 | The human immune system can go awry, either attacking an individual’s body or producing an exag-gerated response to a foreign substance that is normally benign. In these situations, immunotherapies are needed to balance or suppress the unwarranted immune response. In this report: - Approximately 400 product candidates and development programs are identified.
- Current and emerging therapies for selected autoimmune or inflammatory disorders and prevention of organ transplant rejection, directed against a wide range of putative targets, are summarized.
- Specifically, more than 250 emerging autoimmune disease therapies, 80 asthma therapies in development, and 50+ therapy candidates for allergies are covered.
- The strategic consequences of intense competition in a crowded product space are considered.
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 | Novel applications of immunotherapies and vaccines beyond prevention and treatment of infectious diseases and cancer are reviewed. Those discussed typically target molecules not normally targeted by the immune system. This report: * Covers a wide range of conditions for which immunotherapies may be effective, including Alzheimer’s disease, addiction, other neurological indications, cardiovascular diseases, hematological disorders, ophthalmic diseases, bone metabolism disorders, type 2 diabetes, among others * Reviews emerging immunotherapies and vaccines for these indications as well as business considerations for companies active in these markets * Includes expert interviews |
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 | Ion channels represent a significant opportunity to address an underexploited class of therapeutic targets. Nearly 150 novel ion channel modulators are reported to be in clinical development. This report examines: * Ion channel modulators in clinical development and their potential * Improved molecular understanding of ion channel structure and cellular activity * High-throughput screening methods for identification of novel modulators * Prospects for ion channel modulators and commercial successes to date• Pipeline activities, expert views, and survey results |
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 | In the nearly 35 years since the first process for creating mAbs was introduced, they have remained a centerpiece of the growing biotechnology industry. Thirty therapeutic mAbs have been approved around the world, including 23 in the United States. A number of these drugs have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Rituxan, Remicade, Avastin, Herceptin, and Humira alone generated sales of over $4 billion each in 2008, and global sales for this entire sector surpassed $30 billion last year. |
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 | Within the past several years, a number of government labs as well as private and joint venture CRO’s have or will soon offer preclinical GLP study services to Western clients. This report, built on discussions and facility visits to the most advanced labs, provides a detailed view of the current and evolving preclinical study capabilities in China, their structures and services, as well as an analysis of the comparative costs between US and China-based CRO’s. |
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 | The biopharmaceutical industry is grappling not only with sheer data volume but with the ability of researchers to extract information through identification and contextual analysis of those data that are relevant to a particular set of investigations. This report examines: * Techniques, technology, and software used in life science data mining * Data mining for early preclinical safety assessments * Data mining in clinical trials * Data mining in pharmacovigilance * Business models and solutions in drug development bioinformatics |
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 | Author: K. John Morrow, Jr., PhDThe interdisciplinary fields of Bioinformatics and Computational Biology are locked in a high stakes race with analytical instrument developers and innovators. The pace and scope of change in many fields of biomedical research rivals what we once associated only with semiconductor devices. This report explores the interlocking challenges facing instrumentation advances, computational demands and our evolving systems biology knowledge. Key challenges presented in this report include: •Instrumentation capable of generating terabytes of raw data daily•Storage requirements for human gene sequences•Need for cross platform data analysis standards•Appropriateness of analysis & modeling applications•Database data quality and annotation protocols |
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 | Author: Leslie A. Pray, PhDPharmacogenomics (PGx) is often considered “the great new wave” in medicine, promising better, safer, and more affordable healthcare. Yet its adoption and widespread use in the clinic is up against some tremendous challenges. This report considers:•Drivers of PGx•Applications of PGx in drug development•Industry experiences with PGx and lessons learned•Type of evidence needed to establish clinical utility•Challenges to moving PGx forward•Survey results and expert views on utilization of PGx |
