3^rd International Conference on Biopharmaceutics and Biologic Drugs August 30-31, 2017 Philadelphia, USA
(10 Plenary Forums - 1Event)

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.

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.

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 Biopharma 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.

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 Biopharma 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.

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. Biologics target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. 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 tumor 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 antirheumatic drugs (DMARDs).

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.

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Dis-ease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease- the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

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.

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.

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, Drug toxicity and 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.

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.

rotein–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-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 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.

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.

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 issue of herb-drug interactions looms large over the practice of herbal medicine. Up to now there have been very few incidents recorded of herb-drug interactions, but since the first such reports emerged a decade ago, a concern has been raised: that we know so little about herbs and their potential for interaction with drugs that these incidents could be just the "tip of the iceberg." Virtually all medical writers who review the literature acknowledge the small number of reports, but conclude that the issue of herb-drug interactions is a serious one that must be pursued. In a few instances, the interactions may have been responsible for severe consequences   Examples: Increase or decrease the effect of a blood thinner such as Warfarin and lead to either a bleeding episode or formation of a dangerous clot;

• 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; or
• Increase the effect of an anti-diabetes drug and plunge blood sugar to   dangerously low level.

Pharmaceutical analytic 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.