Cambridge Healthtech Advisors Biotechnology, Pharmaceutical and Life Science Reports

Disease-Related Biomarkers Their Potential in Patient Screening Prognosis and Stratification
Expert guidance in managing discovery and development of disease-related biomarkers

This report focuses on disease-related biomarkers, those related to disease screening, prognosis, and stratification—more specifically, disease-related molecular biomarkers. Aspects covered include:

* Historical and contextual information

* Strategies and technologies currently used for biomarker discovery and development

* Progress in biomarker discovery and development in several disease areas

* Current and future roles of consortia in disease-related biomarker discovery and development

* Market-related considerations, including the role of various sectors, competitive activity, deal activity, and regulatory factors

* Two separate surveys of individuals in (1) the pharma and biopharma sectors, and (2) biomarker discovery and diagnostic sectors. Both surveys capture attitudes, intentions, and current practices of individuals at the forefront of disease-related biomarker discovery and development.

* Profiles of 44 companies active in disease-related biomarkers

* In-depth interviews with 7 disease-related biomarker experts

Combination Drug/Diagnostic Products Pathways to R&D and Commercial Success
This new report from CHI’s Insight Pharma Reports assesses the commercial opportunities and provides the information and guidance that companies need to steer clear of the pitfalls in combination drug/diagnostic R&D. Specifically, it provides:

A quantitative survey, rendered in easy-to-scan charts, of the industry's views, plans, and current actions with regard to combination drug/diagnostic products

A review of drug/diagnostic combinations in current use such as Monogram Bioscience’s Trofile Assay, which was co-developed with Pfizer’s Celsentri (for HIV) as a means to identify responders to the drug

A review of existing safety and status biomarkers that are being used as diagnostics, such as a simple genotyping test to guide warfarin dosing, or molecular markers for identifying responders to Gleevec and Nexavar

Patenting activity around combination drug/diagnostic products in cancer, neurodegenerative disease, respiratory disease, and viral infection

The current state and outlook for reimbursement of diagnostics, including a case study of Genomic Health’s Oncotype DX gene expression test for predicting the benefits of chemotherapy in newly diagnosed breast cancer patients

A model of the potential expansion of a therapeutic market generated by incremental improvements in biomarker test sensitivity

Implications of FDA’s IVDMIA and ASR draft guidances

High-Content Analysis Technologies Applications Market Analysis
This new Insight Pharma report from Cambridge Healthtech Institute delivers the data and the analysis you need to stay on top of this fast-changing market:

Quantitative survey (N=60) of the practices, plans, and views of researchers involved with HCA

Market segmentation and forecast ($ share by application, by company, and by IT/hardware/reagents)

Thorough review of HCA technologies and applications, including new developments and challenges

Total cost of ownership analysis

Main market drivers and barriers

Thought-leader interviews with leading researchers in industry and academia

Position of the dominant players such as Cellomics/Fisher, GE, MDS, BD, and Evotec; and of up-and-coming smaller players

Diabetes and Its Complications: Strategies to Advance Therapy and Optimize R&D
A worldwide epidemic of type 2 diabetes has been in progress since the mid-1980s, according to the World Health Organization. The worldwide number of diabetics was 30 million in 1985 and is projected to increase to at least 366 million by 2030.

In the United States, an estimated 33% of people with type 2 diabetes have a serious co-morbidity associated with the disease, and almost 8% of diabetics have 4 or more of these complications, according to a report from the American Association of Clinical Endocrinologists (AACE).

Metabolic and Inflammatory Disease R&D An Assessment of 5 Highly Promising Therapeutic Classes
At any given time, a number of drug targets are attracting considerable interest from different pharmaceutical companies. The emergence of such targets as hot topics of research usually becomes apparent before the introduction of clinical candidates by a rapid increase in the level of patenting and research activity directed toward them. Metabolic and Inflammatory Disease R&D: An Assessment of 5 Highly Promising Therapeutic Classes, by Peter Norman, MBA, PhD, a new report from Insight Pharma Reports, details targets of high interest that are primarily of relevance to inflammatory or metabolic diseases and toward which few, if any, compounds have progressed into Phase II studies.

Delivery Technologies for Protein Therapeutics Assessment and Outlook
Some of biotech’s most celebrated successes include:

clotting factors

anticoagulants

modern insulins

growth hormone

follicle-stimulating hormone

hematopoietic growth factors

interferons

interleukins

What do they have in common?

They are therapeutic proteins, a market segment that had $34 billion in sales in 2004 and will have a projected $52.2 billion in sales in 2010*.

Cytokine Therapies and Inhibitors A Vibrant Pipeline and Active Approved Market
Cytokines have drawn immense interest from the pharmaceutical industry over the last two decades. Great effort has been devoted to finding ways to reproduce their effects—or to block their activity—in the quest to create novel drugs for cancer, infectious diseases, inflammatory and immune disorders, and myelosuppression. Cytokine Therapies and Inhibitors: A Vibrant Pipeline and Active Approved Market, a new CHI Advances Report, takes a comprehensive look at the full range of cytokine therapies and inhibitors, from products in research and development to products already approved and marketed.

Biomarker SOPs Getting Optimum Value from Your Biomarker Programs
As biomarkers have grown in importance throughout the pharma R&D cycle, managers have moved from informal, intuitive ways of dealing with biomarker discovery and implementation to more formal procedures. In all pharmaceutical companies, standard operating procedures (SOPs) for planning, implementing, and employing biomarkers remain a work in progress, continually evolving as still-scarce outcomes data from biomarker-driven programs becomes available.