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Overview
Elaina McEwan is a director in the Life Sciences Consulting Group in the Litigation Department of Paul Hastings based in the firm’s New York office. Elaina has over 16 years of life sciences industry experience assisting companies in mitigating evolving risk areas and maintaining compliance with industry regulations. She supports corporate compliance, legal counsel and senior leadership on matters related to compliance program design and enhancement, sales and marketing compliance, corporate governance, government investigations, and patient services compliance, among others. In addition to her consulting experience, Elaina has held in-house roles in sales and compliance for two global pharmaceutical companies.
Education
- Seton Hall School of Law, Healthcare Compliance Certification, 2010
- Georgetown University, B.S., 2008
Representations
- Advised a biopharmaceutical company on the enhancement of its global compliance program, including leading a review of its compliance controls, operations, governance and culture; presented findings and recommendations to company’s audit committee of the board and supported additional program enhancements in view of findings.
- Led the redesign of a global pharmaceutical company’s external funding program to include enhanced review and approval procedures for higher-risk funding requests; engagement involved the development of standardized risk-ranking procedures for funding requests and a streamlined review and approval process ultimately leading to a more effective and efficient external funding program; scope included medical education grants, sponsorships, charitable contributions, collaborations and fellowships.
- Supported various pharmaceutical clients in establishing compliance risk assessment procedures, including development of risk assessment methodologies catered to the client’s current needs, execution of risk assessment processes via company surveys and employee interviews, delivery of dynamic risk results and development of actionable mitigation strategies.
- Supported a multiyear engagement with a global pharmaceutical company to develop a comprehensive, enterprise-wide patient services compliance program involving the design and implementation of new processes and controls for various patient services activities including Independent Charity Patient Assistance Program (ICPAP) donations/interactions, free-drug program, copay/savings card programs, specialty pharmacy & hub programs.
- Led numerous compliance program assessments for life sciences companies at varying phases of maturity (i.e., pre-commercial, post-commercial); developed and delivered compliance program roadmaps outlining prioritized work steps and responsibilities for compliance gaps and risks identified.
- Managed multiple Corporate Integrity Agreement (CIA) readiness and implementation efforts for both pharmaceutical and medical device manufacturers, including policy and procedure gap assessment/development, monitoring program design, contract management and needs assessment design, covered/ineligible persons screening, identification & training process design and certifications process design; additionally managed over 10 Independent Review Organization (IRO) engagements.
- Frequently speaks at industry conferences on topics including compliance program design, compliance and enterprise risk assessments, patient services compliance, external funding risk mitigation, and auditing and monitoring program effectiveness.
- Elaina also lead various commercial compliance efforts working in-house for a global pharmaceutical manufacturer.