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 | Author: Allan B. Haberman, PhD Phase II is the critical development stage in which most clinical attrition occurs. This report focuses on approaches to improving R&D productivity in the pharmaceutical and biotechnology industries and considers:•Leading-edge strategies being pursued to improve success rates of therapeutic candidates in clinical development•The use of translational medicine studies and early clinical trial protocols designed to reduce Phase II attrition•Survey results and expert interviews on efforts to improve R&D efficiency. |
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 | The current marketplace for direct-to-consumer (DTC) genetic testing is very dynamic and fluid. At least 42 DTC genetic testing companies have been identified to date, and additional market entrants are likely. Firms marketing and selling genetic tests DTC have numerous factors to consider. This report focuses on health-related decision-making applications of DTC genetic tests and examines various components of this emerging business environment:•The rapidly evolving science and technology•The complex framework of regulatory oversight•Social and ethical issues, including genetic privacy•Consumers’ attitudes toward genetic testing•Activities of companies shaping this sector•Views of industry leaders through exclusive interviews |
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 | A thorough analysis of recent trends in medicinal chemistry and evaluation of their significance for advancing productivity in drug discovery is presented. This report includes:•A critical evaluation of chemical and computational technological modalities, their current and potential value, and their commercial manifestations.•A consideration of market dynamics with an emphasis on outsourcing and user views on the implications of current practices in drug discovery organizations.•Insights gleaned from an extensive literature review, discussions with industry experts, and an opinion survey of personnel active in medicinal chemistry for drug discovery. |
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 | Proteases constitute one of the largest potential drug target enzyme families, with 647 human gene products incorporating protease sequences and mutated proteases having been identified. In addition, there are many more proteases found in viruses, bacteria, and parasites, which are also potential drug targets. The therapeutic promise of protease inhibitors has been most clearly demonstrated by angiotensin-converting enzyme (ACE) and HIV drugs. |
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 | Molecular diagnostic applications in the areas of oncology, personalized medicine, inherited disorders, prediction of genetic disease risk, and many others are rapidly increasing in number as this burgeoning field expands beyond infectious disease testing. This report focuses on these newer applications of molecular diagnostics, analyzing: |
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 | A vast new opportunity for clinical trials has emerged in Europe as a result of the collapse of the Soviet Union and events during the last decade of the 20th century. The result is the emergence of dozens of sovereign countries and gone is the political dividing line between East and West Europe. Now these countries join the countries of Western Europe as well as the CIS to offer a spectrum of clinical trial options. |
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 | Neurodegenerative diseases are drawing immense interest from the pharmaceutical industry and have inspired heavy competition in the race to introduce the next generation of improved drugs. Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, and amyotrophic lateral sclerosis are analyzed in this report, which:Reviews their symptoms and pathology, presumed causes, methods of diagnosis, epidemiology Examines existing drug therapies for each disorder Surveys the R&D picture for each disease Tabulates the approximately 150 compounds in clinical development Discusses particularly noteworthy drug candidates. |
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 | Molecular imaging has become an increasingly indispensable tool in life sciences basic research, in translational medicine, and in routine medical diagnostics. This Biomedical Imaging report covers its top applications areas: medical diagnosis and translational research both relevant to pharmacology and drug development. |
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 | Author: Pavle Vukojevic, MDA vast new opportunity for clinical trials has emerged in Europe as a result of the collapse of the Soviet Union and events during the last decade of the 20th century. The result is the emergence of dozens of sovereign countries and gone is the political dividing line between East and West Europe. Now these countries join the countries of Western Europe as well as the CIS to offer a spectrum of clinical trial options. |
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 | Commercialization of stem cells can potentially help to treat an astounding variety of medical conditions. After a slow start, the stem cell age is finally poised to begin, as numerous factors converge to catapult stem cell technology into the medical mainstream. This report considers: * The current state of stem cell science and technology * Supplies and services * Major applications of stem cell science * Sources of funding, regulatory hurdles, and the commercial outlook * IP challenges, public perception, bioethical concerns, and diversity in policies |
