Patents by Inventor Gerald Spotts

Gerald Spotts has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • Publication number: 20230360762
    Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.
    Type: Application
    Filed: July 20, 2023
    Publication date: November 9, 2023
    Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED
    Inventors: Kameswara Rao KUCHIMANCHI, Alexandra LOEW-BASELLI, Gerald SPOTTS, Myungshin OH, Michael Don HALE, Martin WOLFSEGGER
  • Patent number: 11783931
    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.
    Type: Grant
    Filed: December 11, 2020
    Date of Patent: October 10, 2023
    Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
    Inventors: Gerald Spotts, Roman Pichler, Michael Nelson
  • Patent number: 11749394
    Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.
    Type: Grant
    Filed: July 13, 2021
    Date of Patent: September 5, 2023
    Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Patent number: 11670409
    Abstract: Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is less than the predetermined threshold. A dosing regimen is determined for the patient based on the PK profile.
    Type: Grant
    Filed: April 13, 2017
    Date of Patent: June 6, 2023
    Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Publication number: 20210343375
    Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.
    Type: Application
    Filed: July 13, 2021
    Publication date: November 4, 2021
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Patent number: 11081211
    Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.
    Type: Grant
    Filed: October 14, 2020
    Date of Patent: August 3, 2021
    Assignees: BAXALTA INCORPORATED, BAXALTA GMBH
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Publication number: 20210098103
    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.
    Type: Application
    Filed: December 11, 2020
    Publication date: April 1, 2021
    Applicant: Shire Human Genetic Therapies, Inc.
    Inventors: Gerald SPOTTS, Roman PICHLER, Michael NELSON
  • Publication number: 20210027876
    Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.
    Type: Application
    Filed: October 14, 2020
    Publication date: January 28, 2021
    Applicants: BAXALTA INCORPORATED, BAXALTA GMBH
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Patent number: 10896749
    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.
    Type: Grant
    Filed: January 22, 2018
    Date of Patent: January 19, 2021
    Assignee: SHIRE HUMAN GENETIC THERAPIES, INC.
    Inventors: Gerald Spotts, Roman Pichler, Michael Nelson
  • Publication number: 20200312436
    Abstract: Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is less than the predetermined threshold. A dosing regimen is determined for the patient based on the PK profile.
    Type: Application
    Filed: April 13, 2017
    Publication date: October 1, 2020
    Inventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
  • Publication number: 20190365317
    Abstract: Embodiments of the present disclosure relate to a physiological sensing and therapeutic administration system. The system comprises a sensor and a pharmacokinetic (PK) server. The sensor (e.g., a physiological sensor) is configured to acquire real-time physiological measurements of a patient. The PK server is configured to determine a recommended administration of a therapeutic for the patient based on the acquired real-time physiological measurements of the patient. Due to the patient metabolizing therapeutic, the therapeutic has a time-varying concentration level in the patient. For instance, the concentration of the therapeutic in the patient decreases after an infusion.
    Type: Application
    Filed: January 29, 2018
    Publication date: December 5, 2019
    Inventors: Gerald Spotts, Roman Pichler, Michael Nelson
  • Publication number: 20180218782
    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.
    Type: Application
    Filed: January 22, 2018
    Publication date: August 2, 2018
    Inventors: Gerald Spotts, Roman Pichler, Michael Nelson
  • Publication number: 20140379629
    Abstract: A system and method for providing a therapeutic plasma protein dosing regime includes determining a pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The example system and method also include determining a first dosing regime for a first specified dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient over a time period based at least upon the pharmacokinetic profile and determining a second dosing regime for a second specified dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient over the time period based at least upon the pharmacokinetic profile. The example system and method further include displaying the first dosing regime and the second dosing regime on a client device such that the first dosing regime is displayed in conjunction with the second dosing regime.
    Type: Application
    Filed: June 20, 2014
    Publication date: December 25, 2014
    Inventors: Alexandra Loew-Baselli, Gerald Spotts, MyungShin Oh