June 5, 2014
CTI Clinical Trial and Consulting Services to Present, Chair & Exhibit at DIA 2014 50th Annual Meeting
For Immediate Release [Cincinnati, OH ~ June 5, 2014]
CTI Clinical Trial and Consulting Services (CTI), an international, privately held, full-service contract research organization will present, chair, and exhibit at the DIA 2014 50th Annual Meeting, Celebrate the Past – Invent the Future, in San Diego, June 15-19.
CTI’s Peter J. Mallow, PhD, Assistant Director, Health Economics, will chair the session “Pricing, Economics, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach to Rare Diseases” on Monday, June 16th at 11:00am – 12:30pm PST. The session will present a strategy to assess orphan drug development that accounts for pricing, economics, reimbursement, and market size. During the session, Dr. William Irish, CTI’s Vice President, Biostatistics and Health Outcomes Research, will present on the topic “Rare Disease Aspects of Pricing, Economics, Reimbursement, Market Share (PERMS) Strategy”. 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. Dr. John Rizzo, Professor Economics and Preventative Medicine at Stony Brook University and CTI Academic Affiliate, will also present on the PERMS Strategy.
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 15, 8:30am -12:00pm PST. 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 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 quality standards.
CTI will also exhibit throughout the meeting at booth #2316.
The DIA 2014 50th Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.
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.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.
About DIA's 2014 50th Annual Meeting
Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development and life cycle management of medical products. The meeting aims to foster innovation that will lead to the development of safe and effective medical products and therapies for patients. For more information, visit www.diahome.org/dia2014.