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Today's podcast is about the regulatory aspect of digital pathology and how it fits into the space between research and clinical use called translational medicine.

The podcast guest, Esther Abels, is a regulatory expert in digital pathology and a female leader in the field. She was involved in the team effort that brought the first Phillips clearance of a whole slide scanner to the attention of the FDA.

Translational research has the potential to bridge the gap between discovery and clinical practice. Its goal is to use evidence from research to target diseases and apply the insights in the clinic. 

Digital pathology is seen as a tool to expedite the development pipeline for drugs and medical devices through the use of algorithms and AI.

There are however regulatory requirements that need to be taken into consideration when developing and using digital pathology tools. For example tissue image analysis tools used to support clinical decisions need to adhere to the FDA's guidance for software as a medical device. 

The FDA is also working to define data sets that can be validated and reused for algorithm development. 
There are ongoing efforts in Europe and the US to draft laws and frameworks related to artificial intelligence and validation techniques for AI tools.

It is a best practice to engage with the FDA early and this process for drug and medical device companies starts with a pre-submission to the FDA, seeking advice and discussing the approach. To be successful the role of a regulatory architect is crucial in overseeing the process and guiding it from point A to B to Z.

In addition to being a regulatory expert in the digital pathology field, Esther is also the immediate past president of the Digital Pathology Association (DPA).  Because digital pathology brings people together from various fields, including pathologists, toxicologists, lab personnel, regulatory experts, and clinical development personnel, during her presidency Esther focused on collaboration between those different fields. 

Esther Abels is a regulatory consultant who can be found on LinkedIn and her YouTube channel, which features helpful guidance and information videos.

THIS EPISODE'S RESOURCES:

✔️ Previous podcast with Esther: REIMBURSEMENT FOR DIGITAL PATHOLOGY IN THE CLINIC – HOW DOES THAT WORK? W/ ESTHER ABELS, VISIOPHARM
✔️ FDA GUIDANCE - CLINICAL DECISION SUPPORT SOFTWARE
✔️ FDA GUIDANCE - SOWTWARE AS A MEDICAL DEVICE
✔️ FDA GUIDANCE LIST FOR DIGITAL HEALTH
✔️ Beyond the Scope Podcast "CPT Coding and Digital Pathology Reimbursement"
✔️ ESTHER ABELS LINKEDIN
✔️ ESTHER ABELS YOUTUBE

💻 Bridging the Gap Between Pathology and Computer Science

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