Call for Abstract
2nd International Conference on Clinical Trials, will be organized around the theme “Exploring Cutting Edge Technologies and Global Clinical Trials of the Future”
Clinical Trials 2016 is comprised of 16 tracks and 138 sessions designed to offer comprehensive sessions that address current issues in Clinical Trials 2016.
Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.
Register now for the conference by choosing an appropriate package suitable to you.
Pre-clinical research also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety data is collected. The main goals of pre-clinical studies are to determine the safe dose for First-in-man study and start to assess product's safety profile. Products may include new or iterated or like-kind medical devices, drugs, etc.
A study of 10 major countries that are major sources of preclinical outsourcing suggested that spending on preclinical outsourcing is increasing every year. In 2014, total outsourcing spending accounted for 13.8% of total preclinical spending, with in-house spending accounting for the remaining 86.2%. Countries such as India and China are able to provide a cost advantage of 50% to 60%, making them attractive destinations for preclinical research outsourcing. &D spending on pharmaceuticals in the U.S. has increased from $21.9 billion in 1996 to $65.3 billion in 2009, while NDA/BLA approvals decreased from 53 in 1996 to 25 in 2009. The ever-increasing cost of drug development in the U.S. is driving large pharmaceutical companies to outsource preclinical work to low cost countries such as India and China. Large pharmaceutical companies based in the UK, France, Germany and Switzerland, also account for a large share of preclinical outsourcing.
- Track 1-1Investigational new drug process
- Track 1-2In Vitro and In Vivo screening
- Track 1-3Developing pharmacological profile of the drug
- Track 1-4Conducting toxicity studies
- Track 1-5Pre-clinical research leading to clinical trials
Clinical trials, also known as clinical studies that follows a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge
Clinical Trials and debates associated with it have been in headlines since past few months pursuant to the strict view taken by the apex court on the matter. The number of deaths in India resulting from clinical trials has increased to an unendurable figure of 2,868 during the period 2005-2021. If on the one hand this figure relating to number of deaths resulting from clinical trials is fearful, on the other hand the decline in the number of clinical trials and approval given for conducting such trials in last few months is equally shocking. Till April 2013, only 12 (twelve) clinical trials have been approved by the authority as compared to almost a three digit figure in last years. This certainly raises a concern for the future of clinical trials in India- country which once was perceived as a fertile place for growth of clinical trials by most of the multi-national corporations. Currently estimated at USD 500 million, India's clinical research market was projected to more than double and cross USD one billion mark by 2016 driven by favourable factors like diverse and accessible population, availability of low cost and effective resources
- Track 2-1Conducts of pediatrics and geriatrics Clinical Trials
- Track 2-2Misconduct and Fraud in clinical trials
- Track 2-3Patient recruitment
- Track 2-4Emerging breakthroughs
- Track 2-5Types of clinical trials
- Track 2-6Public and Patient involvement
- Track 2-7Risks and benefits of participants
- Track 2-8Clinical research phase studies
- Track 2-9Barriers and solutions to clinical trial recruitment
- Track 2-10New drug application
- Track 2-11Preparing data for FDA submission
- Track 2-12Pros and Cons of Clinical Trials
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. Types of Study Designs Meta-Analysis, Systematic Review, Randomized Controlled Trial, Cohort Study, Comparative Study, Case-control Study, Cross-sectional study, Case Reports and Series, Animal Research Studies, Test-tube Lab Research
- Track 3-1Design and end points of clinical trials
- Track 3-2Randomized placebo- controlled trials
- Track 3-3Trial and protocol designs that reflects patient considerations
- Track 3-4Patient consideration and patient oriented trial designs
- Track 3-5Experimental Study designs
- Track 3-6Observational study designs
- Track 3-7Trial design: formulation development, manufacturing and analytical testing
- Track 3-8Randomized Clinical Trials
- Track 3-9Study designs for medical devices
- Track 3-10Clinical testing
Clinical trials for the development of a new drug are, for the most part, initiated and financed by industry. There are also many clinical trials initiated by academic clinical researchers. Whether initiated by industry or by academic clinical investigators clinical research is often performed in national, European and worldwide consortia, which can sometimes, be very large ones. Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. As a consequence, clinical research is highly regulated. To facilitate collaborations across borders, many aspects of this regulation are harmonized at the European level but also worldwide.
