Allied Academies cordially invites participants from all over the world to attend Global Summit on Biopharma and Biotherapeutics, scheduled during May 14-15, 2018 at Montreal, Canada mainly focused on the theme “Addressing the Challenges in Biopharmaceutics and Biological products”.
Global Summit on Biopharma and Biotherapeutics will focus on many interesting scientific sessions and covers all frontier topics in Biopharmaceuticals which includes Challenges in Biopharmaceutics, Biopharmaceutical Drug Discovery & Development, Clinical Trials in Biopharmaceutics, BA/BE Studies, Biosimilars & Biologics Drugs, and many more. The conference also includes Keynote speeches by prominent personalities from around the globe in addition to both oral and poster presentations.
Why to attend?
With members from around the world focused on learning about Pharma and its advances; this is your best opportunity to reach the largest assemblage of participants from the Pharma community. Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new drug developments, and receive name recognition at this 2-day event.
Track 1: Biopharmaceutics: Research Scope and Prospects
Biopharmaceutics explore the interrelationship of the physical/chemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption and the use of this information to optimise the therapeutic efficacy of the drug products. The process of movement of drug from its site of administration to the systemic circulation is called as absorption. The concentration of drug in plasma and hence the onset of action, and the intensity and duration of response depend upon the bioavailability of drug from its dosage form. Bioavailability is defined as the rate and extent (amount) of drug absorption. Any alteration in the drug’s bioavailability is reflected in its pharmacological effects. Other processes that play a role in the therapeutic activity of a drug are distribution and elimination.
Pharmacodynamics of drugs
Pharmacokinetics of drugs
Potency of drug products
Track 2: Novel Approaches in Biopharmaceutics
The overall objective of this research program is to promote novel principles for specific drug delivery and targeting to the active site by using complex in vivo models. An innovatory, cutting edge and multi-disciplinary collaboration using clinical models will accommodate research teams from: pharmaceutical technology, material science, biopharmaceutics and pharmacokinetics, drug metabolism, toxicology, oncology, gastroenterology, endocrinology, urology and regulatory science.
Recent technology in biopharmaceuticals
Biomedical computational drug discovery
Novel therapeutics of modern biotechnology
Track 3: Biopharmaceutics Drug Discovery & Development
Biopharmaceutics studies about the physical and chemical properties of a drug, and its dosage form, as related to the onset, duration, and intensity of drug action, including constituents and mode of manufacture. Drug discovery implicate the use of high throughput screening techniques to analyse new compounds, both synthetic and natural, as novel drugs. Regrettably, this approach has yielded very little achievement 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 fulfilment for appropriate potency levels and suitable pharmacokinetics, in order to achieve efficacy in small animal disease models.
Pharmacogenetics in Drug Discovery and Development
Synthesis and Development Techniques in Drug Discovery
Innovative Strategies to Develop Drug Discovery
Track 4: Clinical Trials in Biopharmaceutics
A fundamental component to this mission across the biopharmaceutical industry is determining and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically meaningful medicines. The challenges facing the pharmaceutical industry make the choice of a strategic discovery partner more important than ever.
Bioassay and its types
Phases of Clinical Research
Clinical trial protocol
Clinical trial management system
Track 5: BA/BE studies for Biopharmaceuticals
BA/BE studies are finished initially and belated clinical trial definitions, Formulations used as a part of clinical trial and constancy studies. Everybody has collect more on their plate than any time in late remembrance, and diverse consultant discover themselves always re-organizing their work exercises.
BA/BE studies are regulated by regulations to establish therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. BE studies are done for Early and late clinical trial formulations, Formulations used in clinical trial and stability studies, if different Clinical trial formulations and to-be-marketed drug product When it comes to cost and productivity metrics, it’s often said that what gets measured gets done. Part of this is human nature.
