Bigpicture’s latest review paper: A practical guide to digital pathology

A few years ago, digital pathology under Good Laboratory Practice (GLP) was largely uncharted territory. Today, thanks to the joint efforts of pathologists, QA experts, IT specialists, and industry leaders across Europe and globally, that landscape has taken shape.

Bigpicture's newly published review paper, available via Toxicologic Pathology (SAGE Journals, online first June 3, 2025), marks a significant step forward. Co-authored by experts from Bigpicture’s partners Boehringer Ingelheim, Pfizer, Novartis, Janssen, and Deciphex, it synthesizes the current regulatory landscape and offers clear, practical guidance for laboratories working toward digital pathology under GLP conditions.

“We didn’t create new rules,” says Dr. Gabriele Pohlmeyer-Esch (Bigpicture co-lead WP5, Boehringer Ingelheim), the paper’s lead author. “We wanted to translate what’s already out there, make it usable and offer an informed outlook on the perspectives of AI.”

Bigpicture turns complexity into clarity

From the beginning, Bigpicture’s ambition was to provide more than infrastructure. It is set out to truly make a difference, by connecting stakeholders, surfacing challenges, and co-creating practical solutions. This review paper is a product of that approach: grounded in years of consortium discussions, interactions with regulatory authorities, and on-the-ground experience from early adopters.

The result is a reference point for the entire field:

• A structured overview of existing regulatory guidance (OECD, EMA, FDA)
• Steps for validating digital pathology workflows under GLP
• Insights on infrastructure, data integrity, and archiving
• A realistic look at where AI fits in, and where it doesn’t (yet)

“This is the most complete and most recent summary available today,” says Gabriele. “It reflects what we know, and what we’ve learned by doing.”

From collaboration to a culture shift

The paper’s development wasn’t easy. It required commitment across borders and disciplines, with final steps towards submission taken over the holiday season. But that challenge also became a strength, bringing together not only consortium partners, but also internal teams within companies. “Within Boehringer Ingelheim, Bigpicture helped us align our pathology teams in Germany and the US. It brought people together who had never worked this closely before,” notes Gabriele.

And beyond technical progress, a deeper transformation is taking place: digital pathology is changing the way pathologists work, and how they see their role. “If you’ve spent 30 years behind a microscope, this shift feels like going from horse carriage to car. It takes vision, leadership, and people who are truly willing to try something new.” says Gabriele.

Looking ahead

Boehringer Ingelheim’s ambition is clear: to fully implement GLP-compliant digital workflows by the end of the year. And for others just beginning the journey Gabriele has some valuable advice on where to start: “Secure management support, because without resources, nothing moves. And build a team of early adaptors. You need motivated people who believe in this.”

Bigpicture will continue to support the transition. With this review paper as a foundation, the consortium helps the industry to create more shared tools, more regulatory dialogue, and more momentum for labs that want to lead the change.

 Published in Toxicologic Pathology, June 2025