PV24 Speakers

Subject to change.

 

 

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Keith Wharton, MD, PhD

Global Medical Affairs Leader, Roche Diagnostics Solutions


Keith, a board certified pathologist, joined Roche in 2022 following multiple roles in biotech/biopharma. Keith earned MD/PhD at UCLA, followed by fellowships at Stanford University. He joined industry in 2009, using integrative pathology to enable therapy development as well as improving understanding, diagnosis, and treatment of disease. As part of Global Medical Affairs, he supports DP and multiplex tissue staining projects as a foundation for precision pathology diagnostics of the future.

 

 

SESSIONS

Advancing Regulatory Science in Digital and Computational Pathology: A Collaborative Dialogue
   Tue, Nov 5
   02:10PM - 02:30PM ET

Background: As digital and computational pathology become increasingly integrated into clinical practice, the Pathology Innovation Collaborative Community (PIcc), convened by the Medical Device Innovation Consortium (MDIC), recognizes the critical importance of regulatory science in this evolving landscape. We propose a focused session at the 2024 Visions meeting to foster collaborative dialogue on regulatory topics within digital pathology, specifically addressing its adoption in the USA.Introduction: This session aims to facilitate dialogue among stakeholders from industry, academia, and regulatory agencies to address key regulatory challenges and opportunities in adopting digital pathology in the USA. Leveraging diverse expertise, we seek to advance regulatory science and accelerate the development and adoption of innovative medical devices in pathology.Session Objectives: - Provide an overview of current regulatory advances and challenges in digital pathology adoption in the USA. - Discuss the results of the PIcc regulatory landscape survey and gather audience input through a digital survey. - Highlight the role of PIcc in advancing regulatory science and fostering industry-academia-regulatory partnerships. - Share insights from regulatory agencies, including the FDA, on regulatory considerations for digital pathology technologies.Session Format: The session will include short impulse talks by representatives from PIcc, MDIC, regulatory agencies (e.g., FDA), and industry stakeholders, followed by a panel discussion. Talks will cover specific regulatory challenges, innovative approaches, and collaborative initiatives in digital pathology.Interactive Component: A digital survey will be used to gather real-time audience input on key regulatory issues and broader community needs, enhancing engagement and inclusivity.Specific Focus: The session will focus on '<em>Taking the First Steps to Digital Pathology Adoption in the USA</em>,' including understanding rules and regulatory precedents. It will also address the results of the PIcc regulatory landscape survey.Benefits of Participation: - Gain insights into current regulatory trends and challenges in digital pathology adoption. - Network with key stakeholders from industry, academia, and regulatory agencies. - Contribute to the advancement of regulatory science and development of innovative medical devices. - Enhance visibility and recognition within the pathology community through oral presentation and abstract publication in the Journal of Pathology Informatics. - Participate in an interactive digital survey to provide real-time input on critical issues, ensuring inclusivity and capturing a wide range of perspectives.Conclusion: This session represents a collaborative effort to address critical regulatory issues in digital pathology adoption, leveraging the results of the PIcc regulatory landscape survey. By engaging diverse stakeholders, we aim to drive progress in regulatory science and improve patient care through innovative technologies.

 

Learning Objectives

  1. Provide an overview of current regulatory advances and challenges in digital pathology adoption in the USA. Discuss the results of the PIcc regulatory landscape survey and gather audience input through a digital survey.  
  2. Highlight the role of PIcc in advancing regulatory science and fostering industry-academia-regulatory partnerships.
  3. Share insights from regulatory agencies, including the FDA, on regulatory considerations for digital pathology technologies.
[Roche]: Decoding Regulatory Trends in Digital Pathology for Primary Diagnosis
   Sun, Nov 3
   02:45PM - 03:45PM ET

This presentation aims to provide an overview of the recent trends in anatomic pathology workflows and explore regulatory pathways for digital pathology systems. Our discussion will include a review of performance studies necessary for regulatory clearance in the USA, with a particular focus on the Roche Digital Pathology Dx (VENTANA DP 200). These studies are crucial for validating the reliability and accuracy of digital pathology systems in clinical applications. Furthermore, we will speculate on the compliant adoption of future technologies in pathology labs and how predetermined change control plans (PCCPs) aim to reduce regulatory burden and enhance flexibility. Join us as we navigate through the current and future state of digital anatomic pathology, and discover strategies for leveraging digital advancements while maintaining compliance.

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