EuroSciCon extends its warm welcome to all its participants to Clinical Research & Biomarkers 2018 scheduled on July 19-20, 2018 at Prague, Czech Republic with a theme “The Current Aspects and The Future of Clinical Research and Biomarkers”. EuroSciCon organizes Global Events with Conferences, Symposiums and Workshops on Medical, Pharma, Engineering, Science, Technology and Business.
We gladly welcome attendees all around the world for the hearing of the foremost recent innovations and inventions in the field of Clinical Research and Biomarkers. This Conference will provide a forum for exchange of ideas and authoritative views by leading scientists, industry specialists and also from the academicians of the best institutes from around the globe. Outstanding keynote speakers and well known leading scientists and experts from around the globe will be expected to share their knowledge and talk about various aspects related to various frontiers in the field if Biomarkers and Clinical Research.
Our aspiration is to gather peer researchers, young scientists, academicians & industrialists to meet, discuss and share the knowledge that’s still more to be revealed. Gain and grab the knowledge. Conferences and symposia provide unlimited opportunities to strengthen the community, and are also the collective body of knowledge. We cordially encourage you to attend and contribute to one of the major events of 2018 on the field of Clinical Research and Biomarkers. The conference will reveal the present and future aspects in the field of Clinical Research and Biomarkers which are the need of the hour for instant and précised treatment.
Who and Why ??
Biomarkers & Clinical Research 2018 Conference brings together the specialists from all the aspects to meet and discuss the future of Clinical Research and Importance of Biomarkers in today’s world to thrive and survive with a better health. The conference will bring together Directors, Doctors, Director of Laboratories, Universities, Industries ,Delegates, Clinical Research specialists, Investigators, Post-Doctoral Fellows, Research and Diagnostic Laboratories, Clinical Fellows, Students, Biomedical Research companies, CRO’s, Healthcare Institutions, Market Research and Consulting Firms, Pharmaceutical Companies, Medical device specialist and all the interested participants willing to enhance and update the knowledge on Biomarkers and Clinical Research.
Scope and Importance:
The global clinical trial management system market is valued at the estimated USD 534.0 Million in the year 2016, and is projected to grow at CAGR of 11.5% during forecast period of 2016-2021, to reach USD 920.0 Million by the year 2021. The growth in this market is driven primarily by factors as increasing R&D expenditure of life science and clinical research industries, rise in number of clinical trials, and increasing adoption of CTMS solutions. On the other hand, factors such as lack of skilled professionals for operating advanced CTMS solutions and also budget constraints of small- and medium-sized pharmaceutical and biotechnology companies and small CROs are restraining growth of the global clinical trial management system.
SESSIONS AND TRACKS
Biomarkers are the molecules which indicate normal/abnormal process taking place in the body and might be the sign of an underlying condition or disease. Various types of molecules can serve as biomarkers, such as DNA (genes), proteins or hormones since they all indicate the status of your health. Biomarkers take part in various processes like disease diagnosis and prognosis, prediction and calculation of treatment response, and also safety evaluation. The molecular biomarkers are exclusively being developed and validated to be used in drug development, and are used to support approval of drug products.
- Molecular Biomarkers
- Cancer Biomarkers
- Lipid biomarkers
- Oncology Biomarkers
- Neurological Biomarkers
- Inflammatory & Immunological Biomarkers
- Cardiovascular Biomarkers
- In-silico biomarkers
- Pathological biomarkers
Biomarkers in molecular form are called the Molecular Biomarkers. These involve in the processes of disease diagnosis, disease prognosis, prediction & calculation of the treatment response and evaluation. These are developed and validated to be used in drug development processes.
- Protein biomarkers
- Nucleic acid based biomarkers
- Small molecule biomarkers
- Lipid biomarkers
- MicroRNA biomarkers
Current genomics & biotechnology techniques promise development of biomarkers for predicting individual disease risk which enables the early detection of disease and improved diagnostics classification towards better & informed individualized treatment. Biomarkers are the biological measurements which are used for predicting the risk of diseases for enabling early detection of disease.
