7^th European Biopharma Congress April 27-28, 2020 Prague, Czech Republic

Track 1: Biotherapeutics

A biopharmaceutical is likewise called as a Biological or Biologic pharmaceutical medicine thing manufactured from natural sources through extraction. The progression of a pharmaceutical medicine regularly takes a typical of 10 – 15 years. Such a lot of effort, time and money, it is particularly pressing that the right headways and materials are gotten in the examination, change and amassing of the pharmaceutical solutions, entire process consolidates pre-exposure, pre-clinical trials, exhibit dispatch to post advancing watching. The wellsprings of prescription things fuse peptides and proteins, including monoclonal antibodies and neutralizer pieces. From 2000 to 2006, biologics spoke to 33% of all New Active Substances that were pre moved, and are reflected to the present headway pipelines of the pharmaceutical business.

• Regulatory peptides
• Insulin
• Erythropoietin

Track 2: Biopharmaceutical Informatics

Biopharmaceutical informatics endeavors to use information technology, sequence-and structure-based bioinformatics analyses, molecular modeling and simulations, and statistical data analyze towards biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence.

• Applications of computation in biologic drug development
• Physics-based molecular modelling
• Protein sequence-structural contexts and degradation reaction mechanisms
• De risk biopharmaceutical development
• Creation of databases and data mining
• Pre-clinical immunogenicity risk assessment of biotherapeutics

Track 3: Biopharmaceutical Engineering

Pharmaceutical building is a piece of pharmaceutical science. Innovation which includes improvement and assembling of items, procedures, and parts in the pharmaceuticals business. The touchy advancement in the pharmaceutical business turned into the main thrust for our new Biopharmaceutical Engineering Program. The branch of biopharmaceuticals is quickly forming into upstream medication definitions and downstream plan handle, by utilizing biopharmaceutical designing standards

• Synthesizing new medications
• Beginning of mass production
• Controlled drug release

Track 4: Biopharmaceutical Products - Clinical Trials

Clinical Trials is a multidisciplinary program with broad participation with members from around the globe focused on learning about clinical research and its advances. This is your best opportunity to reach the largest assemblage of participants from Clinical Trials community that is from academia, clinical research entities, medical groups, related associations, societies and also from government agencies, pharmaceutical, biomedical and medical device industries. Clinical Trials will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials. It promotes better understanding by the general public about the importance of clinical trials in prevention, diagnosis and treatment of disease.

• Clinical trial market
• Genome annotation
• Single-nucleotide polymorphism
• Gene and protein expression

Track 5: Biopharmaceutical Companies & Market Analysis

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.

• Pharmaceutical companies market
• Global Analytical Instrumentation Market in Pharmaceuticals
• Generic and Biosimilar Pharmaceuticals (GLOBAL) - Industry Report

Track 6: Biopharmaceutical Drug Discovery and Development

In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology

• Drug Delivery from Plant Extracts
• Drug Disposition
• Drug Elimination

Track 7: Biopharmaceutical Production in Transgenic Animals

Medicate security is a noteworthy concentration of pharmaceutical microbiology. The most imperative commitment of microbiology to the pharmaceutical business is the improvement of anti-infection agents. Pathogenic microscopic organisms, growths and poisons delivered by microorganisms. The results of microbial digestion are all conceivable contaminants of prescriptions, however the current hereditary controls have empowered the creation of more improved medications. Antibodies are likewise a vital commitment of microbiology towards improvement of medications. Aside from medications and bio items advancement, microbiology assumes an essential part in quality control of a pharmaceutical research center. Anticipation of microbial tainting in pharmaceutical arrangements like injectables, eye drops, nasal arrangements and inward breath items.

• Assisted reproduction
• Transgene regulation
• Biopharmaceutical production

Track 8: Biopharmaceutical - Pharmacovigilance & Pharmacodynamics

Pharmacodynamics and pharmacokinetics are two key areas of pharmacological medicine. Pharmacodynamics is that the study of the molecular, organic chemistry, and physiological effects of medicine on cellular systems and their mechanisms of action. PK focuses rather on how the body affects the drug, in terms of its absorption, metabolism, distribution and elimination. Today, pharmacologists use a range of techniques, together with genetic science, biological science and chemistry, to elucidate and manipulate the pharmacologic action of drugs for health functions. BA and BE ofttimes accept pharmacokinetic measures such United Self-Defense Group of Colombia to assess extent of general exposure and Cmax and Tmax to assess rate of systemic absorption.

• Advances in pharmacokinetic interactions
• Advances in pharmacodynamic interactions
• Drug and substance abuse
• Drug-drug interactions
• Systems Pharmacology
• Data monitoring for trials with an adaptive design

Track 9: Biosimilars, Biologics & Biomakers

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. Biosimilars is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

• Biosimilar Electrophoresis and Formulation.
• Fluid chromotography
• Immunoassays
• Spectrometry
• Biosimilar research pipelines

Track 10: Bioavailability & Bioequivalence on Biopharmaceutical Products

Assume a key part in the medication improvement period for both new medication items and their non-specific reciprocals. These studies are likewise critical in the post endorsement period within the sight of certain assembling changes. Data in the general arrangement of information that guarantee the accessibility of protected and successful pharmaceuticals to patients and experts. BA/BE studies has been resolved to have down to earth and general wellbeing esteem for pharmaceutical supporters, for administrative offices, and for patients and specialists.

• Universal approach about comparative bioavailability
• Bioavailability studies of new drugs
• bioavailability of generic drugs

Track 11: Drug Delivery from Plant Extracts

Nanotechnology has been increasingly employed in drug delivery as it increases the drug dissolution rate, leading to enhanced drug absorption and bioavailability. Many nanostructures have been proposed for drug delivery, each one having their own advantages and drawbacks. This manuscript revises the use of lipid- and polymer-based nanostructures in the association of different extract, establishing a relation between the type of Nano systems and its preparation method to the different plant extracts and most abundant compounds. Depending on the method of extraction, plant extracts can contain an enormous variety of active molecules, such as phenolic compounds, essential oils, alkaloids, among others. In many cases, from a pharmacological point of view, it is interesting to work with crude extract or fractions instead of a single isolated compound. In any case, in order to achieve a final product some issues must be overcome, including poor stability, solvent toxicity, and low solubility of the bioactive compound.

• Plant extracts toxicity
• in vitro and in vivo biological activities
• Cyclodextrins

Track 12: Drug Disposition & Dissolution

Assumes a focal part all through pharmaceutical innovative work. These studies help in the disclosure and determination of new compound elements, bolster wellbeing evaluation, and are basic in characterizing conditions for protected and successful use in patients. ADME contemplates give the main premise to basic judgments from circumstances where the conduct of the medication is comprehended to those where it is obscure.

Disintegration has become an important and broadly used test receiving more accentuation worldwide from regulatory specialists amid the last 15 years. It is a critical quality control excessively and a guide, making it impossible to formulation development. Dissolution testing measures change on stability, and is utilized to build up in-vitro in-vivo correlations for some products. The disintegration test has experienced changes and updates subsequently of the expanded regulatory interest and the pharm practical industry's examination of aspects of disintegration testing to additionally enhance and get it the technique.

• Drug metabolism
• Biotransformation
• Glucuronidation
• Biorelevant dissolution

Track 13: Drug Elimination

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 necessarily differentiate between distribution and elimination, and does not indicate which elimination processes are involved.

Drug elimination is usually divided into two major components: excretion and biotransformation. Drug excretion is the removal of the intact drug. Nonvolatile and polar 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 anesthetics, alcohol, or drugs with high volatility, are excreted via the lungs into expired air.

