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World Congress on Biotherapeutics and Bioanalytical Techniques, will be organized around the theme “Advances and Innovations in Development of Biotherapeutics”
Biotherapeutics 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Biotherapeutics 2017
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Biotherapeutics usually refers to therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics are basically agents, used to treat and avoid human disease by interrelating with the microbial ecology of the host. Biotherapeutics have the ability to target specific molecules within the human body, and have a good track record with patient safety. Manufacturing Biotherapeutics is complex, as they are larger compounds in both size and structure, and can be sensitive to environmental conditions. Additionally, Bio therapeutic manufacturing includes many regulations such as signal processing, biology and engineering process control. Moreover, they require sophisticated production and control processes and are dependent upon the host cells of living organisms to produce the necessary active pharmaceutical substances.
- Track 1-1Formulation & Development of Biotherapeutics
- Track 1-2Small & large molecule therapeutics
- Track 1-3Biochemical and biophysical characterisation
- Track 1-4The complexity of biotherapeutic medicines
Synthetic Immunology including the development and regeneration of immune cells, immune organ development and artificial regeneration, and the synthetic approach towards understanding human immune system. Immune cell therapy involves engineering or isolating cancer-fighting immune cells (T cells), growing large numbers of these cells in the laboratory and then infusing them back into patients.
- Track 2-1Types of synthetic immunology
- Track 2-2Biological device engineering
- Track 2-3Advanteges of synthethic immunology
- Track 2-4Research treands in synthetic immunology
MicroRNAs (miRNAs) are a class of small (18–24 nucleotide long) RNAs that are involved in regulation of gene expression by targeting messenger RNAs (mRNA). Deregulation of miRNAs has been reported in many human diseases such as cancer, cardiovascular disease and autoimmune disorders. Since miRNAs can be efficiently inhibited by modified/synthetic antisense oligonucleotides, there is great interest in developing anti-miRNA therapies for several diseases. In addition to tissues/cells, miRNAs were also detected in various biofluids such as serum/plasma, urine, saliva, cerebrospinal fluid and amniotic fluid. Usually miRNAs present in biofluids are packed in exosomes or associated to proteins or lipoproteins and hence protected from enzymatic degradation. Because of their stability and specificity, several studies demonstrated the utility of circulating miRNAs as diagnostic and prognostic biomarkers in disease such as cancer, cardiac disease and autoimmune disease. More recently, microRNAs have been investigated as potential safety biomarkers. Thus miRNAs received much attention not only as global intracellular and intercellular regulators but also as therapeutic targets and disease or safety biomarkers. Hence there is great interest in miRNA identification and profiling.
- Track 3-1Micro RNA biogenesis
- Track 3-2microRNA expression
- Track 3-3microRNA targets
- Track 3-4microRNA evolution
- Track 3-5genomics
- Track 3-6Application of RNA interference
- Track 3-7Treatment pathways
Oncolytic Virotherapy is the experimental treatment of cancer patients based on the administration of replication-competent viruses that selectively destroy tumor cells but leave healthy tissue unaffected. Virotherapy is a safe and effective cancer treatment. It improves time to progression, survival and quality of life for cancer patients. Virotherapy is particularly important in the treatment of those cancers types, which are insensitive to radiotherapy or chemotherapy, for example, melanoma.
Oncolytic viruses refer to those viruses that are able to eliminate malignancies by direct targeting and lysis (killing) of cancer cells within the Tumor, leaving non-cancerous cells unharmed. Oncolytic viruses by definition have a natural attraction to cancer cells (tropism), though their safety profile in patients, selectivity and replication competence vary significantly by type and strain of virus.
- Track 4-1Resent advances in oncolytic virotheraphy
- Track 4-2Role in cancer treatment
- Track 4-3Drawbacks of oncolytic virotherapy
- Track 4-4Different procedures involved in the thearpy
Immunopharmacotherapy is the treatment or prevention of disease by taking measures to increase immune system functioning (as by the administration of antibodies or hypo sensitization). Immune cell therapy involves engineering or isolating cancer-fighting immune cells (T cells), growing large numbers of these cells in the laboratory and then infusing them back into patients. Immune cells are naturally present in most tumours, but usually have been deactivated by the cancer or simply lack the numbers to eradicate the cancer on their own.
