Anoixis Corporation - Natick, MA since Oct 2006
President & CEO
Vertex Pharmaceuticals Aug 1997 - Oct 2006
Sr. Director /Global Head, Dept. of Clinical Pharmacology
U.S. Food and Drug Administration - Rockville, MD Jun 1992 - Aug 1997
Senior Reviewer/Expert Scientist (Pharmacometrics)
Education:
The University of Glasgow 1988 - 1991
Ph.D. (Clinical Pharmacology, Pharmacometrics
Skills:
Drug Development Clinical Pharmacology Pharmacokinetics Clinical Development Pharmacometrics Pharmacodynamics Fda Pharmaceutical Industry Pharmacology Clinical Trials Gcp Drug Discovery Pk/Pd Biomarkers Drug Delivery Cro Regulatory Submissions Infectious Diseases Oncology Biopharmaceuticals Medical Writing Modeling and Simulation Population Pk/Pd Modeling Ind Good Clinical Practice U.s. Food and Drug Administration Winnonlin Cancer Toxicology Translational Medicine Cro Management Population Pk Exposure Response Analysis Clinical Study Design Strategic Consulting Translational Research Exposure Qtc Analysis Scenario Planning Drug Development Strategy Ectd Clinical Pharmacology Sections
Isbn (Books And Publications)
Pharmacometrics: The Science of Quantitative Pharmacology
Pravin Chaturvedi - Andover MA, US Ene Ette - Framingham MA, US
Assignee:
Vertex Pharmaceuticals Incorporated - Cambridge MA
International Classification:
A61K 38/21 A61K 38/00
US Classification:
424 857, 424 854, 514 2, 514588, 514894
Abstract:
The present invention relates to optimal compositions useful in treating HCV infections in humans. These compositions comprise alpha-interferon or pegylated alpha-interferon and an IMPDH inhibitor selected from VX-148 or VX-944, wherein the IMPDH inhibitor is present in an amount such that a ratio of Cavg/Cmin is between 1 to 10, wherein:The present invention also relates to methods of producing and using the optimal compositions to treat HCV infections in humans.
Hui-May Chu - Natick MA, US Ene Ette - Framingham MA, US Lindsay McNair - Allston MA, US John Alam - Cambridge MA, US
Assignee:
Vertex Pharmaceuticals Incorporated - Cambridge MA
International Classification:
A61K 38/21 A61K 38/00 A61K 31/14
US Classification:
514588, 514 43, 514894, 424 857, 424 854
Abstract:
The present invention relates to antiviral therapies and compositions for treating or preventing Hepatitis C infections in patients and relates to other methods disclosed herein. The invention also relates to kits and pharmaceutical packs comprising compositions and dosage forms. The invention also relates to processes for preparing these compositions, dosages, kits, and packs.
Optimal Compositions And Methods Thereof For Treating Hcv Infections
Pravin Chaturvedi - Andover MA, US Ene Ette - Framingham MA, US
International Classification:
A61K038/21 A61K031/7056 A61K031/365
US Classification:
424/085700, 514/043000, 514/470000
Abstract:
The present invention relates to optimal compositions useful in treating HCV infections in humans. These compositions comprise alpha-interferon or a derivative thereof and an IMPDH inhibitor, wherein the IMPDH inhibitor is present in an amount such that a ratio of Cavg/Cmin is between 1 to 10, wherein: a Cavg is average plasma concentration produced by said IMPDH inhibitor in said human; and a Cmin is estimated trough concentration produced by said IMPDH inhibitor in said human. The present invention also relates to methods of producing and using the optimal compositions to treat HCV infections in humans.
Methods For Determining Optimal Doses For A First Investigational Administration In Humans
Christopher Godfrey - Natick MA, US Amit Roy - Plainsboro NJ, US Ene Ette - Framingham MA, US
International Classification:
G06F017/10
US Classification:
703002000
Abstract:
The present invention provides a method for determining an optimal dose range of a compound for a first investigational administration of that compound in a human. The method involves stochastic simulation of allometric parameters to produce outcome distributions that provide a basis for selecting an optimal dose range. The present invention also provides optimal doses of compounds under clinical evaluation in the first administration of such compounds to humans.
Ene Ette - Framingham MA, US John Alam - Cambridge MA, US Robert Kauffman - Chestnut Hill MA, US
International Classification:
A61K038/21 A61K038/05 A61K031/7056
US Classification:
424085400, 514043000, 514018000
Abstract:
The present invention relates to therapeutic combinations comprising VX-497, ribavirin, and interferon. The present invention also relates to methods using the therapeutic combinations of the present invention for treating HCV infection or alleviating one or more symptoms thereof in a patient. The present invention also provides kits comprising the combinations of the present invention.
- Cambridge MA, US Gurudatt Ajay Chandorkar - Waltham MA, US Ene Ikpong Ette - Framingham MA, US Bradley John Maroni - Boston MA, US Charlotte Suzanne Hartman - Carmel IN, US Ramin Farzaneh-Far - Brookline MA, US Jula Kern Inrig - Yorba Linda CA, US
Provided herein are specific doses of, and dosing regimens for, using a HIF prolyl hydroxylase inhibitor in treating or preventing anemia, such as anemia secondary to or associated with chronic kidney disease, anemia secondary to or associated with non-dialysis dependent chronic kidney disease anemia associated with or resulting from chemotherapy, or anemia associated with AIDS.
- Cambridge MA, US Gurudatt Ajay Chandorkar - Waltham MA, US Ene Ikpong Ette - Framingham MA, US Bradley John Maroni - Boston MA, US Charlotte Suzanne Hartman - Carmel IN, US Ramin Farzaneh-Far - Brookline MA, US Jula Kem Inrig - Yorba Linda CA, US
Assignee:
Akebia Therapeutics, Inc. - Cambridge MA
International Classification:
A61K 31/4418 A61K 9/20 A61K 9/28
Abstract:
Provided herein are specific doses of, and dosing regimens for, using a HIF prolyl hydroxylase inhibitor in treating or preventing anemia, such as anemia secondary to or associated with chronic kidney disease, anemia secondary to or associated with non-dialysis dependent chronic kidney disease anemia associated with or resulting from chemotherapy, or anemia associated with AIDS.
Name / Title
Company / Classification
Phones & Addresses
Ene I Ette President
ALAYTHACE PUBLISHING CORPORATION
214 N Main St SUITE 104, Natick, MA 01760 8 Summer Ln, Framingham, MA 01701
Ene I Ette Manager
PERISSEU, LLC
214 N Main St STE 104, Natick, MA 01760
Ene I Ette President, Chief Executive Officer/president