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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