Bringing data quality to the CRO-BioPharma partnership

Drug sponsors value – and rely on – the CRO-BioPharma partnership and the work that contract research organizations (CROs), perform. And it is increasingly the small and mid-size biotechs that recognize the value of data quality. In fact, while large pharma companies are expected to grow R&D spending at a rate of 4% annually, R&D spending in biotech is forecast to grow twice as fast, up to 8% per year, reaching $46 billion in revenue by 2025.¹

This growth is being driven by the rising number of drugs in preclinical trials, an increase in outsourcing R&D activities, and more product pipelines in biotech. With regard to the latter, there was a 33% increase in drugs in the preclinical pipeline from 2019-2022, largely being developed by biotechs, that lack the infrastructure to develop their own drugs.² So it is not surprising that an overwhelming majority (81%) of respondents to a recent survey indicated the CRO-BioPharma relationships as “very important” or “important” to their research.³

Are CROs underserving drug sponsors in the CRO-BioPharma partnership?

While biotechs believe there is great benefit in partnering with a CRO in R&D, many report feeling underserved by these relationships. A survey revealed that almost 45% of respondents graded their experience with their current CRO as moderately or completely unsatisfactory.³ And 53% of BioPharma decision makers would consider changing their preferred CRO in the next year.⁴ A deep dive into these numbers reveals that one of the industry’s biggest concerns when outsourcing to a CRO is quality, particularly in the areas of bioanalytical testing and data management.¹

Bioanalysis, the detection and quantitative measurement of drug products in biological samples, is a critical part of biopharmaceutical drug development. It arguably plays the most definitive role in tying therapeutic outcomes to the presence of pharmacologically relevant drug levels in the target biological system – starting with animal models and followed by humans. The focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure.

The results of such studies are pivotal components of regulatory submissions that tie the drug to a specified therapeutic indication. As such, the success of the downstream clinical development is heavily dependent on meticulous recordkeeping with the bioanalytical data generated in the lab. As a vital component of preclinical and clinical drug development, bioanalytical groups are grappling with the pressure to improve efficiency while maintaining accuracy and reproducibility with the regulatory constraints of a compliant environment.

Biotech companies report that they do not feel that today’s CROs deliver enough on integrating technology point solutions.¹ Add to that the reality that bioanalytical labs work with a crowded and siloed set of systems and processes. From part electronic to part paper-based workflows, to standalone point solutions, the result is a lack of insight into data and impediments to reporting and results handling. Today’s successful CRO must transform its bioanalytical operations to support regulatory and operational considerations while generating high-quality data for informed, real-time insight and reporting.

Raising the data quality game

Despite biotech companies reporting a low level of satisfaction with CROs in the area of data quality, a McKinsey and Company report¹ emphasizes that CROs have a chance to up their game with biotech. One way to do this is through digital transformation by implementing an integrated data management software solution.

IDBS Polar BioAnalysis is a cloud-based platform designed to solve workflow and data analysis challenges. The end game is to bring consistency, quality and reproducibility to preclinical drug qualification. Planning, execution and analysis are all linked together to provide secure and compliant data management that will transform your bioanalytical operations.

CROs who have already implemented the IDBS platform report improved operational efficiencies of 20 to 30% and reduced overall study duration of more than 50%. Additionally, Polar BioAnalysis supports ICH M10 compliance and provides contextualized easy access study data for rapid reporting and audits. The software eliminates deviations within specified methods through real-time quality control.

Becoming a trusted CRO partner

In the highly competitive CRO market, where compliance, quality and data integrity are critical to winning and retaining business, today’s sponsors require a high degree of confidence in their CRO partners. Successful CROs will invest not only in cultivating relationships with biotech leaders but also in bioanalytical platforms that help bring projects to fruition. This can pay dividends when these drug sponsors succeed in development and launch or get acquired by established pharma companies, bringing opportunities for additional programs. The CRO that helped develop a biotech company’s asset can become a trusted partner for further development projects.¹

 

References

1. CROs and biotech companies: Fine-tuning the partnership, By Joachim Bleys, Edd Fleming, Hannah Mirman, Lydia The, McKinsey & Company, June 9, 2022.
2. CRO sector: M&A drivers and market trends, Q1 2022.
3. What Stands in the Way of an Efficient CRO-Pharma Collaboration? By Ekaterina Bulaeva, Amalia Iljasova, Applied Clinical Trials, May 18, 2022.
4. What Does The Pharma Industry Want From CROs? Informa Pharma Intelligence.