4^th International Pharma & Clinical Pharmacy Congress Nov 07-09, 2016 Las Vegas, Nevada, USA

In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy.

The Western European biomarkers market in drug discovery and development will continue to grow - from $ million in 2013 to $ million in 2019, at a compound annual growth rate (CAGR) of % from 2013 to 2020.The use of biomarker-based tests in drug discovery, early diagnosis and prognosis is in the growth stage.

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy.[1] They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

Birkett (2003) defined bioequivalence by stating that, "two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bio availabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. Pharmaceutical equivalence implies the same amount of the same active substance(s), in the same dosage form, for the same route of administration and meeting the same or comparable standards."

The overall emerging markets for therapeutic drugs totalled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

The method by which a drug is delivered can have a significant effect on its efficacy. Some drugs have an optimum concentration range within which maximum benefit is derived, and concentrations above or below this range can be toxic or produce no therapeutic benefit at all. On the other hand, the very slow progress in the efficacy of the treatment of severe diseases, has suggested a growing need for a multidisciplinary approach to the delivery of therapeutics to targets in tissues. From this, new ideas on controlling the pharmacokinetics, pharmacodynamics, non-specific toxicity, immunogenicity, biorecognition, and efficacy of drugs were generated. These new strategies, often called drug delivery systems (DDS), are based on interdisciplinary approaches that combine polymer science, pharmaceutics, bioconjugate chemistry, and molecular biology.

Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect.

Pre-formulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation. In dealing with protein pre-formulation, the important aspect is to understand the solution behaviour of a given protein under a variety of stress conditions such as freeze/thaw, temperature, shear stress among others to identify mechanisms of degradation and therefore its mitigation.

Applications and various formulations for which contract manufacturing, research and packaging are widely used are also discussed separately in the report. The report also takes into account various new developments and regulatory aspects in this industry. The report also covers significant patents in each category. Analysis of global market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.The North American market is estimated to reach nearly $73 billion in 2011 and is expected to increase at a 7.9% compound annual growth rate to reach nearly $107 billion in 2016.

Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. It may involve scientific site-targeting within the body, or it might involve facilitating systemic pharmacokinetics; in any case, it is typically concerned with both quantity and duration of drug presence. Drug delivery is often approached via a drug's chemical formulation, but it may also involve medical devices or drug-device combination products. Drug delivery is a concept heavily integrated with dosage form and route of administration, the latter sometimes even being considered part of the definition

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Regulatory affairs (RA),  also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc.  Regulatory affairs also has a very specific meaning within the healthcare industries.

Starting in 1980 the European Union started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation. Concurrently the EU had been developing the concept of New Approach Directives where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).

Many in the Regulatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.

Regulatory Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or outtask regulatory affairs to external service providers. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Documentation is a set of documents provided on paper, or online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is becoming less common to see paper (hard-copy) documentation. Documentation is distributed via websites, software products, and other on-line applications.

Professionals educated in this field are termed documentalists. This field changed its name to information science in 1968, but some uses of the term documentation still exists and there have been efforts to reintroduce the term documentation as a field of study.

Overview of the global market for intelligent transportation systems (ITS) and related technologies and applications of global market trends, with data from 2012 through 2014, and projections of CAGRs through 2019. Analysis of intelligent transportation system devices by functional category, application, vehicle type, geography, and other factors and Examination of crucial innovative breakthroughs as well as a detailed patent analysis, Comprehensive profiles of major players in the ITS industry.

The main aim of pharmacovigilance is to provide complete and clear information related to drug safety  and various risks and benefits  associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events  which could not be provided by clinical trials involving in-vivo method. It enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation gives an outlook on the rules and laws to follow in Pharmacovigilance practice. The Role of pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines.

Drug Safety is the pharmacological science ensuring safety and related to the collection, detection, assessment, monitoring, and prevention of adverse side effects with pharmacological action of pharmaceutical products. According to US FDA a drug is regarded as safe by looking at side effects, its manufacturing process and results of animal testing and clinical trials. In this track, we discuss Drug safety and its applications in various fields such as Softwares, Training etc.

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.

Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.

Liposomes and nanoparticles: Nanoscale drug delivery systems using liposomes and nanoparticles are rising technologies for the rational delivery of chemotherapeutic drugs in the treatment various ailments. Nanoparticles present possible dangers, both medically and environmentally.

The pharmaceutical industry is directly impacted by the research conducted with prescription drugs, vaccines, and OTC drugs being manufactured based on findings from the study of life sciences. Clinical trials are conducted to ensure that products being developed are tested on how well they work on individuals affected by the diseases or conditions they are created to treat.

An adverse drug reaction (ADR) is an injury caused by taking a medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse drug event (ADE) refers to any injury occurring at the time a drug is used, whether or not it is identified as a cause of the injury.

Bioinformatics plays key role in experimental molecular biology as image and signal processing allow extraction of useful results from large amounts of raw data. In the field of genetics and genomics, it aids in sequencing and annotating genomes and their observed mutations, in the text mining of biological literature and the development of biological and gene ontologies to organize and query biological data, in the analysis of gene and protein expression and regulation.

The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing. Regulators are becoming more cautious about approving truly innovative medicines.

World Pharma Congress is a productive conclave focussing in collaboration and communication among the Pharma Professional Business Entrepreneurs and  Pharma Indusrtrial Persons. Meetings fall apart thanks to sloppy agendas in making their Annual planning about developing their Business. Here's how some of the world's top execs participate in this congress and share their views and ideas.