2^nd International Conference and Expo on Biopharmaceutics and Biologic Drugs September 14-16, 2016 San Antonio, USA

The overall aim of this research program is to develop novel principles for specific drug delivery and targeting to the active site by using complex in vivo models. An innovative, cutting edge and multi-disciplinary collaboration using clinical models will include research teams from: pharmaceutical technology, material science, biopharmaceutics and pharmacokinetics, drug metabolism, toxicology, oncology, gastroenterology, endocrinology, urology and regulatory science

The global market for process analytical technology (PAT) instrumentation in 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014. The projected PAT instrumentation market is expected to be valued at around $450.6 million by 2019 at a compound annual growth rate (CAGR) of 6.7% for the period of 2014 to 2019. 

Drug discovery involves the use of high throughput screening techniques to identify new compounds, both synthetic and natural, as novel drugs. Unfortunately, this approach has yielded very few successes in the field of anti-infective drug discovery. The identification of both molecular targets that are essential for the survival of the pathogen, and compounds that are active on intact cells, is a challenging task. Even more formidable, however, is the requirement for appropriate potency levels and suitable pharmacokinetics, in order to achieve efficacy in small animal disease models. 

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.

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. Other pathways for drug excretion may include the excretion of drug into bile, sweat, saliva, milk (via lactation), or other body fluids. Volatile drugs, such as gaseous anaesthetics, alcohol, or drugs with high volatility, are excreted via the lungs into expired air. 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. The units for clearance are millilitres per minute (mL/min) or liters per hour (L/h). The volume concept is simple and convenient, because all drugs are dissolved and distributed in the fluids of the body. 

An important component to this mission across the biopharmaceutical industry is identifying and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically meaningful medicines. Although there has been progress across this range of road blocks by individual companies, the underlying economics continue to threaten the R&D business model. The challenges facing the pharmaceutical industry make the choice of a strategic discovery partner more important than ever. At Array Bio Pharma we offer a fully integrated, world-class small molecule drug discovery platform. Our experience allows us to harness this capability to move rapidly from hit identification through IND and clinical proof of concept.  During a research project, we seamlessly integrate proprietary compound collections, state of the art structural biology and computational chemistry with highly experienced medicinal chemists and biologists leading from the bench. 

New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014

Biologic Drugs are the drugs that are made from a living organism or its products and are used in the prevention, diagnosis, or treatment of diseases. Biological drugs include antibodies, interleukins, and vaccines.

A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. At that time the Biowaiver was only considered for scale-up and post approval changes (SUPAC) to pharmaceutical products.

Biological Medicine is the science, practice, and art of healing that is a fundamental form of medicine, applicable to each human body, regardless of the illness. Biological medicine has a simple objective: identify the source of disorders, imbalances, and weaknesses in the human regulatory system and heal the whole body

Pharmaceutical manufacturing operations are inefficient and costly. Compared to other Industrial sectors, the rate of introduction of modern engineering process design principles, new measurement and control technologies, and knowledge management systems is low. Opportunities for improving efficiency and quality assurance through an improved focus on design and control, from an engineering perspective, are not generally well recognized. Quality and productivity improvement share a common element -reduction in variability through process understanding. Reducing variability provides a "win-win" opportunity from both public health and industry perspectives. And, since pharmaceutical product manufacturing technologies and practices are generally similar between both innovator and generic companies, facilitating efficiency improvements provide opportunities for both sectors of the pharmaceutical industry. An efficient and secure US pharmaceutical manufacturing sector will be essential in the 21st Century.

The global market for animal therapeutics and diagnostics totaled $37.8 billion in 2014 and is expected to reach about $46.5 billion in 2019, registering a compound annual growth rate (CAGR) of 4.2% for the period 2014-2019.

A number of methodologies can be adapted to improve solubilisation of poor water soluble drug and further to improve its bioavailability. Solubilisation of poorly soluble drugs is a frequently encountered challenge in screening studies of new chemical entities as well as in formulation design and development. Any drug to be absorbed must be present in the form of an aqueous solution at the site of absorption. ‘Solubility’ is defined as maximum amount of solute that can be dissolved in a given amount of solvent. Quantitatively it is defined as the concentration of the solute in a saturated solution at a certain temperature. In qualitative terms, solubility may be defined as the spontaneous interaction of two or more substances to form a homogenous molecular dispersion. A saturated solution is one in which the solute is in equilibrium with the solvent. The solubility of a drug is represented through various concentration expressions such as parts, percentage, molarity, molality, volume fraction, mole fraction. Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

The global medical device coating market reached $4.8 billion in 2010 and $5.4 billion in 2011. The market is expected to grow from $5.7 billion in 2012 to nearly $8 billion in 2017, a five-year compound annual growth rate (CAGR) of 6.7%.

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. An approach to developing the programs in regulatory science that leverages what has been learned in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such an program is broad, noted that it is necessary to break out of the mindset that regulatory science resides totally with FDA and that the field's obligation is to create a workforce that will function within the confines of FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program include understanding research and scientific methodology, pharmacology toxicology therapeutics, and the science that underpins the regulatory process. 

The regulatory affairs outsourcing market has been segmented into five major service segments: regulatory affairs; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others. The market segments have been extensively analyzed on the basis of their usefulness, efficacy, generated revenue and geographic coverage. The market size and forecast in terms of USD million for each service type has been provided for the period from 2012 to 2020, considering 2013 as the base year. The report also provides the compounded annual growth rate (CAGR %) for each market segment for the forecast period from 2014 to 2020.

