Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.

This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.

This audio conference covers:

• The impact of the schedule of events relative to the number of subjects in a study and the interval between dosing each subject
• The space and equipment needed to conduct a Phase I study
• Staffing requirements, and when there will be peaks and valleys of staff needs in a Phase I study
• The documentation required to support the conduct a Phase I study
• SOP needs for a Phase I unit
• Understanding the training needs of the Phase I site staff

About the speaker:

Lorraine S. DeCesare obtained her BS degree in pharmacy from Drake University in Des Moines, IA. She has over 30 years experience in the pharmaceutical industry with extensive formulation and clinical packaging development, project management, clinical trial management and monitoring experience in numerous therapeutic areas. Most of this experience has been sponsor-based with companies such as Abbott, Adria, Solvay, and UCB; she also has site experience with SFBC Fort Myers and contract research experience with Resource Solutions.

Lorraine’s first position was as a research pharmacist in the solid formulations group with Abbott Laboratories. After developing the Biaxin® tablet, she transferred within Abbott to the clinical research group as a CRA where she monitored the Phase III program for Biaxin as well as numerous Phase I first in man studies. In 1987, after relocating to Atlanta, she joined Adria Labs as a regional CRA monitoring oncology studies for 18 months. After joining Solvay Pharmaceuticals in 1989 as a Senior CRA, she monitored the Phase II fluvoxamine studies in OCD then as Clinical Research Manager, she contributed to the Luvox® NDA for both OCD and depression. After more than 8 years with Solvay, she joined UCB in their newly created US clinical development group as a project manager on their antihistamine projects and eventually became Global Project Leader for their novel anti-asthmatic compound. After leaving UCB, she spent 9 months as a Senior Clinical Trial Manager with Resource Solutions Inc. before opening her own consulting company, LS Drug Development, Inc. (LSD3), in 2002. LSD3 focuses on clinical trial management and the appropriate training of sponsor and site personnel to effectively conduct clinical trials according to GCP, ICH, and their Standard Operating Procedures. She took undertook a 3-year contract (2 003-2006) with SFBC Fort Myers, Inc. as Director, Clinical Operations managing the day-to-day operations of a 120-bed Phase I clinical unit. Since 2006, she has focused on multi-national clinical trial management with UCB and Phase I site set-up and personnel training.

Who should attend?

• Clinical Research Associates
• Clinical Project Leaders
• Clinical Project Managers
• Directors of Project Management
• Phase I Managers