Biomarkers in Drug Development

Why Should You Attend:

With the advent of the targeted therapy, the need to identify novel biomarkers has increased dramatically. In addition of the biological rational that associate the biomarker with the mechanism of action of the drug, there are multiple steps to fulfill before apply the measurement of the biomarker in clinical development.

This session will cover the steps from biomarkers’ discovery to its application in drug development. It will discuss the most common sources of biomarkers, i.e. serum, whole blood, tissue biopsy, etc., plus the selection of gene and/or protein expression as biomarkers.

The training program will also discuss some of the key decision points such as:

• Timelines of searching for potential biomarkers
• Assay development and validation
• Strategies to validate the biomarker(s) in humans
• Incorporation into clinical trials within regulation
• Data analysis
• Data interpretation

Areas Covered in the Webinar:

• What are biomarkers?
• Identification of potential biomarkers, based on biology.
• Role of biomarkers in targeted therapy drug development.
• Assay development and validation.
• Examples of key role played by biomarker identification in the development of approved drugs.
• Exploring biomarker leads in human clinical studies.
• Regulatory guidelines on biomarkers’ strategy - dos and don’ts.
• Clinical operation aspects of biomarker analysis in clinical studies.
• Bio analysis of samples. In house, outsourced, or a combination of both?
• Data analysis, in combination with drug levels (PK/PD).
• Data analysis in combination with clinical outcome.
• Need to develop a companion diagnostic? When is the time to start?

Who Will Benefit:

• Scientists working in drug discovery and development in academia, biotech or pharmaceutical industry
• Preclinical scientists interested in exploring translational medicine research
• Personnel involved in clinical development
• Clinical project leaders and clinical project managers to get an overview of the processes involved
• Bio-tech professionals in preclinical and clinical research
• Biotech companies that are expanding clinical development capabilities

Instructor Profile:

Juan Leal has over 15 years of working experience in pharmaceutical and biotechnological drug development companies, a highly FDA-regulated environment. He has over 15 years of experience in designing, developing and conducting animal studies or clinical trials of new drug products in development.

He has also been a participating team member of 20+ drug development programs, from which 5 drug products were successfully launched, and has supervised 25+ scientists and research assistants. He has also led the design, implementation and evaluation of the clinical biomarkers strategy of five clinical development programs and led the design of in vitro and in vivo models, its validation, and application to evaluate the safety and efficacy of new molecular entities and selection of new drug candidates for clinical development.

Topic Background:

Biomarkers are the short name for biological markers. Biomarkers are measurable biological substances (e.g. proteins in blood). In drug development, biomarkers are used as indicators of pharmacological response to a drug administration. Due to the surge in the development of targeted therapy drugs, the needs to identify specific biomarkers have increased. They are required to determine a drug’s mechanism of action and its association with the drug levels in circulation, which is called pharmacokinetics and pharmacodynamics ratio (PK/PD). The oncology field has leaded the development of biomarkers, due to tumor heterogeneity, which makes necessary to determine prior to treatment the molecular characteristics of a particular tumor of a particular patient, i.e. personalized medicine. In short, it is important to know a) if that tumor is or isn’t expressing the drug target, and b) if the target expressed is wild type or is a mutated form. This analysis will determine what type of drug treatment should be provided. For these complex biological reasons, the FDA is indicating in many cases that there is a need to have a companion diagnostic to clearly indicate if a patient should receive a drug A, drug B or even drug C.

Since there is much expertise involved in this entire process, multiple groups are expected to participate, from preclinical, translational medicine, clinical pharmacology, clinical operations, regulatory affairs, and sometimes project management. It is critical to have a system in your organization to allow a coordinated effort from multiple groups. The biomarker leader should have a dual role, lead scientist with a deep understanding of the target, target’s signal transduction, and desired effect; plus a project leader role to coordinate the activities and deliverables of the different groups involved.

Planning is the most important part of the process. Are all the support groups involved on board? Is all the expertise needed available in house? Do you need to outsource some steps? Are all the clinical sample collection and bio analysis within regulatory guidelines? Remember that clinical studies are very challenging, very expensive and very time involving for many highly skilled professionals, so operational errors (e.g., poor handling of samples) or regulatory errors (e.g., not proper consent for genetic analysis) will not allowed you to maximally optimize the use of the precious clinical samples on the biomarker(s) search and validation in patients.

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