Announcements

Elevation Strategic Development to Exhibit and Speak at Pathology Visions 2022

Morrison, CO (October 7, 2022) – Elevation Strategic Development (ESD) has announced that they will be exhibiting and presented at the Pathology Visions (PathVisions), the Digital Pathology Association’s annual meeting, October 16-18 at the MGM Grand Hotel & Casino in Las Vegas, Nevada.

On Monday, October 17th, ESD's Founder and President, Staci Kearney will be presenting a talk titled Unraveling the Regulatory Complexity of Diagnostic Development in a Changing Landscape.

“Not only is it an exciting time in digital pathology, but the ever-changing regulatory landscape provides unique challenges to those seeking to ensure patients have access to innovative and reliable technologies.” said Staci Kearney, ESD's Founder and President.

To learn more about Elevation Strategic Development, including their service offerings, follow us on LinkedIn at linkedin.com/company/elevation-strategic-development-llc/ or contact Jessica Black at jblack@elevationsd.com.

About Elevation Strategic Development, LLC

Elevation Strategic Development, LLC offers clinical and regulatory affairs consulting services for the diagnostic, medical device, and pharmaceutical industries. The company specializes in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion. All services are fully tailored to each client’s needs, ranging from large perspective planning to detailed implementation, including regulatory strategy, product development plans, clinical study design, regulatory communication meetings, quality system design, clinical trial monitoring, and medical writing.

FOR IMMEDIATE RELEASE

Elevation Strategic Development. LLC

August 1, 2022

Elevation Strategic Development, LLC Expands Team and Services

Morrison, CO (August 1, 2022) – Elevation Strategic Development, LLC announced today the addition of new team members and the expansion of services with the addition of Ashleigh Barkans, Sabrina Abla and Jessica Black to the team.

Ashleigh Barkans is a Principal Consultant, Regulatory Compliance and brings over 10 years of medical device and biotechnology experience to the team. Barkans was with the FDA for seven years before joining industry and focused on QMS and regulatory strategy. As an expert auditor and trainer, Barkans will provide auditing, training, and consultation for Elevation’s clients. “We are excited to have Ashleigh’s experience at the FDA and her extensive knowledge of both domestic and international standards and applications,” said President Staci Kearney. Barkans holds a BS in Biology/Chemistry from Metro State and a Masters in Education from Colorado State University and is a certified lead auditor.

Sabrina Abla is a Principal Consultant, Quality Assurance and brings over 15 years of experience within medical device and biotechnology industries. “Sabrina’s expertise brings a unique perspective to the QMS process and tailors each system to meet the needs of each organization,” says President Staci Kearney. Abla is a graduate of the University of Colorado and has several certifications from the American Society for Quality (ASQ) including certified software quality engineer.

Jessica Black is the Director, Business Development and brings over 10 years of experience within healthcare and biotech business development. As a previous director of business development for highly recognized pharma services, digital pathology and histology CROs, Black will be responsible for client success and expansion of Elevation’s services in emerging markets. “Elevation is poised for growth and with the addition of Jessica to the team, we will be able to expand our market reach and services within the clinical and regulatory industries,” said President Staci Kearney. Black is a graduate of Texas Tech University.

Elevation’s expertise provides our clients with strong advanced diagnostic and co-development strategies. With the expansion of the team, Elevation will strengthen their current services in regulatory compliance and quality systems to offer more robust and comprehensive products, services and new applications for their clients. This continues to include not only guiding the strategy but also executing the strategy for clients as a part of Elevation’s “white-glove” service.

To learn more about Elevation Strategic Development, including their service offerings, follow us on LinkedIn at linkedin.com/company/elevation-strategic-development-llc/ or contact Jessica Black at jblack@elevationsd.com.

About Elevation Strategic Development, LLC

Elevation Strategic Development, LLC offers clinical and regulatory affairs consulting services for the diagnostic, medical device, and pharmaceutical industries. The company specializes in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion. All services are fully tailored to each client’s needs, ranging from large perspective planning to detailed implementation, including regulatory strategy, product development plans, clinical study design, regulatory communication meetings, quality system design, clinical trial monitoring, and medical writing.

Elevation Strategic Development, LLC is pleased to announce that Briana Kennedy has joined the company as Director of Operations and Partnerships.

Mrs. Kennedy brings extensive experience and accomplishments to the Elevation team with a career that spans 20 years in the public health, consumer health, and pharmaceutical sectors.

Mrs. Kennedy started her career at the Centers for Disease Control and Prevention in Atlanta where she worked as a Public Health Law Program Fellow and Editor in Chief of The Proceedings, an annual briefing on Public Health Law in partnership with the US Department of Health & Human Services and the American Society of Law, Medicine and Ethics.

As a co-founder of Bright Brain Institute, Mrs. Kennedy worked with Georgia State University’s Director of Science Education and Director of the Neuroscience Institute to make neuroscience education more accessible to female middle and high school students in Georgia and throughout the United States.

Following her move to Denver, Colorado, Mrs. Kennedy joined Ellipse Analytics as part of a team focused on consumer advocacy and health through rigorous testing in an ISO-certified laboratory to ensure the integrity of ingredients in consumer packaged goods in the global marketplace.

She then moved to Flagship Biosciences where she helped build and oversee product development teams focused on the delivery of clinically validated immunohistochemistry and image analysis LDTs for prospective clinical trials and precision-driven drug development in support of rare disease patient populations.

Mrs. Kennedy is enthusiastic to join the team at Elevation Strategic Development and sees it as a natural extension of her career with public health, patient advocacy, and next-generation pharmaceutical leadership.

Elevation Strategic Development, LLC offers clinical and regulatory affairs consulting services for the diagnostic, medical device, and pharmaceutical industries. The company specializes in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion. All services are fully tailored to each client’s needs, ranging from large perspective planning to detailed implementation, including regulatory strategy, product development plans, clinical study design, regulatory communication meetings, quality system design, clinical trial monitoring, and medical writing.