Global Pharma Summit and Expo July 29-31, 2020 Shanghai, China

Biopharmaceutical Science includes study of the drug discovery and their development, along with their properties, both physical and chemical. It also deals with the biological effects of drugs like onset and duration of action along with their intensity in the body.  Bio-Pharmaceutical Sciences session includes talks on diversified fields like Biopharmaceutics and drug disposition, Innovations in clinical development, Pharmaceutical technology, Drug discovery and design, Pharmaceutics and drug delivery, Routes of administration, Fundamental drug development and etc.

Pharmacodynamics, described as what a drug does to the body, involves receptor binding, post receptor effects, and chemical interactions. Drug pharmacokinetics determines the onset, duration, and intensity of a drug’s effect. Formulas relating these processes summarize the pharmacokinetic behaviour of most drugs. Pharmacokinetics of a drug depends on patient-related factors as well as on the drug’s chemical properties. Some patient-related factors (e.g. renal function, genetic makeup, sex, age) can be used to predict the pharmacokinetic parameters in populations.

Nanotechnology is manipulation of matter on an atomic, molecular, and supramolecular scale. The earliest, widespread description of nanotechnology referred to the particular technological goal of precisely manipulating atoms and molecules for fabrication of macroscale products, also now referred to as molecular nanotechnology. A more generalized description of nanotechnology was subsequently established by the National Nanotechnology Initiative, which defines nanotechnology as the manipulation of matter with at least one dimension sized from 1 to 100 nanometres. This definition reflects the fact that quantum mechanical effects are important at this quantum-realm scale, and so the definition shifted from a particular technological goal to a research category inclusive of all types of research and technologies that deal with the special properties of matter which occur below the given size threshold. It is therefore common to see the plural form "nanotechnologies" as well as "nanoscale technologies" to refer to the broad range of research and applications whose common trait is size.

Researchers discover new drugs through insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. Once researchers identify a promising compound for development, they conduct experiments to gather information on how it is absorbed, distributed, metabolized, and excreted, best dosage, Side effects, how it interacts with other drugs and treatments and its effectiveness as compared with similar drugs.

Drug expansion is the procedure of creating a new pharmaceutical drug to the global market once a lead compound has been found through the procedure of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory statuses, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

Pharmacokinetics of a drug depends on patient-related factors as well as on the drug’s chemical properties. Some patient-related factors (e.g., renal function, genetic makeup, sex, age) can be used to predict the pharmacokinetic parameters in populations. Knowledge of pharmacokinetic principles helps prescribers adjust dosage more accurately and rapidly. Application of pharmacokinetic principles to individualize pharmacotherapy is termed therapeutic drug monitoring.

Pharmacodynamics, described as what a drug does to the body, involves receptor binding, post receptor effects, and chemical interactions. Drug pharmacokinetics determines the onset, duration, and intensity of a drug’s effect. Formulas relating these processes summarize the pharmacokinetic behaviour of most drugs.

Pharmacology focuses on the therapeutic effects of pharmaceutical substances and how they can be used most effectively for medical purpose. Toxicology and Pharmacology are both studies that involve in assessing the properties of chemicals and their actions on the body, but differ significantly in other areas. Toxicology is closely related to the adverse effects that can occur in living organisms that come into contact with chemical compounds. Toxicologists are also concerned with determining the risk of certain substances with risk assessment tools.

Drug delivery systems control the pharmacokinetics, pharmacodynamics, non-specific toxicity, immunogenicity and efficacy of drugs. NDDS is a combination of advance technique and new dosage forms which are far better than conventional dosage forms. Novel drug delivery system classified in to different types based on the diffusion types. Drug Delivery Carriers show great promise as drug delivery systems. Drug delivery may be either active or passive process.  These are designed to target the site specific region, in order to achieve desired therapeutic effect, thereby reducing the side or toxic effects. NTTD Increases the efficacy of the drug and decrease side effects. The global market for drug delivery systems is expected to rise at a compound annual growth rate (CAGR) of 5% and reach nearly $175.6 billion by 2021.

Toxicology is the scientific study of harmful effects of chemical, biological and physical agents in biological systems that establish the extent of damage in living organisms. It includes observing symptoms, mechanisms, detection and treatments of toxic substances, in certain relation to the poisoning of humans. It consists of environmental agents and chemical compounds, as well as Pharmaceutical Compounds that are manufactured for medical use by humans. These substances may produce toxic effects in living organisms including disturbance in growth patterns, discomfort, disease and death. Factors that influence toxicity include the dose, the route of exposure, shape and structure of the chemical, the species, individual human factors and environment.

Pharmacovigilance and Risk Management comprises set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal and therapeutic products including the assessment of the effectiveness of their clinical interventions and combination therapies. Drug industry need to promote companies in pharmacovigilance practice to use information technology and to review software’s used in pharmacovigilance and clinical trials. Monitoring unlicensed, off labels and orphan drugs is major task in risk management. Many experts from different pharmacovigilance CRO’s, pharmacovigilance service providers and industrial delegates are participating in this conference to share their knowledge and discuss about the new updates.

One of the big challenges of medicine today is to deliver drugs specifically to defected cells. Nano particulate drug carriers have the potential to answer to this call, as nanoparticles can cross physiological barriers and access different tissues, and also be provided in a targetable form aimed at enhancing cell specificity of the carrier. Recent developments within material science and strong collaborative efforts crossing disciplinary borders have highlighted the potential of mesoporous silica nanoparticles (MSNs) for such targeted drug delivery. Relatively straightforward inside-out tuning of the vehicles, high flexibility, and potential for sophisticated release mechanisms make these nanostructures promising candidates for targeted drug delivery such as ‘smart’ cancer therapies. Moreover, due to the large surface area and the controllable surface functionality of MSNs, they can be controllably loaded with large amounts of drugs and coupled to homing molecules to facilitate active targeting, simultaneously carrying traceable (fluorescent or magnetically active) modalities, also making them highly interesting.

Biologic Drugs or biologic response modifiers are medications genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. Biologic response modifiers (biologics for short) are drugs that are genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. They target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. The proteins targeted include tumour necrosis factor (TNF), interleukin-1 (IL-1) and interleukin-6 (IL-6), which are involved in joint inflammation. Biologics are typically reserved for people whose arthritis has not responded well to disease-modifying anti-rheumatic drugs (DMARDs).

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. Euro Biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

Medicinal chemistry and pharmaceutical chemistry are disciplines at the intersection of chemistry, especially synthetic organic chemistry, and pharmacology and various other biological specialties, where they are involved with design, chemical synthesis and development for market of pharmaceutical agents, or bio-active molecules. Compounds used as medicines are most often organic compounds, which are often divided into the broad classes of small organic molecules and "biologics", the latter of which are most often medicinal preparations of proteins. Inorganic and organometallic compounds are also useful as drugs.

In particular, medicinal chemistry in its most common practice—focusing on small organic molecules—encompasses synthetic organic chemistry and aspects of natural products and computational chemistry in close combination with chemical biology, enzymology and structural biology, together aiming at the discovery and development of new therapeutic agents. Practically speaking, it involves chemical aspects of identification, and then systematic, thorough synthetic alteration of new chemical entities to make them suitable for therapeutic use. It includes synthetic and computational aspects of the study of existing drugs and agents in development in relation to their bioactivities, i.e., understanding their structure-activity relationships (SAR). Pharmaceutical chemistry is focused on quality aspects of medicines and aims to assure fitness for purpose of medicinal products.

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is involved in every step of the development of a novel medicine and in the post-marketing activities with medicinal products. It is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.

Drugs are removed from the body by various elimination processes. Drug elimination refers to the irreversible removal of drug from the body by all routes of elimination. The declining plasma drug concentration observed after systemic drug absorption shows that the drug is being eliminated from the body but does not indicate which elimination processes is involved. Drug elimination is usually divided into two major components: excretion and biotransformation. Drug excretion is the removal of the intact drug. Non-volatile drugs are excreted mainly by renal excretion, a process in which the drug passes through the kidney to the bladder and ultimately into the urine. Drug elimination in the body involves many complex rate processes. Although organ systems have specific functions, the tissues within the organs are not structurally homogeneous, and elimination processes may vary in each organ, drug elimination was modelled by an overall first-order elimination rate process. Clearance may be defined as the volume of fluid cleared of drug from the body per unit of time.

