Drug and Market Development Life Science, Biotechnology and Pharmaceutical Management Reports

Expanding Opportunities in Contract Research and Contract Manufacture of Biotherapeutics Biologics
D&MD’s Expanding Opportunities in Contract Research and Contract Manufacture of Biotherapeutics/ Biologics market analysis report is a comprehensive compilation of CROs, CMOs and their numerous secondary interconnections. This report traces the funding of the CRO network and highlights failure points along the chain of the biologic’s production including the realization that pharmaceutical productivity decline is most imminent in Phase II failure rates.

Prescription Drug Counterfeiting
The pharma industry loses about $20 billion annually to counterfeiters.

Artesunate, a major weapon against malaria, is widely counterfeited. Researchers have found that up to 33 percent of the artesunate sold in Thailand, Cambodia and Vietnam contained no active ingredients. Of 30 medicines named in a list of drugs especially susceptible to counterfeiting, 23 are used in treating HIV/AIDS and cancer.

Preparing the Common Technical Document CTD for CMC
Regulatory bodies in the US, Canada, EU and Japan accept the CTD document format when applying for IND and NDA approval. This multiparty agreement, led by the ICH Harmonization, facilitates the application process when multi-nation regulatory approvals are being sought. The ground work and preparation of the CTD is critical since it serves as the platform for regulatory filings. Module 3 of the CTD focuses on Chemistry, Manufacturing and Controls (CMC) documentation relating to substance and product quality. Providing the correct information in sufficient detail in this section will reduce delays and costs.

Transdermal and Transmucosal Delivery of Therapeutics 2nd Edition
D&MD's Transdermal & Transmucosal Delivery of Therapeutics, 2nd Edition market analysis report estimates the transdermal/transmucosal drug delivery market is poised for growth through 2010.

Delivering drugs non-invasively through the skin, and particularly through the mucosa in the oral cavity or nose, has grown from a specialized application field to a formulation option that is not only convenient for the patient but also combines sustained or flash delivery with improved metabolic profile. While transdermal and transmucosal drug delivery had mainly focused on smoking cessation and cancer pain a few years ago, the therapeutic scope has since dramatically expanded to include contraception, sexual dysfunction, alcohol abuse, attention deficit disorder, and Parkinson's disease, among others. In addition, new chemical entities are now being specifically tailored for this route of administration as a competitive marketing strategy.

Market Opportunity in the G-Protein Coupled Receptors GPCRs Target Space
G-protein coupled receptors (GPCRs) have proven to be a highly amenable target class to successful therapeutic intervention via small-molecule drugs. There are 324 distinct molecular drug targets for all classes of approved pharmaceuticals of which 25 percent modulate GPCRs.

Current Drug Development Market for Cytokines Chemokines and Growth Factors
D&MD's Current Drug Development Market for Cytokines, Chemokines and Growth Factors focuses primarily on the cytokine market, company pipelines and trials in the field of cytokine research. This report succinctly details all the latest advances in the push to market of cytokine-based therapeutics: which products have evolved, which have failed and new players on the field. Primary readers will have comprehensive updates on relevant company pipelines.

Discovery to IND Filing 2nd Edition
The Discovery to IND process currently takes an average of 6.5 years and consumes over 40% of the total R&D budget for a new drug. This critical, initial phase yields a drug candidate that, with FDA approval of an IND, will enter Phase 1 clinical trials in healthy human volunteers. The stakes are high because the initiation of human clinical trials commits a company to significant additional R&D investment. Consequently, the process of drug candidate discovery through to IND submission which consists of a series linear and parallel, steps, procedures and outcomes critical to reducing the risk of further investment. This initial phase is also governed by the need to present a cogent case before the FDA in order to gain approval to move the candidate into clinical trials.

Molecular Diagnostics - Effective Tools for Disease Management, 3rd Edition
Next-generation molecular diagnostics utilize multiplexing platforms (such as DNA and protein microarrays, or bead-based technologies), to perform parallel biomarker analyses in order to obtain more comprehensive clinical information. During 2005 and 2006, the FDA approved the first DNA microarray instrumentation system for IVD use (Affymetrix's GeneChip System 3000Dx), and the first highly multiplexed diagnostic microarrays: Roche's AmpliChip CYP450 test, and two cystic fibrosis tests - Tm Bioscience's Tag-It and Osmetech's eSensor. Although they have not yet been approved by the FDA, tests based on transcriptomic and proteomic profiling have also debuted successfully on the market.

Commercial Opportunities for Enzyme Technologies, 3rd Edition
While the bulk of the business for enzymes is still serving the industrial market, the growth areas are increasing utilizing biotechnology. Revolutionary changes in molecular biology are churning out thousands of new uses of enzyme technology, fueling major growth in this multi-billion-dollar field.

D&MD's Commercial Opportunities in Enzyme Technologies, 3rd Edition examines the many current opportunities for enzymes as well as areas targeted for future growth. Specific attention is paid to the growing and various uses of enzymes over several industries from industrial uses to therapeutic targets. In addition, this Report profiles companies designing and producing enzymes, detailing their technologies and product pipelines.

Impact of Nano Materials in Drug Delivery and Human Tissue Engineering
Unprecedented levels of funding reaching tens of billions of dollars from governments, large corporations and private venture capital during the last decade, has yet to bear the fruits on the ROI. Optimistic predictions have slowly given way to the painful reality that the impact of nanotechnological applications may take one or two decades before anticipated pay offs become apparent. However, a recent analysis of more than 200 commercially available products that use nano-based technological enhancements in the pharmaceutical, medical or healthcare field is reinforcing the notion that "incremental" modifications of existing drugs, drug delivery devices and tissue engineering products enhanced by nano innovations is actually profitable and beginning to harvest revenue.

Antibody Therapeutics - Product Development, Market Trends, and Strategic Issues, Revised Edition
Several new developments have taken place in the Antibody Therapeutics in the last two years. These developments are primarily in the antibody market place and in clinical development areas as opposed to in the antibody discovery field as was observed in the early part of this decade. That the emphasis in the field has shifted from the discovery area towards product development is obvious by the fact that many of the companies are now involved in building product based collaborations and in some cases major antibody discovery companies have become attractive enough that some of those have been acquired by large pharma organizations.

Kinases - Advanced Strategies and Multiple Targets for Drug Discovery
The kinase-targeted drug market is forecast to reach $58.6 billion in 2010.

D&MD's Kinases: Advanced Strategies for Drug Discovery market analysis report comprehensively reviews protein kinases and assesses their importance as drug targets. Approaches to kinase drug discovery are evolving. Small molecule inhibitors now encompass rationally-designed single-target inhibitors and multi-target inhibitors developed with the aid of new screening and profiling assays. Innovative biopharmaceuticals are making inroads into the market. The range of indications for kinase-targeted drugs is expanding.

Assay Development and Technologies, 2nd Edition
This Guide thoroughly evaluates the capabilities, strengths, weaknesses, and expectations of leading assays and assay technologies.

Assay development is often time consuming and frustrating. But reliable, robust assays are key to every phase of pharmaceutical development. D&MD's Assay Development & Technology, 2nd Edition provides critical information to speed and simplify the development and optimization of most technologies. This Guide eliminates the tendency to "reinvent the wheel" by providing valuable tips that incorporate the author's many years of hands-on experience in the field.

Managing Toxicology for the Future - Improving Predictive Power Through Integrated Technologies, 2nd Edition
About $70 million (20%) of the total R&D costs per drug are spent on ADME/Tox failures.

Preclinical toxicity is one of the major bottlenecks in drug development. In particular, the ability to predict the safety of a drug in the preclinical stage, prior to human testing, has been one of the major bottlenecks in drug development. Current approaches have serious limitations in their ability to predict toxicity in humans, and thus invite substantial risk not only in terms of patient welfare, but also in terms of the cost of late-stage clinical trial failure. The integration of novel and traditional approaches to preclinical toxicity assessment will have a major impact on the ability to predict compound behavior in humans, reduce clinical trial failure, and cut both risk and cost in drug development.

Ion Channels and G Protein-coupled Receptors (GPCRs) Qualitative and Quantitative Analysis
This report focuses on two key pharmaceutical target classes-GPCRs and Ion Channels. GPCRs and Ion Channels are important targets. They are associated with a number of disease areas and are currently associated with blockbuster pharmaceutical sales status. Identifying future direction of industry growth opportunities in these spaces can be challenging.

The Bioprocessing Industry - Increasing Capacity, Production, and Efficiency, 2nd Edition
Recent projections predict a serious shortfall in manufacturing capacity in the next 3 years.

The biotechnology industry has been growing at a rapid rate, currently topping $35 billion worldwide. The industry most affected by this impressive growth is the bioprocessing industry, which provides the means for the fabrication, and testing of biopharmaceutical products. The bioprocessing industry is under constant pressure to increase efficiency, reduce production costs, and speed time to market. To meet these heavy demands, bioprocessing companies are adapting and innovating faster than ever.

Good Manufacturing Practices 3rd Edition
D&MD's updated Good Manufacturing Practices professional development guide provides pharmaceutical and biological companies of all sizes with assistance in regulatory compliance. The guide examines the new FDA Guidance for Industry documents and a new amendment covering an exemption for investigational drugs in Phase 1 studies. The guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.

High Growth Diagnostics - Technology and Market Analyses
D&MD’s High-Growth Diagnostics: Technology and Market Analyses of Segments experiencing Robust Growth in the Various Diagnostics Spaces market analysis report focuses on the market segments within the diagnostics industry that are currently experiencing robust growth. This also analyzes the technologies, markets (both qualitatively and quantitatively), and key companies within this space.

Pain Therapeutics: New Times, New Targets
D&MD’s new Pain Therapeutics market analysis report focuses on new advances in drug discovery and development. The report provides a background on pain, current therapies and research and development in the area. Profiles of companies with major pain programs include Abbott Laboratories, AstraZeneca, GlaxoSmithKline, GW Pharmaceuticals, Johnson & Johnson, Merck & Co., Neuromed Pharmaceuticals, Novartis, Pfizer, Vernalis, VistaGen Therapeutics, Xenome and more. In-depth interviews with industry leaders provide specific case studies from both biotech and academia that give a sense of what’s really going on in the trenches.