Barbara McCuiston is a distinguished leader in the healthcare and regulatory science sectors, currently serving as the President and CEO of the Regan-Udall Foundation for the FDA. With a career spanning over three decades, she has demonstrated exceptional expertise in public health, biopharmaceuticals, medical devices, and patient advocacy. Barbara is recognized for her strategic vision in advancing regulatory science to support the FDA's mission and improve public health outcomes. Her work involves fostering collaboration between the FDA, industry, academia, and patient groups to address complex health challenges and accelerate medical product innovation. Before her current role, she held significant leadership positions in major healthcare organizations and trade associations, contributing to policy development and strategic initiatives that have shaped the healthcare landscape.
Barbara McCuiston's work history includes a series of influential roles in various companies. Here is a detailed list of his professional journey:
Leads the foundation in its mission to advance regulatory science and facilitate the development of innovative medical products by fostering collaboration among the FDA, academia, industry, and patient advocacy groups.
Held senior executive roles in government affairs, policy, and strategy at prominent organizations such as Medtronic, BIO (Biotechnology Innovation Organization), and Johnson & Johnson, significantly influencing healthcare policy and innovation.
Consistently advocated for patient-centered approaches in healthcare innovation and regulatory processes, ensuring patient voices are integral to decision-making in medical product development and access.
Dedicated her career to improving public health by strengthening the scientific foundation for regulatory decision-making, supporting initiatives that enhance product safety, efficacy, and quality.
Successfully built and nurtured numerous public-private partnerships to tackle pressing public health issues, accelerate scientific research, and streamline pathways for medical innovation.
Michigan State University - Year 1989
Michigan State University
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Sunrise Technologies is a global Microsoft Dynamics 365 solutions provider, specializing in ERP, CRM, and Business Intelligence solutions tailored for the retail, manufacturing, consumer goods, and distribution industries. They focus on helping businesses optimize their operations, improve supply chain visibility, and enhance customer engagement through digital transformation. Sunrise Technologies was acquired by Quantiq in 2023.
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