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 | The field of therapeutic vaccines and immunotherapies is rapidly emerging as a promising area. Use of passive immunotherapy (i.e., antibody) products, for prevention of infection or for treatment of many diseases, including cancer, is widespread. In addition, some nonspecific immunomodulators on the market are used to treat certain cancers. |
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 | Current advances in functional screening methodologies, medicinal chemistry, and structure-based drug design have generated large increases in the number and diversity of GPCR drug targets. Furthermore, basic research advances have opened the way for still further exploitation of this target class. |
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 | The prevalence of overweight and obesity is increasing at an alarming rate worldwide, driven by social and economic changes. Obesity is involved in the pathogenesis of major diseases, especially diabetes and cardiovascular disease. Yet there are no sufficiently safe and effective obesity drugs on the market today. This report analyzes: * Product pipelines; * Current obesity drugs and the need for novel therapies; * Obesity drug markets; * Challenges to the successful development of obesity drugs; * The complex disease pathways of obesity and weight regulation. |
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 | As a company develops its business, resources will always be limited and risk will always be involved. This is especially true for companies operating in the high-risk life science industry. To stay on top of the changing pharmaceutical R&D environment, certain measures must be implemented. This report analyzes: * Types of risk that must be faced; * Ways that various risks can be assessed and managed; * How corporate resources can be allocated to meet the goals and create maximum value according to the corporate strategy. |
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 | Aggressive adoption of cancer biomarkers will accelerate the growth of commercial markets for these products. This new report offers in-depth analysis of: * The current cancer biomarker products, applications, and markets * Key validation and assessment cancer biomarker programs integrating established “standards of care” for cancer diagnosis and treatment * Product opportunities for improved screening and early detection, to provide better guidance on therapy, for understanding cancer staging, response to treatment, and prognosis * Profile of business models behind cancer biomarker products and a SWOT analysis associated with specific strategies * Projections for market growth for cancer biomarker product categories |
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 | The current crisis in antibiotic R&D is attributed to an industry pipeline with few late-stage candidates capable of combating the emergence and spread of novel, drug-resistant bacterial strains. This new report offers in-depth analysis of: * Factors driving the field forward and opportunities for large and small pharma * The key scientific challenges to antibiotic drug discovery * The economic and regulatory realities of antibiotic R&D * The broad range of antibacterial approaches being taken across the industry * Select compounds in clinical development |
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 | This report focuses on the current and future applications of Systems Biology in drug discovery, specifically in pinpointing optimal individual targets, and combinations of targets, to overcome metabolic pathway redundancies, leading to efficacious and safe products. Topics covered include: * Application successes at AstraZeneca, Pfizer, and J&J * Landscape of the Systems Biology marketplace and its future * Implications of innovative predictive modeling and global transcription epigenetics analysis * Review of 18 Systems Biology company business models * How SB will enable pharmacological progress in biologically complex “money” diseases * Projections on the future for Systems Biology in leukemia, Alzheimer’s, and Huntington’s diseases. |
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 | * Strategies to develop small- and large-molecule CNS drugs capable of crossing the blood-brain barrier (BBB)* Interviews with leading researchers who are aggressively tackling the BBB challenge in CNS drug discovery and development* Analysis of results from a Blood-Brain Barrier Survey, responded to by a range of companies involved in CNS research and drug discovery/developmentCNS diseases are a major focus of the pharmaceutical industry, with CNS drugs representing some of its most successful products. These include Pfizer’s Zoloft (sertraline, for treatment of depression and certain types of anxiety disorders), Lilly’s Cymbalta (duloxetine, for treatment of depression) and Bristol-Myers Squibb’s/Otsuka’s Abilify (aripiprazole, for treatment of bipolar disorder and schizophrenia). However, drug discovery and development researchers experience difficulty developing CNS drugs that complete clinical trials and win regulatory approval—especially drugs which meet major unmet needs in the CNS area, such as Alzheimer’s disease. The vast majority of drugs fail to cross the BBB, which is causing a major bottleneck in successful development of CNS drug candidates. |
