DxS Ltd has announced that it is taking action to ensure the promise of individualized therapy becomes reality by launching a consultancy and training service on pharmacogenomics and its value in delivering safe and effective medicines.
Only recently (September, 2005), a report by The Royal Society (UK), ‘Personalised medicines: hopes and realities’, confirmed the positive impact that pharmacogenetics will have on drug development in the future, and predicted that patients should expect to see the fruits of this within 15-20 years.
However, DxS believes the time for pharmaceutical companies to start planning for personalised medicine is now.
This view is also supported by the regulators, particularly the FDA, who recently released guidance on ‘Pharmacogenomic Data Submissions’.
By working with experts within their field at DxS, pharmaceutical and clinical research customers can receive training on pharmacogenomics and personalized medicine, learn how to incorporate genotyping into a clinical trial and understand how to weigh up the various options for its use within Phase I, II and III.
Advice on regulatory and ethical aspects, including advice on FDA Pharmacogenomic Data Submissions, and the role of companion diagnostics is also offered.
Furthermore, DxS can also provide research and consultancy advice on which specific SNP markers should be used for certain drug targets.
“In launching the new Pharmacogenomic Training Course,” Dr Stephen Little, CEO of DxS said, “We have found that many companies are still unsure of the implications and opportunities that pharmacogenomics can offer.”
“This indicates a need for guidance on the background to this technology and how it can improve clinical trials by decreasing costs, reducing timescales, and minimising the risks in drug development.”
“In response, we are launching a consultancy service and offering bespoke training courses to allow our customers to keep abreast of recent regulatory and scientific developments to help benefit their clinical development plans”.