16^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 19-21, 2018 Berlin, Germany

The most fundamental goal in drug design is to predict whether a given molecule will bind to a target and if so how strongly. Molecular mechanics or molecular dynamics are most often used to predict the conformation of the small molecule and to model conformational changes in the biological target that may occur when the small molecule binds to it. The therapeutic response of a drug depends upon the interaction of drug molecules with cell on cell membrane related biological events at receptor sites in concentration dependent manner.

Selective and effective localization of the pharmacologically-active moiety at preidentified target(s) in therapeutic concentration, while restricting its access to non-target(s) normal cellular linings, thus minimizing toxic effects and maximizing the therapeutic index accounts from effective and efficient drug delivery.

Molecular mechanics methods may also be used to provide semi-quantitative prediction of the binding affinity. Also, knowledge-based scoring function may be used to provide binding affinity estimates. These methods use linear regression, machine learning, neural nets or other statistical techniques to derive predictive binding affinity equations by fitting experimental affinities to computationally derived interaction energies between the small molecule and the target.

Biomedicine and pharmacotherapy is the science which deals with forefront of fundamental and technical science, biological and medical disciplines, therapeutics and pathological description. General fields of interest include molecular and cell biology, genetic disease, immunology and immunoregulation, cancer, chemotherapy,  nutriceutics, neurodegenerative, cardiac and Infectious Diseases. Special emphasis is placed on studies of specific topics such as differentiation, pharmacology and toxicology, preclinical and clinical pharmacology, the effects of drugs on cell structural and functional elements, the mechanism of gene regulation in normal and pathological cells, the role of viruses and parasites and the therapy of the diseases they induce

Green pharmacy is the design of pharmaceutical products and processes that eliminate or reduce significantly the use and generation of hazardous substances and the prevention/reduction of environmental/safety and health impacts at the source. A new pharmaceutical can be green in terms of the quality and quantity of waste generated during its synthesis. Green chemistry was defined by US academics Paul Anastas and John Warner in 1998, who identified 12 principles, including toxicity reduction, biodegradability and energy efficiency, to assess environmental impact. In part, green chemistry is simply an extension of the broader environmental agenda to reduce resource usage and pollution.

Sustainable pharmacy is a totally new issue and approach. It addresses environmental, economical and social aspects of pharmacy. In the present stage the focus will be on environmental issues along the whole lifecycle of a pharmaceutical entity. That is dealing with resources and energy input but also with waste issues for example during the synthesis and production of an Active pharmaceutical Ingredient. Furthermore, it would also look on the compounds themselves and will aim to improve the degradability of the compounds after their use in the environment to reduce the environmental risk caused by pharmaceuticals in the environment. Another issue is the people using pharmaceuticals such as pharmacists, medical doctors and patients. How can they contribute to more efficient use of pharmaceuticals with less environmental burden and less risk for drinking water.

The focus here is on the role of patients, doctors and pharmacists in contributing to green and sustainable pharmacy by proper use of the pharmaceuticals. An environmental classification system for pharmaceuticals as a valuable piece of information for doctors, pharmacists and patients is presented. We also take a look into the future: how will drug consumption develop?

Since green and sustainable pharmacy is still in its infancy, it attempts to identify lack of knowledge and stimulate more activities on the way to sustainable pharmacy rather than to resolve on-going discussions.

Nanoparticles (NPs) occur naturally and have been in existence for thousands of years as products of combustion and cooking of food. Nanomaterials differ significantly from other materials due to the following two major principal factors: the increased surface area and quantum effects. These factors can enhance properties such as reactivity, strength, electrical characteristics, and in vivo behaviour. As the particle size decreases, a greater proportion of atoms are found at the surface compared to inside. An NP has a much greater surface area per unit mass compared with larger particles, leading to greater reactivity. In tandem with surface area effects, quantum effects can begin to dominate the properties of matter as size is reduced to the nanoscale. These can affect the optical, electrical, and magnetic behaviour of materials. Their in vivo behaviour can be from increased absorption to high toxicity of nanomaterials. New drug carrier systems are one can name soluble polymers, microparticles made of insoluble (or) biodegradable natural and synthetic  polymers, microcapsules, cells, cell ghosts, lipoproteins, liposomes and micelles. Pharmaceutica 2018 evolves to be a drug disintegration conference, emulsion conference, capsule conference, and solubility conference. Pharmaceutical conferences will cover industry case studies, regulatory updates, latest therapies and technology innovations and much more. 