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 | At least 50 companies have a claimed product or service relevant to cardiotoxicity screening, of which 29 have some clear focus on proarrhythmic cardiotoxicity or ion channel screening. This new report offers in-depth analysis of:* 50 commercial entities that offer cardiotoxicity screening products/services* The history and status quo of the current regulatory environment pertinent to drug-induced proarrhythmia* Methods for assessing the potential for drug-induced cardiotoxicity, with a primary focus on proarrhythmia screening* Drugs associated with cardiotoxicity, factors that may predispose to drug-induced cardiotoxicity, and current/proposed cardioprotective approaches* A primer on cardiac anatomy/physiology, with particular consideration given to the various ion fluxes that contribute to the cardiac action potential* Results of an Insight Pharma Reports cardiotoxicity survey undertaken for this report in December 2007 |
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 | inflammatory diseases. Delving in-depth into these efforts, this report provides:* An analysis of six diseases: rheumatoid arthritis, inflammatory bowel disease, psoriasis, lupus, multiple sclerosis, and asthma* An assessment of existing drug therapies for these diseases* Discussion of pharmacological R&D strategies being employed by the industry in developing both biological and small-molecule agents for these diseases* Review of the approximately 200 compounds in clinical development and assessment of particularly noteworthy drug candidates for these diseases |
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 | With the first diagnostics set to debut within a year, the new research and development field of microRNAs is beginning to reveal its potential. This new report establishes a baseline for observing microRNAs’ maturation, including assessments of: * The science and analysis of first-generation microRNA commercial applications * The early adaptors and where they are heading with this emerging technology * Clinical applications, which will begin in oncology, followed by infectious diseases, neurology, metabolic disorders, and cardiovascular diseases * The youthfulness of the field of microRNA * The status of the field, including promises and caveats, companies involved, and pertinent patents and intellectual property * Companies that are either developing microRNAs as clinical tools, investigating microRNAs in basic research, or supplying reagents, kits, microarrays, bioinformatics tools, and other essentials |
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 | Epigenetics is one of the fastest-growing areas of the biological sciences. It’s also a budding industry. This new report offers in-depth analysis of:* The definition, history, and current status of epigenetics* Current and potential commercial applications* An epigenetic approach to cancer etiology* The epigenetics of noncancerous diseases* DNA methylation and histone modifications as biomarkers* The companies involved and their products* Epigenetic therapeutics: demethylating agents, histone modifications, and combinations* The drivers of the epigenetics industry, plus recent major industry deals and patent applications* Results of a quantitative online survey of individuals involved in epigenetics R&D |
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 | The development and growth of assay technologies has pushed translational medicine into a category unto itself. In a broad perspective on this field, this new report:* Defines translational medicine by giving some historical background as well as providing personal definitions from experts in the field* Discusses the evolution of assay technologies* Reviews currently available assay technologies that apply directly to translational medicine* Describes and evaluates current applications of these technologies* Provides case studies of clinicians currently using this technology in their research* Discusses future directions of assay technologies for translational medicine* Gives input from the FDA on translation medicine and assay technologies* Provides interviews from experts in the field of both translational medicine and specific assay technologies* Profiles premier companies active in the field |
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 | The rapidly emerging field of molecular imaging is poised to open new vistas for basic researchers, scientists working in drug discovery and development, and physicians. This new report delves fully into:o The history, evolution, and potential of molecular imagingo The technologies in use today and under development for the futureo Applications in drug development and diagnostic medicineo Market dynamics that are shaping and reshaping commerce in molecular imaging instruments and reagentso Regulatory aspects of the fieldo Interviews with experts active as either providers or users of molecular imagingo Results of an online survey of individuals in pharmaceutical and biotechnology companies and institutional researchers |
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 | The ophthalmology market, although a relatively small niche in the pharmaceutical industry, is more than worthwhile to track for multiple reasons:* It is growing dynamically, and will likely continue this development unbroken for the next 2 or 3 decades.* It offers scientific challenges that are definitely tough but not insurmountable, with the paths to success already discernible.* It is a market that analysts and investors can understand. Severe eye diseases are debilitating but not terminal conditions, and therefore most people know at least 1 person with severe vision impairment and can sympathize—which on the whole creates a more favorable basis for investments. |
