It is widely recognized that efficacy and safety of many drugs and drug candidates is strongly influenced by genetic factors. Single nucleotide polymorphisms (SNPs) and more complex structural variations like insertions/deletions or gene copy number variations in drug-metabolizing enzymes, transporters or targets often affect the pharmacokinetics and pharmacodynamics of a compound. With our extensive experience and capabilities to perform variant analyses, IMGM contributes solutions on the road to a more personalized medicine:
Pharmacogenetic testing already during clinical studies becomes ever more significant, since this approach is able to elucidate some of the underlying causes of inter-individual variability in drug response and adverse drug reactions. Moreover, the effects of drugs or drug candidates on gene expression can be analyzed to obtain valuable insights into their mode of action (pharmacogenomic approach).
Pharmacogenetic and pharmacogenomic information can e.g. be used for:
- Patient stratification and specific recruitment in clinical studies
- Correlation of drug response with genotypes
- Correlation of adverse drug reactions with genotypes
- Individualized dose adjustments
- Re-evaluation of failed drugs by inclusion of pharmacogenetic data
- Analysis of drug effects on gene expression
- Companion diagnostics
In this way, the application of pharmacogenetics and pharmacogenomics is not only able to improve healthcare by sparing patients from ineffective treatments and avoidable side effects, but also to save considerable costs for the pharmaceutical industry by streamlining clinical trials and increasing success rates. Furthermore, official authorities increasingly require or recommend pharmacogenetic testing as an element of the drug approval process.
IMGM is your outsourcing partner of choice for expert pharmacogenetic testing within your clinical study.
Pharmacogenetics - Technology
At IMGM, we offer a broad range of state-of-the-art technologies, analysis platforms and applications to serve your needs in pharmacogenetics, pharmacogenomics and companion diagnostics. Among them are:
- SNP analysis
- Copy number variation analysis
- Gene panel analysis
- Gene expression analysis
- Applied techniques
- Nucleic acid extraction (e.g. from blood, tissue, ...)
- Drug metabolizing enzymes and transporter screening (e.g. Affymetrix DMET array)
- Next generation and Sanger sequencing
- SNP/CNV/InDel analysis (e.g. via arrays, TaqMan technology)
- Amplicon/gene panel design, validation
- High/low resolution HLA genotyping (class I and II)
IMGM's professional Pharmacogenetics Services include
- Pharmacogenetic consulting by your personal IMGM project manager
- Guidance for sample collection and shipment (e.g. sample kit provision)
- Generation of QA-reviewed and GCP-compliant documents
- Secure file transfer based on data format specifications (DFS) and data transfer specifications (DTS)
- Pharmacogenetic testing using state-of-the-art technologies
- Reliable turnaround times
- Professional quality management - ISO 17025, GLP and GCP-compliant
- Strong background in medical diagnostics - analysis of additional clinical study parameters in collaboration with our strategic partner and sister company, the "Center for Human Genetics and Laboratory Diagnostics, Dr. Klein, Dr. Rost and Colleagues"
See a detailed workflow description here.
Official guidelines and recommendations for pharmacogenetic testing
In its “Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products”, the EMA (European Medicines Agency) presents pharmacogenetic analyses as imperative if prior studies indicate that a polymorphic enzyme or transporter is likely to represent an important pathway for a drug or if in vivo studies indicate that substantial inter-individual difference in the pharmacokinetics of a drug are likely to influence its efficacy or safety and cannot be explained by other intrinsic or extrinsic factors. Both targeted (candidate gene) analyses and genome-wide association studies may be applied. Furthermore, the EMA recommends more thorough investigations if there is evidence that genetic factors may play a role for a drug's pharmacokinetic behavior.
The US Food and Drug Administration (FDA) issued the “Guidance for Industry – Clinical Pharmacogenomics: Premarket Evaluation in Early Phase Clinical Studies and Recommendations for Labeling” in January 2013. Recommendations in this FDA guidance go along the same way as those from the EMA guideline, however, without suggesting explicit cut-off values for considering a metabolic pathway to be important.
Go for enhanced analytical power!
Entrust IMGM with your next Pharmacogenetics study.