Key players in the market include Amgen, Inc., AstraZeneca plc, Eli Lilly & Co., Ipsen S.A., Merck & Co., Novartis AG, Novo Nordisk A/S, Roche Holdings AG, Sanofi, Takeda Pharmaceutical Company Limited, and Teva Pharmaceutical Industries Limited. Leading API manufacturers include Bachem Holding AG, PolyPeptide Group, and Peptisyntha Inc. at the pharmaceutical companies’ conference.

The global market for blood-brain barrier (BBB) technology for therapeutics reached $21.8 million in 2013. This market is expected to grow from $38.7 million in 2014 to $471.5 million in 2019, a compound annual growth rate (CAGR) of 64.9% from 2014 through 2019.

Pharmaceutical drug delivery technologies enhance drug absorption, efficacy, and patient experience. Taste maskers increase the commercial viability of your pharmaceutical products by neutralizing the strong, bitter tastes of certain oral medical formulations. Bioavailability of medications within the system can be achieved by increasing the dissolution rate with specialized drug delivery enhancement products. Enhancing the drug delivery technology of final pharmaceutical formulation can increase its commercial success. The main routes of drug delivery are oral, injection/infusion, and transdermal. Drug-eluting stents and other implantable drug delivery devices are presented, as well as externally applied devices. When combined with appropriate targeting moieties, drug-coated nanoparticles, drug-encapsulating liposomes and nanotubes, and tree-like dendrimers enable organ and tissue targeting.

The use of nanotechnology in medicine and more specifically drug delivery is set to spread rapidly. Currently many substances are under investigation for drug delivery and more specifically for cancer therapy. Interestingly pharmaceutical sciences are using nanoparticles to reduce toxicity and side effects of drugs and up to recently did not realize that carrier systems themselves may impose risks to the patient. The kind of hazards that are introduced by using nanoparticles for drug delivery are beyond that posed by conventional hazards imposed by chemicals in classical delivery matrices

These biotechnology derived drugs were formerly administered by injection alone, but today, solutions for inhaled, transdermal, and even oral delivery are available or under investigation for most established products. Nucleic acid delivery technologies , since unprotected or untargeted delivery of gene therapies or RNAi is inconceivable. We then move on to developments in transdermal delivery technology, which includes active systems where delivery is driven by microneedles or energy applied via ultrasound or lasers.

Nanotechnology involves the design of structures measuring 1 to 100 nm in diameter. Nanomaterials are being developed as drug-delivery vehicles, contrast agents, and diagnostic devices, and some are now being studied in clinical trials.

The extraordinary developments of nanotechnology and nanomedicine during the past decade have significantly pushed the frontiers of materials science and the inventive spirit of industrial and clinical users alike. The ever improving ability to design, improve and commercialize new materials is clearly a feature that we just started to observe in recent years.  Novel nanotechnology is a much needed additional avenue at this time, especially when open access can result from the publication process. The industrialization of nanoscale titanium dioxide for a broad range of applications (most of which we are quite familiar with) is only one such example showing how nanomaterials have become a central component in the manufacturing process during the past decade.

The science of nanotechnology is therefore the ability to manipulate these tiny particles. Nanotechnology is increasingly employed to explore the unseen avenues of medical sciences. There are many types of nanoparticles that are used in medicine and other fields, gold particles, Dendrimers, Perfluorocarbon, Nanotube, Iron oxide and FeCo are just few types that are used in this field and will lead to personalized medicine and early target therapy .

The ability to assemble nanoparticles into functional structures is an important challenge that needs to be addressed for the generation of nanoparticle-based devices.

Sol-gel method represents a facile yet powerful strategy for the self-assembly of metal oxides, chalcogenides, and metal-semiconductor hybrid nanoparticle systems into three-dimensionally connected porous nanostructures. In this highlight, the application of later strategy for the assembly of chalcogenide semiconductor and noble metal nanoparticles and their intriguing physical properties is reviewed in the context of future application in catalysis, sensing, and separation technologies.