The global market for E-Clinical Trial Technologies is projected to reach US$3.7 billion by 2020, driven by the rising number of clinical studies, and mounting pressure to contain costs and expedite the clinical trial process. North America remains the most prominent market worldwide, supported by the strict legislative and regulatory atmosphere, and escalating clinical trial expenditure. Asia-Pacific ranks as the fastest growing market with a CAGR of 13.6% over the analysis period. Developing economies with large heterogeneous patient pools and high diseases prevalence are attractive locations for conducting clinical trials.
- Track 4-1Innovative partnering in clinical research
- Track 4-2Strategic development towards FDA approval
- Track 4-3Marketing innovation and service
- Track 4-4Innovation in clinical research technologies and software systems
- Track 4-5Supporting continuous quality improvement through e-Clinical technology
- Track 4-6Exploring outsourcing strategies for rare disease trials
- Track 4-7Collaborate with patients to boost trial productivity
- Track 4-8Driving innovation in patient recruitment
- Track 4-9Creating patient centric trials
- Track 4-10Innovations in patient and community engagement in clinical trials
The process of identification, analysis and either acceptance or mitigation of uncertainty in investment decision-making Essentially, risk management occurs anytime an investor or fund manager analyzes and attempts to quantify the potential for losses in an investment and then takes the appropriate action given their investment objectives and risk tolerance. Inadequate risk management can result in severe consequences for companies as well as individuals. A practice used by different companies to reduce costs by transferring portions of work to outside suppliers rather than completing it internally is called Outsourcing. It is a very important tool for reducing cost and improving quality. If an organization does one or all its work by itself, its work may affect its production quality, so an organization must realize some important areas, from which its cost is reduced and its products stay in high quality.
Clinical Data Management (CDM) industry is the fastest growing and possibly the most profitable segment in Bio Services industry. During 2006-07 it grew to USD40 million, a growth of 53% over the previous year. There are over 70 companies in India offering services in this niche area. Most of them find it a logical extension of their other Bio services business. They include Contract Research Organisations, Clinical Trial Organisations, IT services companies and hospitals. Out sourced Clinical trials to India is a prime growth driver for this market, though they are a few large dedicated CDM companies as well. Indian clinical trials market in 2006 was USD140m and has been growing at a CAGR of 40% for the last 3 years and is likely to scale up to USD600 million by 2010. Correspondingly, CDM market is expected to ramp up to USD150 million by the same time.
- Track 5-1Data management plan development
- Track 5-2Advanced products in data management
- Track 5-3SAS programming in data analysis
- Track 5-4Statistical analysis methods
- Track 5-5Metrics to quantify clinical data quality
- Track 5-6On-shore & off-shore clinical data management
- Track 5-7Handling the complexities in managing non-CRF data
- Track 5-8Electronic data capturing systems
- Track 5-9CRF/eCRF design and development
- Track 5-10Data types and data processing techniques
- Track 5-11Data integration and visualization
Cancer is a group of more than 100 different diseases characterized by the uncontrolled, abnormal growth of cells. These cells form a lump or mass called a tumor. Cancers are divided in to types based on where it begins.
· Carcinomas: A carcinoma begins in the skin or the tissue that covers the surface of internal organs and glands. Carcinomas usually form solid tumors. They are the most common type of cancer. Examples of carcinomas include prostate cancer, breast cancer, lung cancer, and colorectal cancer.
- Sarcomas: A sarcoma begins in the tissues that support and connect the body. A sarcoma can develop in fat, muscles, nerves, tendons, joints, blood or lymph vessels, cartilage, or bone.
- Leukemias: Leukemia is a cancer of the blood. Leukemia begins when healthy blood cells change and grow uncontrollably. The four main types of leukemia are acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, and chronic myeloid leukemia.
- Lymphomas: Lymphoma is a cancer that begins in the lymphatic system. The lymphatic system is a network of vessels and glands that help fight infection. There are two main types of lymphomas: Hodgkin lymphoma and non-Hodgkin lymphoma.
- In this session we listed most common and major cancers in male and female to discuss, example Breast Cancer, Brain cancer, Liver cancer, Blood cancer, Brain cancer, Prostate cancer, Kidney cancer and Pancreatic Cancer etc.
The global oncology drugs market is expected to reach at $111.9 billion by 2020. Patent expiration of key cancer drugs such as Herceptin, Erbitux, Rituxan and Avastin, is expected to boost the growth of cancer biosimilars market by 2020. Going further, the biological therapies are expected to dominate the market by 2020, due to their high efficacy, target specific action and less toxicity. Blood cancer drugs market was the largest revenue generating segment in 2013 owing to the high cost of drugs (immunotherapies) used for the treatment of blood cancer. Geographically, North America, dominates the market followed by Europe. North America accounted for about ~38% share in the overall oncology drugs market in 2013 owing to the heavy investments by multinational companies in research and development of cancer drugs, particularly immune therapeutics, favorable reimbursement policies, and high adoption rate of immunotherapies. On the other hand, Asia-Pacific market would grow at the promising CAGR of 8.7% during the forecast period. Such high growth rate is majorly due to increasing awareness towards advanced therapies namely immunotherapies and increase in per capita healthcare spending.
- Track 6-1Diabetes Mellitus Type 1 Clinical Trials
- Track 6-2Diabetes Mellitus Type 2 Clinical Trials
- Track 6-3Breast cancer research and trials
- Track 6-4Brain, Spine, Lung, Kidney, Blood, Skin and all other cancers research and trials
- Track 6-5Clinical research and Trials on HIV/AIDS
Clinical Trials for different diseases and disorders are conducted for evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition and also finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
The lack of specificity in available AD tests has become a major burden on AD therapeutics development programs, which hold a relatively high 99.6% failure rate. Part of the problem is the 20% to 50% of clinical trial participants who are not suffering from AD, but another form of dementia, that dilute and complicate trial data across sites. The development of treatments effective in the early onset of AD also requires patients to be effectively screened for AD risk and MCI. Responding to outstanding pharmaceutical industry demand for effective AD screening, Amarantus BioScience adjusted its development plan for its AD assay to focus on investigational use only (IUO) applications initially rather than CLIA clearance. The company plans to target a $150 million opportunity in supplying tests and biomarker services to pharmaceutical clients involved in AD therapeutics development.
- Track 7-1Reserach and Trials on Ebola Virus Disease
- Track 7-2Research and Trials on Cardiovascular diseases and devices
- Track 7-3Studies on parasitic, viral, bacterial and fungal diseases
- Track 7-4Clinical trials on rare diseases
- Track 7-5Asthma Clinical Trials
- Track 7-6Research and Trials on behaviors, mental, eating and sleep disorders
- Track 7-7Research and Studies on wounds and injuries
- Track 7-8Trials on surgical and home use Medical Devices
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Study show which medical approaches work best for certain illnesses or groups of people. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. Clinical trials are conducted for every disease. The main reason for carrying out trials is to determine whether one treatment is better than another, 19% on average increase in number of registration per year in Clinical Trials, 47.0% increase in Market Investment in Clinical Trials from 2013-2015
Clinical Trials Management System has made enormous progress in past few years, and according to Transparency Market Research the estimated net worth is approximately US$844 million in 2013, while growing at a compound annual growth rate of 14% during the forecast period, the worldwide Clinical Trials Management System market is expected to acquire market value worth US$1,848.5 million by 2019. United States is the major center in the field of Clinical Trials.
- Track 8-1USA Clinical Trials
- Track 8-2Europe Clinical Trials
- Track 8-3UK Clinical Trials
- Track 8-4Canada Clinical Trials
- Track 8-5Japan Clinical Trials
- Track 8-6Asia Clinical Trials
Based on our research, we forecast that the global clinical trial service market will likely reach more than $64 B by 2020, up from $38.4 B at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach around 72%. In other words, by then close to three fourths of clinical trials will likely be performed by professional CROs.
