COLLIN J. WEBER - ATLANTA GA, US MARY K. HAGLER - LOGANVILLE GA, US PETER S. LINSLEY - SEATTLE WA, US JUDITH A. KAPP - ATLANTA GA, US SUSAN A. SAFLEY - DECATUR GA, US
International Classification:
A61K045/00 A61K039/395
US Classification:
424/423000, 424/093700, 424/131100
Abstract:
This invention provides a method of inhibiting viable cells transplanted into a subject from being destroyed by the subject's immune system which comprises: a) containing the viable cells, or tissue comprising the viable cells, prior to transplantation within a device comprising a semipermeable membrane; and b) treating the subject with a substance which inhibits an immune-system costimulation event in an amount effective to inhibit the subject's immune system from responding to said contained cells or tissue. In one embodiment, the substance which inhibits an immune-system costimulation event is CTLA4. Also provided by this invention is a method of treating diabetes in a subject which comprises: a) containing viable insulin-producing cells, or tissue comprising such cells, within a device comprising a semipermeable membrane; b) transplanting an effective amount of such contained viable insulin-producing cells into the subject; and c) treating the subject with an effective amount of a substance which inhibits an immune-system costimulation event.
Resumes
Principal Research Scientist, Global Regulatory, New Product Development
Elanco
Principal Research Scientist, Global Regulatory, New Product Development
Aratana Therapeutics
Senior Director Regulatory Affairs
Ceva Animal Health Sep 2014 - Jul 2017
Senior Manager Regulatory Affairs
Bayer Animal Health Aug 2012 - Sep 2014
Regulatory Affairs Manager
Virbac Jan 2007 - Aug 2012
Regulatory Affairs Manager
Education:
Temple University 2002 - 2005
Master of Science, Masters
Auburn University 1980 - 1986
Master of Science, Masters, Bachelors, Bachelor of Science
Skills:
Regulatory Affairs Pharmaceutical Industry Pharmacovigilance Regulatory Submissions Regulatory Requirements Fda Glp Gmp Sop Clinical Development Biotechnology Life Sciences Quality System Validation Clinical Trials Pharmacology Biopharmaceuticals Gcp R&D Veterinary Medicine Capa Technology Transfer U.s. Food and Drug Administration Standard Operating Procedure Lifesciences 21 Cfr Part 11 Microbiology Gxp Ind Pharmaceutical Sales Formulation Research and Development Good Laboratory Practice Good Clinical Practice Corrective and Preventive Action