|By PR Newswire||
|September 1, 2014 11:10 AM EDT||
NEW YORK, Sept. 1, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Early-Stage Minimally-Invasive Biomarkers in Alzheimer%s Disease: A Comprehensive Analysis and Market Study of New Developments and Opportunities, 2014
Biopharm Reports has carried out a comprehensive analysis and market study of new developments relating to early-stage minimally-invasive biomarkers in Alzheimer's disease, which have been 'functionally reviewed' alongside existing AD drugs and candidates in the AD drug pipeline, and applicable commercial AD diagnostics.
New advances have been made in the discovery and validation of biomarkers in Alzheimer's disease (AD), offering much-needed opportunities to accelerate disease research, drug discovery and the development of low-cost minimally-invasive tests that will be available to much wider patient populations.
This report gives a comprehensive and up-to-date analysis of new findings relating to the discovery and clinical evaluation of AD-related biomarkers with potential to allow early detection or progression of this disease, based on minimally-invasive or non-invasive methods. With a focus on controlled human studies of AD, these biomarker findings are 'functionally reviewed' alongside drugs and drug candidates in the development pipeline, and a market analysis of applicable (minimally-invasive) AD-related diagnostics tests, platforms and developments. This report also includes an analysis of related opportunities in AD research, drug discovery, clinical trials and clinical diagnostics.
This work was carried out to provide a detailed and up-to-date analysis of minimally-invasive AD biomarkers and related opportunities to commercial developers in this field, including companies involved in AD drug R&D, diagnostics companies and others supplying applicable technologies into life science and clinical research laboratories. New and emerging developments relating to early-stage biomarkers of AD, presented in this report, are broadly classified into approximately 35 different 'groups', which indicate their biological associations or origins relating to this disease. Overall, more than 270 biomarkers have been identified (where multivariate panels of partially-defined species are identified as one biomarker) and these are further classified in terms of the molecular groups to which they below.
Recent years have seen major advances in the discovery of minimally-invasive biomarkers of AD and early stages of this disease, and related applicable diagnostics capabilities. These include three methods with AD diagnostic accuracies from 95% – 96% and another that predicted conversion from MCI to AD within the year, with an accuracy of 87%. Of seven others, three gave diagnostic sensitivities and specificities relating to early-stage AD ranging from 85% to 89% and 82% to 97%, respectively, and four provided sensitivities and specificities relating to the detection of AD, ranging from 82% to 95% and 79% to 97%, respectively.
While larger long-term studies are required, these and other findings show that diagnostic capabilities relating to AD have reached an important breakthrough point, offering opportunities to accelerate research, drug discovery and the development of low-cost minimally-invasive tests that will be available to much wider patient populations.- An in-depth review of candidate biomarkers in Alzheimer's disease - A focused analysis of early-stage biomarkers identified in AD patient studies - Covering more than thirty five areas of the AD biomarker landscape- Early-stage disease, predictive conversion to AD and disease progression - Validated patient studies citing diagnostic sensitivity, specificity and accuracy - Blood, saliva, urine and other minimally-invasive techniques- Most recent findings and reviewed developments - Functionally reviewed with drugs and drug candidates in the development pipeline - Potential opportunities for companion diagnostics- An in-depth review of the current AD drug development pipeline and companies - Commercial review of minimally-invasive AD diagnostic tests and companies
Few major diseases have proved as unyielding to research as Alzheimer's disease (AD). Even in the 60's and 70's, drugs developed to meet the challenges of cancer were changing the time-course of this disease, and today some cancers can be treated very successfully. Unfortunately, similar progress has not been seen in the case of AD. In 2014, after decades that have seen some of the greatest achievements in medicine, there are still no disease-altering therapies for AD and those few treatments that do exist provide only small, and generally short-lived, benefits for some patients.