Track 14: Drug clearance

Drug clearance can be defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time. Total clearance gives an indication of drug elimination from the central compartment without reference to the mechanism of this process. For drugs that are eliminated by first-order kinetics, clearance is constant. Clearance by the kidneys is called renal clearance, and that by all other organs is referred to as nonrenal clearance. The latter most often represents clearance by the liver. Total clearance is the sum of all body clearances. The same factors that determine renal and hepatic elimination of drugs affect drug clearance.

• drug excretion
• Drug Safety and Availability
• Hepatic drug clearance
• Pharmacogenomics in elimination
• Toxicology in pharmacological studies

Track 15: Drug Interactions - Food, Plants & Diseases

A drug interaction is a reaction between two (or more) drugs or between a drug and a food, beverage, or supplement. Taking a drug while having certain medical conditions can also cause a drug interaction. For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction. A drug interaction can make a drug less effective, increase the action of a drug, or cause unwanted side effects. Food or beverages can affect the absorption of some HIV medicines and increase or reduce the concentration of the medicine in the blood. Depending on the HIV medicine, the change in concentration may be helpful or harmful. Directions on how to take HIV medicines specify whether to take the medicine with food, without food, or either way if the HIV medicine isn’t affected by food.

• Foods which interact with Drug
• Uses of Drug - Related to Diseases
• Effect of Drug on the body according to their amount

Track 16: GMP, GCP and Quality control

Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and QC. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality.

• GMP Guidelines (cGMP) & GxP in Pharmaceuticals
• Regulations and Quality Standards
• Good Clinical Practices and Good Laboratory Practices

Track 17: Medicinal Chemistry & Drug Discovery

Medicinal chemistry  are disciplines at the intersection of chemistry, especially synthetic organic chemistry, and pharmacology and various other biological specialties, where they are involved with design, chemical synthesis and development for market of pharmaceutical agents, or bio-active molecules (drugs)

Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect.

• Synthetic Organic Chemistry
• Structured and fragment based Drug Design
• Molecular Modeling
• Pro Drug synthesis & Drug Targeting
• Current Research in Medicinal Chemistry
• Drug Discovery & Development

Track 18: Pharmaceutical Formulations

Pharmaceutical formulation is defined as the process in which different chemical substances are combined to produce a final medicinal product. The formulation studies involve developing a preparation of drug acceptable for patient. Formulation is the word often used in a way that includes dosage form. Formulation studies consider factors such as solubility, particle size, polymorphism and pH as all of these can influence bioavailability and hence the activity of a drug.

• Formulation and preformulation
• Developing a preparation of the drug
• Formulation types
• Formulation from plant sources
• Quality of Formulation
• Granulated formulations

Track 19: Pharmaceutical Industry

By definition Pharmaceutical Industry is a discipline which incorporates manufacturing, development, marketing and distribution of drug products including quality assurance of these activities. This wide research region identifies with various capacities in pharmaceutical industry and having contact areas with engineering and economics. Pharmaceutical Industry is a complex, multi-factorial condition, with the general point of manufacturing, developing and marketing safe and efficacious medicines including quality assurance of these activities. Research in Industrial Pharmacy is done both locally and under the direction of Faculty of Pharmacy.

Track 20: Pharmaceutical Nanotechnology

Pharmaceutical Nanotechnology based system deals with emerging new technologies for developing customized solutions for drug delivery systems. The drug delivery system positively impacts the rate of absorption, distribution, metabolism, and excretion of the drug or other related chemical substances in the body. In addition to this the drug delivery system also allows the drug to bind to its target receptor and influence that receptor’s signaling and activity. Pharmaceutical nanotechnology embraces applications of nanoscience to pharmacy as nanomaterials, and as devices like drug delivery, diagnostic, imaging and biosensor.

• Nanomedicine and Nanobiotechnology
• Scope of Nano-based drug delivery system
• Applications of nanoscience to pharmacy as Nanomaterials
• More specific drug targeting and delivery in Nanotechnology
• Biopharmaceutics and Liposomes
• Faster development of new safe medicines in Pharmaceutical Nanotechnology

Track 21: Pharmaceutical Packaging

Packaging is one of the largest industry sectors in the world, worth several billions. Pharmaceutical packaging represents a meager percentage of this colossal market. The global healthcare industry has seen a shift in paradigm and is now skewed toward effective and meaningful packaging. Packaging was considered as an afterthought which was required merely in the final stages of manufacturing for many pharmaceutical companies about a decade ago.

• Future of Packaging Materials
• Regulatory Considerations-China, US, EU, Pharmacopoeia
• EN 16679-Anti-Counterfeiting and Tamper Evidence Techniques
• Packaging for Patient Compliance
• Packing technology for Drug Delivery Systems
• Serialization implementation challenges for Pharma Companies

Track 22: Pharmaceutical Regulatory Affairs & IPR

Regulatory affairs are a new profession which is developed by the governments to protect public health. The main aim is controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals and cosmetics. Regulatory affairs also have a very specific meaning within the healthcare industries

• Patents and disputes case studies
• Identification techniques adulterated and misbranded drugs
• FDCA (Federal Food, Drug, and Cosmetic Act )
• Exemption in prescription and OTC drugs
• Experimental animal ethics
• Environmental health hazards
• Developments in global intellectual property
• Lifecycle management of drug products

Track 23: Pharmaceutical Sciences

The Pharmaceutical sciences combine broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Pharmaceutical Sciences is a dynamic and interdisciplinary field that aims to integrate fundamental principles of physical and organic chemistry, engineering, biochemistry, and biology to understand how to optimize delivery of drugs to the body and translate this integrated understanding into new and improved therapies against human disease. At the many of institutes internationally recognized faculty contribute to the field through inquiry into the underlying mechanisms of drug interactions with the human body and development of advanced synthetic or biologically-derived materials that can modulate these interactions in pursuit of better and safer therapies and drug products.

• Pharmaceutical Chemistry
• Pharmacology
• Pharmaceutical Formulations
• Pharmaceutical Analysis
• Pharmaceutical Regulatory Science

Track 24: Pharmacodynamics & Pharmacokinetics

Pharmacodynamics & Pharmacokinetics parameters become important because of the association between host drug concentrations, microorganism eradication, and resistance. Since long scientific advances allowed scientists to come together with the study of physiological effects with biological effects. The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing.

• Drug biotransformation reactions
• Pharmacokinetic aspects
• Drug interactions and pharmacological compatibilities
• Receptor theory for drug effects
• Clinical efficacy and safety evaluation
• Novel options for the pharmacological treatment of chronic diseases

Track 25: Pharmacognosy & Phytochemistry

Pharmacognosy & Phytochemistry is identified with the therapeutic plants. Pharmacognosy is the investigation of substance and organic properties of medications in restorative plants what gives new medications. Phytochemistry which induces the second metabolic development to defend from dreadful little creatures and developments. Pharmacognosy is the examination of medications from consistent sources. The American Society of Pharmacognosy describes as "the examination of the physical, compound, biochemical and natural properties of pharmaceuticals, medicine substances or potential meds or solution substances of regular initiation and also the search for new prescriptions from typical sources. Phytochemistry is the strict sentiment the word the examination of phytochemicals. These are chemicals gotten from plants. In a little sense, the terms are consistently used to portray the broad number of discretionary metabolic blends found in plants. Countless are known to give confirmation against bug ambushes and plant diseases. They moreover demonstrate different cautious capacities with regards to human buyers. Phytochemistry is for the most part used as a piece of the field of Chinese medicine especially in the field of a home developed solution.

• Plant Extraction methods
• Herbal drugs and Formulations
• Ethnopharmacology
• Plant physiology and Biochemistry

Track 26: Pharmacovigilance & Cosmetovigilance

The main aim of pharmacovigilance is to provide complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method. It enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system.

