resource corresponding to the defined permitted action, wherein the defined permitted action comprises one or more of generating a user profile credential, assigning a user profile to a group of permissions, or requesting an authentication operation.
9 . The computer-implemented method of claim 8 , further comprising:
generating and transmitting, by the server, a therapy order request to a second computing device corresponding to a manufacturing site scheduler; and
receiving, by the server, an approved therapy order request from the second computing device.
10 . The computer-implemented method of claim 9 , further comprising:
generating and/or storing location data associated with an ordered patient sample to allow for traceability of the patient sample, the intermediate product, or the final product.
11 . A system for a personalized medicine supply chain platform, comprising:
at least one processor; and
a non-transitory memory including processor executable code, wherein the processor executable code upon execution by the at least one processor causes the at least one processor to monitor chain of custody and chain of identity for a patient sample, by performing operations comprising:
acquiring event data corresponding to the personalized medicine supply chain that is associated with a patient sample;
curating the event data to determine one or more of (i) event identifier data associated with a task in a supply chain event, (ii) time data associated with when the task of the supply chain event occurred, (iii) identity data associated with an identity of an entity or custodian associated with the task of the supply chain event, (iv) description data including information about the task of the supply chain event, or (v) location data associated with where the task of the supply chain event occurred;
analyzing the curated event data to determine transactional processes and identify custody transfer information and custodian identity information for the patient sample; and
generating audit data representing an audit trail of the one or both of the chain of custody and the chain of identity based on the determined transactional processes and identified custody transfer information and custodian identity information, wherein the chain of custody tracks the patient sample from the time it leaves a patient body to infusion of a therapeutic comprising the patient sample into another patient body.
12 . The system of claim 11 wherein:
the chain of custody includes data associated with a custody transfer of the patient sample; and
the chain of identity includes data associated with a change of custodial identity of the patient sample.
13 . The system of claim 11 wherein the audit data representing an audit trail of one or both of the chain of custody and the chain of identity corresponds to each leg of a journey undertaken by the patient sample.
14 . The system of claim 11 wherein the description data includes information pertaining to the task comprising at least one of (i) a verification of a patient, (ii) a scanning of a label on the patient sample, (iii) a verification that a label matched an identifier number, (iv) a verification that an apheresis occurred, or (v) a transfer of a material from one entity to another entity.
15 . The system of claim 11 wherein the processor executable code, upon execution by the at least one processor, causes the at least one processor to monitor chain of custody and chain of identity by:
receiving a request for a personalized therapy order from a first computing device executing a personalized medicine application associated with the personalized medicine supply chain platform; and
authenticating identity information associated with a user of the personalized medicine application on the first computing device based on a set of user criteria including user identity permissions and user roles permissions.
16 . The system of claim 15 wherein the authenticating comprises:
employing an authentication federation scheme operable to authenticate user profiles associated with the personalized medicine application, and generating an access token for access by one or more authentication server devices different from a server comprising the at least one processor configured to execute instructions for the personalized medicine supply chain platform.
17 . The system of claim 11 wherein the processor executable code, upon execution by the at least one processor, causes the at least one processor to monitor chain of custody and chain of identity by:
generating identity data corresponding to one or more user profiles of a personalized medicine application associated with the personalized medicine supply chain platform;
generating a role corresponding to the one or more user profiles, wherein the role comprises at least one regional requirement and at least one therapy type; and
assigning a group of permissions to the role, wherein the group of permissions comprises a defined permitted action for execution by an authenticated user profile and a defined resource corresponding to the defined permitted action, wherein a data store of the system, in communication with the at least one processor, stores at least one of the identity data, the role, the group of permissions, or grant data, and wherein the grant data represents an effective date associated with a grant of the defined permission.
18 . The system of claim 11 wherein the processor executable code, upon execution by the at least one processor, causes the at least one processor to monitor chain of custody and chain of identity by:
generating identity data corresponding to one or more user profiles of a personalized medicine application associated with the personalized medicine supply chain platform;
generating a role corresponding to the one or more user profiles, wherein the role comprises at least one regional requirement and at least one therapy type; and
assigning a group of permissions to the role, wherein the group of permissions comprises a defined permitted action for execution by an authenticated user profile and a defined resource corresponding to the defined permitted action, wherein the defined permitted action comprises one or more of generating a user profile credential, assigning a user profile to a group of permissions, or requesting an authentication operation.
19 . The system of claim 11 wherein the processor executable code, upon execution by the at least one processor, causes the at least one processor to monitor chain of custody and chain of identity by:
generating and transmitting a therapy order request to a second computing device corresponding to a manufacturing site scheduler; and
receiving an approved therapy order request from the second computing device.
20 . A non-transitory, computer-readable medium storing instructions thereon that, when executed by one or more processors of a computing system, cause the computing system to perform operations for monitoring chain of custody and chain of identity for a patient sample in a personalized medicine supply chain, comprising:
acquiring, by a server comprising one or more processors and configured to execute instructions for a personalized medicine supply chain platform, event data corresponding to the personalized medicine supply chain that is associated with a patient sample;
curating, by the server, the event data to determine one or more of (i) event identifier data associated with a task in a supply chain event, (ii) time data associated with when the task of the supply chain event occurred, (iii) identity data associated with an identity of an entity or custodian associated with the task of the supply chain event, (iv) description data including information about the task of the supply chain event, or (v) location data associated with where the task of the supply chain event occurred;
analyzing, by the server, the curated event data to determine transactional processes and identify custody transfer information and custodian identity information for the patient sample in the personalized medicine supply chain; and
generating, by the server, audit data representing an audit trail of the one or both of the chain of custody and the chain of identity based on the determined transactional processes and identified custody transfer information and custodian identity information, wherein the chain of custody tracks the patient sample from the time it leaves a patient body to infusion of a therapeutic comprising the patient sample into another patient body.