Patents by Inventor Michael Don Hale

Michael Don Hale 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: 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: 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
  • 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