我们的管理与支持团队

Validant 的团队成员有一个共同愿景,即确保可以安全可靠地获得世界上拯救生命的医疗产品。他们还奉行一个共同信念,即专家策略应与无缝执行相结合,以创造成功的结果。

Patrick has more than 25 years of leadership, regulatory policy, and strategic advising experience related to biopharmaceuticals and healthcare.

Patrick Ronan

Chief Executive Officer

Patrick Ronan was named the CEO of Validant in April 2021. Patrick previously served as the CEO of Greenleaf Health, Inc. (Greenleaf), a leading regulatory consulting firm based in Washington, D.C., which he founded in 2007. With more than 25 years of leadership experience at the Food and Drug Administration (FDA), on Capitol Hill, and at a leading global pharmaceutical company, Patrick brings a comprehensive understanding of the healthcare sector to Validant.

Prior to founding Greenleaf, Patrick was Vice President of Regulatory Policy & External Affairs at Novartis Pharmaceuticals Corporation, where he supervised U.S. regulatory policy issues and advised all therapeutic areas on FDA-related regulatory matters. In addition, Patrick supervised state regulatory and coverage policy and advocacy activities. At Novartis, Patrick formulated and implemented a regulatory policy agenda, working on policy matters and providing strategic direction to all therapeutic development teams on their interactions with the FDA on a full range of pre- and postmarket product-specific matters.

Patrick served as the FDA’s Chief of Staff from 2005–2007 and in other leadership roles at the Agency preceding this role. As Chief of Staff, Patrick was the principal advisor on all agency issues to former Commissioners Dr. Andrew von Eschenbach and Dr. Lester M. Crawford. Patrick’s FDA career began with his appointment as Assistant Commissioner of Legislation by then Commissioner Dr. Mark McClellan. The following year, Patrick was elevated to Associate Commissioner of Legislation and then Chief of Staff. His work with Congress contributed to the enactment of important modernizations of public health laws governing the regulation of drugs, biologics, medical devices, and foods.

Patrick’s interactions with Congress as the FDA Chief of Staff were a natural extension of his prior experience on Capitol Hill, where he served on the professional staff of the Committee on Energy and Commerce for then Chairman W.J. “Billy” Tauzin and Chairman Joe Barton from 2002–2004. In this capacity on the Committee, Patrick became one of the lead drafters of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and authored numerous pieces of food- and drug-related legislation that were signed into law. Earlier, Patrick was Director of Government Relations at the Washington, D.C.-based Biotechnology Innovation Organization (BIO) and worked for several Members of Congress who represented the constituents of Nevada and Pennsylvania.

Patrick is based in the Chicagoland area, where he resides with his wife, children, and Golden Retrievers.

Patrick Ronan

Chief Executive Officer

 

Purvi Chekuri

LinkedIn

Purvi has more than 20 years of financial management and executive leadership experience within the corporate accounting arena.

Purvi Chekuri

Chief Financial Officer

Purvi Chekuri focuses on the leadership of all aspects of our financial affairs, including corporate accounting, financial planning and analysis, and oversight of tax, treasury, and insurance. She is based out of our headquarters in San Francisco.

With more than 20 years of financial management and executive leadership experience within the corporate accounting arena, Purvi is highly skilled in communicating the parameters of complex business transactions and strategic initiatives to both front line leaders and senior executives. A passionate champion of using automation to drive efficiencies, she’s been instrumental in several key system implementations for Validant.

Purvi was previously the Senior Vice President of Finance and Accounting for the Newport Group, a leading provider of retirement plans, insurance, and consulting services. She also held key positions at Quark Biotech and Docent, Inc., where she was instrumental in preparing the company’s SEC filings for its Initial Public Offering. She holds a Bachelor of Science degree from the Haas School of Business at the University of California, Berkeley and is a licensed CPA in the State of California.

Purvi Chekuri

Purvi Chekuri

Chief Financial Officer

 

Sanny Kataoka

LinkedIn

Sanny has more than 17 years of experience assisting innovative companies with all aspects of their legal affairs.

Sanny Kataoka

Chief Legal Officer

Sanny Kataoka focuses on strategic oversight and implementation of our global legal activities and policies. She is based out of our headquarters in San Francisco.

Sanny previously served as Senior Counsel at the technology-centric firm Paragon Legal, assisting some of San Francisco’s most innovative companies with all aspects of their legal affairs. Prior to that, she was U.S. Senior Counsel at Novadios, LLC, and a litigator at several esteemed Bay Area firms, including Crosby, Heafey, Roach & May (now Reed Smith) and Brobeck, Phleger & Harrison, where she focused on employment law.

Sanny served as a judicial extern for The Honorable Saundra Brown Armstrong of the United States District Court, Northern District, and the U.S. Attorney’s Office, Central District. She is fluent in Cantonese and can speak Mandarin conversationally. Sanny holds a Bachelor’s degree with high honors in Mass Communications from the University of California, Berkeley, and a Juris Doctor degree from the University of California, Los Angeles, School of Law, where she was a Joseph Drown Foundation Scholar.

Sanny Kataoka

Sanny Kataoka

Chief Legal Officer

 

LinkedIn

Nathaniel leads information technology operations and strategic planning for the company, implementing global IT systems and policies that meet the highest standards of data security and quality.

Nathaniel Cartagena

Chief Information Officer

Nathaniel Cartagena was appointed Chief Information Officer (CIO) for Validant in June 2021. He leads information technology operations and strategic planning for the company, implementing global IT systems and policies that meet the highest standards of data security and quality.

Nathaniel has more than ten years of experience as an information technology executive, most recently as Director of IT Services for Greenleaf Health. During his time with Greenleaf, Nathaniel initiated significant security improvements to the organization’s devices, systems, and electronic documents and communications. He also transitioned the firm’s internal IT support from a managed service provider, guiding the organizational change and expectations and optimizing all outsourced processes. Nathaniel’s expert, detailed management of these systemwide IT enhancements enabled Greenleaf to fulfill client expectations for information security and workflow and to support substantial growth of the firm’s team and client base. Throughout these efforts, he continued to provide direct support for all software and hardware solutions, administer and audit existing systems, create training and reference materials to help end users make the best use of tools, and advise on internal and external projects such as the redesign of Greenleaf’s website.

Nathaniel was previously Senior Advisor at Mindovo, Inc., a technology advising firm, where he developed training materials and lessons for new advisor development, created strategic plans for sales initiatives, and led promotional days resulting in record-setting revenues. His client-facing activities focused on developing innovative IT procedures and systems for CEOs, philanthropists, and local celebrities.

Prior to this, Nathaniel mentored students and worked as an advocate and liaison between the student staff and professional staff at Michigan Technological University, earning several awards in recognition of his work. Nathaniel graduated magna cum laude from Michigan Technological University with his Bachelor of Science in Mathematics.

Nathaniel Cartagena

Chief Information Officer

 

Brian Burns Photo

LinkedIn

Brian has over 35 years of experience providing quality, regulatory, medical safety, clinical, and strategic leadership for global healthcare businesses.

Brian Burns

President

Brian Burns is President and a Quality leader at Validant, based in the New England region. Brian brings deep executive experience in Quality and Regulatory strategy and improvement with a track record of comprehensive quality performance improvement.

Prior to joining Validant, he served as an Executive Vice President of Global Quality and Regulatory Affairs at Haemonetics Corporation and Fresenius Medical Care over the course of five years.  Brian led institutionalizing corporate quality systems for all operational areas and upgraded quality systems to support evolving business needs such as combination products while improving complaint handling, operational metrics, supplier quality, clinical quality, and global quality systems training.

Brian served as Executive Vice President of Global Quality, Medical Safety & Regulatory Affairs of Boston Scientific Corporation for seven years.  Brian was responsible for quality assurance for Boston Scientific’s businesses worldwide and served as company liaison to all compliance bodies, including the U.S. Food and Drug Administration, European Union Competent Authorities, and the Ministry of Health, Labour and Welfare, Japan.

Previously, Brian held various Quality Assurance, Operational, and General Manager roles with Cardinal Healthcare, Allegiance Healthcare, and Baxter Healthcare. He received his Bachelor of Science degree in Chemical Engineering with a Minor in Mathematics and Chemistry from the University of Arkansas.

Brian Burns Photo

Brian Burns

President

 

Helm Siegel

LinkedIn

Helm has nearly 20 years of experience as a senior services management professional with a proven track record of achieving results.

Helm Siegel

VP, Client Engagement

As a Vice President for Validant, Helm is responsible for project and personnel management associated with critical initiatives within leading Medical Device, Pharmaceutical, and Biotechnology organizations.

Working exclusively within these FDA-regulated Life Sciences industries, Helm partners directly with each Client’s technical leadership to deploy the most appropriate mix of tactical and strategic consulting resources for any phase of the product lifecycle. Ranging from a single Subject Matter Expert to matrixed groups across multiple divisions, these resources work side-by-side with each client’s teams to support the planning and execution of critical quality systems, product development, manufacturing, engineering, and cGMP regulatory compliance activities.

Before joining Validant, Helm held positions of increasing responsibility within Research, Technical Recruitment and Business Development for Harvey Nash, a UK based executive search and professional recruitment firm serving clients in Europe, Asia, and the U.S. With over 30 offices worldwide, Harvey Nash provides specialized executive search, IT professional services and IT staffing to clients in the technology, finance and banking, health care, manufacturing, and government sectors.

Helm holds a Bachelors Degree in International Affairs and Business from the University of Colorado at Boulder.

Helm Siegel

Helm Siegel

VP, Client Engagement

 

Theodore Hellen

LinkedIn

Theodore brings over 12 years of business experience in healthcare and professional services.

Theodore Hellen

VP, Client Engagement

As Vice President of Client Engagement, Theodore leads Client & Talent Engagement globally and has overall responsibility for account management and talent delivery & management across all sectors of Biotechnology, Pharmaceutical, and Medical Device & Diagnostics.

Working exclusively within these FDA regulated life science industries, they partner with client leadership to deploy the most appropriate mix of execution and strategic consulting resources for any phase of the product lifecycle. Ranging from a single Subject Matter Expert to matrixed groups across multiple divisions, these resources work side-by-side with each client’s teams to support the planning and execution of critical regulatory, quality, and cGMP compliance initiatives.

Previously Theodore was responsible for the development of our European headquarters in Cork, Ireland, where he cultivated business relationships across EMEA regions, grew and led a team of Client and Talent Engagement associates, and led critical business processes and partnerships across EMEA.

Theodore holds a Bachelors Degree in Business Administration from the University of Colorado at Boulder. 

Theodore Hellen

Theodore Hellen

VP, Client Engagement

 

Colm Coveney

Client Engagement Director

Colm Coveney

Colm Coveney

Client Engagement Director

 

Colin Larsen

Sr Client Engagement Manager

Colin Larsen

Colin Larsen

Sr Client Engagement Manager

 

Mara Mitchell

Client Engagement Director

Mara Mitchell

Mara Mitchell

Client Engagement Director

 

John Tritschler

Client Engagement Director

John Tritschler

John Tritschler

Client Engagement Director

 

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