Health economics is a tool to help us prioritise different and sometimes competing health care interventions for these fixed resources and, in doing so, health care is treated as a commodity like any other. Knowledge of health economics coupled with political insight is essential to understand resource allocation and expenditure in a modern health care system. Pharmacists, with their unique knowledge of medicine, are crucial in using pharma-co-economics analysis to influence expenditure and distribution of resources on medicines. Design and management of pharma-co-economic studies

·         Cost and burden of illness studies

·         Drug utilization

·         Budget impact analysis

·         Modelling and simulations

A vaccine is a biological preparation that provides active adaptive immunity to a particular disease. Vaccine generally contains a component that is usually a disease-creating microorganism and is often made from weakened or killed forms of the microbe, pathogen, its toxins, or one of its surface proteins. There are many types of vaccine like – 1.Inactivated, 2.Attenuated, 3.Toxoid, 4.Subunit, 5.Conjugate, 6.Experimental, 7.Valance, 8.Heterotypic. The administration of the vaccine into the body is called vaccination which is the most effective method of preventing infectious disease.

Immunization system contains two types of doses That is – Prime dose & Booster dose. Immunization failed if the patient ignores the booster dose. Booster doses are required to induce an effective immunity. For that reason to skip the booster dose, invention of new generation prophylactic and therapeutic vaccine are required to initiate more effective immunization. Nowadays vaccine allows the incorporation of doses of antigen, that’s why antigen released in a very controlled way. Here the transportation of vaccine to the specific site is done by the carriers in a sustained release and accurate targeting manner.

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. A major aspect of quality control is the establishment of well-defined controls. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. Quality control also plays a major role in analytical method development so it would be great to attend the quality control summit.

Quality Assurance (QA) is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. Quality assurance conferences aims at the need for Effective Internal and External Quality Assurance Auditing and it is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. Quality assurance testing is done by using software called Quality Metrics.

Chromatography and Mass Spectrometry are extensively used in the formulation development stage of generic drug products. The ICH Q3B guidelines address the reporting threshold, identification threshold, and qualification threshold for impurities in the drug product.  Chromatography (LC) and Gas Chromatography (GC) are extensively used to analyse stable compounds. However, for labile compounds require derivatization prior to LC or GC analysis. For certain selected analyses, Liquid Chromatography- Ultraviolet Detection (LC-UVD) and Gas Chromatography-Flame Ionization Detection (GC-FID) techniques may be deemed suitable. However, Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) are usually the techniques of choice when higher specificity and sensitivity are required. Gas Chromatography-Electron Capture Detection (GC-ECD) techniques are commonly used for halogenated PGIs/GIs to enhance sensitivity and selectivity. Occasionally, some spectroscopic techniques like Nuclear Magnetic Resonance (NMR), light scattering, and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) are used in analysing PGIs/GIs.

Pharmacognosy the branch of knowledge concerned with medicinal drugs obtained from plants or other natural sources. Drug Action examines how the drug itself works in a living system, which is the definition of pharmacology. The action of the drug can be studied at the molecular level, in a cell, an organ, and in animals. Specialty fields within Drug Action include molecular biology, pharmacology, pharmacodynamics, toxicology, and biochemistry.

Pharmacognosy gives a sound knowledge of the vegetable drugs under botany and animal drugs under zoology. It also includes plant taxonomy, plant breeding, plant pathology, and plant genetics and by this knowledge one can improve the cultivation methods for both medicinal and aromatic plants.

Paediatric drug specialists guide children and their parents about solution and write prescriptions as needed. They track their patients' therapeutic progress and ensure that there are no harmful drug interactions or unexpected side effects. Paediatric drug specialists regularly work in restorative offices like specialist's workplaces, drug stores, and healing facilities. Paediatric Pharmacy ensures safe and effective drug use and optimal medication therapy outcomes in children up to 18 years of age. Currently there are more than 1,100 BPS Board Certified Paediatric Pharmacy Specialists. Paediatric pharmacists counsel children and their parents about medication and write prescriptions as needed. They track their patients' medical progress and make sure that there are no harmful drug interactions or unexpected side effects.