Scientific Serve appreciate your participation in this Conference. Every Conference is divided into several sessions of subfields. Select the Subfield of your choice please.
The phases of clinical research are the steps in which scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective. Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. A common example of this is combined phase I/II or phase II/III trials. Therefore, it may be easier to think of early phase studies and late phase studies. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are post-approval studies. This session discusses more about clinical trials and its phases.
Fundamental Concepts in Biomarker Research deal with basic statistical concepts and problems relevant to biomarker discovery research. This includes brief assessments of parameter estimation, error types and hypothesis testing, as well as guidelines for selecting and interpreting statistical tests. The problem of multiple?hypotheses testing is explained, including methods based on family?wise error and false discovery rates. Fundamental statistical analysis techniques are introduced for correlation, regression and classification, and survival analysis. The problem of assessing the predictive quality of biomarkers and models using different types of statistical measures is discussed. An introduction to data sampling size estimation is presented. This session discusses on common pitfalls and misinterpretations in statistical analysis for biomarker discovery and fundamental concepts in biomarker research.
SWATH-MS as a tool for biomarker discovery right from basic research to clinical applications. It is time to perform an overview of this growing field with special focus on one of the most promising approaches; and to present future perspectives for its application as a translational tool. Therefore a summary of this technique is presented focusing on two key relevant concepts associated with its application in biomarker discovery: the protein library and the individual digital maps concepts. It is also the purpose of this review to document the likely impact of SWATH-MS in both fundamental and translational research including biomarker identification and creation of diagnostic tools. Finally some of the current restrictions for the implementation of SWATH-MS on a large scale are identified, and potential solutions presented, namely protocol standardization combined with the use of the proper standards. This session discusses more about biomarker discovery and validation.
Biomarkers in health and disorders are concerned with the promising findings in screening children for autism spectrum disorders (ASDs). Using brain magnetic resonance imaging (MRI) to assess cortical development and brain volume, investigators were able to predict in infants as young as 6-12 months of age at risk for ASD that is with an ASD-affected sibling, which children would develop ASD by 24 months of age. While this study requires further validation in a larger cohort 15 of 106 high-risk subjects ultimately developed ASD, it speaks to the vast unmet medical need of biomarkers for neurodevelopmental and psychiatric disorders. Co-morbidities with other psychiatric disorders are also not uncommon and contribute to a dizzying heterogeneity in possible diagnoses. Clinical biomarkers could help transcend these limitations. This session discusses more about biomarkers in health and disorders.
Sepsis is among the most common causes of death in hospitals. It arises from the host response to infection. There is a need for new sepsis biomarkers that can aid in therapeutic decision making and add information about screening, diagnosis, risk stratification, and monitoring of the response to therapy. Currently, diagnosis relies on nonspecific physiological criteria and culture-based pathogen detection. This results in diagnostic uncertainty, therapeutic delays, the miss-and-overuse of antibiotics, and the failure to identify patients who might benefit from immunomodulatory therapies. The host response involves hundreds of mediators and single molecules, many of which have been proposed as biomarkers. It is, however, unlikely that one single biomarker is able to satisfy all the needs and expectations for sepsis research and management. This session discusses more about Molecular Diagnostics and Biomarkers.
Next-generation biomarkers sequencing is beginning to provide powerful insights into genetic mutations and molecular networks underlying disease for a broad set of genes. Next-generation biomarkers sequencing technologies promise to revolutionize a number of areas in clinical practice, including the validation and analysis of sequencing-based biomarkers, a tool increasingly relevant for diagnosis in multiple disease areas and for the selection and monitoring of therapeutic treatments. The recent emergence of positional sequencing is enabling access to better, more accurate sequence information. The overview of the strength of this technology and future implications in the field of molecular biomarkers needs to be assessed and evaluated. This session discusses more about biomarkers sequencing.
Genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. The rapidly expanding knowledge of disease pathogenesis at the molecular level is providing new targets for disease characterization, early diagnosis, and drug discovery and development. Testing is used to find changes that are associated with inherited disorders. Several decades of intensive research have originated multiple factors or biomarkers that are likely to be helpful in the diagnosis, characterization, and therapy selection. A deep understanding of the relative relevance of each biomarker will be a key to efficiently diagnose diseases, adverse drug responses and direct our patients towards the drugs more likely to be of benefit based on their particular profile. The results of genetic tests confirm or rule out a suspected genetic condition or help determine a person's chance of developing or passing on a genetic disorder. Several hundred genetic tests are currently in use and more are being developed. This session discusses more about genomics biomarkers.
