Our Story
Our Approach
Elevation Strategic Development, LLC specializes in product development services for the biomedical industries. We have a passion for driving diagnostic, medical device, and pharmaceutical innovations to market for the improvement of patient care.
Located in historic Morrison, CO, in the foothills of the Rocky Mountains, halfway between each US coast, we pride ourselves on providing personalized attention to our clients through as many on-site interactions as needed to build collaborative, productive relationships.
Our Story
Founder and CEO
Staci J Kearney, PhD, RAC
As a biomedical professional with more than 10 years of experience, Staci specializes in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion. Her most recent therapeutic area of focus has been in oncology and immuno-onocology, including therapeutic/diagnostic codeveloment, but she has experience in multiple therapeutic areas, as well as expert technical knowledge of various methodologies and techniques. Working in both a CRO and Sponsor capacity, she has represented pharmaceutical and device companies as a liaison with FDA and other global regulatory agencies, such as the EMA. Staci holds a PhD in Immunology and has maintained her regulatory affairs certification (RAC) since 2015.
To learn more about Staci's experience and qualifications, please visit her LinkedIn page.
Co-Founder and President, ESD UK
Sabina Patel, PhD
Recently deemed the "Queen of all things IVDR" Sabina has more than 15 years of experience working across the diagnostic, pharmaceutical and regulatory sectors.
She specializes in the design and implementation of regulatory and product development strategies for companion diagnostics. After a brief spell at a Notified Body as a technical file reviewer and the CDx expert under the IVDR, she moved back to pharma to lead the implementation of IVDR requirements in clinical studies including pharma-sponsored clinical performance studies. In this role, Sabina played a critical role in generating IVDR compliant templates and processes for clinical performance studies, and acting as an internal advisor on EU-IVDR, CFR820 and CLIA requirements. This is in addition to her role as a clinician in primary care allowing her to provide valuable insights into key aspects of disease management within the NHS.
To learn more about Sabina's experience and qualifications, please visit her LinkedIn page.
Vice President of Clinical and Quality Programs
Ashleigh Barkans
Ashleigh Barkans has been in the Medical Device and Biotechnology Industry for over 10 years. She started her career as an Investigator with the Food and Drug Administration focusing primarily on Medical Devices. Ashleigh was with the FDA for about seven years before joining industry where she has focused on quality management systems and regulatory strategy. Ashleigh joins the Elevation team as a Principal Consultant in Regulatory Compliance where she brings extensive knowledge of both domestic and international standards and regulations as well as real world applications.
To learn more about Ashleigh's experience and qualifications, please visit her LinkedIn page.
Vice President of Business Development
Jessica Black
To learn more about Jessica's experience and qualifications, please visit her LinkedIn page.
Principal Consultant, Clinical Biomarkers
Ciara Martin
Ciara Martin specializes in the commercialization of spatial biology workflows. For nearly a decade, she has focused on the development, validation, and implementation of biotechnology technologies, with a focus on digital pathology applications. Ciara is an expert in the commercial complexities unique to spatial biology workflows, which require the integration of benchtop sample processing with signal acquisition and quantification instrumentation and software. Ciara's recent commercial leadership role focused on the simultaneous launch of multiple global-scale customer success programs at NanoString, including the formation of the spatial biology data analysis service team. Ciara holds a PhD in Molecular Toxicology received from the University of California Los Angeles.
To learn more about Ciara's experience and qualifications, please visit her LinkedIn page.
Principal Consultant, Regulatory Programs
Chan Chandhasin, PhD
With more than 15 years of experience in oncology and life sciences, Chan specializes in early-phase development efforts across both drug and device programs. Prior to joining Elevation, Chan held project management and medical and scientific affairs roles at multiple biotech companies. Her expertise lies in medical communication, with a focus on translating complex scientific data into clear, strategic purpose. With a strong foundation in scientific, translational, and clinical research, she has played key roles the preparation of regulatory briefing documents, study development plans, clinical study reports, as well as scientific/medical publications and presentations. Chan holds a PhD in Molecular and Cellular Biology from Tulane University.
To learn more about Chan's experience and qualifications, please visit her LinkedIn page.
Controller
Katie Schreiner
As the Controller at Elevation, Katie brings a wealth of experience in financial management, accounting, and strategic planning. With a strong background in overseeing day-to-day financial operations, she ensures accuracy and compliance with financial regulations while driving efficiency and profitability. Katie is passionate about optimizing financial systems and supporting business growth through data-driven insights and sound financial practices.
To learn more about Katie's experience and qualifications, please visit her LinkedIn page.