Pfizer Jan 2006 - 2008
Senior Director, Pharmaceutical R and D, Global Biologics
Pfizer Jan 2006 - 2008
Executive Director
Pfizer 2003 - 2005
Director, Pharmaceutical R and D, Global Biologics
Pfizer 1997 - 2003
Group Leader
Mallinckrodt Medical 1992 - 1997
Research Pharmacist
Education:
The University of Tennessee Health Science Center 1987 - 1992
Doctorates, Doctor of Philosophy
Banaras Hindu University 1982 - 1986
Bachelors, Bachelor of Pharmacy
Skills:
Drug Development Pharmaceutical Industry Technology Transfer Pharmaceutics Biotechnology Gmp Drug Discovery Ind Formulation Biopharmaceuticals Glp Regulatory Affairs Life Sciences Validation Clinical Development Fda Pharmacokinetics Capa Medicinal Chemistry Pharmacology Drug Delivery Analytical Chemistry Immunology Sop Vaccines Hplc Change Control Regulatory Submissions Clinical Pharmacology Gcp Pharmacovigilance Quality By Design Pharmaceutical Research Infectious Diseases Medical Affairs Clinical Trials Parenteral 21 Cfr Part 11 Regulatory Requirements Drug Design Biomarkers Good Laboratory Practice Oncology Lifesciences Cro Translational Medicine Ctms Toxicology Corrective and Preventive Action
Tugrul T. Kararli - Skokie IL, US Sandeep Nema - Grayslake IL, US Aziz Karim - Skokie IL, US
Assignee:
Pfizer Inc. - New York NY
International Classification:
A61K 9/14
US Classification:
424489
Abstract:
A pharmaceutical composition comprises, in powder form, (a) at least one water-soluble therapeutic agent selected from selective COX-2 inhibitory drugs and prodrugs and salts thereof, for example parecoxib sodium, in a therapeutically effective total amount constituting about 30% to about 90% by weight, (b) a parenterally acceptable buffering agent in an amount of about 5% to about 60% by weight, and optionally (c) other parenterally acceptable excipient ingredients in a total amount not greater than about 10% by weight, of the composition. The composition is reconstitutable in a parenterally acceptable solvent liquid to form an injectable solution. A lyophilization process is provided for preparation of such a composition.
Aziz Karim - Skokie IL, US Sandeep Nema - Grayslake IL, US Gary Ewing - Kalamazoo MI, US
International Classification:
A61K031/415 A61K031/365
US Classification:
514/406000, 514/471000
Abstract:
A pharmaceutical composition that is substantially free of water comprises at least one orally deliverable dosage unit comprising a therapeutically effective amount of a sulfonamide prodrug and, where the prodrug is readily degradable ex vivo, has means to inhibit such degradation prior to oral administration. Illustratively the prodrug is parecoxib or a water-soluble salt thereof, and the composition has means to inhibit conversion of the parecoxib to valdecoxib. A method of treating or preventing a COX-2 mediated disorder in a subject comprises (a) dissolving at least one dosage unit of such a composition in a pharmaceutically acceptable aqueous vehicle to form a solution, and (b) orally administering the solution to the subject before substantial precipitation of insoluble matter occurs in the solution.
Justin Abate - Chesterfield MO, US Kevin Muthurania - Chesterfield MO, US Sandeep Nema - Chesterfield MO, US Satish Singh - Chesterfield MO, US Carrie Elliott - Seattle WA, US Tapan Das - Chesterfield MO, US
International Classification:
A61K 39/395 A61P 35/00
US Classification:
4241421, 4241731, 4241541
Abstract:
The present invention provides for novel compositions of anti-CTLA-4 antibodies comprising a chelating agent. Also provided are method of treating diseases and conditions with novel compositions of CTLA-4 antibodies, including various neoplasia conditions.
Stable Immunogenic Compositions Of Staphylococcus Aureus Antigens
Lakshmi Khandke - Nanuet NY, US Akihisa Nonoyama - Apex NC, US Tamara Shafer Hodge - Chesterfield MO, US Sandeep Nema - Chesterfield MO, US
International Classification:
A61K 39/085
US Classification:
42419711, 4242431
Abstract:
The present invention is directed towards a lyophilized or reconstituted multi-antigen or multicomponent immunogenic composition comprising at least one antigen isolated from a staphylococcal bacterium, and methods of making the same.
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Sandeep Nema
Tagline:
Be active, never be inactive, and don’t react to the outcome of the work