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Tuesday, June 28 • 10:30am - 11:45am
#212: Special Populations in Clinical Pharmacology Studies

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-524-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium examines the complex challenges encountered in special population study design. Appropriate management of specialty populations with comorbidities on multiple medications creates challenges in protocol design and enrollment to ensure patient safety and accurate and quality data.

Learning Objectives

Discuss strategies to adapt to industry trends and changing demands of special population studies; Identify options in protocol design and the process for screening patients with comorbidities and concomitant medications; Evaluate the impact of subject population on subject safety data and on assessment of drug safety.

Chair

William B Smith

Speaker

Special Populations in Clinical Pharmacology Studies: Evolving Challenges
William B Smith

Investigational Product and Drug-Drug Interactions in Specialty Populations with Comorbidities: Options in Addressing Safety, Data, Timelines, and Costs
Harry W Alcorn, JR, PharmD

Fast to Patient: Shifting from Healthy Volunteer to Patient Population
Richard Scheyer, MD

QTcF in Special Populations
Robert Kleiman



Chair
avatar for William Smith

William Smith

President, New Orleans Center for Clinical Research
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical Research and Volunteer Group located within the University of Tennessee Medical Center. Dr. Smith has been involved as a Principal Investigator in over 1800 clinical... Read More →

Speakers
avatar for Harry Alcorn

Harry Alcorn

Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 100 protocols and Sub Investigator on over 250 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with Normal volunteer's studies. Clinical Faculty appointments at Uni of Minnesota, Creighton Uni, Uni of Nebraska Medical Center, Uni of Colorado, and Virginia Common... Read More →
RK

Robert Kleiman

Chief Medical Officer and Vice President, Global Cardiology, ERT
Dr. Kleiman is a cardiac electrophysiologist who has performed research in both basic and clinical electrophysiology and practiced clinical electrophysiology for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer, and works with pharmaceutical clients to develop cardiac safety strategies for their clinical development programs, including the design of cardiac safety trials, the analysis of cardiac safety... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical Affairs, Medpace
Dr. Richard Scheyer is VP Medical Affairs at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY Upstate, and completed residency and fellowship at Yale before joining the Neurology faculty. He served on the FNIH Biomarkers Consortium and the Board of... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA