Let’s join 2nd Global Pharma Summit with our full energy and enthusiasm, to be held in Valencia, Spain from 18-19 July, 2019.
Allied Academies cordially welcomes all the attendees, speakers, sponsor’s and other research experts from all over the world to the “2nd Global Pharma Summit”
( Pharma Summit 2019 ) which is going to be held during July 18-19, 2019 in Valencia, Spain. We are very much honored to invite you all to exchange and share your views and experiences in Pharma: “Exploring the Pharma Research and Inventing a Formula for Drug Development".
Allied Academies Organizes Pharma Summit 2019 conference along with 300+ Conferences across the USA, Europe & Asia every year with support from 1000 more scientific societies and Publishes 400+ Open access journals which contain over 30000 eminent personalities as editorial board members.
We invite you to join us at the Pharma Summit 2019, where you will be sure to have a meaningful experience with scholars from around the world. All members of the Pharma Summit 2019 organizing committee look forward to meeting you in Valencia, Spain.
Sessions & Tracks
Pharmaceutical Formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is called a drug mixture or drug formulation. A drug formulation can be given to the patient in various forms like solid, semisolid or liquid. The type of the formulation given depends upon the patient’s age, sex, and health condition and is specific for particular routes of administration.
An analytical technique is a method that is used to determine the concentration of a chemical compound or chemical element. There are a wide variety of techniques used for analysis, from simple weighing (gravimetric analysis) to titrations (titrimetric) to very advanced techniques using highly specialized instrumentation. From the stages of drug development to marketing and post marketing, analytical techniques play a great role, be it understanding the physical and chemical stability of the drug, impact on the selection and design of the dosage form, assessing the stability of the drug molecules, quantitation of the impurities and identification of those impurities which area above the established threshold essential to evaluate the toxicity profiles of these impurities to distinguish these from that of the active pharmaceutical ingredient(API).
Pharmaceutical Formulation in Pharmaceutics is the process in which various chemical substances including the vigorous drug are joined to produce a final medicinal product. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually contains combining the drug into a tablet or a capsule. Formulations confirm that the drug is compatible with these other substances. In the pharmaceutical drug formulations, the different physical, chemical, and mechanical properties of a drug are considered so as to know what other ingredients should be used in the preparation. The various factors like polymorphism, particle size, pH, and solubility are all considered while formulating the drug, also considering the appearance of the tablet.
· Enteral Formulations
· Parenteral Formulation
· Topical Formulations
The drug discovery starts with Pre-Formulation studies which is initiated by disease identification then carried onto suitable drug identification then after Stability analysis of Drug, Behavioural analysis, Dissolution, High Performance Liquid Chromatography or Nuclear Magnetic Resonance (NMR) as per the ICH guidelines.
The global market for Pre-Formulation Studies that is for the drug discovery technologies reached nearly $39.5 billion and $46.5 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.3% to nearly $79.5 billion for the period 2014-2019
· Crystallinty and Polymorphism
· Fine Particle Characterization
· Powder Flow Properties
· Ionization constant- PKa
· PH solubility profile
· Common ion effect- Ksp
· Thermal effects
It is the process of producing or invention of novel and or new medical product, the design of this new product completely based on the knowledge of biological target. Moreover, this process sometimes known as or called rational drug design. Ligand-based drug design- In this branch or type of pharmaceutical formulation the design of the drug will be made or built depends on the knowledge of what binds to it. Structure-based-while this type drug design will depend on the information related with the three dimensional structure of the biological target these information will begotten by using methods like X-ray or NMR.
· Drug targets
· Rational drug discovery
· Computer-aided drug design
· Binding site identification
The drug subjected to drug development undergoes number of trials and are screened at different stages to produce a final potent drug intended for the treatment of various diseases. During this process various properties are checked to see whether the drug is non-toxic to living system and is therapeutic or not. Using suitable excipients and technological preparations the active substances are formulated into final dosage form. The last product is the Actual composition of preparation, manufacturing specification. Drug formulation can have a substantial impact on almost every quality characteristic of an API including potency, bioavailability, solubility, dosage, route of administration and stability. In immune offers parenteral drug formulation R&D services for primary stage and preclinical candidates with a special prominence in nanoparticle based drug delivery technology.
· Particle size
· Bulk density
In clinical research the scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective.
Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. A common example of this is combined phase I/II or phase II/III trials. Therefore, it may be easier to think of early phase studies and late phase studies. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.
Bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. when a medication is administered intravenously, its bioavailability is 100%.when a medication is administered via other routes (such as orally), its bioavailability decreases (due to incomplete absorption and first-pass metabolism) or may vary from patient to patient. Bioavailability is one of the essential tools in pharmacokinetics, as bioavailability must be considered when calculating dosages for non-intravenous routes of administration.
In determining bioequivalence, for example, between two products such as a commercially available Brand product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study to volunteer subjects, generally healthy individuals but occasionally in patients. Serum/plasma samples are obtained at regular intervals and assayed for parent drug (or occasionally metabolite) concentration. Occasionally, blood concentration levels are either feasible or possible to compare the two products (e.g. inhaled corticosteroids), then pharmacodynamic endpoints rather than pharmacokinetic endpoints are used for comparison. For a pharmacokinetic comparison, the plasma concentration data are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lagtime (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics.
· In vitro-In vivo correlation studies
· Good clinical practice guidelines
Pharmaceutical freeze Technology is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption. Lyophilisation and freeze drying are terms that are used interchangeably depending on the industry and location where the drying is taking place. Controlled freeze drying keeps the product temperature low enough during the process to avoid changes in the dried product appearance and characteristics. It is an first-rate method for preserving a wide diversity of heat-sensitive materials such as proteins, microbes, pharmaceuticals, tissues & Plasma.
Nanomedicine is the medical application of nanotechnology. Nanomedicine ranges from the medical applications of nanomaterials and biological devices, to Nano electronic biosensors, and even possible future applications of molecular nanotechnology such as biological machines. Nanotechnology has provided the possibility of delivering drugs to specific cells using nanoparticles.The overall drug consumption and side-effects may be lowered significantly by depositing the active agent in the morbid region only and in no higher dose than needed.Targeted drug delivery is intended to reduce the side effects of drugs with concomitant decreases in consumption and treatment expenses. Drug delivery focuses on maximizing bioavailability both at specific places in the body and over a period of time. This can potentially be achieved by molecular targeting by Nano engineered devices. A benefit of using nanoscale for medical technologies is that smaller devices are less invasive and can possibly be implanted inside the body, plus biochemical reaction times are much shorter. These devices are faster and more sensitive than typical drug delivery. The efficacy of drug delivery through nanomedicine is largely based upon efficient encapsulation of the drugs, successful delivery of drug to the targeted region of the body, successful release of the drug.
Analytical method development is the process of choosing an accurate assay procedure to determine the composition of a formulation. It is the process of proving that an analytical method is acceptable for use in laboratory to measure the concentration of subsequent samples Analytical methods should be recycled within GMP and GLP environments and must be developed using the protocols and acceptance conditions set out in the ICH guidelines. Analytical method development and validation stand the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It supports in formation of product-specific acceptance criteria and stability of results. Validation should establish that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and validation.
· Identification tests
Chromatography and mass Spectrometry qualitative analysis is employed for analysis of organic compounds. Electro spray ionization (ESI) could be a technique employed in mass spectroscopic analysis. As compare to chromatography and mass spectrometry, HPLC is more flexible informative and trusted by the industry people. Recent advances in sample preparation techniques to beat difficulties encountered throughout measuring of little molecules from bio fluids mistreatment LC-MS. For Measuring, observation and protective your important Investments analytical chemistry instruments are used. Lipidomics, as a novel branch of metabolomics, which is aimed at comprehensive analysis of lipids and their biological roles with respect to health and diseases, has attracted increased attention from biological and analytical scientists. As a result of the complexity and diversity of lipids, accurate identification and efficient separation are required for lipidomics analysis. Mass spectrometry (MS) and chromatography have been extensively developed in the past few decades and hold a distinguished position in qualification and separation science. They are powerful and indispensable tools for lipidomics.
· Role of Spectroscopy as Separation Technique
· Innovations in Mass Spectrometry techniques
· Mass Spectrometry in Proteome Research
· Ion-Mobility Spectrometry-Mass Spectrometry (IMS-MS)
· Liquid Chromatography Mass Spectrometry (LC-MS)
Analytical chemistry is that the study of the separation, identification, quality control and quality assurance of the chemical parts of natural and artificial materials. The maintenance of a desired level of quality in an exceptionally package or product, particularly by resources that of attention to every one stage of the method of delivery or production. Bio analytical Chemistry could be a sub-division of Analytical Chemistry that refuges the measuring of medicine, Ion sensors, Proteins and DNA Sequences in unnatural samples or concentrations. Accurate quantification of the drug samples is extremely very important for several scientific endeavors which cannot delay the result. Therefore the Bio analytical Techniques are in the main focused to bring the correct results of the drug sample to supply an ideal result.
· DNA sequencing
· Ion sensors
· Method development and validation reports
· Detect fake drugs quickly
Ultra fast mw confirmation LC/MS system for synthetic compounds: once a target compound is synthesized, it needs to be confirmed as quickly as possible for downstream processes. An ultra-fast mw confirmation system consisting of nexera UHPLC and an LCMS-2020 mass spectrometer is a powerful choice for such analysis. LCMS- 2020 captures all the narrow peaks separated by prominence UFLC in shorter run times. LCMS software also supports easier operation and integrated workflows.
Preparative isolation LC system with MS for chemical synthesis: high purity and high efficiency are important in preparative isolation process, particularly for such next steps as efficacy and pharmacokinetic studies. Shimadzu LC modular systems are flexible and allow configurations required for preparative scale chromatography. Psiporttm software and the lcms-2020 mass spectrometer ensure qualitative and quantitative analyses of target fractions.a 'one click' approach to sample analysis allows to use pre-configured methods and customized reporting templates.
· X-ray instruments
· particle analyzers
· Uv-visible spectrophotometers
· Micro-volume uv-visible spectrophotometers
· Edman chemistry protein sequencer
· Automated protein seperation
By definition Industrial Pharmacy is a discipline which includes manufacturing, development, marketing and distribution of drug products including quality assurance of these activities. This broad research area relates to different functions in pharmaceutical industry and having contact areas with engineering and economics. Pharmacy practice is the discipline of pharmacy which involves developing the professional roles of pharmacists. Disease-state management, Clinical interventions (refusal to dispense a drug, recommendation change and/or add a drug to a patient's pharmacotherapy, dosage adjustments, Professional development, Pharmaceutical care, Extemporaneous pharmaceutical compounding, Patient care, Drug abuse prevention, Prevention of drug interactions, including drug-drug interactions or drug-food interactions, Prevention (or minimization) of adverse events, Incompatibility, Drug discovery and evaluation, Community Pharmacy etc.,
· Drug discovery and development
· Industrial pharmaceutics
· Pre-clinical studies
· Clinical studies
· Supply chain management
· Waste management
· Product management
A compound is identified by matching its proton and/or carbon NMR spectra to NIH PubChem molecular structures. The matching process involves analyzing 1D proton, 1D carbon, DEPT, and/or HSQC spectra, and comparing the number of NMR resonances, detected proton and carbon shifts, likely number of methyl and methoxy groups, and an optionally specified molecular formula to predicted proton and carbon shifts of PubChem structures. A structure verification module rates the consistency between experimental spectral analysis results and a proposed structure (not limited to PubChem structures) and assigns observed shifts to the proposed structure. The spectral analysis, structure identification, and structure verification are largely automated in a software package and can be performed in minutes.
· Structure Identification
· Structure Verification
· Structure Elucidation
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country. In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. World Health Organization(WHO), Pan American Health Organization (PAHO), World Trade Organization(WTO), International Conference on Harmonization (ICH), World Intellectual Property Organization (WIPO) are some of the international regulatory agencies and organizations which also play essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
· HEALTH CANADA(CANADA)
· MCC(South Africa)
· ANVISA (Brazil)
· EMEA (European Union)
· SFDA (China)
· MoH (Sri Lanka)
Before submitting an IND application, the concerned drug must go through a comprehensive series of in-vitro and in-vivo toxicity testing to ensure maximum safety in clinical trials. Considering the ethical issues and the cost of in-vivo animal tests, the pharmaceutical industry now relies more on in-vitro methods for toxicity testing in the drug development phase. Screening for toxicity should start as early as possible to reveal inappropriate drugs early. This helps to eliminate such drugs from the drug development process timely and saves resources. Hepatotoxicity (toxic effects on the liver) and cardiotoxicity (toxic effects on the heart) are the most severe problems encountered in drug development and the major reason for drug withdrawals. In addition, possible mutagenesis (genotoxicity) caused by the concerned drug candidates is also observed frequently. Genotoxic compounds can cause mutations in DNA and predispose to cancer and reproductive problems. Therefore, it’s crucial to screen for genotoxicity. As per the regulatory guidelines, the standard tests for genotoxicity screening include bacterial reverse mutation test (AMES) and a mammalian genotoxicity assay.
· Ion channel assay
· HERG screening
· Cardiac action potential assay
· In silico 3D-basedstructural model
· Functional assays: assessment of ATP, ADP, ATP/ADP ratios
· Cytology/Membrane leakage assays: LDH, AK test
· Mitochondrial assays: MTT, MTS, XTT
· Genomic/Proteomic assays: BrdU test
Pharmaceutical marketing is the last element of an information continuum, where research concepts are transformed into practical therapeutic tools and where information is progressively layered and made more useful to the healthcare system. Thus, transfer of information to physicians through marketing is a crucial element of pharmaceutical innovation. By providing an informed choice of carefully characterized agents, marketing assists physicians in matching drug therapy to individual patient needs. Pharmaceutical marketing is presently the most organized and comprehensive information system for updating physicians about the availability, safety, efficacy, hazards, and techniques of using medicines. The costs of pharmaceutical marketing are substantial, but they are typical of high-technology industries that must communicate important and complex information to sophisticated users. These costs are offset by savings resulting from proper use of medicines and from lower drug costs owing to price competition.
Pharmaceutical company spending on marketing far exceeds that of its research budget. In Canada, $1.7 billion was spent in 2004 to market drugs to physicians; in the United States, $21 billion was spent in 2002. In 2005, money spent on pharmaceutical marketing in the United States was estimated at $29.9billion with one estimate as high as $57 billion. When the U.S. numbers are broken down, 56% was free samples, 25% was pharmaceutical sales representative"detailing" (promoting drugs directly to) physicians, 12.5% was direct to user advertising, 4% on detailing to hospitals, and 2% on journal ads.
Abstract Submission & Registration
Largest Open Access Publisher and Scientific Events Organizer publishing more than 400 Open Access journals and organizing more than 300 scientific events per year offers membership to students. 2nd Global Pharma Summit Committee would like to invite speakers to submit their research for inclusion in the Pharma Summit 2019 scientific program.
Come Let’s Bring a Transformation in the Scientific Society
The Young Researchers Forum offers young researchers the possibility to meet and discuss research topics and methodologies, share and develop ideas, learn from each other and gain knowledge from senior researchers.
Young Researcher Sessions are organized at the 2nd Global Pharma Summit, to provide a unique platform for Young Researchers/Investigators for presenting latest research projects with an in-depth analysis. Allied Academies cordially invites Young Researchers from Universities/Institutes/Industries to present a short oral presentation during the forum. These oral presentations should be of 10 minutes duration in related scientific track followed by 5 minutes question hour. Therefore, presenters are encouraged to give comprehensive and dynamic talks. Applications will be selected based on past research productivity and future promise.
Pharma Summit 2019 provides the best Place to share and gain knowledge. It is going to be a 2 - day event to ensure network for Drug Developing by using the analytical techniques and inventing formula, global knowledge on pharma, emerging technologies and can transform formulation and drug delivery, Innovative scientific techniques, new utilities of Pharmaceutical Sciences at one place.
Global Pharmaceutical Industry - Statistics & Facts:
The pharmaceutical industry is responsible for the development, production and of medications. Thus, its immense importance as a global sector is inarguable. In 2014, total had exceeded one trillion U.S. dollars for the first time. North America is responsible for the largest portion of these revenues, due to the leading role of the U.S. pharmaceutical industry. However, as in many other industries, the Chinese pharmaceutical sector has shown the highest over previous years. Still, the leading pharmaceutical companies come from the United States and Europe. Based on prescription sales, NYC-based is the world’s largest pharmaceutical company. In 2017, the company generated some 52.5 billion U.S. dollars in pure pharmaceutical sales. Other top global players from the United States include , Merck & Co., and AbbVie. Novartis and Roche from Switzerland, GlaxoSmithKline and AstraZeneca from the United Kingdom, and French are the European big five. Branded, patented medicines by far make up the largest . Humira, an anti-inflammatory drug, generated over 18.4 billion U.S. dollars of revenue worldwide in 2017. Oncologics continue to be the leading based on revenue. In 2017, cancer drugs made 81 billion U.S. dollars of revenue globally. Other major therapy classes were pain drugs and antidiabetics. More than any other industry, the pharmaceutical sector is highly dependent on its research and development segment. Some pharmaceutical companies invest 20 percent and more of their revenues in . The United States is a traditional stronghold of pharmaceutical innovation. The origin of most new substances introduced to the market can be traced back to the United States. Because of the steady loss of patent protection, the invention of new drugs is of vital importance for the pharmaceutical industry. Revenue losses due to patent expiry often are very significant, as can be seen with Pfizer’s from 2012 on.
