IP Library Granted Patent US 11,783,931
Granted Patent B2
US 11,783,931 · App. 17/119,011 · Granted Oct 10, 2023

Drug monitoring tool

Inventors: Gerald Spotts (Lexington, MA); Roman Pichler (Lexington, MA); Michael Nelson (Lexington, MA)
Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
G16H20/10G06N7/01G09C5/00G16C20/30G16H10/60G16H50/30G16H50/50H04L9/0637G16B40/00G16B50/00G16C20/90
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Quick Facts
Patent No.
US 11,783,931
App. No.
17/119,011
Granted
Oct 10, 2023
Kind
B2
Abstract

A 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 and delineate a plurality of zones within the interactive user interface associated with the time-varying therapeutic plasma protein level. The plurality of zones includes 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.

Claims (14)

1. A drug monitoring tool that enables a patient to view a personalized real-time indication of clotting factor VIII levels following a prophylactic infusion event, the tool comprising:

a data receiver configured to receive a pharmacokinetic (PK) profile of a patient for clotting factor VIII based on (i) a Bayesian model of PK profiles of sampled patients having received an infusion of clotting factor VIII and (ii) at least one of a bodyweight, a von Willebrand factor (“vWF”) level, and/or an age of the patient; and

an interactive user interface configured to:

display to the patient a graphical representation of a time-varying therapeutic plasma protein level of the patient based on an administered dose of a clotting factor VIII and the PK profile of the patient;

delineate a plurality of zones within the graphical representation associated with the time-varying therapeutic plasma protein level, wherein each zone is associated with a particular concentration range of clotting factor VIII within the patient and based on the PK profile, the plurality of zones comprising at least:

a safe zone indicating to the patient that the time-varying therapeutic plasma protein level of clotting factor VIII for the patient is within a first concentration range above an upper threshold that is considered safe for physical activity; and

a danger zone indicating to the patient that the time-varying therapeutic plasma protein level of clotting factor VIII for the patient is within a second concentration range below a lower threshold and physical activity should be limited.

2. The drug monitoring tool of claim 1 , further comprising an activation toolkit configured to enable access to functionalities of the drug monitoring tool in response to at least of: receiving the PK profile the patient and/or receiving a log of a first prophylactic infusion.

3. 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 at a particular time, 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.

4. The drug monitoring tool of claim 3 , wherein the graphical control element is slidable between the plurality of zones.

5. 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 PK profile of the patient.

6. The drug monitoring tool of claim 5 , 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.

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 Dec 11, 2020
From: SPOTTS, GERALD; PICHLER, ROMAN; NELSON, MICHAEL
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 054616/0312 →