• Drug safety methods
• Detection of adverse effects and other drug related problems
• Pharmacoepidemology and drug safety
• Safety monitoring of medicinal products
• Ongoing and systematic monitoring of the safety of cosmetics
• Set up & implimentation of cosmetovigilance system

Track 27: Pharmaceutics & Novel Drug Delivery Systems

It is defined as the method by which a drug is delivered can have a significant effect on its efficacy i.e. the drug become more efficacious in order to minimize drug degradation, drug adverse effect, and in order to increase the drug bioavailability to produce better therapeutic effect. NDDS covers various aspects like pharmacokinetics & pharmacodynamics, non-specific toxicity, immunogenicity, bio recognition, and drug’s efficacy based on preferable approaches that include polymer science, pharmaceutical technology, dispensing pharmacy, packaging technology, bio conjugate chemistry, and molecular biology. NDDS based on two mechanism i.e. physical and biochemical. Physical mechanism is like dissolution, osmosis, absorption, distribution, bioavailability, excretion and diffusion. Biochemical mechanism is like gene-protein therapy, liposomes-niosomes, Nano-micro particles, Monoclonal antibodies.

• Preformulation studies and accelerated stability studies
• Nanotechnology in drug delivery system
• Lipid drug delivery system
• Recent advances in targeted drug delivery systems

Track 28: Pharma Analytical Techniques and Instrumentation

The development of the pharmaceuticals brought a revolution in human health. These pharmaceuticals would serve their intent only if they are free from impurities and are administered in an appropriate amount. To make drugs serve their purpose various chemical and instrumental methods were developed at regular intervals which are involved in the estimation of drugs. He review highlights a variety of analytical techniques such as titrimetric, chromatographic, spectroscopic, electrophoretic, and electrochemical and their corresponding methods that have been applied in the analysis of pharmaceuticals.

• Novel Approaches to Analytical and Bioanalytical Methods
• Biomolecular Analysis
• Analytical Instrumental Techniques

Track 29: Radiopharmaceuticals

A Radiopharmaceutical is a drug that can be used either for diagnostic or therapeutic purposes. It is composed of a radioisotope bond to an organic molecule. The organic molecule conveys the radioisotope to specific organs, tissues or cells. The radioisotope is selected for its properties. The global radiopharmaceuticals market was worth US$3.8 billion in 2011 and is expected to be growing at a stupendous CAGR of 18.3% to reach a value of US$12.2 billion by 2018.

• Radiopharmaceutical Usage
• Bio-engineering in Pharmaceutical Industry
• Engineering models in biomedicine
• Bionic human
• Clinical laboratory sciences
• Biomedical data engineering

On the groundwork about markets, biopharmaceutical can stay segmented within 4 categories namely biosimilar market, enzyme market, protein therapeutics market yet most cancers monoclonal antibodies market. Global biosimilar market has the highest market share and is expected to maintain its high growth rate for the estimated period. This industry is driven by the factors such as high pharmaceutical expenditure, and the presence of expensive drugs in this sector. Moreover worldwide protein therapeutics market is additionally expected to enroll exceptionally high development rate for the evaluated period attributable to its effectiveness in objective treatment which has practically no symptoms. Worldwide chemical market and disease monoclonal market are relied upon to develop at an unfaltering pace for the guage period.

On the basis of geography the biopharmaceutical market can be segmented in four key regions namely North America, Europe, Asia Pacific, and Row. North America has the highest industry share for the estimated period owing to presence of sophisticated healthcare infrastructure, growing geriatric population base and increased healthcare expenditure in the region. Asia Pacific is expected to register the highest growth rate for the forecasted period mainly due to presence of unmet industry opportunities in the region.

The pharmaceutical industry plays a significant role in developing medications and vaccines to reduce the incidence of diseases, to treat diseases and enhance the quality of life of people. The industry’s main contribution is engaging in technological advancements through innovative research to meet the complex healthcare demands of populations. The global market for pharmaceuticals is expected to grow at an annual rate of 4.9% to $1.3 trillion by 2020. The U.S pharma market is expected to grow to $320 billion by 2020. The Japan market, the third largest pharmaceutical market, has a forecasted growth of 3% while the U.S has an expected growth rate of 5.6%.