October 12, 2012
CTI Clinical Trial and Consulting Services (CTI) announces that their Director, Regulatory and Scientific Affairs, Kathryn Wekselman, PhD RN will serve as a session leader at the 2012 Regulatory Affairs Professionals Society (RAPS) Annual Conference, taking place October 26-30, 2012 in Seattle. Dr. Wekselman will preside over the session “Biosimilars Update”, a trans-regional panel discussion providing insight into experts’ vision for where the biosimilar regulatory environment is heading and the challenges that have been encountered (or may be anticipated) as biosimilar products are developed.
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. She consults on drug development and regulatory strategy, clinical trial design, feasibility assessments and clinical outcome measurement. Previously, Dr. Wekselman was director of regulatory consulting and submissions at Kendle International and senior director of research services at Camargo Pharmaceutical Services, managing regulatory consulting groups performing research and preparing submissions necessary for drug development and approval for 505(b)(1), 505(b)(2), biologic and ANDA drug programs. Dr. Wekselman also worked at Procter & Gamble Pharmaceuticals, where she was a medical writer, medical monitor and project leader. Dr. Wekselman holds a PhD in nursing from the University of Cincinnati and an MLS from Emory University.
According to their website, RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization.