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This 700-page report is an essential tool for making the most successful strategic decisions.

- User Requirements : In-depth profiles of 52 major pharmaceutical and biotechnology laboratories performing HTS including information on · the success of HTS in finding leads and clinical drug candidates · target validation · number of targets · impact of genomics on HTS · current and expected throughput and number of compounds per screen · compound selection · current assays and best assays for finding leads · possible use of ADME/Tox studies in HTS - high-information content screening · use of cell-based assays and future projections · current and future detection modes · use of imaging technologies · perceptions of label-free detection · current and expected use of microplate formats and miniaturization plans · needed services · organizational changes · number of laboratories · how HTS laboratories are integrated into the drug discovery process · budgets · requests of suppliers · future plans and new technologies

- Suppliers : Information on important suppliers in the HTS marketplace with new products and services in areas such as assay development, reagents, kits, consumables, instrumentation, robotics, compound libraries, bioinformatics, and screening: technologies, acquisitions and organizational changes, sales and marketing practices, trade shows, customers, and more

- Market Overview : Analysis of HTS market size and growth, market trends, overall user requirements, and competitive environment

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120 pages

Edited by Mike Silver, Ph.D., Cambridge Healthtech Institute

The first of Cambridge Healthtech Institute's Summit Reports takes a close look at some of the key technologies that promise to take proteomics into the realm of automation and high throughput analysis. Although automation is being applied to what has traditionally been the workhorse of protein analysis - 2D gel electrophoresis - many limitations remain as to the speed, sensitivity and reproducibility of this decades old method. In this report, the insight and experience of several pharmaceutical industry leaders on emerging technologies are captured from a 2000 Proteomics conference organized by Cambridge Healthtech Institute. Here they present some of the important tools, such as microarrays, phage display and structural analysis that will hopefully bring us closer to a full account of the human proteome.

Contributors include major players in the proteomics market: Ciphergen, Amersham Pharmacia Biotech, Molecular Staging, Morphochem, Phylos, Dyax and the European Molecular Biological Laboratory. Key issues discussed include:

· The impact of automation on proteomics

· Consensus rules for protein-protein interactions and their implication for drug design

· Protein chips and related, enabling technologies

· Methods that impart amplification on proteins: phage display and Profusion technologies

· Post-proteomic technologies such as automated live cell assays

· Recent collaborative activity and technology position of all major players in proteomics
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Published December 2000

120 pages

Edited by Mike Silver, Ph.D., Cambridge Healthtech Institute

The first of Cambridge Healthtech Institute's Summit Reports takes a close look at some of the key technologies that promise to take proteomics into the realm of automation and high throughput analysis. Although automation is being applied to what has traditionally been the workhorse of protein analysis - 2D gel electrophoresis - many limitations remain as to the speed, sensitivity and reproducibility of this decades old method. In this report, the insight and experience of several pharmaceutical industry leaders on emerging technologies are captured from a 2000 Proteomics conference organized by Cambridge Healthtech Institute. Here they present some of the important tools, such as microarrays, phage display and structural analysis that will hopefully bring us closer to a full account of the human proteome.

Contributors include major players in the proteomics market: Ciphergen, Amersham Pharmacia Biotech, Molecular Staging, Morphochem, Phylos, Dyax and the European Molecular Biological Laboratory. Key issues discussed include:

· The impact of automation on proteomics

· Consensus rules for protein-protein interactions and their implication for drug design

· Protein chips and related, enabling technologies

· Methods that impart amplification on proteins: phage display and Profusion technologies

· Post-proteomic technologies such as automated live cell assays

· Recent collaborative activity and technology position of all major players in proteomics
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By Aya Yamamura, Cambridge Healthtech Institute

The rapidly emerging science of genomics is about to revolutionize various aspects of oncology practice, including how anticancer drugs are discovered and developed, how cancers are detected and classified, and finally how patients are treated and monitored. Since the discovery of oncogenes and, more recently,of tumor suppressor genes, cancer has become one of the most important diseases in the design of therapeutic approaches based on genetics and genomics research and technologies. Unlike the markets for monogenic diseases, most of which are caused by inherited mutations in a single gene, the market for cancer is enormous, and the commercial sector is expressing significant interest in clinical applications of genomics research. 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 diagnostic research development, leading to a dramatic increase in the number of anticancer drugs undergoing clinical development. Genomics-based drugs are expected to expand the cancer market significantly. Given that these drugs are expected to have improved side-effect profiles, opportunities for these drugs to be used as maintenance therapy-thus, capturing significantly larger patient populations than current short-term chemotherapy (usually six months)-are considerable.

In this report, we briefly review the current understanding of the molecular genetics of cancer and detail current activity in developing drugs and diagnostic tests based on genomics research. We also discuss how the emergence of these new approaches will reshape the management of cancer, particularly given the emergent and inevitable impact of pharmacogenomics research.

The report also includes market projections for selected genomics- and genetic-based anticancer agents and discusses the prospects for genomics-derived cancer management as described by participants in Cambridge Healthtech Institute's exclusive survey of 500 U.S. oncologists.

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By Kent E. Vrana, Ph.D., Wake Forest University School of Medicine and Willard M. Freeman, Wake Forest University School of Medicine

In 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 expression. 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, covers key applications, and discusses the activities of major companies in this field, profiling more than 20 of them in-depth. It also discusses the outlook for the field and includes experts' views on key technologies and where the field is heading.