By interacting with biological molecules, therefore at nanoscale, nanotechnology opens up a vast field of research and application. Interactions between artificial molecular assemblies or nano devices and biomolecules can be understood both in the extracellular medium and inside the human cells. Operating at nanoscale allows to exploit physical properties different from those observed at microscale such as the volume/surface ratio.

A second area exhibiting a strong development is “nanodrugs” where nanoparticles are designed for targeted drug delivery. The use of such carriers improves the drug bio distribution, targeting active molecules to diseased tissues while protecting healthy tissue. A third area of application is regenerative medicine where nanotechnology allows developing biocompatible materials which support growth of cells used in cell therapy.

The application of nanotechnology to medicine raises new issues because of new uses they allow, for instance.

France is a country where the medical development of nanotechnology is significant, like Germany, the United Kingdom or Spain, as regards the European Union. 

Smart drug delivery is a method of delivering medication to a patient in a manner that increases the concentration of the medication in some parts of the body relative to others. This means of delivery is largely founded on nanomedicine, which plans to employ nanoparticle-mediated drug delivery in order to combat the downfalls of conventional drug delivery. These nanoparticles would be loaded with drugs and targeted to specific parts of the body where there is solely diseased tissue, thereby avoiding interaction with healthy tissue. The goal of a targeted drug delivery system is to prolong, localize, target and have a protected drug interaction with the diseased tissue. The conventional drug delivery system is the absorption of the drug across a biological membrane, whereas the targeted release system releases the drug in a dosage form. The advantages to the targeted release system is the reduction in the frequency of the dosages taken by the patient, having a more uniform effect of the drug, reduction of drug side-effects, and reduced fluctuation in circulating drug levels. The disadvantage of the system is high cost, which makes productivity more difficult and the reduced ability to adjust the dosages.

Targeted drug delivery systems have been developed to optimize regenerative techniques. The system is based on a method that delivers a certain amount of a therapeutic agent for a prolonged period of time to a targeted diseased area within the body. This helps maintain the required plasma and tissue drug levels in the body, thereby preventing any damage to the healthy tissue via the drug. The drug delivery system is highly integrated and requires various disciplines, such as chemists, biologists, and engineers, to join forces to optimize this system.

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%.

Biomaterials are any substance that has been engineered to interact with biological systems for a medical purpose - either a therapeutic (treat, augment, repair or replace a tissue function of the body) or a diagnostic one. Biomaterials  can be derived either from nature or synthesized in the laboratory using a variety of chemical approaches utilizing metallic components, polymers, ceramics or composite materials. They are often used and/or adapted for a medical application, and thus comprise whole or part of a living structure or biomedical device which performs, augments, or replaces a natural function. Such functions may be benign, like being used for a heart valve, or may be bioactive with a more interactive functionality such as hydroxy-apatite coated hip implants. Biomaterials are also used every day in dental applications, surgery, and drug delivery. For example, a construct with impregnated pharmaceutical products can be placed into the body, which permits the prolonged release of a drug over an extended period of time. A biomaterial may also be an autograft, allograft or xenograft used as a transplant material. Pharmaceutica 2017 have penetrated into the biomaterials realm and hence a biomaterials conference.

Global revenue for vaccine technologies was nearly $31.8 billion in 2011. This market is expected to increase from $33.6 billion in 2012 to $43.4 billion in 2017 at a compound annual growth rate (CAGR) of 5.3%.

Vaccine is a material that induces an immunologically mediated resistance to a disease but not necessarily an infection. Vaccines are generally composed of killed or attenuated organisms or subunits of organisms or DNA encoding antigenic proteins of pathogens. Sub-unit vaccines though exceptionally selective and specific in reacting with antibodies often fail to show such reactions in circumstances such as shifts in epitopic identification center of antibody and are poorly immunogenic. Delivery of antigens from oil-based adjuvants such as Freunds adjuvant lead to a reduction in the number of doses of vaccine to be administered but due to toxicity concerns like inductions of granulomas at the injection site, such adjuvants are not widely used. FDA approved adjuvants for human uses are aluminium hydroxide and aluminium phosphate in the form of alum. Hence, search for safer and potent adjuvants resulted in the formulation of antigen into delivery systems that administer antigen in particulate form rather than solution form.