For dosage forms it is common to differentiate the various types by classifying them according to their physical state into gaseous (e.g. anaesthetics), liquid (e.g. solutions, emulsions, suspensions), semisolid (e.g. creams, ointments, gels and pastes) and solid dosage forms (e.g. powders, granules, tablets and capsules). Most dosage forms contain several phases. Sometimes the phases of a dosage form are of the same state, for example for an emulsion which contains two liquid phases (oil and water). Whilst both phases are liquid, they differ in their physical properties, for example density and electrical conductivity, and are separated from each other by an interface. However, more often the dosage form contains phases of different states. For example, a suspension contains a liquid and a solid phase. Therefore classification into gaseous, liquid, semisolid or solid dosage forms may sometimes appear somewhat arbitrary. Finally, in these multiphase dosage forms usually one or more phases are dispersed, whilst other phases are continuous. In a suspension the solid phase is dispersed and the liquid phase is continuous, and in an oil-in-water emulsion the oil phase is dispersed and the water phase is continuous. In some dosage forms the determination of the type and number of phases is not as straightforward.

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%.

Protein–protein interactions between membrane-localized receptors and intracellular signalling molecules control neuronal function and theoretically provide a rich source of vastly overlooked targets for drug discovery in neuropsychopharmacology. But, unlike the well-defined binding pocket of transporters and receptors, the flat, expansive, and adaptive topology of the protein–protein interface presents a sizeable challenge to the goal of identifying small molecules that result in a gain or loss of function of the protein complex. This is offset by the growing body of evidence to suggest that a few amino acids at the interface (‘hot spot’) contribute to the majority of the binding energy in protein–protein interactions suggesting that modulators with a high degree of specificity could be developed. Furthermore, recent advances in screening technologies and accessibility to an ever-increasing diversity of small molecules suggest that protein–protein interactions are a viable option for drug discovery.

The global proteomics market was valued at nearly $5.1 billion in 2014 and is growing at a compound annual growth rate (CAGR) of 18.0% to reach a forecast value of $11.6 billion by 2019.

The assessment of BA/BE of different drug products is based on the fundamental assumption that two products are equivalent when the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses. Should the rate of absorption actually differ between products, it would have to be intentional and reflected in the proposed product label and be clearly demonstrated that it is not essential in the attainment of effective body drug concentrations on chronic use or has been shown to be medically insignificant for the drug. In practice, equivalence is indicated when key pharmacokinetic parameters used to establish rate and extent of the test, and reference products fall within a preset confidence interval. The FDA declares a drug product to be therapeutically equivalent to the innovator product if it is pharmaceutically equivalent, i.e., same active ingredient, dosage form, strength and route of administration, and bioequivalent. Products that are therapeutically equivalent can be used interchangeably. Thus, BE studies are construed to be considered surrogates for comparative clinical trials for the assessment of therapeutic equivalence in safety and efficacy between two drug products. 

The global market for blood-brain barrier (BBB) technology for therapeutics amounted to $12.3 million in 2010 and will reach $387 million by 2015, a compound annual growth rate (CAGR) of 99.3%.

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. Here we outline recent advances which in this sense push MSNs to the forefront of drug delivery development. 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 

Global nanomedicine market was valued at $214.2 billion in 2013 and $248.3 billion in 2014. The total market is projected to grow at a compound annual growth rate (CAGR) of 16.3% from 2014 through 2019 and reach $528 billion by 2019.

An interpenetrating polymer network, IPN, is a combination of two polymers in network form, at least one of which is synthesized and/or cross-linked in the immediate presence of the other. An IPN is distinguished from other multi polymer combinations, such as polymer blends, blocks, and grafts, in two ways: (1) an IPN swells, but does not dissolve in solvents; and (2) creep and flow are suppressed. interpenetrating polymer networks having ionic or covalent bond between the interpenetrating networks are prepared from a first and a second polymer network, at least one of which contains an EPRXE resin, a resin having two epoxide functionalities represented by E and a reactive pendant nonepoxide functionality X. The two resin networks are sequentially cross-linked followed by activation of the pendant functionality of the EPRXE resin to form internetwork links between the two resin networks affording an epoxy resin with both increased strength and toughness. The invention is also directed to the process of making EPRXE resins where the pendant functionalities are primary, secondary, or tertiary amines, protected amino, or protected carboxyl groups.

The global bioplastic demand totaled 1.1 million metric tons in 2013. This is expected to reach 1.4 million metric tons in 2014 and about 6 million metric tons in 2019, a compound annual growth rate (CAGR) of 32.7% for the five-year period, 2014 to 2019.

• Decrease the effect of a blood pressure medication, leading to high blood pressure and a stroke
• Decrease the effect of an anti-infection agent, letting the infection get out of control
• Increase the effect of an anti-diabetes drug and plunge blood sugar to dangerously low level

Pharmaceutical market research deals with the collection, analysis, and interpretation of details and information relating to the market environment of a given pharmaceutical product in general of a medical drug.The primary objective of pharmaceutical market research is to gain as realistic and objective as possible an impression of the marketing opportunities of a given pharmaceutical product, thus enabling the identification of the chances and risks associated with its development potential as early on as possible.

The global orphan drug market totalled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019, demonstrating a compound annual growth rate (CAGR) of 9.2% during the forecast period (2014 to 2019).

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