Expert in Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
Expert ID: 725687 Maryland, USA
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.
|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|
|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|
|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.|
|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)
|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.
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.
|Training / Seminars|
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
|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.|