June 19, 2013
CTI Clinical Trial and Consulting Services (CTI), an international, privately held, full-service contract research organization will present, chair, and exhibit at the DIA 2013 49th Annual Meeting, Advancing Therapeutic Innovation and Regulatory Science, in Boston, June 23-37.
CTI’s Ryan Gifford, Senior Manager, will chair the session “Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness” on Tuesday, June 25th 4:00pm – 5:30pm EST. The session will discuss data collection and its application in examining health care utilization patterns and new insights to therapeutic treatment. During the session, Dr. William Irish, CTI’s Vice President of Health Outcomes and Biostatistics, will present on the topic “EMR Use for Medical Research: A Conceptual Framework”. Dr. Irish is an internationally recognized expert in the areas of study design and analysis. He has been a thought leader in health outcomes and biostatistics for more than twenty years, beginning as a faculty member at the University of Pittsburgh, continuing throughout his career at various biotechnology companies, and most recently with CTI.
Additionally, CTI’s Dr. Kathryn Wekselman, Director, Regulatory and Scientific Affairs, will lead a session titled “Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document Writing” on Sunday, June 23, 1:00pm - 4:30pm. This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions and regulatory document writing. Dr. Kathryn Wekselman has 15 years of experience in the pharmaceutical industry and 10 years of experience as a nursing clinician and academician. At CTI, Dr. Wekselman is responsible for preparing regulatory submissions (e.g., meeting requests and briefing packages, orphan drug designation requests, pediatric assessment plans, INDs and marketing applications), ensuring that all work meets quality standards. CTI will also exhibit throughout the meeting at booth #1819.
The DIA Annual Meeting is the premier event for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and related medical products. There is no other industry meeting of its kind that can rival the depth and breadth of experience that this meeting delivers through its 22 content-area tracks, 250 sessions, and 20+ tutorials.