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 | Recent developments reflect the explosion in the number of kinase inhibitors that have entered clinical development in the past few years:* By the end of 2006 seven kinase inhibitors had reached the market, three in the period December 2005-December 2006.* Their collective sales exceeded $4 billion.* Three more kinase inhibitors have been approved in 2007.* In addition to ongoing studies of approved kinase inhibitors seeking line extensions, a further 11 are in Phase III studies.* More than 130 kinase inhibitors are reported to be in either Phase I or Phase II clinical development, with 47 reported to be in Phase II studies. |
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 | Molecular diagnostic tests are now used for a wide range of applications, including:* Human clinical molecular diagnostic testing* Veterinary molecular diagnostic testing* Identity testing* Forensic testing* Histocompatibility testing |
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 | In the more than 30 years since the first process for creating monoclonal antibodies, or mAbs, was introduced, they have remained a centerpiece of the growing biotechnology industry. Twenty-four therapeutic mAbs have been approved, several of which have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Two drugs, Remicade and Rituxan, generated sales of about $4 billion each in 2006, and global sales for this entire portfolio approached $20 billion in that year. |
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 | Backup compound planning has risen in importance as the percentage of R&D projects focused on unprecedented targets has skyrocketed. Heads of R&D and chemistry, therapeutic area heads, portfolio analysts, and project managers all recognize that there is no surer way to minimize Phase II risk than a well thought-out backup plan. |
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 | The pharma industry is gradually coming to realize that the classically structured clinical trial does not offer enough flexibility to make use of continuously emerging knowledge that is generated as the trial progresses. This report is a comprehensive assessment of the benefits, challenges, and accumulated industry experience with regard to adaptive clinical trials. It includes: * A critique of the structural, conceptual, and ethical issues inherent in the traditional clinical trial. * An in-depth review, based on actual case studies (e.g., Napo, Genaera, Pfizer, Lilly, Millennium, and various academic institutions) of the use of adaptive and Bayesian approaches in Phases I, II, and III * An assessment of various hybrid and seamless designs in which the line between trial stages is blurred * Evolving regulatory positions of FDA, EMEA, and ICH on adaptive designs; industry response and initiatives * A review of specialized software vendors (e.g., Cytel, Tourtellotte, Pharsight, CTriSoft) and their applications that have emerged to support adaptive designs. * A CHI Insight Pharma survey of the views and experiences of individuals involved with adaptive designs * Three future scenarios for the integration of adaptive designs in clinical trials by 2015: (1) United States Leads the Way, (2) Globally Integrated Midphase Revamping, and (3) the Late Phoenix Scenario * Roundtable interviews with senior executives in industry and consulting who bring decades of combined experience in adaptive and Bayesian clinical trial designs |
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| Current trends and future directions in genome sequencingA growing number of companies and academic groups are reporting impressive progress in commercializing new sequencing platforms that offer orders of magnitude of improved throughput and cost. The prospect of routine, personalized genome sequencing is suddenly within reach, not to mention spectacular advances in a host of related fields. This new report from CHI Insight Pharma Reports describes and assesses these developing technologies and their applications: * Pyrosequencing * Sequencing by synthesis * Supported oligonucleotide detection (SOLiD) * Single-molecule sequencing * Nanopore sequencing * Optical trapping |
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| In recent years, there has been an explosion in predictive technologies to help researchers select only the most promising candidates for clinical development. The need for such tools is driven by the disastrous economic consequences of late-stage failures, which account for over 60% of all drug terminations. This report describes a powerful and novel predictive tool called Bayesian network modeling and demonstrates its application in clinical forecasting. Among its many potential benefits, clinical forecasting can: * Reduce drug development costs * Increase median cumulative 7-year revenue per Phase III trial * Redirect capital and human resources to development programs with the greatest likelihood of success * Expose clinical trial subjects to fewer unsafe or ineffective drugs * Improve the accuracy and decision-making utility of market forecasts (which currently assume that all drugs in the projection period will achieve NDA approval) * Increase industry’s and society’s confidence in including pediatric subjects in clinical trials |
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