Transcriptomics : study of the RNA transcripts which are produced by the genomes using high-throughput techniques. Transcriptional profiling is the technique used for identifying the differences in gene expression between the diseased tissues and the healthy tissues. DNA sequencing, mRNA profiling, Proteomics, and Systems Biology help in the analysis of the transcriptional profiling. ESTs and DNA microarrays are the techniques that are used in Transcriptional profiling.
- Transcription analysis and transcriptional profiling
- Gene expression analysis in biomarker research
- Microarray data analysis
Development of Biomarkers
The major usage of biomarkers in clinical investigation is in the form of clinical trials & monitoring. The entire spectrum of disease from the earliest indication till the terminal stages may be resonated through these biomarkers. Biomarker shows the best relationship between its response when it is compared to the health/ecological effect. It provides variety of human and animal materials principally through immuno-assays and quantitative PCR that can be analytically determined at any of the Biomarker Laboratory.
Biomarkers & Pathology
Pathology in the assessment of bosom malignancy is with the aid of biomarker testing. These are particularly the precise appraisal of the estrogen receptor, progesterone receptor. Biomarkers can be prognostic, prescient, or even both. Prognostic biomarkers are free measures for forecasting such extent that the nearness or nonappearance of the biomarker is connected with a patient’s general clinical result (i.e., danger of repeat and mortality).
Biomarkers & Next-Generation Sequencing
Next-generation sequencing involved in DNA sequencing and RNA sequencing is quicker and cheaper than the old methodology and also there is a revolution in the study of genomics and molecular biology due to this. Genetic-based biomarkers are the biomarkers the ones involved in the process of representing genes and gene products as the biomarkers. Genome sequencing using next-gen sequencing helps in the discovery of biomarkers.
- Next-generation sequencing for the discovery of Biomarkers
- Genome sequencing for the discovery of Biomarkers
- MicroRNA sequencing for the prediction of diseases
- Using SNP as biomarkers
- Genome biomarkers
- Cell proliferation markers
- Cytogenetic biomarkers
- Oxidative stress biomarkers
Bioethics and Regulatory Compliance
Bioethics is the investigation of commonly questionable moral issues which are rising up out of new circumstances & potential outcomes which are realized by advances in medication. It is in addition moral insight as it identifies the therapeutic approach, practice, and research. Bioethicists are worried about moral inquiries which emerge in relation to life sciences, biotechnology, prescription, clinical research, reasoning and so forth.
- Compliance and regulatory requirements in clinical research
- Bioethics: Case studies and ethical regulatory guidelines
- Ethics and patient’s rights
- Ethics & Human subject protection
- Value of ethics in clinical research
- Regulatory implications and opportunities for new technologies
- New regulatory flexibility driving positive industry change
- Navigating the clinical trials regulatory landscape
- Bridging regulations to Real-World health care
- Good clinical practice
- Ethical challenges in cancer clinical trials
Biomarkers and Diseases
Biomarkers provide a dynamic & powerful approach to the understanding of diseases with applications in observational & analytical epidemiology, randomized clinical trials, screening, and diagnosis. Biomarkers reflect the entire spectrum of disease from the earliest manifestations till the terminal stages. Biomarkers play an important role in various cardiovascular, neurological and rheumatic diseases which were incurable for a very long. Biomarkers have brought revolution in prediction, diagnosis & treatment of the diseases that were difficult to handle before.
- Biomarkers for Alzheimer’s
- Biomarkers for Cardiovascular diseases
- Biomarkers for Neurodegenerative diseases
- Biomarkers for Diabetes
- Biomarkers for Huntington diseases
- Biomarkers for Behcet s disease
- Biomarkers for other diseases
- Biomarkers in psychiatry
Current Researches & Innovations
Biomarkers have gained immense scientific value and interest in the practice of medicine. They are potentially useful in the whole spectrum of disease process The ability of biomarkers in improved treatment and reduced health-care costs is potentially greater than in any other area of current medical research. The latest innovations and emerging technologies are leading to the further advancements and enhancements in the various fields.
- Biomarker research in Neurology
- Cell Free Biomarkers
- Challenges in Biomarkers research
- Biomarkers of Environmental Pollutants
- Genomic and proteomic approaches
- Metabolomics and metabonomics methods
- Transcriptomics for the discovery of Biomarkers
- Data Mining Methods
- Application of Bioinformatics in Biomarkers research
- Biomarkers and Nanotechnology
Biomarkers in Drug Discovery & Development
The aim of drug discovery and development is to identify effective drug and provide it in right dosage at the right frequency to affected organism. Biomarkers are the effective tool to identify the mechanism of action of the drug that can correlate pharmacokinetics andpharmacodynamics (PK & PD) of drug. Biomarkers aids in finding the safe procedure of drug administration. In genomics, the biomarker challenge identifies unique molecular signatures in complex biological mixtures which unambiguously correlate to biological events for validating novel drug targets and also predict drug response.
- Biomarker discovery and Identification methods
- Translational biomarkers in drug development
- Biomarker discovery and clinical validations
- Biomarkers and new therapeutic strategies
- Novel technologies in drug discovery
- Why formulation and delivery strategies fail
- Experimental and computational approaches
Clinical Applications of Biomarkers
There are numerous clinical applications of Biomarkers in the treatment of diseases such as cardiovascular, acute kidney injuries, and cancer treatments. The Biomarkers are even used in the development of vaccines and drug which is a major application in the field.
- Clinical Applications in Cardiovasculardiseases
- Application of Biomarkers in the development of drugs
- Vaccine and drug development
- Other Applications of Biomarkers
Biomarkers and Radiology
Even though radiological sciences have the long history in the medical field, Imaging Biomarkers have given it a new turn. In the modern day radiology, biomarkers have an undividable integral part which has become the major reason for the latest developments in this field.
- Imaging biomarkers
- Quantitative imaging biomarkers
- Clinical imaging and Biomarkers
- Cancer screening
- Screening for other diseases
- New generation tools and technologies
Biomarkers are intended to replace surrogate endpoints in clinical trials process. Surrogate markers are used to conduct the clinical trial and gather a number of endpoints which is impractical when the primary endpoint is undesired or the event number is small. Biomarkers help in the diagnostics and clinical development processes. Biomarkers case study plays an important role in finding new treatments for the patients who need new drugs and to be used widely in various clinical practices.
- Case reports on molecular biomarkers
- Case reports on cancer biomarkers
- Case reports on diagnostics
- Case reports on drug discovery
- Case reports on imaging
- Imaging biomarkers
- Quantitative imaging biomarkers
Biomarkers and Personalized Medicine
Personalized Medicine is known for its use of genomic information in addition to the family history, environmental factors and lifestyle to manage the health. Accurate predictions can be made about a person’s susceptibility to developing a disease, the course of the disease and to respond to the treatment. Personalized Medicine is a new field of research and evidence-based literature is required for integrating into healthcare delivery.
- Diagnosis and intervention
- Drug development and usage
- Cancer genomics
- Challenges and probable solutions
- Tumour biomarkers
- Diagnostic and prognostic biomarkers
Biomarkers: Validation and Verification
- Omics Technologies in Biomarkers Discovery and Validation
- Latest diagnosis techniques
- Assessment of drug response
- Application of tools
- Advancements in analysis
Clinical Research and Methodology
With increasing initiatives for improving the effectiveness and safety of patient care, there is a growing emphasis on evidence-based medicine and incorporation of high-quality evidence into clinical practice. The various procedures to be followed for Clinical Research & Methodology will be summed up in this session.
- Principles and practice of Clinical Research
- Ethical, Regulatory and Legal Issues
- Conducts of Clinical Trial
- Quality regulation
- GCP & GMP
- Registry of clinical trials
- Designing clinical research
Clinical Research and Clinical Trials
Clinical trials are research studies that aid to explore medical strategy, treatment method, or device .i.e. safe and effective for humans. These studies may show which medical approaches works best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making. The purpose of clinical trials is research on the methods and procedures so that the studies follow strict scientific standards. These standards protect patients and help to produce reliable decisions on the study results.