Because they allow high-throughput analysis of gene expression, hybridization arrays have drawn the most attention in the gene expression field lately, and they will be the dominant technology in the near future. However, several other alternatives for gene expression analysis are available: Serial Analysis of Gene Expression (SAGE), quantitative reverse transcription-polymerase chain reaction (QRT-PCR), differential display, and subtraction cloning. All these technologies have certain drawbacks; for example, SAGE is a powerful tool for gene discovery (finding previously unknown genes), but it is ill-suited for high-throughput analysis of many samples. Proteomics is the ideal approach for analyzing gene function because it allows direct examination of gene products (i.e., proteins); two-dimensional electrophoresis and mass spectrometry are two technologies underlying proteomic analyses. However, the infrastructure and high levels of expertise required for proteomics currently make this approach largely inaccessible to most institutions.

Arrays will be a critical technology for basic research as the emphasis in genomics moves increasingly from sequencing to analysis of genes' functions. In particular, they are providing important insights into mechanisms involved in cell-cycle control, cancer, and neurobiology. Clinical profiling is one of the largest potential markets for arrays. As gene-expression-monitoring technology is optimized, it has the potential to be used more widely in the clinic-to diagnose patients, to monitor their response to therapy, or to help select the most appropriate subjects for clinical trials. In drug development, gene-expression arrays can be used to screen drug candidates against cell lines, compare the effects of drug candidates with those of existing "gold-standard" drugs on gene expression, and monitor patients in clinical trials.

The key types of premanufactured hybridization arrays are macroarrays, microarrays, oligonucleotide arrays, and microelectronic arrays. Most organizations that use arrays are considering the possibility of designing custom arrays, which would give them greater flexibility and make them less dependent on the offerings of companies providing prefabricated arrays. However, the expense and long lead times required for in-house production of arrays make it much easier, in the short term, to use ready-made arrays.

The gene expression analysis field is going through a period of dramatic innovation, and tremendous opportunities lie ahead for companies in this field. However, technical hurdles must be overcome before arrays achieve routine, widespread use in research and clinical settings. For example, reliability and ease of use will have to improve, and costs will have to decrease.

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By Allan B. Haberman, Ph.D., Haberman Associates and the Biopharmaceutical Consortium, and Malorye A. Branca, Cambridge Healthtech Institute

As the map of the human genome approaches completion, drug companies 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 system-wide methods of gene function analysis-will provide a key advantage in this race. As a result, there has been a tremendous explosion of interest in this area. This comprehensive report reviews current and emerging technologies for studying gene function, and the business and strategic considerations for those participating in such studies. More than 100 companies are covered, and in-depth profiles are provided for 19 firms. Eleven industry experts provide insights about the key applications in functional genomics, as well as future directions in the field.

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By Malorye A. Branca, Cambridge Healthtech Institute, and Kenneth Rubenstein, Ph.D., The Lion Consulting Group

Some genomic companies are shifting their attention from finding and sequencing genes to examining markers of human variation-single nucleotide polymorphisms (SNPs). Sometimes called "The Human Genome Project, Part Two," this involves finding and mapping these tiny-singe base pair-variations. SNPs have drawn attention as potential markers of human variation because they are both common (occurring relatively frequently compared with other markers) and plentiful (there may be as many as 30 million).

This report details the SNP-related activities of 60 companies, focusing on the leaders in developing technologies and applying SNPs to drug discovery, pharmacogenomics, and other pharmaceutical activities. Information, insight, and opinion are provided by ten expert Editorial Advisory Board members (listed below), and detailed profiles are given for 27 of the companies leading this field.

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By Malorye A. Branca, Cambridge Healthtech Institute, and Lucy J. Sannes, Ph.D., Sannes & Associates

More than a dozen companies, including Amgen, Biosource Proteomics, Glaxo Wellcome, Hoffmann-La Roche, Incyte Genomics, Millennium Pharmaceuticals, and Oxford GlycoSciences, are using proteomics-the study of protein expression and function-to advance drug or diagnostic discovery and development. Preliminary results suggest that this new field will quickly lead to better pharmaceuticals in certain therapeutic areas, but with hundreds of tools to choose from and dozens of emerging applications, picking the right approach is critical. This report facilitates such decisionmaking. It forecasts how proteomics will most successfully be used, in which therapeutic areas it will have its first impact, and how its various tools and approaches will evolve.

Proteomic technologies and applications of more than 50 companies are discussed, and detailed profiles, with contact information, are provided for 23 companies.

Written in language targeting business professionals, this report:

--Describes proteomics and how it is being used

--Evaluates current and emerging tools and approaches

--Assesses industry leaders and their strategies

--Examines prospects for various therapeutic and other applications

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Includes the latest miniaturization technologies applied to genomics, proteomics, diagnostics, microfluidics etc.
Abstracts

Collectively, the current value of markets for proteomic technologies is about $2 billion and is expected to increase to $6 billion by the year 2005 and $10 billion by the year 2010. 2-D gel electrophoresis is the largest single segment worth about $600 million. The largest expansion will be in bioinformatics and protein biochip technologies. This report updates the current market situation and includes reviews of :

- 2-D gel electrophoresis for protein separation and analysis of proteins by mass spectrometry

- Microanalytical protein characterization with multidimentional liquid chromatography/mass spectrometry /MALDI-MS

- Yeast two-hybrid systems for studying protein- protein interactions.

- Protein Chips

- Toxicoproteomics ( the evaluation of protein expression for understanding of toxic events)

- The use of bioinformatics for analyzing the massive amount of data generated from both genomics and proteomics.

- The use of proteomic technologies for molecular diagnostics

- Profiles of 130 companies

Includes 16 presentations focussed on the latest developments in HTS Assay Technology.

Abstracts

This report summarises news and press releases for the first six months of 2000, includes news from 56 companies and features detailed write-ups of 35 papers on ADME/toxicity in early stage drug discovery, chemical information in the 21st Century, chemical information and e-commerce, electronic notebooks and cheminformatics.