The fundamental challenges to the development of more effective treatments for AD reflect scientist's poor understanding of this disease. While hallmark neurological changes seen in AD have been mapped in some detail, efforts to translate this knowledge into an understanding of the underlying causative mechanisms, and the subsequent use of this understanding to produce disease-altering treatments, have not so far been successful. More fundamentally, scientist's poor understanding of AD is also seen in uncertainties relating to the diagnosis of this disease, particularly in its early stages, and the consequential absence of adequate diagnostic tests.
Many believe that current AD treatments are not effective since by the time the disease is symptomatic, the point at which current treatments are given, the underlying neurological damage has already reached a point of no return. Current treatments may therefore be 'too little, too late'. It is also believed that the changes leading to AD may begin many years or even decades before the first symptoms are seen. Unfortunately, causative basic of these early changes are not understood either. This has focused much attention on fundamental disease research and the discovery of disease markers, in the hope that new findings will provide insights into the changes that take place as this disease develops, while also identifying new treatment strategies.
Some of the most important advances in AD biomarker discovery have been provided by imaging methods such as MRI and PET, which have helped to map the time-course of this disease, as well as changes relating to molecules such as Abeta and Tau. Studies have also profiled biomarkers in cerebrospinal fluid (CSF), particularly relating to Abeta. However, while these methods are important in AD research, both are complex and expensive and are therefore not readily available to the wider population.
The lack of accessibility of these techniques in routine research and diagnostic testing has limited their use, with inevitable consequences on the progress of AD research and clinical investigation. Moreover, there is significant interest, and a rational basis for, investigating AD from changes that take place outside of the central nervous system, notably those that might be identified and monitored in the blood and other biofluids. Such approaches, if successfully translated into accurate and reliable diagnostic methods, offer minimally-invasive or non-invasive approaches and the hope of simpler and cheaper tests that will be available to much wider populations. With a focus on the most recent advances, this report provides an in-depth analysis of AD biomarkers identified using minimally invasive approaches, mostly in blood, but also including urine, saliva and other areas.
The goal for this study was to identify and profile as many advances relevant to early-stage minimally invasive candidate AD biomarkers as possible, by combining a 'wide-net' approach on the one hand, and focused analyses around the most promising findings on the other. With a focus on human studies involving AD patients (and those with (presumed) early-stage disease) and studies published over the last five year, 40,000+ AD were identified, which were narrowed down to 800 by in-depth analysis. During this process, study findings were analysed by structured systematic manual approaches and the use of in-house developed tools designed to assist the identification of biomarker relationships, correlations or associations in this field. Subsequently, these findings were functionally reviewed* alongside current drugs and drug candidates in the development pipeline (marketed, Phases 3 to 1 and preclinical) and applicable commercially available or developmental minimally-invasive diagnostics. Biomarkers
New and emerging developments relating to early-stage biomarkers of AD, presented in this report, are broadly classified into approximately 35 different 'groups', which indicate their biological associations or origins relating to this disease. Together, these areas embrace the current AD-biomarker landscape. Overall, more than 270 biomarkers have been identified (where multivariate panels of partially-defined species are identified as one biomarker) and these are further classified in terms of the molecular groups to which they below.
AD Drug Pipeline
This report covers today's AD drug development pipeline, up until August 2014. These are 'functionally reviewed'* where currently known minimally invasive AD biomarkers allow. Today, there are four FDA approved drugs for AD and 103 in the development pipeline. Of these, 11, 41, 30 and 21 candidates are at phase 3, phase 2, phase 1 and preclinical stages, respectively. An analysis of these drugs and candidates in terms of molecule types shows that small molecules represent the major group (70% overall), followed by antibodies (8%), vaccines (7%) and others (15%). In terms of the general pharmacological targeting strategies, 34 (32%) of candidates are targeted around Abeta. *'Functional integration' in this context relates to links, associations or direct connections between specific biomarkers and the underlying drug pharmacological mechanisms of specific drugs.