- Track 5-1Diseases treated by immunopharmacology
- Track 5-2Types of cells involved in immunopharmacotherapy
- Track 5-3Vacination strategies
- Track 5-4Mechanism of immunopharmacotherapy
Innovative Therapies includes correcting a defective gene, inserting a gene-drug, grafting cells capable of regenerating healthy tissue. In patients with rare, severe immune-mediated inflammatory diseases (IMIDs), biologics are often the last treatment option when standard therapy with classical immunosuppressive drugs fails. However, clear guidelines on biologic prescription in these diseases are often lacking. A major reason is that proper randomized controlled trials (RCTs) are difficult to design due to the low prevalence, heterogeneity of patients, and the severe medical condition of patients. Since RCTs are usually required for registration of therapy for a specific disease, physicians often prescribe biologics off-label in these diseases. Off-label prescription can be defined as the prescription of a drug for conditions other than current registered indications. This means that the drug is approved by either FDA or EMA for a certain disease, yet there is no definitive proof for the efficacy of the specific drug for other conditions. The physician’s decision to prescribe off-label in such cases is often based on the pathophysiology of the disease or shared symptoms with other diseases in which the biologic has proven to be effective. This is called rational prescription and may lead to innovative treatment options, especially in rare diseases.
- Track 6-1Types of inovative therapies
- Track 6-2Problems involved in innovative therapies
- Track 6-3Breakthrows
Stem cell therapy, also known as regenerative medicine, promotes the reparative response of diseased, dysfunctional or injured tissue using stem cells or their derivatives. It is the next chapter of organ transplantation and uses cells instead of donor organs, which are limited in supply. Stem cells have the power to go to these damaged areas and regenerate new cells and tissues by performing a repair and a renewal process, restoring functionality. Regenerative medicine has the potential to provide a cure to failing or impaired tissues.
- Track 7-1Techniques involved in transplantation
- Track 7-2Process and procedures
- Track 7-3Adult and embryonic stem cell
- Track 7-4Complications associated
- Track 7-5Obstacles in the therapy
- Track 7-6Major breakthroughs
- Track 7-7Disadvantages/ Side effects
Cancer Biotherapeutics encompasses all biologically derived materials that have been processed or engineered to treat cancer, including cancer-killing viruses, immune cell therapies and antibody therapies. All of these therapies have mechanisms that enlist the immune system (are immunotherapeutic), are highly promising and targeted, and are the subject of much excitement in research. In contrast to conventional therapies, biotherapeutics for cancer treatment are not based on man-made chemicals that flood the system with toxins. Biotherapeutics are designed to specifically target cancer cells without harming healthy cells, which results in greater effectiveness and fewer, less severe, side effects. Even in early phase clinical trials, biotherapeutics have provided complete remission for a number of patients who had run out of treatment options.
- Track 8-1Hurdles associated in the cure
- Track 8-2Diagnostics
- Track 8-3Immuno oncology
- Track 8-4Innovative approaches for cancer
- Track 8-5Cancer immune therapy
- Track 8-6Optimisation of antibody products
Clinical Biotherapeutic aspects including study design, drug-drug interactions, QT assessment, immunogenicity, comparability, special populations (hepatic and liver failure), PK and PD, regulatory expectations of PK and PD characterization, as well as reviewing factors which influence the ADME of Biotherapeutics. The objectives of early clinical development of therapeutic proteins are the same as for small molecules i.e. to investigate the molecule in a manner that will gain necessary knowledge about its tolerability safety pharmacokinetics (PK) and if possible pharmacodynamics (PD) effects in the most appropriate human populations while simultaneously protecting their safety. However, there are specific features of proteins that must be considered when designing clinical pharmacology studies.
- Track 9-1Pharmacokinetics of therapeutic proteins
- Track 9-2pharmacodynamics of therapeutic proteins
- Track 9-3Toxicology of therapeutic proteins
- Track 9-4Toxicology measures in therapeutic proteins
- Track 9-5Clinical development of therapeutic proteins
Biotherapy is the treatment to stimulate or restore the ability of the immune (defence) system to fight infection and disease. Biological therapies, sometimes called biotherapy, immunotherapy or biological response modifier therapy, is designed to repair, stimulate, or enhance your body’s own immune responses. Biological therapy is thus any form of treatment that uses the body's natural abilities that constitute the immune system to fight infection and disease or to protect the body from some of the side effects of treatment. Biotherapy often employs substances called Biological response modifiers (BRMs). The body normally produces low levels of BRMs in response to infection and disease. Large amounts of BRMs can be made in the laboratory to treat cancer, rheumatoid arthritis, and other diseases.
