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The Advantages of Integrated Toxicology
Faster Data-Driven Decisions
The drug development process is notoriously slow and expensive. Bringing a new drug from discovery to market can take a staggering 10-15 years, with average costs exceeding a whopping $1-2 billion USD*. This harsh reality underscores the urgent need for innovative solutions to streamline safety testing and accelerate the delivery of life-saving treatments. What if there was a way to streamline safety testing and accelerate the path to life-saving treatments? Introducing Integrated Toxicology, a revolutionary approach that empowers researchers to make faster, data-driven decisions.
In response to this challenge, our Integrated Toxicology offering has enabled researchers to make decisions faster and move ahead to their next milestone. We were fortunate to connect with Dr. Brian Roche, a leading expert in the field, who graciously agreed to share his insights in this exclusive interview. Dr. Roche, General Manager at Charles River’s Kansas site, has more than 20 years’ experience in preclinical drug development with a focus on research from early pharmacology through GLP safety pharmacology studies. He will shed light on the core concept of integrated toxicology at Kansas, explore the many advantages available to you, and examine how it's poised to revolutionize the future of toxicology testing. Throughout this interview, we'll address a range of topics relevant to your needs, unpacking the buzz surrounding integrated toxicology at Kansas together.
Kansas together.
“By bridging discovery and safety assessment, through integrated toxicology, we are building a strategic lab of the future, collaborating across the drug development spectrum and connecting the data.”
Brian Roche, PhD
1. How does integrated toxicology differ from traditional, non-GLP toxicology testing approaches typically employed by pharma and biotech companies?
Dr. Roche: Integrated Toxicology breaks away from traditional GLP toxicology testing by prioritizing speed and flexibility in lead optimization. This new purpose-built, non-GLP facility located in Kansas, backed by Charles River's scientific expertise, allows clients to assess a compound's safety profile rapidly. By integrating lab automation, robust data collection, and digital pathology, our experts streamline workflows and empowers researchers to make faster, data-driven decisions. This early de-risking of compounds translates to significant efficiency and cost savings for clients by identifying unsuitable candidates before they enter more expensive and time-consuming GLP studies.
2. Can you elaborate on the specific types of non-GLP toxicology services that are integrated within the Kansas facility?
Dr. Roche: Our scientists seamlessly integrate various non-GLP toxicology services to expedite lead optimization. This includes in vivo studies to assess a compound's safety profile in live animals, alongside in-vitro testing using cells or tissues. Additionally, they offer expert necropsy and digital pathology to analyze drug effects on organs at a microscopic level. This comprehensive, non-GLP approach allows for faster data-driven decisions on drug candidates
3. Beyond efficiency gains, what are some key advantages for clients who choose to run integrated toxicology studies compared to traditional non-GLP testing methods?
Dr. Roche: Beyond speeding up non-GLP testing, our technical staff in Kansas provides a powerful advantage: informed decision-making. Our safety expertise elevates the science behind your studies. The integrated approach seamlessly combines services, while robust data empowers faster choices about drug candidates, potentially reducing animal use and overall development time. Standardized protocols ensure trust in the results, making integrated toxicology a comprehensive solution for accelerating the path to safe and effective drugs.
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4. Why is the Kansas facility, particularly well-suited to deliver this integrated toxicology offering? Does the facility have any specific resources or expertise that contributes to the success of ITox?
Dr. Roche: Leveraging our globally recognized expertise in safety assessment, with a proven track record supporting over 80% of FDA-approved drugs in the last five years and 85% in 2023 alone, the Kansas facility isn't inherently better equipped, but rather serves as a "proof-of-concept" site for integrated toxicology. This focus on innovation likely grants them greater flexibility to experiment with new technologies and workflows. Additionally, as a central point for the program, Kansas might receive more resources and be the first to benefit from expertise and data integration across the entire Charles River network, ultimately expediting the delivery of this innovative toxicology approach.
5. Can you provide examples of how integrated toxicology streamlines the drug development process for clients, potentially impacting critical timelines and milestones?
Dr. Roche: Here are specific examples of how integrated toxicology streamlines the drug development process for clients, impacting critical timelines and milestones:
- Ultra-Fast Study Start-Up: Imagine initiating your non-clinical studies in just four days. Unlike traditional methods that require coordinating with multiple providers, Kansas integrates everything under one roof. This streamlined approach lets you hit the ground running, potentially saving weeks compared to conventional non-GLP testing.
- Rapid Data Generation: Our focus on lab automation and robust data collection allows for quicker turnaround times on study results. This faster access to data empowers researchers to make informed decisions on drug candidates sooner, potentially accelerating decisions about moving a compound forward or abandoning an unsuitable one. This can significantly impact timelines for lead optimization.
- Streamlined Workflows: Digital pathology within integrated toxicology eliminates the time-consuming manual processes associated with traditional histopathology. This translates to faster analysis of tissue samples, allowing for quicker assessment of a drug's potential effects on organs at a microscopic level. This can expedite decisions about safety profiles and potential risks.
- Reduced Bottlenecks: Standardized protocols across this solution minimizes potential delays due to miscommunication or inconsistencies in testing procedures. This ensures smooth execution of studies, reducing the risk of bottlenecks that could hold up progress.
De-risk early in your development journey and reach human trials faster. Don't wait—see how you can make faster data-driven decisions by ultimately accelerates the path to market for new treatments.
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6. Considering the current pressure on costs and timelines in drug development, how does integrated toxicology in Kansas contribute to bringing new drugs to market faster and more efficiently?
Dr. Roche: Facing extreme pressure on drug development costs and timelines? Kansas offers a revolutionary solution to get you to market faster. Forget six-month waits for exploratory toxicology data. Integrated toxicology launches non-clinical studies in just four days, leveraging advanced automation and scientific expertise to deliver real-time data access and comprehensive reports within 10 days. This rapid data empowers faster, data-driven decisions, allowing you to eliminate risky candidates early and optimize your development program. Streamlined workflows, digital pathology, and standardized protocols further compress timelines, accelerating your path to the clinic. Integrated toxicology unlocks the power of speed and efficiency, bringing new treatments to patients in need quicker.
Dr. Roche's expertise paints a promising picture for the future of toxicology testing with Kansas being at the forefront of innovation. As the field continues to evolve, an integrated approach holds the potential to revolutionize the way we assess drug safety and accelerate the delivery of life-saving treatments.
Learn more about how integrated toxicology can benefit your specific needs.
*Hinkson IV, Madej B, Stahlberg EA. Accelerating Therapeutics for Opportunities in Medicine: A Paradigm Shift in Drug Discovery. Front Pharmacol. 2020 Jun 30;11:770. doi: 10.3389/fphar.2020.00770. PMID: 32694991; PMCID: PMC7339658.