Biologics Consulting Group, Inc.

Stuart Portnoy, MD - Senior Consultant (Medical Devices)

EXPERTISE

Expert at guiding new medical devices through the regulatory and clinical process and negotiating with the FDA. Eight years of experience regulating medical devices at the FDA: reviewed or supervised review of hundreds of cardiac device applications along multiple pathways - IDEs, PMAs, and 510(k)s. Evaluated clinical risks and benefits of new high-risk technologies, many high visibility. Pioneered inter-center combination drug/device product review process including drug-eluting stents. Negotiated FDA jurisdictional designation for combination products.

EDUCATION:

M.D.	George Washington University School of Medicine (1991)
M.S.	Bioengineering, University of Pennsylvania (1989)
B.S.	Chemical Engineering, Tufts University (1985)

EXPERIENCE:

CURRENT
POSITION Aug. 2007 to present:

Senior Consultant - Medical Devices, Biologics Consulting Group, Inc., Washington, DC.

2002 - Jul. 2007

Executive Director, Medical Device Consulting, PharmaNet, Inc., Washington, DC.

Advised medical device manufacturers on regulatory strategy, clinical trial design, and technical considerations to gain FDA market-approval for new products.

2001 - 2002

Branch Chief, Interventional Cardiology Devices Branch, Food and Drug Administration, Rockville, MD.

Managed a team of engineering and medical reviewers. Assigned manufacturers' submissions to team members. Reviewed, edited, and signed-off on team's work.
Negotiated clinical trial design and FDA approval requirements with device manufacturers.
Developed approach to regulating combination products, especially drug-eluting stents. Coordinated regulatory review process with CDER and Commissioner's Office, Program of Combination Products.
Evaluated Requests for Designation (RFDs) for combination products.

2001

Acting Deputy Director, Division of Cardiovascular Devices, Food and Drug Administration, Rockville, MD

Assisted Director in managing 70-person cardiac device review division.
Managed high-profile projects, clinical and scientific personnel, administrative staff, and made decisions for approval of cardiac devices.

1994 - 2000

Medical Officer, Food and Drug Administration, Rockville, MD

Reviewed pacemakers, defibrillators, ablation catheters, and other cardiac electrophysiology devices.
Approved or disapproved devices based on evaluation of safety and effectiveness data.
Negotiated FDA requirements with medical device manufacturers regarding the following:
- Clinical Trial Design
- Product Labeling
- Post-Approval Studies
- Device Recalls

BIOMEDICAL ENGINEERING RESAERCH EXPERIENCE

Optimized a technique for growing human cells on industrial-grade synthetic fabrics.
Harvested tissue plasminogen activator for use in treating heart attack patients.
Researched underlying mechanisms of arrhythmias that result in sudden cardiac death
and published research results in the Journal of the American College of Cardiology.
Designed and performed experiments investigating techniques for controlled drug delivery.

1993 - 1994

VA Medical Center, Washington, DC.

1985 - 1986

Weizmann Institute of Science , Rehovot, Israel

1984 - 1985

MIT, Lab of Dr. Robert Langer , Cambridge, MA

PROFESSIONAL LICENSES & MEMBERSHIPS:

Licensed to Practice Medicine in Virginia (since 1992)
Heart Rhythm Society (member)

PROFESSIONAL ACTIVITIES & PRESENTATIONS:

Stanford Biodesign Fellowship Program - Project Team Advisor, Stanford University Palo Alto, CA (2007)
RAPS Annual Conference, Track Chair, Regulatory Affairs Professionals Society (2007)
Health Care Compliance Certification Program, Advertising, Promotion & Labeling of Medical Devices, Seton Hall Law School , Newark, NJ (semi-annual)
Chairman, Forging the Way for Combination Products for Drug, Devices, & Biologics, Center for Business Intelligence , Minneapolis, MN (2005)
Horizons West Coast Conference, Conference Chair, Combination Products Track, Regulatory Affairs Professionals Society in Santa Clara, CA (2004)
Predicting FDA Approvals & Rejections of Cardiac Devices, Transcatheter Cardiovascular Therapeutics Lazard Healthcare Research , Washington, DC (2004)

PUBLICATIONS:

Advertising & Promotion of Medical Devices": Stuart Portnoy. Journal of Health Law, Spring 2006.
Combination Products -- Regulatory Strategy for Preclinical and Drug Testing": Stuart Portnoy and Steven Koepke. Medical Device & Diagnostic Industry (MD&DI) Magazine, May & June 2005.

Page Updated: August 20, 2008