Other reasons driving the development of vaccines as controlled drug delivery systems are as follows:

·         Immunization failure with conventional immunization regimen involving prime doses and booster doses, as patients neglect the latter. Vaccines delivery systems on the other hand:

·    Allow for the incorporation of doses of antigens so that booster doses are no longer necessary as antigens are released slowly in a controlled manner.

·   Control the spatial and temporal presentation of antigens to the immune system there by promoting their targeting straight to the immune cells.

The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.

A medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

·         Diagnosis, prevention, monitoring, treatment or alleviation of disease;

·         Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

·         Investigation, replacement or modification of the anatomy or of a physiological process;

Medical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of mechanical engineering. Pharmaceutica 2018 is considered to be a medical devices conference.

The drug-device combination market is not fragmented and the key players in this market are Medtronic, Boston Scientific Corp., Edwards Life sciences Corp., Stryker Corp., QLT Inc. etc. The maximum number of new product developments is expected to take place in the bone graft substitutes, advanced wound care products and antimicrobial catheter markets. Our patent analysis indicates that E.U. has filed for the maximum number of patents followed by the U.S.

Peptides and proteins have great potential as therapeutics. Peptides can be designed to target a broad range of molecules, giving them almost limitless possibilities in fields such as oncology, immunology, infectious disease and endocrinology. While the peptide and protein therapeutic market has developed significantly in the past decades, delivery has limited their use. Although oral delivery is preferred, most are currently delivered intravenously or subcutaneously due to degradation and limited absorption in the gastrointestinal tract. Therefore, absorption enhancers, enzyme inhibitors, carrier systems and stability enhancers are being studied to facilitate oral peptide delivery. Additionally, transdermal peptide delivery avoids the issues of the gastrointestinal tract, but also faces absorption limitations. Due to proteases, opsonization and agglutination, free peptides are not systemically stable without modifications.

Currently, the market for peptide and protein drugs is estimated to be greater than US$40 billion/year, or 10% of the pharmaceutical market. This market is growing much faster than that of small molecules, and will make up an even larger proportion of the market in the future. At present there are over 100 approved peptide-based therapeutic drugs on the market, with the majority being smaller than 20 amino acids. Compared with the typical small-molecule drugs that currently make up the majority of the pharmaceutical market, peptides and proteins can be highly selective as they have multiple points of contact with their target. Increased selectivity may also result in decreased side effects and toxicity.

Major drugs driving growth of the overall smart drug delivery market include Angiomax, Copaxone, Forteo, Sandostatin, Velcade, Victoza and Zoladex.

There has been increased activity in the field recently regarding the development and research on various printing techniques in fabrication of dosage forms and drug delivery systems. These technologies may offer benefits and flexibility in manufacturing, potentially paving the way for personalized dosing and tailor-made dosage forms.

2D and 3D printing permits fabricating functional structures of metals, polymers, and biomaterials. 3D structures can be printed on a variety of surfaces with characteristic permeability, porosity, hydrophobicity/hydrophilicity and surface energy. This allows controlling the properties of the printed substances. Besides accurate patterning, printing on tailored functionalized substrates and multi-layer printing makes automated high-speed manufacture of complex structures possible. It opens up new avenues for tailoring physicochemical properties of organic substances.

3D-printing (3DP) is the art and science of printing in a new dimension using 3D printers to transform 3D computer aided designs (CAD) into life-changing products. This includes the design of more effective and patient-friendly pharmaceutical products as well as bio-inspired medical devices. It is poised as the next technology revolution for the pharmaceutical and medical-device industries. After decorous implementation scientists in collaboration with CAD designers have produced innovative medical devices ranging from pharmaceutical tablets to surgical transplants of the human face and skull, spinal implants, prosthetics, human organs and other biomaterials. a limitation exists in the availability of 3D printable biomaterials for most applications.

With the FDA approval of the first 3D printed tablet, Spritam®, there is now precedence set for the utilization of 3D printing for the preparation of drug delivery systems.

