For Immediate Release: February 2, 2015
Medpace’s Michelle Petersen to present on best practices in conducting Rare Disease Studies Outsourcing in Clinical Trials West Coast 2015, 3-4 February 2015, San Francisco
CINCINNATI, OH — (February 2, 2015) –Michelle Petersen, MS, Medpace Clinical Trial Manager, will present “Successful Strategies for Operating a Rare Disease Clinical Study,” at Arena International’s annual Outsourcing in Clinical Trials West Coast meeting.
Rare Disease has been a neglected area for drug research, but with increased global legislation targeted to Rare Disease development, pharmaceutical companies are racing to find cures. Rare Disease and Orphan Drug research is challenging because of the difficulty in finding the correct subjects and investigative sites. Patient retention in studies is often difficult as well.
Ms. Petersen’s topic will focus on the planning and execution of a clinical study for an orphan indication with consideration for the unique set of challenges these diseases present. This session will focus on successful strategies and best practices for addressing some of these including:
- Unique methods to site selection and feasibility
- Successful recruitment/retention approaches
- Overview of common study execution needs
- Optimal training and monitoring strategies
Medpace, with a physician driven, full-service model has deep experience in Rare and Orphan Disease clinical studies.
ABOUT MICHELLE PETERSEN, MS
Michelle Petersen has over 8 years of experience in pre-clinical and clinical research that includes managing global studies in various phases of development. She has managed multiple global orphan /rare diseases and neuroscience trials. She is a member of Medpace’s specialized orphan/rare disease team and is adept in developing strategies necessary to address the potential challenges to recruitment and logistical requirements of studies of this nature. Ms. Petersen coordinates all aspects of the trial implementation process and ensures the overall quality of trial conduct. Ms. Petersen’s comprehensive knowledge of orphan/rare disease trial conduct results in the successful execution of these complex studies. She has a Master of Science degree in Physiology with a focus on molecular mechanisms of ALS.
Medpace is a global full-service clinical research organization (CRO) providing Phase I-IV core development services for drug, biologic, and device programs. Medpace has strong experience supporting development programs across a number of therapeutic areas including oncology, cardiovascular, metabolic/diabetes, infectious disease, neuroscience, regenerative medicine, gastrointestinal diseases, pediatrics, and orphan disease. With extensive medical expertise, and renowned regulatory affairs department, Medpace employs 2000 employees and has clinical trial experience in over 45 countries and 6 regions – the US, Europe, Central and Eastern Europe, India, Asia Pacific, and China. From feasibility, research site compatibility, safety, and logistics, Medpace brings innovative efficiencies and operational excellence to both drug and device development programs. In addition, Medpace offers integrated imaging, central and bioanalytical lab capabilities, and clinical pharmacology through wholly-owned business units to provide cohesive, streamlined, and standardized trial management. Our mission is to accelerate the global development of safe and effective medical therapeutics.