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Dear All,

 

Here is a brief Bio of our speaker at 12pm in ENGR 1602 –

 

BIOGRAPHICAL SKETCH

Provide the following information for the key personnel and other significant contributors.
Follow this format for each person.

 

NAME

Eugene F. Civillico

POSITION TITLE

Health Physicist

eRA COMMONS USER NAME

CIVILLICO

EDUCATION/TRAINING 

INSTITUTION AND LOCATION

DEGREE

(if applicable)

YEAR(s)

FIELD OF STUDY

Harvard College, Cambridge, MA

B.A.

June 1998

Biology

University of Pennsylvania School of Medicine

Ph.D.

May 2006

Neuroscience

Princeton University

Postdoctoral

2006-2009

Neuroscience

 

A. Personal Statement

 

I lead a research group within the Division of Biomedical Physics in FDA/CDRH’s Office of Science and Engineering Laboratories.  We focus on common problems in the translation of novel neurotechnology and neurorehabilitation concepts into successful clinical solutions.  Recently, we have become interested in the disconnect between the designed technical capabilities of next-generation prosthetics and their ability to solve medical problems, as defined by their users and the payer/provider community. This topic touches on an issue of rapidly expanding importance for CDRH and the biomedical stakeholder community – namely, the role of the patient’s voice in medical product development and regulatory approval.  Accordingly, I will be very pleased to assist with the work being proposed, which could result in one of the largest data sets ever collected on the subject of what impairments are most burdensome to potential prosthesis users, and how their views could influence their risk tolerance.

 

In addition to my research efforts, I provide subject matter expert consulting reviews for neurological and physical medicine device submissions to CDRH’s Office of Device Evaluation, which performs premarket review of new medical devices. I also work with the Office of the CDRH Center Director to identify and promote mission-relevant research directions for our intramural labs. These experiences at CDRH have given me the knowledge necessary to orient research output in an impactful direction. By building on the momentum of various public and private patient-centered benefit/risk assessment initiatives, I will help to ensure that the results of the proposed work are consistent with FDA guidelines on quantifying patient preferences, and are communicated to all relevant stakeholders for maximum impact. In addition, my experience in quantitative methods development as a systems neuroscientist will help me contribute to the proposed work.

 

B. Positions and Honors

1998                B.A. Biology, magna cum laude

                  Harvard College, Cambridge, MA

Awarded certificate in mind/brain/behavior, indicating successful completion of an interdisciplinary program of introductory coursework, advanced seminars, and independent research in the neurosciences

 

2006          Ph.D., Neuroscience

University of Pennsylvania School of Medicine, Philadelphia, PA.

Mentor: Diego Contreras, M.D., Ph.D.

 

2006-09     Postdoctoral fellow, Dept of Molecular Biology and Princeton Neuroscience Institute, Princeton University, Princeton, NJ

Mentor: Samuel S.-H. Wang, Ph.D.

 

2013-present  Group Leader, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, FDA

 

2011-2013       Neuroscientist, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, FDA

 

2009-2011       Lead Electrophysiologist, CNS Drug Discovery and Development, Otsuka Maryland Medicinal Laboratories

 

2001    NIH Pre-Doctoral Training Grant in Cell and Molecular Biology T32-GM07229

 

 

 

 

Claudia Borke

Academic Program Coordinator

Volgenau School of Engineering, Department of Bioengineering

3800 Nguyen Engineering Building, 1G5

4400 University Drive

Fairfax, VA 22030

Phone: (703) 993-4190

Fax: (703) 993-2077