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Addressing the Challenges in Biopharmaceutics and Biological products
- Biopharmaceutics 2018

About Conference

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.

Reason for holding the conference at Canada

Canada's biopharmaceutics industry has expanded rapidly in the last decade, as measured by industry-wide revenues, the launch of new companies, and the continuous diversification of its products. Canada has the largest per capita number of biotechnology companies in the world and is second only to the United States in absolute number of biotechnology companies. It ranks third in revenues, after the US and the UK, generating $1.9 billion per year. Among G7 countries, Canada has exhibited the fastest rate of growth in the number of workers devoted to R&D, external patent applications, and business expenditures on R&D.

Why to attend Biopharmaceutics 2018:

   Meet researches from Biopharmaceutics and pharmaceuticals industries.

   To meet global experts in biopharma and pharma industries.

   To know latest techniques and latest innovations in pharma market.

   To grow your Business development from pharma industries.

   Keep pace with current development and innovations in the industry.

 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.

Target Audience:

Welcome Message


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.

Sub Tracks:

            Pharmacodynamics of drugs

           Pharmacokinetics of drugs

           Potency of drug products

           Applied biopharmaceutics


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.

Sub Tracks:

            Recent technology in biopharmaceuticals

            Patient Assistance

            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.

Sub Tracks:

        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.

Sub Tracks:

         Bioassay and its types

         Pre-Clinical Testing

         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.

Sub Tracks:

         Drug-release studies

         Drug Absorption and Distribution

         Bioequivalence Protocols: In vitro-In vivo correlation

         Dissolution Studies

         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

 Sub Tracks:

           Solubility of poorly and high soluble drug

           Drug Safety and Efficacy

           Recent Biopharmaceutical Innovations

           Pharmacokinetics -Dynamic Modelling

           PK and PD in New Drug Development

           Drug-Drug Interaction


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).

Sub Tracks:

           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.

Sub Tracks:

          BCS biowaivers

          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.

Sub Tracks:

          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.

Sub Tracks:

            Types: Parenteral, Topical, External

            Routes of administration: Oral, Rectal, Vaginal, Lingual etc.

            Inhalation formulations

            Formulation from plant source

            Other routes


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.

Sub Tracks:

           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.

Sub Tracks:

          Protein-protein Interactions: Druggability and Chemical Space

          Protein targeted using nucleosome binding surface

          Peptides binding to modulate gene expression

          Epigenetic agent

 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.




Market Analysis

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.

Organizing Committee
OCM Member
David P.Elder
London, United Kingdom

Holiday Inn EXPRESS &Suites Montreal Airport, 10888 Chemin de la Côte-de-Liesse, Lachine, QC H8T 1A6, Canada

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