- Track 10-1Immune system-targeted therapies
- Track 10-2Endocrinological (hormonal) therapies
- Track 10-3Tyrosine kinase inhibitor therapy
- Track 10-4Gene therapy
- Track 10-5DNA repair enzyme inhibitor therapy
- Track 10-6Adoptive cellular therapy
Analytical biotherapeutics include identity by microbiological characterization of the strain, purity (monosepsis), strength by determination of viability, development of cell based potency assays. This also includes advanced characterization technologies for a range of complex therapeutic proteins to provide complete understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. Analytical Biotherapeutics mainly focuses on assay and validation methods, hot spots identification, post-translational modifications, impurities, critical quality attributes formulation and stability.
- Track 11-1Recombinant protein expression and production
- Track 11-2Extractables and leachables
- Track 11-3Advancements in analytical technology
- Track 11-4Advances in bioassays and functional characterization
For the discovery of drug process disease target identification/validation, generation of highly potent compounds targeting proteins, pharmacokinetics and drug metabolism each of these steps produces a large volume of samples that require rapid and accurate analysis. Similarly Mass spectrometry (MS) has become the method of choice in structural characterization of small molecules and proteins it not only measures the molecular weight (MW) of compound, but also provides structural information by fragmentation studies via tandem MS/MS. The development of electrospray ionization (ESI), matrix-assisted laser desorption/ionization (MALDI) or soft ionization and ambient MS has further augmented the role of MS in the studies of small molecules and proteins.
- Track 12-1Ultraviolet-Visible (UV-VIS) spectrophotometry
- Track 12-2InfraRed (IR) spectroscopy
- Track 12-3Mass spectrometry in the idenfication of small organic molecules
With the advent of newer drug molecules either partially synthesized, totally synthesized or isolated from naturally occurring microbial and plant products—it has become absolutely necessary to ascertain and examine critically their physical characteristics, chemical equivalence, chemical impurities and their prescribed limits, degradation of products, metabolites and above all their biological features. The dosage forms having either single or multi-component formulated product. The fundamental reasons for this sudden legitimate is to ‘analysis of drug substances’ are perhaps due to the tremendous growth in the progress of ‘medicinal chemistry’ towards achieving one ultimate objective which is to obtain ‘better drugs for a better world.
Forensic labs are often called in to identify unknown powders, liquids and pills that may be illicit drugs. There are basically two categories of forensic tests used to analyse drugs and other unknown substances: Presumptive tests (such as colour tests) give only an indication of which type of substance is present -- but they can't specifically identify the substance. Confirmatory tests (such as gas chromatography/mass spectrometry) are more specific and can determine the precise identity of the substance.
- Track 13-1Sample preparation
- Track 13-2Extraction techniques
- Track 13-3Extraction from solid samples
- Track 13-4Extraction from liquid samples
Metabolism was previously known as ‘detoxication’ mechanism in the body. It is the mechanism of elimination of foreign and undesirable compounds from the body and control the level of desirable compounds such as vitamins in the body. Metabolism of the drug plays significant role in selection and characterisation of drugs. The major site of metabolism in the body is Liver.
- Track 14-1Synthetic porfirines
- Track 14-2The Fenton-reaction
- Track 14-3Electrochemical oxidation
- Track 14-4In vitro and ex vivo techniques
- Track 14-5Immobilized enzyme reactors (IMER)
- Track 14-6Liver cell lines
- Track 14-7Liver slices, isolated perfused liver
- Track 14-8Integrated discrete multiple organ co-culture system (IdMOC)
The development of the bioanalytical techniques brought a progressive discipline for which the future holds many exciting opportunities to further improvement. The main impact of bionalysis in the pharmaceutical industry is to obtain a quantitative measure of the drug and its metabolites. The purpose is to perform the pharmacokinetics, toxicokinetics, bioequivalence and exposure response like pharmacokinetic / pharmacodynamic studies. Various bioanalytical techniques are performed in bioanalytical studies such as hyphenated techniques, chromatographic techniques, and ligand binding assays. This review extensively highlights the role of bioanalytical techniques and hyphenated instruments in assessing the bioanalysis of the drugs. Some techniques commonly used in bioanalytical studies include.
- Track 15-1Hyphenated techniques
- Track 15-2Chromatographic methods
- Track 15-3Ligand binding assays
- Track 15-4Electrophoretic techniques
A method of separating and analysing mixtures of chemicals through various processes of chemical analysis in which the constituents of a mixture are separated into distinct bands or spots on an adsorbent material. There are two main categories of chromatography: preparative and analytical. Analytical work uses small sample sizes; the objective is to separate compounds in order to identify them. Preparative work uses large quantities of samples and collects the output in bulk; the point of the chromatography here is to remove impurities from a commercial product.
- Track 16-1Applications and technologies
- Track 16-2High-performance liquid chromatography (HPLC)
- Track 16-3Supercriticalfluid chromatography (SFC)