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Biomarker Strategies

Comprehensive, biomarker-led clinical development strategies, with Precision Contact us
From patient selection and stratification to enhancing your understanding of mechanism of action (MOA) and therapeutic potential to defining meaningful study endpoints, we’ll work with you to develop a robust biomarker strategy that maximizes your insight into patient biology through an efficient, cost-effective, and targeted study.
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Integrating clinical research with translational science for maximum insight

Biomarkers are pivotal in the development of next-generation therapies, providing critical insights that guide every stage of development and clinical research. From predicting disease progression to determining the most effective treatments, biomarkers help answer essential questions that drive innovation in patient care.

At Precision, we were purpose-built around the promise of precision medicine. Our organization is dedicated to helping biotechs and pharmaceutical companies develop therapies for patients in need. Partnering with Precision puts your innovation on an accelerated path to approval, leveraging our expertise in biomarker strategies to enhance your clinical research and bring life-changing treatments to market faster.

In-depth understanding and experience are the keys to successful biomarker-driven trials

Developing an effective biomarker strategy can be challenging as it requires an in-depth understanding and integration of what are typically three separate disciplines: clinical trial operations, biomarker assay development and implementation, and data science.

  • Specialized Experts
  • Optimized Logistics
  • Maximized Insights

  • Built for Biomarker Research

    Precision's  fully integrated approach to biomarker-driven studies stands apart from other CROs. In-house teams handle all aspects of the study—clinical trials, specialty lab services, and data science/computational biology. This allows for a clear and in-depth understanding of all the complexities and nuances of biomarker-driven trials.

    We know what works, what doesn’t work, and what it takes to succeed. And with every project, we keep getting better.

     
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  • Designing Clinical Strategies with Biomarkers

    Selecting an appropriate biomarker and assay is just one part of an effective biomarker strategy. Knowing the logistics around clinical trial operations is just as important. Issues around the practicalities of sample collection timing, sample amounts needed for the assay, and sample handling and management are dependent on the biomarker assay but will also affect trial design. Some challenges can be overcome by using a different assay or even a different biomarker.

    At Precision, we design with biomarkers in mind, and our experience in clinical trial operations, clinical trial design, and biomarker assay development and implementation all contribute to our success in designing and implementing biomarker strategies.

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  • Integrating Operations with Biomarkers Analysis

    Another challenge faced by biomarker-driven clinical trials is integrating the clinical data with the biomarker data. To really get the most information from the biomarker data, you often need to understand the clinical data that goes with it. But for studies where clinical trial operations are not integrated with biomarker analysis, combining the two data streams can be quite complicated.

    At Precision, we recognized this challenge early on and developed the QuartzBio Translational Science Platform to overcome it. With QuartzBio harmonizing and integrating the clinical data with the biomarker data while also handling sample inventory management, you can build a highly detailed, fully informed view of trial results from the molecular level up to the patient level, enabling maximum insight into each sample.

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Case Study

Use of flow cytometry data to achieve optimal dose: A phase 1 immunotherapy trial

Precision for Medicine, oncology and rare disease is currently managing a two-part, phase 1 study that is looking at safety and efficacy of a novel agent: a recombinant, humanized monoclonal antibody targeting a specific receptor, resulting in potent antibody-dependent cellular cytotoxicity. Part 1 of the study is a dose escalation design, where we look at escalating doses of the novel agent in combination with varying levels of different immunotherapies to help augment the level of antitumor activity of the immune response to the tumor cells.

In typical dose escalation studies, patients are treated with escalating doses of the study drug in various combinations until a certain level of unacceptable toxicities (adverse events) that are consistently seen in the treated patients is reached. The goal of these studies is to find the highest tolerated and safe dose, with a balanced amount of adverse risk.

Download this case study to learn how our teams are navigating this study to  accomplish meaningful clinical outcomes. 

Download case study

Applying biomarkers in dose-finding and dose expansion studies

Biomarkers serve as a valuable tool in optimizing the dosing strategy for maximum efficacy and safety. They bridge the gap between the preclinical and clinical stages of drug development, facilitating a more targeted and effective approach to treatment.
What you need to know

Proactive Planning to Optimize the Use of Biomarkers in Oncology Clinical Trials

Oncology drugs developed through a biomarker-guided precision medicine design are 38% more likely to be commercialized. Yet this good news comes with critical operational considerations that can mean the difference between success and failure.

Begin optimizing your biomarker strategy—download the white paper now.

Download white paper

Read our latest Precision insights

 Stay ahead with the latest insights in biomarkers and integration strategies in global clinical development from our experts. 

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Specialized capabilities in every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.

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