IP Library Granted Patent US 10,896,749
Granted Patent B2
US 10,896,749 · App. 15/876,827 · Granted Jan 19, 2021

Drug monitoring tool

Inventors: Gerald Spotts (Lexington, MA); Roman Pichler (Lexington, MA); Michael Nelson (Lexington, MA)
Assignee: SHIRE HUMAN GENETIC THERAPIES, INC.
G16H20/10G06N7/005G09C5/00G16C20/30G16H10/60G16H50/30G16H50/50H04L9/0637G16B40/00G16B50/00G16C20/90
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,896,749
App. No.
15/876,827
Granted
Jan 19, 2021
Kind
B2
Abstract

Embodiments of the present disclosure relate to a drug monitoring tool. The drug monitoring tool comprises a data receiver and an interactive user interface. The data receiver is configured to receive a pharmacokinetic (PK) profile of a patient. The interactive user interface is configured to display, to the patient, a time-varying therapeutic plasma protein level of the patient. The time-varying therapeutic plasma protein level is based on an administered dose of a clotting factor VIII and the PK profile of the patient.

Claims (46)

1. A drug monitoring tool, the tool comprising:

a data receiver configured to receive, from a secured server, a patient pharmacokinetic (PK) profile of a patient, wherein the secured server comprises: (I) a Bayesian model of pharmacokinetic (PK) profiles of sampled patients, the Bayesian model including (i) a therapeutic plasma protein clearance and (ii) a volume of distribution relationship for a therapeutic plasma protein based upon at least one of patient age or body weight, and (II) a PK server configured to determine the patient PK profile based upon the Bayesian model, and at least one of a bodyweight, von Willebrand factor level, and an age of the patient; and

an interactive user interface configured to:

display to the patient a graphical representation predictive of a time-varying therapeutic plasma protein level of the patient, the time-varying therapeutic plasma protein level determined by the drug monitoring tool based on the timing and amount of an administered dose of a clotting factor VIII to the patient and the patient PK profile; and

delineate a plurality of zones within the graphical representation associated with the time-varying therapeutic plasma protein level, the plurality of zones comprising at least:

a safe zone indicating to the patient that the time-varying therapeutic plasma protein level is within a first concentration range considered safe for physical activity; and

a danger zone indicating to the patient that the time-varying therapeutic plasma protein level is within a second concentration range and physical activity should be limited.

2. The drug monitoring tool of claim 1 , wherein:

the data receiver is a camera configured to scan a quick response (QR) code storing patient information that includes at least PK profile information; and

the drug monitoring tool further comprising a QR code processor configured to extract and process the patient PK profile.

3. The drug monitoring tool of claim 2 , further comprising a QR code generator configured to generate the QR code having patient information encrypted using AES-256 encryption with cipher block chaining (CBC) and public-key cryptography standards (PKCS) padding.

4. The drug monitoring tool of claim 3 , wherein the QR code generator is located at the secured server remote from the drug monitoring tool.

5. The drug monitoring tool of claim 1 , further comprising an activation toolkit that allows the drug monitoring tool to provide the graphical representation predictive of the time-varying therapeutic plasma protein level only after receiving the patient PK profile and a log of a first prophylactic infusion.

6. The drug monitoring tool of claim 1 , wherein the interactive user interface includes a graphical control element configured to receive patient input corresponding to a request for the time-varying therapeutic plasma protein level within the patient at a particular time selected by the patient; and wherein the interactive user interface is configured to display the graphical representation of the time-varying therapeutic plasma protein level within the patient at the particular time.

7. The drug monitoring tool of claim 6 , wherein the graphical control element is slidable between the plurality of zones.

8. The drug monitoring tool of claim 1 , wherein the graphical representation provides an estimated amount of time until the time-varying therapeutic plasma protein level reaches the danger zone.