- Track 9-1Basis for a successful sponsor-CRO partnership
- Track 9-2The past, present and future of clinical research
- Track 9-3Clinical development of the future
- Track 9-4Clinical trial site of the future
- Track 9-5Clinical assessments of the future
- Track 9-6Outsourcing of technologies
- Track 9-7Mobile technology
- Track 9-8Business development tactics for clinical research sites
The major factors contributing to the growth of the clinical trial supplies market include globalization of clinical trial activities, increasing R&D investments and government support, and rising incidences of various diseases. Furthermore, increasing expansion activities by CROs is another major factor driving the growth of this market.
- Track 10-1Building an action plan in CTS
- Track 10-2Site management in clinical research
- Track 10-3Selection and benefits of CTMS
- Track 10-4Fundamentals of outsourcing in clinical devices
- Track 10-5Globalization & Outsourcing
- Track 10-6Strategic or tactical outsourcing
Improvements in FDA review process efficiency and more frequent and timely interactions with FDA Overall; the therapeutic area with the highest clinical research burden across all phases is respiratory system ($115.3 million) followed by pain and anaesthesia ($105.4 million) and oncology ($78.6 million) trials. Use of lower-cost facilities/in-home testing and wider use of mobile technologies appear to be most effective in reducing costs across therapeutic areas and trial phases. Use of lower-cost facilities and/or in-home testing can reduce per-trial costs by up to $0.8 million (16 percent) in Phase 1, $4.3 million (22 percent) in Phase 2, and $9.1 million (17 percent) in Phase 3, depending on therapeutic area
- Track 11-1Compliance and regulatory requirements in clinical research
- Track 11-2Ethical regulatory guidelines
- Track 11-3Capacity building in clinical research
- Track 11-4Bioethics: Case studies
- Track 11-5Pharmacokinetics-Pharmacodynamics for regulatory decision
- Track 11-6Ethical and regulatory issues
Business development in clinical trials aiming at developing and implementing growth opportunities within CRO’s, the basis for business development is successful Sponsor-CRO partnership and development of strategies to attract sponsors, pharmaceutical companies and nonprofit organizations.
The global market for portable medical equipment products (PMEPS) will grow from $54.2 billion in 2015 to $65.7 billion in 2020 with a compound annual growth rate (CAGR) of 3.9% for the period of 2015-2020.Examination of portable medical electronic products, specifically medical diagnostic equipment and imaging systems, drug delivery devices, interventional medical electronics, first-aid equipment, and body function testers. Analysis of market trends, with data for 2014, estimates for 2015, and projections of compound annual growth rates (CAGRs) through 2020.
- Track 12-1New therapeutic targets in drug design/discovery
- Track 12-2Evaluation of dose related toxicity and therapeutic inefficacy
- Track 12-3Individual Drugs TDM
- Track 12-4TDM Challenges and Advances
- Track 12-5Thin layer chromatography (TLC), HPLC and GLS
- Track 12-6Radio immuno assay (RIA) and Enzyme Immuno assay
- Track 12-7Fluorescence polarization Immunoassay (FPIA)
- Track 12-8Gender & Pathophysiology
A case report is a means of communicating something new that has been learnt from clinical practice. It could be about an unusual or previously unknown condition, a rare presentation or complication of a known disease, or even a new approach to managing a common condition. A case report provides the detailed report of symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient and play major role in the field of medical research and evidenced based medicine. Moreover, case reports can serve as an early warning signal for the adverse effects of new medications, or the presentations of new and emerging diseases.
The global pharmacovigilance and drug safety market is poised to grow at a CAGR of 6.5% during 2014-2019, and is expected to reach a value of $154.1 Million in 2019. MarketsandMarkets is world’s No. 2 firm in terms of annually published premium market research reports. Serving 1700 global fortune enterprises with more than 1200 premium studies in a year, M&M is catering to multitude of clients across 8 different industrial verticals. We specialize in consulting assignments and business research across high growth markets, cutting edge technologies and newer applications.
- Track 13-1Absorption
- Track 13-2Bioavailability
- Track 13-3Effect of age
- Track 13-4Biotransformation
- Track 13-5Enzyme inhibition and induction
- Track 13-6Lipid solubility
- Track 13-7Interaction with foods or other drugs
- Track 13-8Patient compliance and Protein binding
- Track 13-9Adverse Outcome Pathways
Heart and blood vessel disease also called cardiovascular disease includes numerous problems, many of which are related to a process called atherosclerosis. Atherosclerosis is a condition that develops when a substance called plaque builds up in the walls of the arteries. This buildup narrows the arteries, making it harder for blood to flow through. If a blood clot forms, it can stop the blood flow. This can cause a heart attack or stroke.
There are four main types of cardiovascular diseases. They are:
- Coronary heart disease
- Peripheral arterial disease
- Aortic disease
- Track 14-1Toxicogenomics in regulatory application
- Track 14-2Screening tools to predict toxicity & targets
- Track 14-3Signature/biomarker qualification
- Track 14-4Bioinformatics and interpretive challenges in toxicogenomics
- Track 14-5Challenges of conventional toxicology approaches
- Track 14-6Toxicogenomics as a predictive tool
- Track 14-7Environmental and Comparative Toxicogenomics
- Track 14-8Toxicogenomics Roles
- Track 14-9SAR/QSAR models
- Track 14-10Hypothesis generation to aid in the determination of MOA(s)
The pharmacovigilance is related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products, and it is needed in different stages of product life cycle, and the safety surveillance and risk management. Information received from patients and healthcare providers via pharmacovigilance agreements, plays a critical role in providing the data necessary for Pharmacovigilance to take place, in order to market or to test a pharmaceutical product, adverse event data must be submitted to the local drug regulatory authority. Finally pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients by safety surveillance and risk management
The global pharmacovigilance market was valued at USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% during the forecast period. ADR represents a substantial burden on healthcare systems and is one of the prominent reasons of morbidity in developed countries. Approximately 5% of total hospitalizations in a year are due to ADR which makes reporting and preventing of the same a notable growth fuelling factor for this market. Growing prevalence of chronic disorders coupled with rising geriatric population base has heightened the need for new drug development. With an upsurge in the drug production, regulatory authorities such as the U.S. FDA and EMEA (European Medicines Agency) have intensified drug safety regulations prior and post commercialization. Growing complexity of drug safety regulations is thus, expected to boost market growth during the forecast period. Additionally, there is an additional pressure from the regulators for electronic submission especially in European countries which would further accentuate the demand for this market in this region
- Track 15-1Priorities and needs of PV at different stages of a product life-cycle
- Track 15-2Challenges and opportunities in PV lifecycle management
- Track 15-3IT solutions for pharmacovigilance
- Track 15-4Safety surveillance and risk management lifecycle
- Track 15-5Innovation and trends in clinical drug safety
A platform aimed to connect Entrepreneurs, Proposers and the Investors worldwide. It's intended to create and facilitate the most optimized and viable meeting place for engaging people in global business discussions, evaluation and execution of promising business ideas. An investor could be able to find out the highest potential investment opportunities globally, which provide good return on investment. For entrepreneurs, this would be an ideal place to find out suitable investors and partners to start and/or expand their business. Thus it is a perfect place to connect Entrepreneurs, Business Owners, Early Stage Companies and Established Corporates with National or International Investors, Corporate Investors and Potential Business Partners
Pharmaceutical industry is also called as “sleeping giant”. This industry is world’s largest industry in terms of revenues and investments. Its world’s recession proof sector and is highly organized and regulated. Indian pharmaceutical industry is third largest pharmaceutical market in terms of volume and fourteenth in terms of value. Currently, Indian pharma industry is growing at rate of 15% compound annual growth rate (Facts as per Market Line Advantage Report 2014). Different segments such as clinical research, contract research, contract manufacturing and project management are having very high demand now a day.