Pharmacodiagnostics: Technologies, Competition, and Market Models examines the reasons why the business environment of pharmaceuticals is changing in favor of pharmacodiagnostics, or theranostics, and describes market models that are likely to emerge as the pharmaceutical and diagnostic industries collaborate to bring personalized medicine to fruition.

Pharmacodiagnostics and personalized medicine promise to address the key problems faced by the pharmaceutical industry. In addition to the clinical problems caused by ADRs, there are also well-documented commercial problems for the pharmaceutical industry, which has experienced a number of recent high-profile drug withdrawals due to unacceptable safety profiles. With the number of recalls increasing, the need for a solution is becoming critical. Furthermore, with the era of blockbuster drugs in decline, pharmaceutical companies need to incorporate personalized medicine into their drug sales models to decrease drug development costs, reduce the drug development cycle, and possibly resuscitate failed drugs.

The potential to develop personalized medicine is much greater now than at any time in the history of the drug industry. The raw data are available, and there are few technical hurdles to be overcome to allow the discovery and development of pharmacodiagnostic tests. However, the success or failure of pharmacodiagnostics will depend largely on the pull from the consumer for personalized medicine, or the push from industry. Indeed, a variety of market forces—regulatory, payer, provider, and consumer—will influence the acceptance of pharmacodiagnostics. Pharmacodiagnostics: Technologies, Competition, and Market Models analyzes these factors in detail.

Ultimately, the rise of pharmacodiagnostics will necessitate collaborative relationships between pharmaceutical and diagnostic companies with shifting power balances and opportunities for economies of scale and scope. The report projects that four principal relationships—Turnaround, Make-to-Order, Use-to-Order, and Integrated—are likely to exist. Each model is presented in terms of its varying degrees of financial benefit in return for investment in the development of companion products, underpinned by high-quality relationship management.

About the Authors

Dr. Stephen Little is founder and CEO of DxS Ltd ( www.dxsgenotyping.com) an established personalized medicine company focused on providing genetic analysis services and technologies to enable the delivery of safe and effective medicines. The services provide support for drug development, diagnostic product development and pharmacodiagnostics.

Prior to DxS, Dr. Little was responsible for research and development at AstraZeneca’s diagnostic business unit. AstraZeneca Diagnostics discovered, developed and manufactured DNA diagnostic products and also provided forensic and paternity testing through its Cellmark brand. He has over 25 years of experience in the application of molecular biology within industry and has particular experience in the invention and development of technologies for human genetic analysis with over 35 patents in his name. Before joining AstraZeneca he worked for Celltech PLC in the field of microbial gene expression.

Dr. Little trained as a microbiologist at Heriot-Watt University in Edinburgh and then later in Molecular Biology at the University of Edinburgh. He can be reached at stephen.little@dxsgenotyping.com.

Dr. Edward D. Blair is a founding director of Integrated Medicines (www.integratedmedicines.co.uk) a start-up aimed at enabling personalised medicine by matching diagnostic-type tests with proprietary pharmaceuticals. He is also Chief Science Officer & Executive Director of Phynova Group plc and a non-executive Director of ImmunoDiagnostics Systems plc.

Until May 2003, Dr. Blair was a Director in Translational Medicine at GlaxoSmithKline (Cambridge) and remains a visiting scholar & lecturer in biotechnology at the University of Cambridge. He has more than 15 years experience in the pharmaceutical industry, evolving through Wellcome Research Laboratories, GlaxoWellcome and GSK, and has been involved in all aspects of early phase drug development from target identification & routine compound screening through pre-clinical development & Phase II clinical trials. His broad therapeutic area experience includes viral, respiratory, liver & neurodegenerative disease, and cancer gene therapy, with research conducted in collaboration with esteemed UK , European & US academic groups.

Dr. Blair trained as a molecular biologist/biochemist at the National Institute for Medical Research in Mill Hill, London and at the University of California at Irvine , and is an expert in the field of virology, having edited two books and published more than 30 primary papers on the subject. He is also inventor on five patents. Dr. Blair can be reached at eddie.blair@integratedmedicines.co.uk.