October 14, 2014
CTI Clinical Trial and Consulting Services Announces Promotions
FOR IMMEDIATE RELEASE [Cincinnati, OH ~ October 14, 2014] CTI Clinical Trial and Consulting Services (CTI) announces the promotions of Kathryn Wekselman and Shawna Bredek.
Kathryn Wekselman, PhD, RN promoted to Senior Director, Regulatory and Scientific Affairs
Wekselman joined CTI in 2012 after spending nearly 20 years in the pharmaceutical and clinical research industry, including time at INC Research, Camargo Pharmaceutical Services, and P&G Pharmaceuticals. At CTI, Wekselman is a regulatory expert responsible for interacting with global regulatory agencies, preparing regulatory submissions (e.g., meeting requests and briefing packages, orphan drug designation requests, pediatric assessment plans, INDs and marketing applications), and ensuring that all work meets high quality standards.
“Kathy has a deep knowledge of global regulatory affairs and drug development, including facilitating direct interactions with the FDA and EMA, and extensive hands-on experience in the preparation of key documents intended for regulatory submission,” according to Lynn Fallon, CTI’s President. “Kathy will continue to play a lead role across a wide range of regulatory projects and share her extensive knowledge with both staff and clients.”
She also has a decade of experience as a nursing clinician and academician. Wekselman held Adjunct Faculty Member positions at Northern Kentucky University, University of Cincinnati, Miami University, and Xavier University. Kathy earned a Bachelor of Arts in Art History from Oberlin College and a Master of Librarianship from Emory University. She went on to complete a Bachelor of Science in Nursing and a Doctor of Philosophy in Nursing from the University of Cincinnati.
Shawna Bredek promoted to Director, Clinical Trials
Bredek has been with CTI for nearly 13 years, working initially as a clinical research associate before moving into study management ten years ago. She has led numerous global studies of various sizes, phases, and complexities during her tenure with CTI, including studies in pediatric populations and in cell/gene therapy. Recently, Bredek has been an integral part of the Community Research integration, and she will continue to support the ongoing integration and future operational activities for the clinical research center.
“Shawna has been an instrumental leader at CTI,” according to Kevin Schwarz, CTI’s Chief Operating Officer. “She is able to manage and train others in clinical operations, thanks to her vast background in global study management and in many complex therapeutic areas. Her previous experience in patient recruitment and early phase trials will be a huge asset to the continued growth of CTI in the future as well.”
Prior to CTI, Bredek spent more than five years with Phoenix International Life Sciences and Hilltop Research. She earned a Bachelor of Science from Miami University.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is an innovative, international drug and device development organization that delivers a full spectrum of clinical trial and consulting services from bench to commercialization with a focus on immunology and a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology and startup firms with clinical and disease area expertise from a unique mix of academic, medical and industry specialists; rich intellectual capital in transplantation, immunology, infectious diseases, hematology, cardiology, nephrology, hepatology, regenerative medicine and rare diseases; flexible study designs that accelerate development programs and deliver high approval ratings that are among the best in the industry; and exceptional global project management and gold standard safety and data management systems that strengthen their program’s success potential. Established in 1999 and headquartered in Cincinnati, OH; CTI has offices in North America, Europe and South America.