Biomarker Identification Techniques are concerned with biomolecules that serve as indicators of biological and pathological processes, or physiological and pharmacological responses to a drug treatment. The high abundance of albumin and heterogeneity of plasma lipoproteins and glycoproteins biomarkers are difficult to identify in human serum. Due to the clinical significance the identification of disease biomarkers in serum holds great promise for personalized medicine, especially for disease diagnosis and prognosis. Assessing some common and emerging proteomics techniques utilized in the separation of serum samples and identification of disease signatures. The practical application of each protein separation or identification technique is analyzed using specific examples. Biomarkers of cancers of prostate, breast, ovary, and lung in human serum have been assessed as well as those of heart disease, arthritis, asthma, and cystic fibrosis. This session discusses more about biomarker identification techniques.
Translational biomarkers deal with the study of refinement of disease taxonomy utilizing molecular phenotypes has led to significant improvements in the precision of disease diagnosis and customization of treatment options. The efforts are on to identify novel biomarkers to understand the impact of therapeutically altering the underlying molecular network on disease course, and to support decision-making in drug discovery and development. Gaps in knowledge regarding disease heterogeneity, combined with the inadequacies of surrogate disease model systems, make it challenging to demonstrate the unequivocal association of molecular and physiological biomarkers to disease pathology. The current landscape in biomarker research and highlight strategies being adopted to increase the likelihood of transitioning biomarkers needs to be discussed in this session of translational biomarkers.
Biomarkers and radiology deals with studies on appropriate use of imaging biomarkers defined as anatomic, physiologic, biochemical, or molecular parameters detectable with imaging methods used to establish the presence or severity of disease. It offers the prospect of smaller, less expensive and more efficient preclinical studies and clinical trials. Scientists, government regulators, and industry have all recognized the potential of biomarkers in imaging. When the presence of an imaging marker is closely linked with the presence of a target disease; detection and or measurement of the biomarker is accurate, reproducible, and feasible over time; and measured changes are closely linked to success or failure of the therapeutic effect of the product needs to be evaluated. By applying this paradigm to the array of imaging modalities, the radiology community is poised to become a major force in preclinical and clinical evaluations of new medical treatments. This session discusses more about biomarkers and radiology.
Enzymes as biomarkers focus on cancer research. The discovery of cancer biomarkers in cancer research holds promising future for early detection, diagnosis, monitoring disease recurrence and therapeutic treatment efficacy to improve long-term survival of cancer patients. Most of the functional information of the cancer-associated genes resides in the proteome. Since cancer is a complex disease, it might require a panel of multiple biomarkers in order to achieve sufficient clinical efficacy. Serum plasma is the most accessible biological specimen collected from patients. Serum proteomic diagnostics would be the most promising new test for cancer. With the advent of new and improved proteomic technologies, such as protein chips and mass spectrometry coupled with advanced bioinformatic tools, it is possible to develop potential cancer biomarkers. This session discusses more about enzymes as biomarkers.
Biomarkers and pharmacology complement each other. Biomarkers quantitatively measurable indicators of biological or pathogenic processes once validated play a critical role in disease diagnostics, the prediction of disease progression, and or monitoring of the response to treatment. They also represent drug targets. A number of different methods can be used for biomarker discovery and validation, including proteomics methods, metabolomics, imaging, and genome wide association studies and can be analyzed using receiver operating characteristic plots. The relative utility of single biomarkers compared to biomarker panels is discussed along with paradigms for biomarker development. The importance of systematic optimization of many parameters in biomarker analysis include validation, reproducibility, study design, statistical analysis and avoidance of bias are critical features used by these consortia. This session discusses more about biomarkers and pharmacology.
Transcriptional Profiling is one of the most popular study types known as Expression Profiling. It involves the quantification of gene expression of many genes in cells or tissue samples at the transcription (RNA) level. The quantification can be done by collecting biological samples and extracting RNA in most cases total RNA following a treatment or at fixed time-points in a time-series, thereby creating 'snap-shots' of expression patterns. Genomes with well-annotated transcripts and genes namely the human genome, a researcher can choose to focus on quantifying transcription of all or a subset of transcripts, genes, coding exons, non-coding RNA, and so forth. This session discusses more about transcriptional profiling.
