Streamline drug development with a lab informatics platform

 

Introduction: The high stakes of PK studies in drug development

Drug discovery is a long, costly journey—often taking 10–15 years and billions of dollars. A major contributor to failure is poor pharmacokinetic (PK) profiles or PK studies, with over 80% of new drugs failing due to inadequate ADME-Tox (absorption, distribution, metabolism, excretion and toxicity) characteristics.¹

Before drugs can be tested on humans, regulatory agencies must certify their safety and effectiveness. Improving ADMET properties (absorption, distribution, metabolism, elimination and toxicity) is crucial to reducing failures in later stages of drug development.

The challenge: Reducing risk of PK studies before IND submission

Understanding a compound’s PK profile early in the PK studies can prevent costly failures. Regulatory agencies like the FDA, EMA and PMDA now recommend early in vitro studies to assess drug-drug interaction (DDI) potential before filing an investigational new drug (IND) application.

The guidance highlights examining potential interactions between a drug candidate and drug-metabolizing enzymes, the potential of a drug candidate to act as a substrate or inhibitor of drug transporters, and the potential impact of drug metabolites on safety and efficacy using a risk-based approach—all prior to IND submission. Exploring and understanding DDI and ADME-Tox parameters before filing an investigational new drug (IND) may allow for more informed planning of clinical studies and could prevent unexpected outcomes, says Madison (Knapp) Esely-Kohlman, Director of Business Development at Alturas Analytics, Inc., a CRO providing personalized MS/MS bioanalytical services.²

The solution: A tiered approach to ADME-Tox studies

Understanding a compound’s pharmacokinetic profile can alert a drug developer early if a candidate is likely to fail, and that data can be used to adjust a drug’s chemistry to optimize its PK profile before advancing through more expensive development phases.

Both in vivo and in vitro assessments have become important strategies for the initial selection or identification of chemical leads. While screening can be precise, reducing the overall number of molecules likely to present issues on pharmacokinetic and toxicity properties, in vivo and in vitro ADME-Tox studies can be expensive and time-consuming.

In vitro studies conducted early in the development process can inform about DDI, impacting the decision to move forward with an IND. Sponsors must consider which non-clinical studies are required to determine PK properties and DDI potential before entering the clinic.

Additionally, many scientists find that in silico assays at early stages can avoid PK problems and costly mistakes later in development. Whereas in vitro or in vivo analyses are only possible after the molecule has already been synthesized, in silico ADME-Tox is useful for pre-screening a high number of compounds.²

BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, including ADME-Tox products and research services, performs in vitro ADME-Tox studies earlier in development, to weed out weak drug candidates and validate the strong ones. The company’s lab in Kansas City, KS, relies on a custom-built data management infrastructure, which includes the IDBS E-WorkBook, an advanced electronic laboratory notebook (ELN). E-WorkBook is a scalable enterprise, cloud-based, research and development data management platform. Scientific workflows are documented, data is captured, and knowledge is retained so previous projects can be searched and reused.

“BioIVT’s digital transformation journey evaluates and revamps lab operation processes for more streamlined workflows”, explains Dr. Joanna Barbara, site lead – ADME Research Products & Services at BioIVT. Essentially, using the E-WorkBook software, the lab services team relies on custom templates to design, execute and document experimental processes, document material and equipment use, register samples and create sequence lists for sample analysis. The analytical services team imports sequence lists into LC-MS/MS instruments, executes and documents sample analysis, and exports raw data. The data management team imports the raw sample data back into E-WorkBook and processes the data. The study director team performs a final review and approval of the processed data and generates a data summary report that is delivered to the client. After all experiments are performed, data summary reports generate a semi-automated report in E-WorkBook as the final study deliverable.

This digital transformation enabled BioIVT to offer tiered study options:

• Tier 1: Early ADME-Tox and DDI risk assessment
• Tier 2: IND submission-ready data
• Tier 3: Customized eCTD documentation

The results: Measurable ROI and efficiency gains

For labs operating on tight budgets, investing in technology like an electronic lab notebook can be hard to justify when considering time for the implementation and ongoing maintenance in an inflationary economy. These constraints may ultimately wind up hindering the research process. However, any time and cost incurred from implementation and maintenance is outweighed by the efficiency gains in the long run.

