Predictive Pharmacogenomics:

Revolutionizing Health Care Through New

Diagnostic Approaches and Patient-Tailored Treatments

This report comprehensively examines the emerging technologies under-lying predictive pharmacogenomics and personalized medicine, the lead-ing companies applying these technologies, and the impact predictive pharmacogenomics will have on medicine and pharmaceutical markets. The report is based on interviews with more than 20 experts, who helped shape the focus of this study. More than 30 companies and their tech-nologies are discussed in detail, and contact information and areas of spe-cialization are supplied for more than 80 companies overall. Case studies of the impact of pharmacogenomic technologies on sales of specific drugs and diagnostics are presented, and we discuss the business and scientif-ic issues shaping this field and how this area is most likely to evolve. Companies discussed in detail include Celera Genomics, diaDexus, DNAPrint, deCODE Genetics, Gemini Genomics, Genaissance Pharmaceuticals, Gene Logic, Genentech, Genome Therapeutics, Genomica, Genset, Golden Helix, GlaxoSmithKline, Genzyme Genetics, Incyte Genomics, Millennium Pharmaceuticals, Myriad Genetics, Novartis, Oxagen, Quintiles, and Variagenics.

REPORT ARCHIVEGenomic-Scale Gene Expression Analysis: Advancing from DNA to DiseaseIn an era when vast amounts of information on all human genetic material are becoming available, the "one-gene-at-a-time" approach to analyzing gene expression is wholly inadequate. Not only would such an approach be inefficient, it would not sufficiently illuminate patterns of gene expres-sion. Therefore, the current challenge is to develop/optimize methods for monitoring thousands of gene products simultaneously�\that is, methods of multiplex gene expression analysis. This report reviews current and emerging technologies for gene expression analysis and discusses the activities of key companies in this field, profiling 20 of them in-depth. It also includes expert commentaries, covers key applications, and discusses the outlook for the field.

Genomic Deals Review: January 1999-March 2000Almost 400 genomic deals were announced in 1999, with activity increas-ing steadily from quarter to quarter. This report, based on CHI's extensive Drug Discovery and Development Deals Database, reviews the activity of major dealmakers�\such as Affymetrix, Aurora Biosciences, and Incyte Genomics�\and examines key trends in 1999 (e.g., deal participation by geographic region, activity by large pharmaceutical companies versus smaller firms, types of deals, and types of technologies). For example, our analysis of database findings reveals that the technologies most often involved in 1999 deals were bioinformatics, gene expression monitoring, and functional genomics. The report also reviews first-quarter 2000 activi-ty and trends. Nearly 150 companies are mentioned in reference to deals, and the 14 most active companies are profiled. Functional Genomics: Applying High-Throughput and Systemwide ApproachesAs the map of the human genome approaches completion, drug compa-nies face increasing pressure to stake their claims on those genes whose products will be the most valuable drug targets. Deft use of functional genomics�\particularly high-throughput and systemwide methods of gene function analysis�\will provide a key advantage in this race. As a result, there has been a tremendous explosion in interest in functional genomics. In this report, we mention the activities of more than 100 companies and review the major issues impacting this field, the most significant scientific advances, and the leading companies and their approaches. Eleven indus-try experts provide insights about key applications in functional genomics, as well as future directions of the field, and 19 company profiles are also provided.

Impact of Genomics on Cancer Diagnosis, Therapeutics, and PharmacogenomicsSince the discovery of oncogenes and, more recently, of tumor-suppressor genes, cancer has become one of the main targets of genomics-based drug discovery. The explosion of information generated by large-scale genomics-related technologies has resulted in an exponential increase in the number of genes and proteins available for pharmaceutical and diag-nostic research and development, leading to a dramatic increase in the number of anticancer drugs undergoing clinical development. In this report, we briefly review the current understanding of the molecular genet-ics of cancer. We then provide detailed information on the current activity in developing drugs and diagnostic tests based on genomic research.

The report also includes market projections for selected genomics- and genet-ic- based anticancer agents and discusses the prospects for genomics-derived cancer management as described by participants in CHI's exclu-sive survey of 500 U.S. oncologists. Sixteen leading experts were inter-viewed for the report, which contains 17 company profiles as well as a list of leading cancer centers and cancer researchers. Single Nucleotide Polymorphisms: Commercial and Scientific ProspectsResearchers are racing to identify the estimated 3 million to 30 million human single nucleotide polymorphisms (SNPs) and thereby generate optimal drug targets. These markers of human variation have already pro-vided key information about diseases such as sickle-cell anemia, cystic fibrosis, Down's syndrome, Tay-Sachs disease, Alzheimer's disease, and colon cancer. The markets for smarter, SNP�\related drug discovery approaches�\and the products stemming from them-have multimillion-dol-lar potential. This report contains 27 company profiles and input from 10 leading experts in the field.

Proteomics: A Key Enabling Tool for Genomics?More than 50 companies are providing services, tools, or supplies for pro-teomics (the study of protein expression and function) or applying this new approach to discover and develop drugs and diagnostics. This report high-lights recent advances in protein expression and mapping and describes new frontiers such as protein chips and protein-complex studies. We pro-file 23 market leaders and emerging competitors offering innovative approaches, and we describe potential breakthroughs and market oppor-tunities on the horizon. Fourteen leading industry experts provide insights and opinions regarding the current technologies, how proteomics will evolve, and the applications for which proteomics is likely to be the most fruitful.