CHOATE CONSTRUCTION Raleigh, NC Jun 2006 to Nov 2014 Senior EstimatorCANNON DESIGN Grand Island, NY Feb 2004 to Jun 2006 Senior AssociateSUMMIT CONSTRUCTION GROUP Lancaster, NY Aug 1986 to Jan 2004 Vice President EstimatingFOSTER WHEELER ENERGY CORP Livingston, NJ Aug 1981 to Jul 1986 Proposal ManagerEICHLEAY CORP Pittsburgh, PA Jul 1979 to Aug 1981 Project Engineer / EstimatorFURNCO CONSTRUCTION Lancaster, NY May 1974 to Jun 1979 Field Engineer / Estimator
Education:
ERIE COMMUNITY COLLEGE Williamsville, NY Jun 1972 to May 1974 A.A.S. in Civil Technology
10, Medical Team Leader at the FDAs Center for Drug Evaluation, Dr. Thomas Marciniak urged that cangrelor not be approved, explaining that there was not enough evidence to prove that the drug would be more effective than its current competitor, while DRs. Fred Senatore and Nhi Beasley suggested th
Date: Feb 13, 2014
Category: Health
Source: Google
FDA panel rejects blood thinner from Medicines Co.
The FDA's lead reviewer on the drug, Thomas Marciniak, published a strikingly negative review of the company's three studies ahead of the meeting. Marciniak argued that patients did not receive Plavix at appropriate times and doses, exposing them to unnecessary risks and distorting the trial finding
In the background information provided in advance of the CRDAC meeting, the FDA's Thomas Marciniak, MD, found data from supporting clinical trials unconvincing and recommended against approval for both indications until flaws in the trials had been corrected to the FDA's satisfaction.
Thomas Marciniak wrote that he feels cangrelor shouldn't be approved for patients who are undergoing an angioplasty, a procedure that is used to open narrowed or blocked coronary arteries. Marciniak said he has concerns about the way studies of the drug were run, and he said cangrelor doesn't appear
rom knowing who is on the drug. The data were reanalyzed by Duke University School of Medicine. Thomas Marciniak, the medical team leader in the FDAs Division of Cardiovascular and Renal Products, questioned in June whether Records trial design biased the data, rendering Dukes assessment moot.
Last week a medical reviewer for FDA said GSK's analysis of a study it used to justify Avandia's safety was completely misinterpreted. Dr. Thomas Marciniak, in a posting on the FDA web site, said the study actually shows the opposite of the company's position - Avandia may cause heart attacks.
Date: Jun 10, 2013
Category: Health
Source: Google
With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial
For the most part, the FDA documents released today express strong support for the DCRI re-adjudication. But one FDA official, Thomas Marciniak, remains highly critical of RECORD and says the trial data and, therefore, the analysis of the data from GSK and DCRI are completely unreliable.All partieBuried in the massive document is a bitter feud between an FDA rebel, Thomas Marciniak, and his bosses and other senior officials in the FDAs drug division. (Marciniak was the subject of a recent New York Times article that publicly revealed another dispute with some of the same officials over the
Date: Jun 03, 2013
Source: Google
Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial ...
Although the primary clinical review and the statistical review support approval for the new indication (the drug is already approved for venous thromboembolism prophylaxis and stroke prevention in AF), one reviewer, Thomas Marciniak, the Medical Team Leader, issued a blistering memorandum suggestin