AD Minimally-Invasive Diagnostics
This report identifies 20 companies with AD-related diagnostics tests, platforms and developments relating to minimally-invasive techniques and capabilities. These diagnostic capabilities are presented on a company-by-company basis, however this group does not include laboratory suppliers of technologies such as PCR, microarray, mass spectrometry, flow cytometry, immunoassay, which are used or are generally applicable to AD research and clinical testing. Companies with imaging technologies or other related specifically to tests on CSF (which requires invasive techniques) are not included.
This report provides a systematic 'functional analysis' of minimally-invasive AD biomarkers presented in this report. This is based on the analysis of links, associations or direct relationships between specific biomarkers and the underlying pharmacological mechanisms of specific drugs. For example, there are a number of candidate biomarkers relating to Abeta, which are discussed in the context of Abeta targeting drugs. This has been carried out to assist in the identification of biomarkers that may provide important insights in research, drugs discovery, clinical trial end-points and potential companion diagnostics.
This report includes an in-depth analysis of biomarkers-related opportunities in AD research, drug discovery, clinical trials and clinical diagnostics.
Chapter 1. Background 26
1. Alzheimer's Disease
1.1 Statistics and Costs1.2 Histopathology1.3 Amyloid Beta (Abeta)1.4 Tau Proteins and Neurofibrillary Tangles1.5 Cholinergic Hypothesis1.6 Diagnosis1.7 Cognitive Tests1.8 Stages of AD1.9 Treatment of AD1.10 Biomarkers1.11 Genetics1.13 Blood Brain Barrier1.14 Pathogenesis of Alzheimer's disease
Chapter 2. Blood Biomarkers 40
Chapter 3. Autoantibodies 83
Chapter 4. Urinary Biomarkers 105
Chapter 5. Salivary Biomarkers 108
Chapter 6. Other Biomarkers 111
Chapter 7. AD Drug Pipeline 114
7.2 Approved Drugs
7.3 Phase 3 Drugs
7.4 Phase 2 Drugs
7.5 Phase 1 Drugs
7.6 Preclinical Drugs
Chapter 8. Diagnostics Companies of Minimally-Invasive AD Diagnostics 147
Chapter 9. An Integrated Analysis of AD Biomarkers 156
9.1 Introduction9.2 Minimally-Invasive Biomarkers9.3 Diagnostic Sensitivity, Specificity and Accuracy9.4 The Drug Development Pipeline9.5 Drug Target Areas9.6 Integrated Analysis
Chapter 10. Conclusions and Opportunities 178
Figure 7.1 AD drugs and candidate AD drugs/treatments, from current marketed products, through to preclinical studies.
Figure 7.2 AD drugs and candidate AD drug/treatment by molecule types, from current marketed drugs, through to Preclinical studies.
Figure 7.3 AD drugs and AD candidate drug/treatment by general targeting strategies, from current marketed drugs, through to preclinical studies.
Figure 7.4 Phase 3 AD drug candidates by molecule types
Figure 7.5 Phase 3 AD drug candidates, by pharmacological targeting areas
Figure 7.6 Phase 2 AD drug candidates by molecule types
Figure 7.7 Phase 2 AD drug candidates, by pharmacological targeting areas
Figure 7.8 Phase 1 AD drug candidates by molecule types
Figure 7.9 Phase 1 AD drug candidates, by pharmacological targeting areas
Figure 7.10 Preclinical AD drug candidates by molecule types
Figure 7.11 Preclinical AD drug candidates, by pharmacological targeting areas
Figure 9.1 AD drugs and candidate AD drugs/treatments, from current marketed products, through to preclinical studies.
Figure 9.2 AD drugs and AD candidate drug/treatment by general targeting strategies, from current marketed drugs, through to preclinical studies.
Figure 9.3 AD drugs and AD candidate drug/treatment by general targeting strategies by phase, from current marketed drugs, through to preclinical studies.
Table 1. Statistics and Costs relation to Alzheimer's disease, based on WHO statistics on Global Dementia.