Biomarkers in Nanomedicine is concerned with cancer biomarkers as indicators produced by tumor cells spreading in the body and are commonly used in cancer detection. However they are present in too low concentrations to be efficiently detected in early phases. However the targeted delivery of specific nanoparticles into the tumor can induce a local interaction with cancer cells and forces them to significantly increase the production of these biomarkers. Biomarkers detection becomes much easier and can provide an earlier diagnosis to doctors than biopsies. Early detections of cancers allow early and less burdensome treatments, increasing also the chances of recovery. Iron oxide nanoparticles are one useful tool against cancer because, when “nano”-engineered with a specific coating, they bind particularly well to the tumors. This session discusses more about biomarkers in nanomedicine.
Biomarkers are of high importance in medicine particularly in the realm of personalized medicine. Biomarkers are valuable for predicting prognosis and dose selection. They are helpful in detecting therapeutic and adverse responses and in patient stratification based on efficacy or safety prediction. Thus biomarkers are essential tools for the selection of appropriate patients for treatment with certain drugs to and enable personalized medicine that is providing the right treatment to the right patient, at the right dose at the right time. In contrast to the few fully validated biomarkers, many exploratory biomarkers and biomarker candidates have potential applications. Prognostic biomarkers are of particular significance for malignant conditions. And diagnostic biomarkers are important in autoimmune diseases. This session discusses more about biomarkers and personalized medicine.
Blood Biomarkers are concerned with the studies of multiple sclerosis (MS), an autoimmune demyelinating disorder of the central nervous system. Few biomarkers are available in multiple sclerosis clinical practice like cerebrospinal fluid oligoclonal bands and immunoglobulin index, serum anti-aquaporin 4 antibodies, and serum anti-John Cunningham virus antibodies. There is a significant unmet need for biomarkers to assess prognosis, response to therapy, or potential treatment complications. There are several limitations in the process of discovery and validation of a good biomarker, such as the pathophysiological complexity of multiple sclerosis and the technical difficulties in globally standardizing methods for sampling, processing, and conserving biological specimens. This session discusses more about blood biomarkers.
Biomarkers in clinical research and development have greatly accelerated over the last few years. The potential clinical benefits for disease-specific biomarkers include a more rapid and accurate disease diagnosis, and potential reduction in size and duration of clinical drug trials, which would speed up drug development. The application of biomarkers into the clinical arena of motor neuron disease should both determine if a drug hits its proposed target and whether the drug alters the course of disease. It should highlight the progress made in discovering suitable biomarker candidates from a variety of sources, including imaging, neurophysiology and proteomics. There has been tremendous effort to discover biomarkers; very few have been translated to the clinical stage. This session discusses more about biomarkers in clinical research and development.
Advances of Biomarker Testing and diagnostic tests continue to evolve with expanded uses, new targets for assessment, and the introduction of newer and higher-sensitivity assays. These tests are powerful adjuncts to standardized clinical care in various different therapeutic areas, including cardiology, infectious disease, oncology, immunology, hematology, and endocrinology. This important collection includes information on the latest advances in clinical application and appropriate integration of biomarkers and diagnostic tests into clinical care. Testing practices are intensely deliberated, influencing diagnostic quality and affecting pathologists, oncologists and patients. The advances in biomarker testing are mainly in the fields of genetic testing, cancers and other diseases in their diagnosis, treatment and imaging. This session discusses more about advances in biomarker testing.
Biomarker Patenting and Marketplace deals with concerns relating to the problems and bottlenecks involved in biomarker patenting. We could speculate that researchers will be encouraged by faculty to focus on patentable research which could exclude biomarker discovery. Patentable research provides licensing revenues for universities and patent holders. For instance, it is estimated that CRISPR gene editing technology in eurokaroyte cells could generate billions in revenue for MIT. Expanding on biomarker discovery we could speculate that there is also limited incentive for non-academic researchers to engage in identifying novel biomarkers unless some revenue pathway, such as drug development is possible. This is unfortunate because there are important biomarkers used in risk stratification which are critically important for prognosis and therapy algorithms. This session discusses more about biomarker patenting and marketplace.
Case Reports in biomarkers is concerned with the quality scientific manuscripts on physical and biological markers, parameters or substances that can indicate the presence of a disease and its possible health outcomes in all areas of disease biomarker research. It accentuates scientific research in varied aspects of the rapidly growing field of disease biomarker research. Reports in disease markers focus on clinical importance of different disease markers viz. autoimmune disease markers, cardiovascular disease markers, infectious disease markers, celiac disease markers, molecular biomarkers, biomarkers for bipolar disorder, autism biomarkers, cytogenic biomarkers and individual health biomarkers. Such case reports deal with the recent research developments pertaining to biomarkers in reproduction, lactation and infertility, kidney biomarkers, biomarkers in diabetes, cancer biomarker, etc. This session discusses more about such case reports.