9. A drug monitoring system, the system comprising: a remote server system comprising:

a Bayesian model of pharmacokinetic (PK) profiles of sampled patients, the Bayesian model including (i) a therapeutic plasma protein clearance and (ii) a volume of distribution relationship for a therapeutic plasma protein based upon at least one of patient age or body weight,

a PK server that determines a patient PK profile based upon the Bayesian model and at least one of a bodyweight, von Willebrand factor level, and an age of a patient, and a quick response (QR) code generator that generates a QR code storing the patient PK profile; and

a drug monitoring tool comprising:

a camera that reads the QR code,

a code processor that extracts the patient PK profile from the QR code, and

an interactive user interface that displays a graphical representation of a time-varying therapeutic plasma protein level of the patient determined by the drug monitoring system based on the timing and amount of an administered dose of a clotting factor VIII to the patient and the patient PK profile, the graphical representation delineating a plurality of zones within the graphical representation associated with the time-varying therapeutic plasma protein level, the plurality of zones comprising at least:

a safe zone indicating to the patient that the time-varying therapeutic plasma protein level is within a first concentration range considered safe for physical activity; and

a danger zone indicating to the patient that the time-varying therapeutic plasma protein level is within a second concentration range and physical activity should be limited.

10. The system of claim 9 , wherein the quick response (QR) code generator generates the QR code using a plurality of fields each independently selected from the group consisting: schema version, clinic patient ID, weight, alpha, beta, K21, V1, duration, dosing interval, FVIII baseline, target, trough, time above, time below, and timestamp.

11. The system of claim 9 , wherein the quick response (QR) code generator generates the QR code using a plurality of fields, each field encoded using UTF8.

12. The system of claim 9 , wherein the graphical representation provides an estimated amount of time until the time-varying therapeutic plasma protein level reaches the danger zone.

13. A method of using a patient pharmacokinetic (PK) profile to predict drug levels, the method comprising:

receiving, at a user device, a patient PK profile for a clotting factor from a server system that determines the patient PK profile based on a Bayesian model of sampled patients and at least one of a bodyweight, a von Willebrand factor level, and an age of a patient;

determining, by the user device, time-varying levels of the clotting factor predicted using the patient PK profile to result in the patient from the timing and amount of an administered dose of the clotting factor; and

displaying, via an interactive user interface of the user device, the time-varying levels of the clotting factor predicted in the patient within a plurality of zones, the time-varying levels of the clotting factor being positioned within either:

a safe zone indicating to the patient that the time-varying levels of the clotting factor is within a first concentration considered safe for physical activity; or

a danger zone indicating to the patient that the time-varying levels of the clotting factor is within a second concentration and physical activity should be limited.

14. The method of claim 13 , further comprising:

providing a graphical control element by which a user can inquire about the time-varying levels of the clotting factor at a particular time selected by the user; and

displaying a first estimated level of the clotting factor predicted using the patient PK profile to be in the patient at the particular time.

15. The method of claim 14 , wherein the graphical control element is slidable between the plurality of zones.

16. The method of claim 13 , wherein the Bayesian model comprises (i) a clotting factor clearance and (ii) a volume of distribution relationship for the clotting factor based on age or bodyweight of the sampled patients.

17. The method of claim 13 , wherein:

receiving the patient PK profile includes using the user device for:

scanning a quick response (QR) code storing patient information that includes at least PK profile information; and

extracting and processing the patient information stored within the QR code.

18. The method of claim 17 , wherein the server system generates the QR code having patient information encrypted using AES-256 encryption with cipher block chaining (CBC) and public-key cryptography standards (PKCS) padding.

19. The method of claim 17 , wherein the QR code includes at least one of or any combination of: patient identifying information, patient physiological data, patient dosing information, and/or PK profile information of the patient, wherein the patient dosing information includes a prophylactic dosing regimen for a particular clotting factor VIII drug.

20. The method of claim 13 , further comprising performing, for the patient, the determining step and the displaying step in response to receiving the patient PK profile and a log of a first prophylactic infusion.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: SHIRE HUMAN GENETIC THERAPIES, INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 055766/0572 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2018
From: SPOTTS, GERALD; PICHLER, ROMAN; NELSON, MICHAEL
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 045588/0922 →
Continuity (2)
Provisional Application 62451391 · Jan 27, 2017
Related Publication 20180218782A1 · Aug 2, 2018
Cited By (1)
US 12,462,938