- Clinical study designs
- Preclinical research
- In vitro and in Vivo studies
- Phases & types of clinical trials
- Surgical clinical trials
- Investigational new drug process
- Developing pharmacological profile of the drug
- Drug discovery and development
Clinical Data Management and Analytics
Clinical Data Management is the process of handling the data received from various clinical trials. The inherent goal of any clinical data management system is to produce & maintain the quality data. CDM being the critical phase in the process of clinical research leads to generation of high-quality, reliable, and statistically sound data from the clinical trials.
- Big data for clinical trials
- Artificial intelligence in clinical research
- Tools for CDM
- Regulations, guidelines, and standards in CDM
- Review and finalization of study documents
- Database designing
- Standard operating procedures
- Database design and build
Pharmacovigilance and Drug Safety
- PV: Current Regulation & Challenges
- Pharmacovigilance and Risk Management
Biomarkers and Cancers
Biomarkers play a significant role in cancer prognosis, diagnosis, and treatment. There are a number of cancers which are hard to diagnose. The latest designed biomarkers & their applications are an added advantage in these kinds of cases. Cancer Epidemiology, treatment and latest research is greatly relayed on these biomarkers.
- Biomarkers for lung cancer
- Biomarkers for prostate cancer
- Biomarkers for blood cancer
- Biomarkers for adrenal cancer
- Biomarkers for colorectal cancer
- Biomarkers for gastric cancer
The clinical trials are the scientific studies of effects, risks, efficacy & benefits of new and even existing medicines. Trials are supposed to be carried out before a product reaches the hospital or local pharmacy. They are undertaken at various stages, or say ‘phases’, and include trials on healthy individuals; patients with a disease; & also studies conducted after the launch of the new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or Contract Research Organisations on their behalf. There are various roles and responsibilities in these phases of Clinical Trials
- Clinical CROs
- BA/BE Centers
- Data Management
- IT Companies in Healthcare/Clinical Domains
- Central Laboratories
- Packaging & Labeling
- Investigator & Site Staffs
CRO & Sponsorship:
CRO provides support to the pharma industries in the form of research services outsourced on contract basis. In the conduct of clinical trials, a sponsor is an individual/institution/company/ organization that takes responsibility to initiate, manage or finance clinical trial, but it actually does not conduct the investigation. The sponsor is responsibility is for implementing & maintaining QA and QC systems with written SOPs so as to ensure that trials are conducted and data is generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement.
- Business development tactics
- Strategies to attract sponsors
- Clinical Trials for Small Sponsors
- Evolving Strategic Partnerships
- Patient-pharma relationship CR
Research and Trials on HIV/Diabetes/ Cancer:
Clinical trials are the safest and fastest method to determine any new medical approaches for HIV prevention/ treatment are safe and effective in individuals. All the medicines used to prevent and treat HIV in the United States were initially studied in clinical trials.
There are several types of cancer clinical trials, Each type of trial is designed to answer different research questions and will help researchers learn things that will help people in the future.
Diabetes/Diabetes mellitus describes a group of metabolic diseases in which the person has high glucose, either because insulin production is inadequate, or because the body’s cells do not respond to insulin, or both. Clinical trials are conducted for both the Type 1 and Type 2 diabetes.
- Clinical research and Trials on HIV/AIDS
- Oncology clinical trials
- Breast cancer research and trials
- Diabetes Mellitus Type 1 Clinical Trials
- Diabetes Mellitus Type 2 Clinical Trials
- Brain, Spine, Lung, Kidney, Blood, Skin and all other cancers research and trials
Globalization of Clinical Trial:
The globalization of clinical research is a recent phenomenon, in which number of studies is taking place on a global scale, with a significant increase of clinical trials in developing countries. Developed markets in the USA, Europe, Germany, and Japan still generate the large share of clinical trial activity. According to the report China, Japan, India, and Korea are the most active sites for clinical trials among developing nations.
- Globalization of drug development
- Japan clinical trials
- Strategies for successful globalization of clinical trials
- Europe clinical trials
- USA clinical trials
- Mutual recognition of clinical study results
- Comparative impact of globalization
- Ethical and scientific implications
- Asia clinical trials
- UK clinical trials