EMA Lays Out Best Practices for Pharmacogenomics

The EMA is spelling out how companies can use genomic data to improve drug development research.

As the pharmaceutical industry moves toward a genomic basis for individualized treatments, an EMA draft guidance issued in May has identified a slew of pitfalls companies can avoid by properly employing pharmacogenomics.

The agency pointed toward the “poor quality of employed analytics” as one of the foremost drawbacks of misusing pharmacogenomics in trial design, along with the lack of appropriate phenotype identification and inadequate patient selection. While previous pharmacogenomics guidances have focused on issues such as clinical development and risk management, this document concentrates on analysis and applying that to best practices.

As an example, the EMA recommends taking into account all these genetic variations in trial design and data analysis.

With regard to the tumor genome, the EMA recommends a liquid biopsy to isolate circulating tumor DNA and to acquire information about the tumor DNA through sequencing.

For the design of genomic sequence analysis, the EMA recommends studying genomic variations, employing appropriate DNA-isolation methods, validating critical sequencing results, using sequence databases cautiously and employing bioinformatics methods such as algorithms.

The draft guidance delves into technical and chemical approaches to genomic biomarker analytics, recommending that all of these be validated by a second, independent test, identifying shortcomings and providing advice to improve the quality of analysis.

Next-generation sequencing (NGS), for instance, might provide miscalled variants from sequencing artifacts. In addition to an independent test to validate the data, the EMA recommends increasing targeted NGS libraries.

The guidance highlighted one trial as particularly well designed. The prospective, randomized trial was designed to identify one polymorphism and clearly defined endpoints in a well-characterized population. The clinical trial enrolled 1,956 patients in 19 countries and demonstrated a specific influence of HLA-B*5701 produced by abacavir.

The draft guidance could save pharmaceutical companies money, Darshan Kulkarni, principal attorney of Kulkarni Law Firm, tells IPRM. Kulkarni says that with this guidance, pharmaceutical companies will avoid making mistakes and can prevent retrials.

The comment period closes on Sept. 16. Read the draft guidance here: www.fdanews.com/05-02-16-Pharmacogenomics.pdf. — José Vasquez

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