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Tuesday, June 28 • 2:00pm - 3:00pm
#252: Capturing Real-World Data in Rare Diseases

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Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-591-L01-P; CME 1.00; IACET 1.00; RN 1.00

Although much can be learned from interventional-type clinical trials, a fuller picture of disease course and experiential journey can only be understood by observing patients longitudinally in real-world settings where co-morbid conditions, medication noncompliance, economic considerations, and a host of other factors come into play. However, capturing real-world data in rare diseases poses distinctive demands: fewer patients, patient inability to report on disease experience due to youth or infirmity, and need for longitudinal tracking. This panel seeks to present conventional and novel approaches to capturing real-world data in rare diseases.

Learning Objectives

Discuss the benefit of real-world data; Summarize the distinctive demands for real-world data and data collection in rare diseases; Describe ways to address real-world data demands in rare diseases.

Chair

Badri Rengarajan, MD

Speaker

Unique Paradigms to Rare Diseases Research
Donny Chen, MBA

Real-World Evidence and Rare Diseases
Derenda Nichols



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes; Director, BD and Market Research, Nodality; Regulatory Team Leader, Genentech; Junior Engagement Manager, McKinsey. Education: A.B., Biology and Public... Read More →

Speakers
avatar for Donny Chen

Donny Chen

Director, Medical Affairs Research Operations, PPD
Donny Chen, director of medical affairs research operations at PPD, has spent the last 17 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated Phi Beta Kappa from the University of Chicago with concentrations in economics and medicine. He received his MBA from the Chicago Booth School of Business with... Read More →
avatar for Derenda Nichols

Derenda Nichols

Senior Director, Clinical Trial Management, Medpace
Derenda Nichols has more than 25 years experience in the CRO industry. Her diverse background includes monitoring and site management, regulatory affairs, medical writing, global project management, operations and most recently, executive management. She has successfully participated in planning and executing large, multi-country projects a variety of therapeutics including orphan/rare diseases. She is currently a Sr. Director, Clinical Trial... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA