Kathryn Van Wie Email and Phone Number

Expanded role to include Commercial Strategy, Market Development, Market Access, Marketing and Communications.Lead key strategic and business development initiatives including:Expanding clinical trial services for biotech and pharmaceutical drug development.Establishing international market for the Syn-One Test.Identifying partnership and licensing opportunities for new product offerings.Interim head of Regulatory, Quality, Legal, and Compliance:Establishing comprehensive Corporate Compliance program.Providing regulatory and legal guidance on areas of FDA/FTC product communication considerations and Healthcare Fraud & Abuse including Stark, AKS, EKRA, CMPL, FCA.Developing global regulatory strategy to support ex-US expansion.Leading activities in preparation for FDA's Laboratory Developed Test Final Rule phase-out of its enforcement discretion policy.Overseeing Quality Assurances team, ensuring compliance with CLIA/CAP and other regulatory authorities.

Lead key strategic initiatives including:Expanding clinical trial services for biotech and pharmaceutical drug developmentEstablishing international market for the Syn-One TestIdentifying partnership and licensing opportunities for new product offerings

HCP marketing lead for next-in-class rare disease product. Developed brand plan and budget for launch preparations. Worked cross-functionally on brand positioning, customer segmentation, and core messaging.

Led operations for the North America Leadership Team, annual brand planning and budgeting processes for US and Canada. Supported head of North America Commercial Operations in defining and developing executive communications and employee engagement plan. Developed first of its kind program to provide mobile blood tests and eye exams to patients, navigating complex legal and operational challenges.

Product attorney providing legal and strategic counsel to global Commercial and Medical Affairs organizations. Advised stakeholders on advertising and promotion, scientific exchange, social media and digital strategies, patient support services, and other issues related to healthcare fraud and abuse.

Advised patient advocacy, corporate communications, regulatory, medical, and commercial on post-marketing product activities, advertising, promotion, labeling, and other external communication. Provided direction on antitrust, products liability, privacy, and healthcare fraud and abuse.

Led commercial contacting operations and supported commercial business through contract management. Managed contracts paralegal.

Drafted complex contracts supporting market research, health economics, publications, regulatory operations, marketing and product promotion, managed markets, patient advocacy, patient engagement, advisory boards and speaker programs with healthcare providers.

Coordinated access to GxP-related systems in compliance with applicable regulations for internal and external controls.

Developed lesson plans and conducted English immersion classes varying from elementary education levels to corporate translation.

Managed vendor contractors of the company's largest client account to ensure compliance with the Fair Credit Reporting Act. Facilitated client audits and analyzed data to drive performance decisions and organized contractors for onsite investigation