The View From Here: Pharmacogenetics in the real world – everything you need to know about how to use it

The compelling arguments for the use of pharmacogenetics in drug development are well known and rehearsed.

Having listened to and taken on board its importance, the healthcare industry in its broadest sense is incorporating it into business models and procedures. For example, biopharmaceutical companies big and small are adopting pharmacogenetics in recognition of the value it can add, and industry regulators such as the US FDA and the European EMA are working to develop guidelines as to the kind of data they want to see. In addition, we are going to need pharmacogenetics in order to generate the cost-effectiveness data that is needed when talking to the final gatekeepers before widespread drug uptake – the payers. In synergy with what's going on in the industry, academic research groups worldwide are increasing the understanding of the role our genes play in the development of disease, and in defining how individuals respond to drugs. These groups represent a valuable source of genetics data and expertise, and are ideal collaboration partners.

So the stage the sector is at now is one of implementation of pharmacogenetics, and the questions that are being asked are much more practical. Companies need to know how to incorporate pharmacogenetic thinking at all stages of drug development – from target to market, not forgetting companion diagnostic development. They need to know what pharmacogenetic questions to ask in order to satisfy the regulators, and how to design the trials that will answer those questions. And once they’ve generated this data, how is it to be analysed? Answering these kinds of questions and more is the aim of London Genetics’ second Annual Pharmacogenetics Conference – Pharmacogenetics: Why, How and When? Challenges, Opportunities and How to Harness the Value, to be held in November in the UK. It follows on from London Genetics' inaugural conference – Harnessing Genetic Knowledge to Improve Clinical Development and Patient Care – from which one of the main conclusions was that the role of genetics and pharmacogenetics needed to be clarified going forward, and there was also an emphasis on the need for collaboration. (The proceedings of the 2009 conference were published in Drug Discovery today in May 2010 and are included as part of this mailing.)

London Genetics, an expert in the use of pharmacogenetics in clinical drug discovery and development, has itself in the last year been working to show how pharmacogenetics can be used, as exemplified by the first awards from its proof-of-concept fund and its recently announced partnership with Diaceutics on biomarker development.

Building on these foundations, this year's pharmacogenetics conference has been developed around four main themes:

  • The impact of pharmacogenetics on clinical development, drug labels and prescribing;
  • Insights into how biopharmaceutical companies are using pharmacogenetics in their drug development and regulatory activities;
  • How pharmacogenetics can generate cost-effectiveness data and what it means for decision makers such as pharmacists;
  • The latest genetics research coming from London Genetics’ academic partners on disease pathways, exciting new drug targets and how to identify patients with the highest risk of developing adverse reactions to drug treatment.

The first of these themes will be explored by a range of speakers, from the EMA, medical research, the International Serious Adverse Events Consortium and the US healthcare manager Medco Health Solutions. Topics for discussion are expected to include how the EMA is working with pharmacogenetics, and the value of pharmacogenetics in improving patient safety while extending product lifecycle and ease of use. Warfarin will be the case in point here – it is well known that warfarin dosing is difficult to get right, and wrong dosing can be dangerous. Since the genetic variations that affect how we metabolise this generic drug are known, extensive studies in the US and Europe are underway to clarify the clinical and economic outcomes of genetics-directed prescribing. The European studies are being directed by London Genetics' adviser Professor Munir Pirmohamed of the Wolfson Centre of Personalised Medicine in Liverpool, UK, and one of his colleagues will provide an exciting insight into the challenges of performing these collaborative studies, and perhaps some early results.

The industry-focused session should also generate some insight into how fully companies are integrating pharmacogenetics into their drug development methodology. Speakers from companies as diverse as Qiagen, GlaxoSmithKline and Amgen will discuss the role of companion diagnostics, how genetics is influencing clinical trial design and the importance of biomarkers in defining the clinical usefulness of products – a factor of increasing importance in this era of value-based pricing. In September last year Qiagen made a huge step forward in its personalised medicine expertise, with the acquisition of UK-based DxS, of which conference speaker Dr Stephen Little was a co-founder and CEO. He is now VP of Personalised Healthcare at Qiagen, and we expect his views on how this market is expected to develop in the future to be particularly perceptive.

The conference session on evidence-based medicine in the era of pharmacogenetics will bring a strong dose of economic reality to the agenda. It will again drum home the message that if there is not enough healthcare money to go round, then the industry needs to be able to demonstrate the value of its innovations in a quantifiable way. Chaired by a clinician with a strong industry background in clinical trial management at Quintiles, there will be a speaker from the Science Policy unit at Pfizer, as well as some insight into the pharmacy perspective from the UK's Chief Pharmaceutical Officer at the Department of Health.

One of London Genetics's strengths is its seven academic partners, all London centres of excellence in genetics research. With a combined research budget of over £650m a year and a network of over 3,000 researchers, genetic data of great relevance to the biopharmaceutical industry is being generated at a prodigious rate. One of the highlights of the conference is its genetics research sessions, which will bring an insight into some of these latest findings in obesity, atherosclerosis, as well as insulin and glucose metabolism – key areas of activity for much of the sector.

The in-depth discussion at the conference of these four themes will be supplemented by panel debates at the end of each session, as well as extensive networking opportunities both during the two days and also at the conference dinner. London Genetics’ second Annual Pharmacogenetics Conference is being held on November 9-10 at Cumberland Lodge, Windsor, UK. For more information and to register for the conference please go to, call Caz Roberts on +44(0) 207 3170 8820 or e-mail

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