PathAI Announces Two New Executives to Expand Regulatory Expertise and Precision Oncology Commercial Strategy

PathAI, a leading provider of AI-powered pathology tools to advance precision medicine,  announced that Nick Anderson, Ph.D., has joined as Vice President of Regulatory Affairs, while Hisani Madison, Ph.D., MPH, has joined as the Franchise Head of Precision Oncology. These new leaders will build on the company’s position at the forefront of AI-driven pathology and will advance its growth in the precision diagnostics market with their regulatory and commercial expertise.

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These new leaders will build on the company’s position at the forefront of AI-driven pathology and will advance its growth in the precision diagnostics market with their regulatory and commercial expertise.

With over ten years at the U.S. Food and Drug Administration (FDA), Dr. Anderson has worked extensively in digital pathology regulation and medical device review. At the FDA, he reviewed dozens of digital pathology submissions, and led the review and authorization of the first whole slide imaging system to allow for interpretation of digital slides prepared from biopsied tissue. Dr. Anderson was also a primary author of FDA’s Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices guidance, which lays out the standards followed by all manufacturers in the whole slide imaging space. In his new role, Dr. Anderson will work closely with internal product teams and external regulatory bodies like the FDA and European Medicines Agency to ensure that PathAI understands, meets or exceeds set standards, allowing the company to remain leaders in digital and AI-powered pathology.

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“The regulatory landscape is evolving and regulated devices are a core product offering for PathAI. Dr. Anderson will help sharpen our focus on bringing new AI-driven tools and products to market for both biopharma companies and healthcare providers,” said Andy Beck, M.D., Ph.D., Co-founder and CEO of PathAI.

With deep experience in regulatory and strategic issues across the precision medicine field, Dr. Madison brings strong cross-functional expertise to PathAI, with a focus on the development of oncology products, both diagnostic and therapeutic. As Executive Director and Precision Medicine Franchise Lead for Immuno-Oncology at AstraZeneca, she led a global precision medicine team to define and drive the precision medicine strategy and diagnostic delivery for the immuno-oncology clinical development program. In her role as senior reviewer within the Office of In Vitro Diagnostics and Radiological Health at the FDA, Dr. Madison led the reviews of pre-market diagnostics, including for the approval of the first FDA-approved companion diagnostic NGS oncopanel, FoundationOne CDx (Foundation Medicine, Inc.).

“Dr. Madison brings exceptional talent to PathAI, combining knowledge in precision oncology and companion diagnostics, an understanding of the regulatory requirements for innovative diagnostics, and therapeutic development experience,” said Nick Brown, Chief Commercial Officer for Biopharma and Digital Diagnostics at PathAI. “Dr. Madison will help propel PathAI forward in the oncology space by refining our companion diagnostic strategy and broader offerings to oncology developers.”

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