Biomarker Strategies

Purpose-built to advance biomarker-driven clinical development, Precision understands how to realize the full potential of biomarker use in clinical trials. 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.

Biomarker Strategies

Purpose-built to advance biomarker-driven clinical development, Precision understands how to realize the full potential of biomarker use in clinical trials. 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.

Integrating clinical research with translational science for maximum insight

Biomarkers – what questions can they help to answer?

In-depth understanding and experience are the key 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 (increasingly incorporated into translational science departments), and data science.

What sets Precision apart from other CROs when it comes to biomarker-driven studies is our fully integrated approach. Because our in-house teams handle all aspects of the study-clinical trials, specialty lab services, and data science/computational biology-we have 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.

Integrating biomarkers with clinical operations

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.

Integrating clinical operations with biomarker 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 and 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.

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

Case Study: Use of flow cytometry data to achieve optimal dose: a phase I immunotherapy trial

Precision for Medicine, Oncology and Rare Disease is currently managing a two-part, phase I 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.

Application of biomarkers in dose-finding and dose-expansion studies

Traditionally, phase 1 oncology trials have relied on a classic 3+3 dose escalation design for defining a recommended phase 2 dose. However, targeted therapies and immunotherapies often have toxicity profiles that are very different from those of cytotoxic agents and may require novel dosing strategies.

With chemotherapy, the goal of dose finding was to find the highest safe dose, or maximum tolerated dose (MTD), to optimize cancer cell killing. In the case of targeted therapies and immunotherapies, these agents may not produce dose-limiting toxicity, even at doses significantly higher than where activity has been identified, and their side effects may not be dose dependent.

This makes it challenging to prospectively define decision criteria for stopping dose escalation. Consequently, it may be more appropriate to identify an optimal biologic dose (OBD) rather than an MTD. Doing so takes into account not only what is happening clinically, but also what is happening in the tumor microenvironment that can help lend insight into proper dosing.

An integrated look at biomarker data can help inform the dose-finding and dose-expansion decision process.

“We’ve developed ways to define patients entering into those different cohorts that can get approval on a hundred or fewer patients”

Gerald Messerschmidt, MD, FACP
Chief Medical Officer

“We’ve developed ways to define patients entering into those different cohorts that can get approval on a hundred or fewer patients”

Gerald Messerschmidt, MD, FACP
Chief Medical Officer

Tell us about your project requirements

Developing a biomarker strategy is most effective when done in conjunction with your clinical trial strategy development. Hear what our experts have to say about your study.

Tell us about your project requirements

Developing a biomarker strategy is most effective when done in conjunction with your clinical trial strategy development. Hear what our experts have to say about your study.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

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