As Founder and CEO of Elevation Strategic Development, Dr. Staci Kearney is an expert in regulatory, clinical, and quality for advanced diagnostics. For almost two decades, Dr. Kearney has worked on the discovery, development, and implementation of biomarkers to support precision medicine, including a direct expertise in digital pathology systems and AI software. Her expertise lies not only in the development of diagnostic products as medical devices, but also in the development and use of advanced technologies for patient care under clinical laboratory standards. Therefore Dr. Kearney has a unique perspective on the interface of regulatory standards for the authorization and implementation of diagnostics by diverse methodologies.

 

Dr. Kearney has a PhD in immunology from the University of Colorado-Anschutz and has maintained her Regulatory Affairs Certification (RAC) since 2015.​​​​​​​​​​​​​​

Sabina Patel is President and co-founder of Elevation Strategic Development UK and a recognised expert in companion diagnostics, precision medicine and clinical evidence generation. With more than 15 years of experience spanning diagnostic assay development, global clinical studies, regulatory strategy and performance evaluation, she has held leadership positions at AstraZeneca, QIAGEN and BSI.

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Throughout her career, Sabina has supported the development, validation and implementation of diagnostic tests across the product lifecycle, from early assay development through global clinical trial deployment, regulatory approval and commercialisation. She has extensive experience supporting multinational precision medicine programmes and companion diagnostic strategies across North America, Latin America, Europe and Asia-Pacific, providing a unique perspective on the scientific, operational and regulatory challenges associated with bringing innovative diagnostics to patients worldwide.

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At Elevation, Sabina advises clients on clinical evidence strategies, performance studies, companion diagnostics and global regulatory pathways, helping organisations navigate increasingly complex diagnostic development and market access landscapes.​​​​​​​​​​​​​​​​​​​

With over ten years of experience as in Quality and Regulatory, Ashleigh is passionate about ensuring compliance, safety, and effectiveness of biotechnology products and services. She has a strong background in medical devices, FDA regulations, auditing, quality management systems, clinical trial management, CAPA, and GMP, as well as a Master's degree in Education and Human Resources and a Bachelor's degree in Biology and Chemistry.

 

As the Director of Clinical & Quality Programs at Elevation Strategic Development, LLC, Ashleigh works with cross-functional teams to design, implement, and monitor clinical trials, quality systems, and regulatory strategies, ensuring alignment with global standards and best practices. She also leverages her expertise in adult education to provide training, coaching, and mentoring to staff and stakeholders on clinical and quality topics. 

Jessica Black serves as Vice President of Business Development at Elevation Strategic Development, where she builds strong client relationships and supports the company’s growth with a thoughtful, people-first approach. She brings experience in digital pathology and CLIA laboratory services, along with a genuine appreciation for the role clear communication, trust, and collaboration play in successful partnerships.

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Known for being purposeful and grounded, Jessica values authenticity and ethics in every interaction. Her background gives her a well-rounded perspective that helps her connect scientific, technical, and business needs in a practical and supportive way.

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Katie Schreiner is the Controller at Elevation Strategic Development, bringing over 20 years of accounting and finance experience across a variety of industries. With a Bachelor's degree in Accounting and a diverse professional background, Katie has developed a well-rounded expertise that gives her a unique and versatile perspective on financial management.

 

Katie supports the company's financial operations with a steady, detail-oriented approach, with core strengths in financial reporting, financial analysis and modeling, monthly close,  and operations management. Her broad experience helps ensure the business runs smoothly, efficiently, and with clarity across every stage of the accounting process.

Chan Chandhasin is the Principal Consultant of Regulatory Programs at Elevation Strategic Development, where she brings more than 15 years of strategic program leadership experience across biotech, clinical, and regulatory functions. She is known for building strong programs, aligning cross-functional teams, and helping organizations move complex initiatives forward with clarity and confidence.

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Her background includes deep experience in regulatory strategy, organizational build-out, and execution across dynamic life science environments. Chan combines strategic thinking with a collaborative, hands-on approach, making her a trusted partner for teams navigating regulatory programs and broader business goals.

Sarah is an experienced quality and compliance professional with broad experience in the life sciences industry. She brings deep expertise in quality management systems, internal and external audits, SOP development, CAPA oversight, deviation management, and risk assessment — all grounded in FDA and global regulatory standards.

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Her background bridges academic research, biologics process development, and scientific/technical support of GMP manufacturing operations for both clinical and commercial products. Her experiences give her a practical, end-to-end understanding of what it takes to build and sustain audit-ready quality programs.

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At Elevation Strategic Development, she applies this expertise to help clients achieve the highest quality standards — designing robust quality management systems, facilitating audits, and ensuring compliance throughout clinical trial execution and beyond.