Biologics: Targets and Therapy

Dr Doris Benbrook

Dr Benbrook

Professor and Director of Research, Department of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

Dr. Doris Mangiaracina Benbrook is a professor at the University of Oklahoma where she serves as Director of the Women's Cancer Program. During her PhD thesis research in biochemistry at Loyola University Medical School in Illinois, she demonstrated that the target of the antibiotic Norfloxacin in Pseudomonas aeruginosa is DNA gyrase. As a postdoctoral fellow at the Burnham Institute in California, she cloned nuclear receptors for thyroid hormone, retinoic acid, and cholesterol. During her research fellowship in the Imperial Cancer Research Fund in London, England, she demonstrated crosstalk between the AP-1 and CREB signal transduction pathways. 

Dr. Benbrook's past research at the University of Oklahoma focused on developing heteroarotinoid compounds selectively targeted at specific retinoid receptors to improve the therapeutic ratios of retinoids as pharmaceuticals for the prevention and treatment of cancer. The current generation of Flexible Heteroarotinoids (Flex-Hets) developed by her research team acts independently of the retinoid receptors and associated toxicities. The lead Flex-Het compound, SHetA2, is currently in preclinical development at the USA National Cancer Institute's Rapid Access to Intervention Development (RAPID) program. Her current research includes a systems biology approach to study the processes of carcinogenesis and chemoprevention in efforts to identify new biological targets. 

Since 1991, Dr. Benbrook has been an active member of the Gynecologic Oncology Group (GOG), an international cooperative clinical trials group, where she has been involved in development of translational research to address significant clinical questions in the GOG clinical trials. At national and international levels, she has served as member and chair of multiple grant review panels and on the editorial advisory boards of multiple journals.

Professor Shein-Chung Chow

Professor Chow

Professor of Biostatistics & Bioinformatics, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA

Professor Shein-Chung Chow is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. Prior to joining Duke University, he held various positions including the Director of TCOG (Taiwan Cooperative Oncology Group) Statistical Center and the Executive Director of National Clinical Trial Network Coordination Center, Taiwan; Vice President, Biostatistics, Data Management, and Medical Writing at Millennium Pharmaceuticals, Inc., Cambridge, MA, USA; Executive Director, Statistics and Clinical Programming at Covance, Inc., and Director and Department Head at Bristol-Myers Squibb Company, Plainsboro, NJ, USA. Through these positions, Prof. Chow provides technical supervision and guidance to project teams on statistical issues and presentations before partners, regulatory agencies or scientific bodies, defending the appropriateness of statistical methods used in clinical trial design or data analyses or the validity of reported statistical inferences. Prof. Chow identifies the best statistical and data management practices, organizes and leads working parties for development of statistical design, analyses and presentation applications, and participated on Data Safety Monitoring Boards in clinical research and development.

Prof. Chow's professional activities include playing key roles in many professional organizations such as officer, board of directors member, advisory committee member, and executive committee member. He has served as program-chair, session-chair/moderator, panelist and instructor/faculty at many professional conferences, symposia, workshops, tutorials and short courses. He is also the Editor-in-Chief of the Journal of Biopharmaceutical Statistics, Drug Designing – Open Access, and of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Most recently, representing academic and scientific experts, Prof. Chow was invited to speak at US FDA Public Hearings on Approval Pathway for Biosimilar and Interchangeable Biological Products (November 2-3, 2010) and Draft Guidances Relating to the Development of Biosimilar Products (May 11, 2012). 

Prof. Chow is the author or co-author of over 250 methodology papers and 24 books, which include Advanced Linear Models, Design and Analysis of Bioavailability and Bioequivalence Studies (1st, 2nd, and 3rd editions), Statistical Design and Analysis in Pharmaceutical Science, Design and Analysis of Clinical Trials (1st and 2nd editions), Design and Analysis of Animal Studies in Pharmaceutical Development, Encyclopedia of Biopharmaceutical Statistics (1st, 2nd, and 3rd editions), Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Statistical Design and Analysis of Stability Studies, Translational Medicine,  Handbook for Adaptive Design in Pharmaceutical Research and Development, Controversial Statistical Issues in Clinical Trials, Design and Analysis of Bridging Studies, and BIOSIMILARS: Design and Analysis of Follow-on Biologics, and Quantitative Methods for Traditional Chinese Medicine Development. Prof. Chow is currently working on two books: one is for Biosimilar Drug Development and the other one related to HIV/AIDS Research.

Prof. Chow received a BS in mathematics from National Taiwan University, Taiwan, and a PhD in statistics from the University of Wisconsin, Madison, Wisconsin, USA.