One of the key requirements that BioIVT had, as do all CROs when seeking a new platform, is a fast and significant return on investment. Rising costs in R&D and clinical trials are plaguing the life science community and the industry is looking for ways to mitigate those costs. Many point to increasing complexity, an uncertain regulatory environment (i.e. Inflation Reduction Act and the Biosecure Act) as key contributors to increasing trial costs.

BioIVT realized significant improvements:

• An overall time savings of at least 20% (equivalent to a weekly time saving of approximately 8 hours per user)*
• 30% reduction of study cycle times*
• At least 30% time savings was most notable for the CRO Study Director across all activities.*

“Incorporating E-WorkBook into our efficient data management system led to reduced study timelines and costs for numerous clients,” says Barbara. “These efficiencies enabled us to develop standard tiered in vitro ADME-Tox/DDI study options, with design and deliverable options tailored to the stage of preclinical drug development and each client’s risk management approach and preferred in/outsourcing strategy.”

These gains helped BioIVT deliver reports up to four weeks faster*, reducing costs and improving client satisfaction.

Why a lab informatics platform makes sense

In an era of rising R&D costs—averaging $2.3 billion per drug³—and increasing regulatory complexity, investing in a scalable, cloud-based platform is a strategic move. Unlike on-premises or hybrid systems, cloud platforms offer:

• Lower upfront and maintenance costs
• Real-time collaboration and remote access
• Automated updates and streamlined workflows

Conclusion: A smarter path to drug development

By adopting a lab informatics platform, BioIVT not only improved operational efficiency but also enhanced their ability to deliver high-quality, regulatory-ready data. This case illustrates how digital transformation can drive both scientific and business success.

Start your journey with IDBS today.

About the author

Lisa Postava, Product Marketing Manager, Preclinical & clinical, IDBS

Lisa Postava is the Product Marketing Manager for Preclinical and Clinical at IDBS. Prior to IDBS, she worked in both research and clinical settings both at the University of Pittsburgh and in various marketing and product management roles for 20 years at Thermo Fisher Scientific with her last role being Director of Strategic Marketing, NA.

 

References: 

1. Kola, I., & Landis, J. (2004). Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery, 3, 711–716. https://doi.org/10.1038/nrd1470
2. BioIVT. (n.d.). Timing of in vitro studies: Early, thorough ADME for your compound’s success. Retrieved June 26, 2025, from https://bioivt.com/blogs/timing-of-in-vitro-studies-early-thorough-adme-for-your-compounds-success
3. Deloitte. (2024). Measuring the return from pharmaceutical innovation 2024. Retrieved June 26, 2025, from https://www.deloitte.com/us/en/Industries/life-sciences-health-care/articles/measuring-return-from-pharmaceutical-innovation.html
4. Myung, Y., de Sá, A. G. C., & Ascher, D. B. (2024). Deep-PK: Deep learning for small molecule pharmacokinetic and toxicity prediction. Nucleic Acids Research, 52(W1), W469–W475. https://doi.org/10.1093/nar/gkae254
5. Beaney, A. (2025, January 13). Respite from rising trial costs is a distant dream in 2025. Clinical Trials Arena. Retrieved June 26, 2025, from https://www.clinicaltrialsarena.com/analyst-comment/respite-rising-trial-costs-distant-dream-2025/
6. Deloitte. (2024). Pharma R&D returns are improving. Retrieved June 26, 2025, from https://www.deloitte.com/ch/en/about/press-room/deloitte-pharma-study-r-and-d-returns-are-improving.html
7. Beaney, A. (2024, July 31). FDA drug application costs set to rise to $4.3m from October. Clinical Trials Arena. Retrieved June 26, 2025, from https://www.clinicaltrialsarena.com/news/fda-cost-revealed-2025-application-drug/
8. Allied Market Research. (2024). Electronic Lab Notebook (ELN) Market Research, 2033. Retrieved June 26, 2025, from https://www.alliedmarketresearch.com/electronic-lab-notebook-market-A72618
9. BioIVT. (n.d.). Tiered ADME study options tailored to fit specific goals. Retrieved June 26, 2025, from https://bioivt.com/blogs/tiered-adme-study-options-tailored-to-fit-specific-goals

*Customer data on file at IDBS. This result was originally obtained using IDBS E-WorkBook; IDBS Polar delivers the same or higher gains as IDBS E-WorkBook in a like-for-like implementation, with added value from advanced analytics, AI/ML and reporting.