Expert Details

Expert in Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology

Expert ID: 725687 Maryland, USA

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As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers.

She is a board certified cardiologist. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company.

She is a board certified cardiologist and electrophysiologist. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company that produced electrophysiologic catheters.

She is a board certified cardiologist and electrophysiologist with extensive experience implanting devices. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company.

She worked for the FDA in CDRH approving IDEs. In addition, she wrote IDEs in industry.

While with industry, she worked with the engineers on developing new product lines.

While with industry, she worked with the team to develop a business strategy for a start-up company.

Education

Year Degree Subject Institution
Year: 2003 Degree: MPH Subject: Clinical Trials Institution: Johns Hopkins University
Year: 1991 Degree: MD Subject: Medicine Institution: University of Rochester
Year: 1987 Degree: ScB Subject: Psychology Institution: Brown University

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Owner Department: Responsibilities: FDA regulatory consulting for medical device companies
Years: 2006 to 2008 Employer: CryoCor, Inc Title: Chief Medical Officer Department: Responsibilities: She was responsible for designing and running clinical trial. She obtained FDA approval for the first cryoablation product used for atrial flutter which involved running and FDA panel meeting. She assisted in strategic planning for the company.
Years: 2002 to 2006 Employer: National Naval Medical Center Title: Staff Cardiologist Electrophysiologist Department: Responsibilities: She had clinical and teaching responsibilities.
Years: 2000 to 2002 Employer: FDA Title: Medical Officer in Office of Device Evaluation Department: CDRH/ODE/DCD Responsibilities: Pacing, Defibrillation and Leads Branch Responsible for first biventricular pacing devices and MADIT

Government Experience

Years Agency Role Description
Years: 2000 to 2002 Agency: FDA Role: Medical Reviewer Description: She was responsible for reviewing cardiac devices. She led several panel meetings and approved several high profile devices.

Career Accomplishments

Associations / Societies
ACC, AHA, HRS
Licenses / Certifications
Licensure and Certification:
American Board of Internal Medicine: Certified in Internal Medicine (1994) Certified in Cardiovascular Diseases (1997) Certified in Clinical Electrophysiology (1998)
Virginia License (1997) Maryland License (2000) DC License (2003)
Professional Appointments
Committees and Contributions:
Center for Medicare and Medicaid Services: Cardiology Working Group for Coverage Issues JFK-Columbia Hospital-IRB Member NASPE -NASPE/Industry Task Force Founder of JFK-Columbia Hospital ICD support group Arrhythmias in Women-author of slide set by Medtronic, Inc. Executive Committee for AVID II
Medical / Professional
Medicine Residency at Johns Hopkins Hospital from 1991-1994; Fellowship in Cardiology and Electrophysiology from 1994-1998 at Duke University.

Postdoctoral Training:
Internship and Residency:
1991-1994 Internal Medicine, Johns Hopkins Hospital, Baltimore, MD
Fellowship: 1994-1998 Fellow in Cardiology and Electrophysiology, Duke University Medical Center, Durham, NC
Publications and Patents Summary
She has 21 publications in cardiology.
Abstracts: 33

Additional Experience

Training / Seminars
Invited Lectures/Reviews:
1999: Santa Fe, NM Women and Arrhythmias, Medtronic
1998-2000: various company sponsored lectures on Women and cardiac disease in local
areas in South Florida
May 2001: NASPE-FDA role in clinical trials for Pacing for Atrial Fibrillation
May 2002: NASPE-FDA role in clinical trials for Biventricular Pacing February 2003: Heart Failure Society of America-Panelist for Key Issues in Trial Design
for Devices in Heart Failure
May 2003: NASPE-Clinical Trial Designs for Devices, perspective from outside the FDA from a former insider.
October 2003: National Center for Early Defibrillation-Over-the-Counter AED Policy Options
November 2003: Cardiac Electrophysiology Review Invited Review on FDA approval process for MADIT II
November 2003: New Indications for ICDs-Plenary Session -Army ACP meeting, San Antonio, TX
May 2004: NASPE-Why We Still Need Randomized Controlled Clinical Trials
Marketing Experience
She was the Chief Medical Officer for a small start-up company involved in the first trial for ablation of atrial firbillation.
Other Relevant Experience
She has Regulatory Skills and expertise in FDA Panel Preparation, Clinical Trial Design and Medical Device Business Strategy.

Fields of Expertise

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