Related Experiment Video
Updated: Nov 4, 2025
13:24
Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
Published on: April 11, 2016
12.0K
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development
Timothé Ménard1, Alaina Barros2, Christopher Ganter2
1F. Hoffmann-La Roche AG, Basel, Switzerland. timothe.menard@roche.com.
Therapeutic Innovation & Regulatory Science
|May 28, 2021
Summary
Next-generation sequencing (NGS) is revolutionizing precision medicine, but a lack of comprehensive quality guidelines for its use in clinical trials poses challenges. This research proposes a framework to ensure robust quality for NGS in drug development.
Area of Science:
- Genomic Medicine
- Clinical Diagnostics
- Biotechnology
Background:
- Next-generation sequencing (NGS) and falling genomic testing costs are transforming precision medicine.
- NGS integration into clinical drug development promises accelerated trials and improved patient care through targeted therapies and less invasive monitoring.
Purpose of the Study:
- To address the absence of a holistic GxP-like framework for pharmaceutical sponsors utilizing NGS in clinical trials, Companion Diagnostics (CDx), and Comprehensive Genomic Profiling (CGP).
- To identify and translate existing regulations and guidelines into actionable clinical quality considerations for NGS service providers.
Main Methods:
- Review and analysis of existing Health Authority (HA) guidances and regulations.
- Identification of applicable quality considerations related to technology, data quality, patient safety, and oversight.
- Development of a proposed framework for pharmaceutical sponsors.
Main Results:
- Existing regulations offer a basis for clinical quality considerations in NGS.
- Key areas for quality consideration include technology, data integrity, patient data, and oversight mechanisms.
- A need for a comprehensive, GxP-like framework for NGS in clinical drug development is highlighted.
Conclusions:
- The study identifies critical quality considerations for pharmaceutical sponsors using NGS services.
- A proposed framework can guide the development of essential guidelines for NGS clinical quality.
- Establishing robust quality standards is crucial for advancing precision medicine through NGS.
More Related Videos
Related Concept Videos
03:00Next-generation Sequencing
95.2K
The first human genome sequencing project cost $2.7 billion and was declared complete in 2003, after 15 years of international cooperation and collaboration between several research teams and funding agencies. Today, with the advent of next-generation sequencing technologies, the cost and time of sequencing a human genome have dropped over 100 fold.
Next-Generation Sequencing Methods
Although all next-generation methods use different technologies, they all share a set of standard features....
Next-Generation Sequencing Methods
Although all next-generation methods use different technologies, they all share a set of standard features....
95.2K
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
55
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
55
01:28Preclinical Development: Overview
5.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.4K
01:11Clinical Trials: Overview
4.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.0K
03:21RNA-seq
10.8K
RNA sequencing, or RNA-Seq, is a high-throughput sequencing technology used to study the transcriptome of a cell. Transcriptomics helps to interpret the functional elements of a genome and identify the molecular constituents of an organism. Additionally, it also helps in understanding the development of an organism and the occurrence of diseases.
Before the discovery of RNA-seq, microarray-based methods and Sanger sequencing were used for transcriptome analysis. However, while...
Before the discovery of RNA-seq, microarray-based methods and Sanger sequencing were used for transcriptome analysis. However, while...
10.8K
01:57Sanger Sequencing
763.9K
DNA sequencing is a fundamental technique that is routinely used in the biological sciences. This method can be applied to a range of questions at different scales - from the sequencing of a cloned DNA fragment or the study of a mutation in a gene up to whole-genome sequencing. However, despite the widespread use of sequencing today, it was not until 1977 that Fredrick Sanger and his collaborators developed the chain-termination method to decode DNA sequences. It relies on the separation of a...
763.9K