The high degree of flexibility and control with 3D printing enables the preparation of dosage forms with multiple active pharmaceutical ingredients with complex and tailored release profiles. A unique opportunity for this technology for the preparation of personalized doses to address individual patient needs. This review will highlight the 3D printing technologies being utilized for the fabrication of drug delivery systems, as well as the formulation and processing parameters for consideration

Pharmacokinetics is currently defined as the study of the time course of drug absorption, distribution, metabolism, and excretion. Clinical pharmacokinetics is the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient. Primary goals of clinical pharmacokinetics include enhancing efficacy and decreasing toxicity of a patient’s drug therapy. The development of strong correlations between drug concentrations and their pharmacologic responses has enabled clinicians to apply pharmacokinetic principles to actual patient situations.

Pharmacodynamics refers to the relationship between drug concentration at the site of action and the resulting effect, including the time course and intensity of therapeutic and adverse effects. The effect of a drug present at the site of action is determined by that drug’s binding with a receptor. Receptors may be present on neurons in the central nervous system (i.e., opiate receptors) to depress pain sensation, on cardiac muscle to affect the intensity of contraction, or even within bacteria to disrupt maintenance of the bacterial cell wall.

A route of administration is the path by which a drug, fluid, poison, or other substance is taken into the body. Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration. Routes can also be classified based on where the target of action is. Action may be topical (local), enteral (system-wide effect, but delivered through the gastrointestinal tract), or parenteral (systemic action, but delivered by routes other than the GI tract).

Routes of administration are usually classified by application location (or exposition). The route or course the active substance takes from application location to the location where it has its target effect is usually rather a matter of pharmacokinetics (concerning the processes of uptake, distribution, and elimination of drugs). Nevertheless, some routes, especially the transdermal or transmucosal routes are commonly referred to routes of administration. The location of the target effect of active substances is usually rather a matter of pharmacodynamics (concerning e.g. the physiological effects of drugs). Furthermore, there is also a classification of routes of administration that basically distinguishes whether the effect is local (in "topical" administration) or systemic (in "enteral" or "parenteral" administration).

Nanotechnology has finally and firmly entered the realm of drug delivery. Performances of intelligent drug delivery systems are continuously improved with the purpose to maximize therapeutic activity and to minimize undesirable side-effects. The primary goals for research of nano-bio-technologies in drug delivery include:

• More specific drug targeting and delivery,
• Reduction in toxicity while maintaining therapeutic effects,
• Greater safety and biocompatibility, and
• Faster development of new safe medicines

Pharmaceutical conferences offers presentations by researchers from a number of disciplines, from the life sciences to engineering, who will address a range of topics including peptide and protein delivery, gene delivery, cell delivery, vaccines, transdermals, pulmonary delivery, new materials, and other subjects, from varied disciplines while focusing on the central theme of drug delivery.

Key players in the market include Amgen, Inc., AstraZeneca plc, Eli Lilly & Co., Ipsen S.A., Merck & Co., Novartis AG, Novo Nordisk A/S, Roche Holdings AG, Sanofi, Takeda Pharmaceutical Company Limited, and Teva Pharmaceutical Industries Limited. Leading API manufacturers include Bachem Holding AG, PolyPeptide Group, Peptisyntha Inc. and Lonza Inc.   

The global market for blood-brain barrier (BBB) technology for therapeutics reached $21.8 million in 2013. This market is expected to grow from $38.7 million in 2014 to $471.5 million in 2019, a compound annual growth rate (CAGR) of 64.9% from 2014 through 2019.

The global market for Business Development of Drug Delivery Technology in 2010 was $131.6 billion and is expected to rise at a compound annual growth rate (CAGR) of 5% and reach nearly $175.6 billion by 2016. The U.S. constituted approximately 59% of the total drug delivery market in 2010 and was $78 billion. It is forecast to reach nearly $103 billion in 2016 at a CAGR of 4.7%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion and is expected to grow to $49 billion by 2016 at a CAGR of 5.6% for 2013, Drug Delivery Global market reached $150.3 billion, according to BCC research. This was an increase from $142 billion the previous year. Given its predicted annual growth the market represents a considerable business opportunity, which has been reflected in the increasing number of drug delivery specialists.

Consistent quality and competitive costs of product improves Production performance and continuity of supply and Product and technology auditing and due diligence with minimizing Regulatory Issues, quality control, and business development Business opportunities in drug delivery. Pharmaceutical conferences offer unparalleled opportunities to establish new business relationships with companies from 40 countries through pre-scheduled one-on-one meetings with decision makers.