Drug Absorption and Distribution
Bioequivalence Protocols: In vitro-In vivo correlation
Bio accessibility Factor
BA/BE study for orally inhaled drug products
Track 6: PK/PD for Biopharma drug products
Pharmacodynamics is the effect that drugs have on the body; while pharmacokinetics is the examination of the way in which drugs move through the body during absorption, distribution, metabolism and excretion. Drugs may undergo Pharmacokinetics and Pharmacodynamics and toxicity trial through animal testing. This data permits researchers to allometrically assess a safe initial dose of the drug for clinical trials in humans. In this track primary focus will be on uses in pharmacodynamics interactions, Drug and substance misuse, Drug-drug interactions.
Pharmacokinetics influences arrangement over the route of administration. For drugs to produce their effects they must interact with the body. This can happen in many ways and depends on the properties of the drug. The processes that occur after drug administration can be broken down into four distinct areas (known as ADME):
A: Absorption of the drug
D: Distribution of the drug molecules
M: Metabolism of the parent drug
E: Excretion or elimination of the drug and its metabolites
Solubility of poorly and high soluble drug
Drug Safety and Efficacy
Recent Biopharmaceutical Innovations
Pharmacokinetics -Dynamic Modelling
PK and PD in New Drug Development
Track 7: Biosimilars and Biologic Drugs
Biosimilars are the generic version of biological. A biosimilar is a biologic therapeutic item which is duplicate of a unique item that is produced by an alternate organization. It is the new buzz word in pharmaceutical industry. Biosimilars are highly comparable to licensed reference product not accept minor differences in clinically passive components; also there are no clinically needful disparities between the biologicals and the reference product in terms of safety, purity, and potency.
Biologic Drugs are genetically occurred from a living organism, such as a virus, protein, to maintain the body’s natural response to infections and diseases. Biologics target proteins, and cells responsible for the manifestation and damage of rheumatoid arthritis and other types of inflammatory arthritis. The proteins targeted include tumours necrosis factor (TNF), interleukin-1 (IL-1) and interleukin-6 (IL-6), which shows effect in joint inflammation. Biologics are reserved for people whose arthritis has not retorted well to disease-modifying anti rheumatic drugs (DMARDs).
Biosimilar GMP protein analysis
Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
Biosimilars Pharmacoeconomic Modelling
Advances in biological products
Generic biological drugs
Track 8: BCS and Solubility Enhancement
The Biopharmaceutical Classification System (BCS) is an experimental model that calculates portability and solubility under endorsed guidelines. The main purpose of the system was to aid in the governance of post-approval modifications and generics, providing approvals based solely on in vitro data when applicable. Waivers, dispensation to skip in vivo bioequivalence studies, are reserved for drug products that expedient certain concerns around solubility and permeability and that are also rapidly dissolving. The objective of this work was to advise the biowaivers potential of biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs.
A number of techniques can be adapted to develop solubilisation of poor water soluble drug and further to improve its bioavailability. Solubilisation of meagrely soluble drugs is a periodically encountered objection in screening studies of advanced chemical entities as well as in formulation architecture and advancement. Any drug to be absorbed necessary to be existent 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 terms of quality, solubility defined as the instinctive communication of two or more substances to produce a homogenous molecular diffusion. A saturated solution is one in which the solute is in stability with the solvent. The solubility of a drug is characterized through several concentration expressions such as parts, percentage, molarity, and molality.
Dissolution testing in drug formulation
In vitro diffusion cells for dissolution testing in formulation development
In vitro preclinical ADME/BCS testing
Track 9: Biopharma Regulatory Affairs
Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated 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 a 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 purpose is to create a workforce that will function within the FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process.
Role of Regulatory Authorities
Overview of drug, biologic and device regulatory pathways
Regulatory Approvals for Biopharma drug products
Biopharma Regulatory challenges
Track 10: Formulations of Biopharmaceuticals
Pharmaceutical formulation is illustrated as the process in which different chemical materials are incorporated to form final medicinal substances. The formulation studies associates developing a preparation of drug tolerable for patient. Formulation is the word often used in a way that consists dosage form. Formulation studies examines factors such as solubility, polymorphism, particle size, and pH as all of these can effects bioavailability and hence the reaction of a drug.
Formulations are classified into two types: based on Route of administration and Physical form. Based on route of administration they are classified as Oral, Topical, Rectal, Parenteral, Vaginal, Inhaled, Ophthalmic and Octic.
