PV26 Speakers

Subject to change.

 

 

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Purvi Gaglani

Regulatory Affairs Expert, Roche Diagnostics


Purvi Gaglani leads Regulatory Affairs for Digital Pathology at Roche, working closely with the FDA on complex submissions for Computational Pathology, Companion Diagnostics, and Software as a Medical Device. A seasoned biotech professional, she brings deep expertise across regulatory strategy, verification and validation, design control, and quality systems to bring innovative diagnostics to market.

 

 

SESSIONS

Roche Breakfast Workshop: Computational Pathology: The Future of Companion Diagnostics
   Sat, Oct 17
   07:30AM - 08:30AM PT
  Seaport Ballroom A-D

Tumor biology doesn't care about our scoring bins. It is inherently continuous and highly complex—yet our standard companion diagnostics still force pathologists to reduce rich, predictive data into simplistic, visual estimations. When patient outcomes hang in the balance, can we really afford high interobserver variability? In this panel style workshop, we will explore how advanced computational algorithms are moving diagnostics beyond visual estimation by delivering highly reproducible, cell-level quantitative signals. More importantly, we will bridge the gap between scientific promise and laboratory reality. Our panel includes digital pathology pioneers, AI developers, and regulatory leaders who will give you the practical playbook on what it takes to actually deploy these advanced tools. We will discuss how computational CDx devices on the horizon will fundamentally alter the way we practice medicine and how pathology is at the very forefront of this revolution.

 

Learning Objectives:

  1. Understand the shift from manual scoring to digital pathology solutions, including their key regulatory landscapes.
  2. Identify limitations in traditional visual diagnostics and why computational models are essential for modern therapies.
  3. Examine a real-world case study for computational pathology's clinical utility and emerging trends shaping oncology.

 

 

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