Spending on medicines and healthcare in Spain witnessed steady growth in 2017, reflecting strong potential for new medicine development, infrastructure building and new entry/expansion opportunities. Both Pharmaceutical sales and consumption are on the rise and the outlook to 2025 remains robust driven by strong pharmaceutical market fundamentals. The goal of this report is to provide complete strategic analysis and forecast the pharmaceutical industry segments over the near to long term future. This report focuses its attention on pharmaceutical market in Spain and presents market trends, drivers and challenges facing the R&D professionals, investors, manufacturers, strategists, regulatory and other players. It also presents the pharmaceutical sales of prescription medicines and generic drugs. Further, pharmaceutical imports and exports data is also provided for the country. The research study on Spain healthcare spending provides outlook of total spending, government expenditure, private expenditure to 2025. Further, the level of out-of-pocket costs borne by patients is also analyzed. It additionally explores the level and growth of expenditure on healthcare, new drugs and ongoing research studies. The report also considers the Spain
healthcare industry prospects and infrastructure detailing hospitals, physicians, bed count, and other facilities. The report also analyzes the disease epidemiology trends through details of leading causes of death.
Recent Trends in Spain Pharmaceutical Market:
The pharmaceutical market in Spain is expected to rise in value from $23.7 billion in 2016 to $25.1 billion by 2021, research and consulting firm Global Data noted in a report published in April 2017. The forecast represents a compound annual growth rate of close to 1%. Growth is being driven by consolidation of the biotechnology sector, government support, an infrastructure that encourages innovation, the availability of highly qualified workforce, and favorable cost benefit ratio of human capita, said the report. The aging population is also thought to have a key role in driving Spain’s healthcare sector to 2021. According to Global Data, the introduction of tax incentives for R&D spending by the Spanish government has eased the impact of austerity measures introduced in 2010, and the pharmaceutical industry has, as a result, made some recovery. Following the introduction of price containment measures by the Spanish government—which included forming homogenous groups of substitutable products so that pharmacists can provide the cheapest drug, eliminating the two-year period that existed for pharmaceutical companies to reduce the price of their medicines below the reference price, and making it mandatory for pharmacists to dispense the cheapest available medicine—the pharmaceutical market contracted in value by 13.7% between 2010 and 2014. In 2015, the Spanish pharmaceutical industry invested $1.2 billion in R&D following the introduction of tax incentives, a move that has created a strong R&D base. The demand for innovative medicines is expected to help boost the local pharmaceutical market. The government is also investing in the implementation of electronic clinical records and the use of information and communication technology to integrate the services provided by public hospitals with those of the National Health System (Sistema Nacional de Salud, SNS). These efforts will be a boon to the industry. The introduction of e-health services allows patients to make appointments and obtain prescriptions online, improving access and thus driving the healthcare sector.
Pharmaceutical Companies in Spain:
· Merck & Co
· Johnson & Johnson
· Boehringer ingel
· Novo Nordisk
Major Pharma Associations around the Globe:
· International Pharmaceutical Federation(FIP)
· International Pharmaceutical Students'Federation (IPSF)
· European Association of EmployedCommunity Pharmacists in Europe (EPhEU)
· Pharmaceutical Group of the European Union(PGEU)
· National Pharmacy Association
· Pharmaceutical Society of NorthernIreland
· Royal Pharmaceutical Society (RPS)
Pharmaceutical Companies in the World:
· Pfizer, The United States
· Novartis, Switzerland
· Merck & Co, The United States
· Sanofi S.A., France
· Roche-, Switzerland
· GlaxoSmithKline, the United Kingdom
· AstraZeneca, the United Kingdom
· Johnson & Johnson, the United States
· Eli Lilly & Co, the United States
· Abbott Laboratories, the United States
· Bristol-Myers Squibb, the United States
· Teva Pharmaceutical Industry, Israel
· Takeda pharma, Japan
· Bayer Schering, Germany
· Boehringer-Ingelheim, Germany
· Bristol-MyersSquibb, United Kingdom
· NovoNordisk, Denmark
· Biogen,United Kingdom
· OtsukaPharmaceutical, Japan
· GileadSciences, the United States
· Mylan, The United States
Related Associations and Societies:
Societies in USA:
· Drug Information Association
· Canadian Society for Pharmaceutical Sciences (CSPS)
· Chemical Society Reviews
· American Association of Pharmaceutical Scientists (AAPS)
· American Association of Pharmacy Technicians (AAPT)
· American Associations of Pharmaceutical Scientists (AAPS)
· The Pharmaceutical Research & Manufacturers Association (PhRMA)
Societies in Asia and Pacific:
· Indonesian pharmaceutical association
· Pharmaceutical Association of Malaysia (PhAMA)
· Malaysian Pharmaceutical Society
· International Society for Biological Therapy of Cancer
Societies in Europe:
· Pharmaceutical Group of the European Union (PGEU)
· The Pharmaceutical and Novel Drug
· Delivery Healthcare Sciences Society (PHSS)
· Association of the British Pharmaceutical Industry (ABPI)
· Pharmaceutical Group of European Union (PGEU)
· Pharmaceutical Group of European Union (PGEU)