The Expert in Compliance

Steve Vincze delivers immediate value to Biotech, Specialty Pharma and MedTech businesses by creating precision risk assessments and compliance programs that propel growth.

Prior to forming TRESTLE Compliance, Vincze split his private-sector career between service as an in-house or outsourced Sr. VP or VP Chief Compliance Officer for several life science and healthcare companies and as a consultant, forming his own firms as well as serving as a non-equity partner for a “Big 4” firm. Vincze was a Counsel to a U.S. House of Representatives Oversight Committee.

He has been recruited to address high-profile cases and to support legal, commercial and executive teams and Boards of Directors with his compliance expertise, in addition to working with a range of life science companies on a global scale, including the most prominent U.S., Japanese and European companies.

Vincze was an Officer, U.S. Marine Corps (USMC), in which he received various citations, decorations and a full scholarship to law school; served as a prosecutor and defense counsel; served in the Office of the Secretary of Defense; and later was selected to serve as a counsel and professional staff member of the Government Operations Committee in the U.S. House of Representatives.

He has an A.B. Degree from Columbia University, a J.D., Southern Methodist University School of Law, an LL.M. in International & Comparative Law with distinction, Georgetown University Law Center, and an MBA, University of Chicago Booth School of Business.

 

LICENSES AND CERTIFICATIONS

FCPA Expert Certification, The FCPA Blog, Issued July 2020

OneTrust Certified Privacy Professional, OneTrust, Issued June 2020

Privacy Management Professional, OneTrust, Issued June 2020

BioBasics: Biotech for the Non-Scientist, Biotech Primer, Issued March 2019

State Bar of Texas — Active Member in Good Standing, State Bar of Texas, Issued May 1989

 

“When it comes to effective compliance, what matters is doing what’s right, not just what’s required.”

– Steve Vincze

“I approach this not just as a lawyer, not just as a former compliance officer and not just as a government guy, but as a businessman.”

– Steve Vincze

“This is a lot more than just, what are the rules and how do we do them, it’s about how do we get the business to succeed in launching their products and bringing value to patients and being part of that fabric, and weaving into the commercial DNA, and creating a compliance culture.”

– Steve Vincze

“I call myself, and quite literally I am, the Marine of Compliance. And I’ve lived through some of the biggest settlements in the pharmaceutical industry. And I’ve seen what can happen when things go wrong.”

– Steve Vincze

Where I’ve Been & What I’ve Done

1971 - 1975

Phillips Academy

1975 – 1982

Columbia University in the City of New York

A.B. History
Dean's List, Varsity Crew (Invited to U.S. National Team), President of Delta Psi (St. Anthony Hall)

Recruited Athlete for Crew/Rowing from Phillips Academy.

1982 - 1995

United States Marine Corps

Served in several positions over eleven years of active duty and two years of reserve service. Began service as an artillery officer, graduating with Honor. Served in the field and was recommended for White House duty. Selected as one of two first lieutenants for a full-scholarship to law school under the Funded Law Education Program (FLEP). Graduated with Honor. Served with distinction at Parris Island, SC and then recommended for duty as a member of a joint military staff in the Office of the Secretary of Defense in the Pentagon. Received the Defense Meritorious Service Medal as a Captain. Selected for promotion to Major prior to leaving active duty and accepting congressional staff position. Recommended for a position as a counsel to the House Committee on Goverment Operations on Capitol Hill. Also, served two years as a reserve military intelligence officer as a defense attache to Hungary.

1985 – 1988

SMU Dedman School of Law

J.D. Law
Moot Court Board, Honor Council (Elected Student Representative)

Attended on a full scholarship, the Funded Law Education Program (FLEP), through the United States Marine Corps. Member of the Moot Court Board and elected to the Student Honor Council

1993 - 1995

U.S. House of Representatives

Defense Counsel, Professional Staff Member

Counsel to the Chairman of the House Committee on Government Reform and Oversight, specializing in DOD/defense fraud and abuse, national security and international relations matters.

1993 - 1998

Georgetown University Law Center

LL.M (with distinction) in International & Comparative Law

Graduate Thesis: International Healthcare Compliance Programs: A Public and Private Sector Partnership to Defeat a Common Enemy -- Fraud and Abuse

1995 - 1997

Medaphis Corp

VP, Compliance Officer

Recruited to establish first compliance program for this industry-leading, publicly-traded company that had just come under federal investigation for alleged billing improprieties in CA.

Successfully established compliance program from scratch and worked with the Office of Inspector General, HHS, to establish reputation as an industry leader. Was elected to the Board of Directors of industry association, IBMA, later renamed, HBMA.

