BioCelerate: Uniting the Preclinical Ecosystem

Preclinical research and collaboration have historically been conducted in silos. When BioCelerate was established in 2016, our goal was to bring together sponsors to identify ways to collaborate on developing solutions that aim to improve efficiencies in preclinical research.

BioCelerate has made tremendous strides in the past seven years—from developing a toxicology and background control data sharing database through our Toxicology and Background Control Data Sharing Initiative to creating a common template suite for preclinical study protocols and study reports through our Common Templates for Nonclinical Initiatives, to collaborating with the FDA CDER in a public-private partnership to develop an open-source way to better conduct cross-study analysis using CDISC SEND data sets with our SEND Implementation for Cross-Study Analysis Initiative.

Launch of the BioCelerate Collaboration Forum

As BioCelerate matures, it became apparent that there was an unmet need for a collaborative forum that convenes stakeholders from across the industry ecosystem and allows them to engage on challenges, opportunities, and possible solutions with the goal of evolving and modernizing preclinical research.

Earlier this year, we launched the BioCelerate Collaboration Forum, with our first forum being held at the Society of Toxicology Annual Meeting. Attendees from Sponsors, Health Authorities, CROs, technology vendors, and data collection and data service providers were participants in this inaugural event.

Sarah Lopes, Director at Pfizer, co-lead of the BioCelerate Collaboration Forum, and Initiative Lead for BioCelerate’s Nonclinical Common Templates Initiative, gave an overview of BioCelerate, its goals, and how to become involved with the Forum. Bob Friedman, Chief Technologist and Chief Solution Architect at Xybion, presented some opportunities for preclinical protocol automation through an OpenStudyBuilder solution.

Using Virtual Controls in Preclinical Research

For the second meeting of the Collaboration Forum, BioCelerate hosted a public webinar in June on “The Use of Virtual Controls in Preclinical: Promise and Predicament.” During the event, panelists addressed how virtual controls may play a role in a reduce, reuse, recycle strategy, considerations to ensure the scientific validity of study designs, the likely challenges and/or barriers to success, and potential ways to overcome them.

Our featured panelists included:

• Laura Lofti, Translational Sciences & Data Analytics Manager, Charles River Laboratories
• Lars Mecklenburg, Site Managing Director, Executive Director Safety Assessment, Labcorp
• Kevin Snyder, Associate Director, Nonclinical Informatics, United States Food & Drug Administration
• Thomas Steger-Hartmann, Head of Investigational Toxicology, Vice President, Bayer AG Pharmaceuticals
• Esther Vock, Director of Special Toxicology, Boehringer Ingelheim Pharmaceuticals, and Governing Council member of BioCelerate

The event was widely attended, and participants were engaged in an active discussion on previous data reuse scenarios, data interoperability, and data use and sharing. Participants expressed a desire to develop such a solution in the next five years collaboratively. Across the group, there was optimism for a practical and pragmatic approach with an acknowledgment of a high evidence bar.

A post-event survey provided an insightful snapshot of where the industry is headed. Interestingly, about half of the attendees were familiar with the use of virtual control groups in preclinical research, with 30% of respondents unfamiliar with the concept.

Other findings included:

• 86% of respondents can visualize the prospective use of virtual controls in the preclinical setting, though they were equally split between thinking adoption would be widespread or inconsistent.
• The top three primary challenges to implementing virtual controls are a lack of coordination among stakeholders, scientific barriers and challenges, and resistance to change.

In its inaugural year, the forum has established strong connections across multiple stakeholders working in preclinical research and has helped to identify how the BioCelerate can collaborate to develop new solutions and resources to improve advance conversation and innovation in preclinical research.

Our next forum will be held in early 2024 with a focus on BioCelerate’s SEND Harmonization for Cross-Study Analysis Initiative, a collaboration between BioCelerate and US FDA CDER. During this forum, you will hear from presenters about the value this solution can deliver.

You can sign up for BioCelerate events here to receive an email once registration opens for the next BioCelerate Collaboration Forum.

Tom Kelly is a Program Director at TransCelerate BioPharma and its preclinical subsidiary BioCelerate. In this role, he oversees all projects on behalf of the preclinical and clinical data sharing parts of the portfolio. Tom is an accomplished leader with 20 years of progressive experience in healthcare, pharmaceutical R&D operations, and strategy leadership.  Most recently, he was the Director of Operations for the Immunology Therapeutic Area Leadership Team at CSL Behring.