Table 7.1 Approved drugs for the treatment of AD.
Table 7.2 Phase 3 candidate drugs for the treatment of AD.
Table 7.3 Phase 2 candidate drugs for the treatment of AD.
Table 7.4 Phase 1 candidate drugs for the treatment of AD.
Table 7.5 Preclinical candidate drugs for the treatment of AD.
Table 8.1 Companies with marketed or developmental products relating to minimally-invasive AD diagnostics.
Table 9.1 Candidate biomarkers of with AD
Table 9.2 Sensitivity, specificity and accuracy levels reported from nineteen AD diagnostics studies
Table 9.3 Numbers of AD drugs and pipeline candidate AD drugs, classified according to their general pharmacological targeting mechanisms and pipeline phase
Table 9.4 AD drugs and pipeline candidate AD drugs, classified according to their general pharmacological targeting mechanisms.
Table 9.5 Abeta targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.6 Cholinergic targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.7 Serotonin targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.8 Energy metabolism targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.9 Tau targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.10 Other targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.
Table 9.11 Other AD drugs and AD drug candidates showing integrated biomarkers
Intl: +1 339-368-6001
"We help companies that are using a lot of Software as a Service. We help companies manage and gain visibility into what people are using inside the company and decide to secure them or use standards to lock down or to embrace the adoption of SaaS inside the company," explained Scott Kriz, Co-founder and CEO of Bitium, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 27, 2014 07:00 PM EST Reads: 1,309
15th Cloud Expo, which took place Nov. 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, expanded the conference content of @ThingsExpo, Big Data Expo, and DevOps Summit to include two developer events. IBM held a Bluemix Developer Playground on November 5 and ElasticBox held a Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of Bluemix, its services and functionalit...
Nov. 27, 2014 07:00 PM EST Reads: 1,171
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Nov. 27, 2014 06:00 PM EST Reads: 1,702
Some developers believe that monitoring is a function of the operations team. Some operations teams firmly believe that monitoring the systems they maintain is sufficient to run the business successfully. Most of them are wrong. The complexity of today's applications have gone far and beyond the capabilities of "traditional" system-level monitoring tools and approaches and requires much broader knowledge of business and applications as a whole. The goal of DevOps is to connect all aspects of app...
Nov. 27, 2014 06:00 PM EST Reads: 1,034
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Nov. 27, 2014 05:00 PM EST Reads: 1,282
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public cloud. Consequently this approach requires risky, deep "surgery" including changes to firewalls, subnets...
Nov. 27, 2014 04:45 PM EST Reads: 1,145
Want to enable self-service provisioning of application environments in minutes that mirror production? Can you automatically provide rich data with code-level detail back to the developers when issues occur in production? In his session at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how to accomplish this and more utilizing technologies such as Microsoft Azure, Visual Studio online, and Application Insights in this demo-heavy session.
Nov. 27, 2014 04:45 PM EST Reads: 1,079
DevOps is all about agility. However, you don't want to be on a high-speed bus to nowhere. The right DevOps approach controls velocity with a tight feedback loop that not only consists of operational data but also incorporates business context. With a business context in the decision making, the right business priorities are incorporated, which results in a higher value creation. In his session at DevOps Summit, Todd Rader, Solutions Architect at AppDynamics, discussed key monitoring techniques...
Nov. 27, 2014 04:30 PM EST Reads: 1,143
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water,...
Nov. 27, 2014 04:00 PM EST Reads: 1,216
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Nov. 27, 2014 04:00 PM EST Reads: 1,601
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
Nov. 27, 2014 03:00 PM EST Reads: 1,243
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Nov. 27, 2014 03:00 PM EST Reads: 897
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
Nov. 27, 2014 03:00 PM EST Reads: 1,427
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Nov. 27, 2014 01:00 PM EST Reads: 1,626
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
Nov. 27, 2014 11:00 AM EST Reads: 1,233