1996-1997

Healthcare Billing & Management Association

Board Member

1997 - 1998

Healthcare Management Advisors

VP, Compliance Services

Recruited to establish compliance services division for billing management consulting company. Succeeded in developing business and generating over $700,000 of contracts in eight months. Left to establish own consulting firm on encouragement of clients and family.

1998

Harvard Kennedy School

Executive Education Field of Study: Effective Decision-Making

1998 - 2001

Vincze & Frazer, LLC

President & CEO

Founder of multi-disciplined professional services consulting firm with clients across the country, specializing in healthcare regulatory compliance, especially billing compliance for hospitals, integrated medical centers and physician practices.

2000-2003

Health Care Compliance Association(HCCA)

Board Member

2001 - 2008

TAP Pharmaceutical Products Inc.

VP, Ethics & Compliance Officer/Privacy Officer

Recruited to develop and implement an industry-leading compliance program and implement TAP's 7-year CIA effectively. The "TAP case" was the largest settlement with the Federal government in the pharmaceutical industry at the time (2001). The TAP case focused on sales and marketing commercial compliance issues and drug pricing issues. It was the impetus for the OIG compliance guidance for the pharmaceutical industry and the Pharma Code.

2004-2005

American Medical Association

Member, National Task Force for Continuing Medical Education

2004 - 2006

The University of Chicago Booth School of Business

Number one student in Strategic Leadership class. Excelled also in Competitive Strategy, Marketing, and Macroeconomics.
First TAP Executive sent to Executive MBA program in five (5) years; sent on full scholarship.

2006-2008

RAND Corporation

Member Advisory Board to RAND Center for Corporate Ethics, Law and Governance

2008 - 2013

Deloitte

Director (Non-equity Partner), Deloitte

Co-led and sold the largest life science compliance project in the firm's history in the first year for over $4.0 million. Focused on commercial compliance restructuring, policies and procedures, training and testing and FCPA/ anti-corruption global compliance issues with some of the largest pharmaceutical and biotech companies in the world.

2013

Warner Chilcott

Sr. VP, Chief Compliance Officer

Recruited to reorganize, restructure and implement a comprehensive compliance program focused on commercial compliance, to ensure product launches proceeded as scheduled, to implement compliance processes that properly addressed issues raised in an open, on-going Federal criminal investigation, and to position the company for a successful acquisition within six months.

2014 - 2016

Polaris

Boston Managing Partner

Opened the Polaris Boston office as Boston Managing Partner in Kendall Square, Cambridge, serving biotech, specialty pharma, pharma and medical device companies in the greater Boston/New England region.

2016 - Present

Marine Corps Scholarship Foundation

Volunteer/Supporter

2017 - Present

TRESTLE Compliance

Founder/President & CEO

TRESTLE Compliance is a highly specialized consulting firm offering the full spectrum of ethics and compliance, risk and regulatory services. Lead a multi-disciplined team of professionals, each with 20+ years of expertise, to create custom, properly scaled solutions with precision, speed and unmatched value.

2019 - Present

Cycle Pharmaceuticals Limited

U.S. Chief Compliance Officer & Privacy Officer (outsourced through TRESTLE Compliance, LLC.)

Support the U.S. Commercial team and report to the U.K. General Counsel, with direct access to the CEO, to provide U.S. commercial compliance, privacy and in-house legal counsel support. Provide oversight, training, monitoring, auditing and overall support to ensure a credible, effective and properly scaled compliance and privacy program meets current U.S. governmental standards, both federal and state.

2020 - Present

Compliance Week

Advisory Board Member

Invited as a recognized compliance leader to join fellow compliance leaders to serve as an advisor to Compliance Week.

2021 - Present

BeyondSpring Pharmaceuticals, Inc.

Interim U.S. Chief Compliance Officer (outsourced through TRESTLE Compliance, LLC.)

Volunteer Experience

Advisory Board Member

Compliance Week

2020 - Present

Volunteer/Supporter

Marine Corps Scholarship Foundation

2016 – Present

Member Advisory Board to RAND Center for Corporate Ethics, Law and Governance

RAND Corporation

2006 – 2008

Member, National Task Force for Continuting Medical Education

American Medical Association

2004 – 2005

Board Member

Health Care Compliance Association

2000 – 2003

Board Member

Healthcare Billing & Management Association

1996 – 1997

In The Press

CEOWORLD Magazine

April 2021

Paradigm Shift Podcast

Part 1

June 2021

Paradigm Shift Podcast

Part 2

June 2021

Training Unleashed

August 2021