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Wednesday, June 29 • 2:00pm - 3:15pm
#335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials

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Limited Capacity seats available
Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-521-L04-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will cover multi-ethnic, special populations, and patient diversity in clinical trials. It will illustrate an assessment of over 10,000 trials, recently conducted by sponsor companies, to quantify the differences of pediatric trials from adult studies. It will illuminate the learning’s in site identification, site qualification, and enrollment from the DOVE study, a 14-country study representing a mix of traditional and developing regions. It will then evaluate and analyze the available data regarding the characteristics of medicines approved for older patients in European Union and the US, contributing to the information in the geriatric population in order to discuss their access to innovative drugs.

Learning Objectives

Discuss country-specific differentiation in site activation, subject recruitment, and data quality, especially around developing regions, as demonstrated by the DOVE study; Classify the difference in performance between pediatric and adult studies; Describe the challenge of addressing geriatrics adequately in the assessment of medicines including the necessity to increase global regulatory dialogue and communication.

Chair

Lisa Palladino Kim, MS

Speaker

Pediatric Studies: Experiences, Best Practices, and Trends
Conrad Hawkins

Conduct of Clinical Trials in Special Populations and Developing Regions: Challenges and Opportunities
Stephen G. Reams, MA

Medicines Development for Geriatric Patients: Unmet Needs?
Dinah Duarte, PharmD, MSc


Chair
avatar for Lisa Kim

Lisa Kim

Director of Capstone / Lecturer, Rutgers School of Health Professions, United States
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Research Management Program. Lisa has 15 yrs of Pharmaceutical expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt... Read More →

Speakers
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Conrad Hawkins

Conrad Hawkins

Associate Consultant, KMR Group Inc.
Conrad Hawkins is an associate consultant of KMR Group, a firm specializing in measuring and improving biopharmaceutical R&D performance, evaluating clinical productivity, clinical trial cycle times and enrollment processes as well as study start-up. His areas of expertise include... Read More →
avatar for Stephen Reams

Stephen Reams

Advisor, Clinical Project Management, Eli Lilly and Company
Steve has more than 27 years experience in the pharmaceutical industry, including assignments in both discovery research and clinical product development at Eli Lilly and Company. His roles have spanned multiple disciplines including clinical operations, data management, and clinical... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium