Strathmore's Roundtable Biography for
Margaret C. Minkwitz, Ph.D.

	Margaret C. Minkwitz, Ph.D.
Biography	I have worked in the pharmaceutical industry for 23 years in the area of Clinical Development. I am a Statistician by training and have worked on the design of programs, studies, reports and regulatory applications for marketing approval for new treatments or indications for patients. I am proud to have been instrumental in designing programs that have been able to provide evidence of effectiveness of medications for depressive episodes in bipolar disorder, asthma (first in class leukotriene antagonist), new indications for an effective antibacterial agent, and working on possible new medicines to treat Alzheimer's disease. It is rewarding to set up the trial to demonstrate efficacy and assess the safety of these medications for patients suffering from these diseases. I am currently a Director of Statistical Science, where I manage the statistical staff supporting the Neuroscience therapeutic area at AstraZeneca, Inc. AstraZeneca is a large international pharmaceutical company that focuses on the research, development and marketing of prescription medications. Among the products currently approved for use and marketed by AstraZeneca are: SEROQUEL®, SEROQUEL XR®, CRESTOR®, NEXIUM®, PULMICORT RESPULES®, MERREM®, SYMBICORT®, ARIMIDEX®, CASODEX®, ZOMIG®, ZOLODEX®, TOPROL XL®, ATACAND®. To date, I have co-authored 43 papers, presentations and posters in various medical journals related to clinical research done to support the development of these products. My recent papers have been in various psychiatric journals and associated with the use of SEROQUEL® in bipolar disorder, primarily bipolar depression. Born in Corning, NY in 1946 and married to Vernon C. Minkwitz Jr. in 1990, I have 4 children and 9 grandchildren. I have the following degrees: 1966 Associate of Applied Science in Math and Science from Corning Community College, NY; 1980 Bachelor of Science, dual major Math and Biology from Elmira College, NY; and 1983 Master of Science and 1986 Doctor of Philosophy in Biostatistics, from Cornell University, NY. While in school, I was a member of Phi Beta Kappa, Beta Beta Beta and Mu Sigma Rho honor societies. In the years since graduation I have been involved in professional organizations including the American Statistical Association (ASA), The Biopharmaceutical Section of the ASA, The Delaware Chapter of the ASA, The International Biometrics Society, The Caucus for Women in Statistics. I am currently the elected representative for the Biopharmaceutical Section to the Council of Sections of the ASA, and Secretary of the Caucus for Women in Statistics. I have presented Clinical Trial information at medical conferences, made presentations at colleges and professional meetings and have chaired a number of Symposia sponsored by the Delaware Chapter of the ASA, a conference on Bayesian Statistics and contributed paper sessions at the Joint Statistical Meetings. In my spare time, I enjoy music, singing in the church choir and a choral group at work as well as playing in a hand bell choir, and crafts including knitting, embroidery and sewing.
Industry	Pharmaceuticals
Title	Director, Statistical Science
Expertise	Biostatistics, project management, management
Current Organization	AstraZeneca
Type of Organization	Pharmaceutical company, research and development of prescription drugs
Major Product	Nexium®, Atacand®, Crestor®, Seroquel®, Arimidex®, Rhinocort®, Seroquel XR®, Symbicort®, Zomig®
Area of Distribution	International
University/Degree	A.A.S., Math & Science, Corning Community College, NY, 1966; B.S., Biology & Math; 1980, Elmira College, 1980; M.S., Biostatistics; 1983; Ph.D., Biostatistics, 1986, Cornell University, NY
Born	June 30, 1946, Corning, New York
Honors & Awards	National Honor Society; Phi Beta Kappa; Beta Beta Beta; Mu Sigma Rho; New York Regents Scholarship; Presidential Who's Who
Published Works	Co-author of 15 articles in various medical journals for Accolate®, 2 for Merrem®, 25 for Seroquel® and Seroquel XR®
Affiliations	American Statistical Association, International Biometrics Society, Past Secretary, Vice President, President, Symposia Chairman for the Delaware Chapter of the American Statistical Association, Biopharm Section elected past secretary, current Section Representative to the Council of Sections of ASA
Hobbies & Sports	Singing, AstraZeneca singers, St. Mary of the Assumption adult choir and handbell choir; sewing, knitting, needlework
Career Accomplishments	Responsible for statistical support of the US marketing approval for Accolate® including participation in the FDA advisory panel 1996; Delivery of Bipolar Depression Submission for Seroquel® 2004 and Seroquel XR® for Bipolar disorder, 2007
Work History	Pharmaceutical industry since Ph.D., Biostatistician at Dupont; Biostatistics team leader ICI, Zeneca, Associate Director in Medical Affairs managing statistics, data management and medical writing at Zeneca, Director, Statistical Science for Neuroscience at AstraZeneca; Responsibilities include managing statistical resource available to provide statistical input for clinical trials (protocol development through reporting), Global regulatory agency interactions and publications
Children	Catherine Flavin, Richard Cecce, Leanna Williams, Florence Smith; Grandchildren: Christina, Michael, Rebecca and Matthew Flavin, George H. Coates V; Adrionna and Isabella Cecce, Devin and Paige Smith
Spouse	Vernon C. Minkwitz
Married	September, 1990
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