Types: Parenteral, Topical, External
Routes of administration: Oral, Rectal, Vaginal, Lingual etc.
Formulation from plant source
Track 11: Drug Delivery Systems for Biopharmaceuticals
Drug delivery systems are organized technologies for the addressed distribution and/or controlled release of therapeutic agents. Drug delivery systems manages the rate at which a drug is produced and the place in the body where it is affected. Some systems can control both. Drug Delivery shows an important role in the future of pharmaceutical research Novel drug delivery system method. Increasing of dissolution rate of meagrely soluble drugs can be increased by dissolving them in liquid hydrophilic vehicles followed by soaking on highly porous materials. The important part is to deliver an innovative research on the new Targeted drug delivery is a type of delivering medication to a patient in such a manner that enhances the concentration of the medication in some parts of the body relative to others.
Control release drug delivery system
Advancements in oral drug delivery
Transdermal drug delivery system
Targeted drug delivery
Track 12: Protein Interactions as Targeted Therapeutics
Protein–protein interactions between membrane-localized receptors and intracellular signalling molecules control neuronal function and theoretically provide a rich source of vastly excluded 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 approaches in screening technologies and accessibility to an ever-increasing diversity of small molecules propose that protein–protein interactions are a viable option for drug discovery.
Protein-protein Interactions: Druggability and Chemical Space
Protein targeted using nucleosome binding surface
Peptides binding to modulate gene expression
Track 13: Biopharmaceutical Companies & Market analysis
Pharmaceutical analytic market analysis arrangement with the collection, analysis, and resolution of details and data acknowledgement to the market environment of a given pharmaceutical product – in general of a medical drug. The elementary use of pharmaceutical market analysis is to boost as realistic and objective as possible a response of the marketing opportunities of a given pharmaceutical product, thus developing the recognition of the chances and risks combined with its development potential as early on as possible.
Biopharmaceuticals are one of the world's most beneficial ventures. In 2008 alone, the pharmaceutical business sold $773 billion in items around the world a number that has reliably developed for as long as 8 years and is anticipated to increment again by 2.5 to 3.5 percent in 2017, as per the medication statistical surveying firm IMS Health.
In any case, the procedure that transforms look into dollars into pharmaceuticals is a moderate and regularly strenuous one. It now takes a normal of 12 to 15 years and up to $1.7 billion for a medication to go from revelation to advertise, as indicated by The Pharmaceutical Research and Manufacturers of America. Also, regardless of constantly and cash contributed, just a modest bunch of medications are affirmed by the FDA every year.
The U.S. Nourishment and Drug Administration (FDA) and its European Union partner, the European Medicines Agency (EMEA), represent each part of a medication's improvement from chemicals utilized as a part of the medication and clinical study directions, called conventions, to bundling segments and showcasing materials. This strict oversight is intended to ensure persistent wellbeing, and pharma organizations consider administrative oversight important. The consistent weight to hold fast to government commands shapes each part of a pharma company's association, operations, and culture. For instance, sedate organizations keep up capable administrative undertakings divisions-the offices that arrangement with government offices and they have a tendency to be hazard disinclined.
The global pharmaceutical market is expanding
undeviatingly, with sales reaching $1.08 trillion in 2011 – a year-on-year
increase of 7.8%. The mature economies proved very sluggish, but the growth
economies were another matter. Sales in the BRIC countries (Brazil, China,
India and Russia) rose by 22.6%, while sales in the other 13 growth countries
(the ‘fast followers’, as we call them) rose by 7.2%.9 If this pattern
continues, the market for medicines could be worth nearly $1.6 trillion by
2020. 10 Indeed, it could be worth even more. Demand for pharma’s products is
growing dramatically, as the global population increases, ages and becomes more
sedentary. In 2010, there were an estimated 6.9 billion people. By 2020, there
will be more than 7.6 billion.11 and, if present trends are any guide, many of
them will have health problems In short, there are more people – and more sick
or elderly people – in the world today than ever before. More people have
access to affordable healthcare than ever before. And, by 2020, access to
healthcare may well be regarded everywhere as a basic human right.