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World Biosimilars 2020

About Conference


 

World Biosimilars 2020 will be a great platform for exchanging new ideas and research. This gathering will provide networking sessions for Scientists, pharmacist, Biopharmaceuticals, Professors, Business Assistants, Students, and individuals from all biosimilar & Pharmaceutical groups. It also helps in continuing education opportunities and quality information shared by Keynote Speakers, Symposia, hands-on workshops, and exhibition.

Conference Series LLC LTD conducts 1000+ Global Events comprehensive of 300+ Conferences, 500+ Upcoming and Previous Symposiums and Workshops in USA, Europe and Asia with help from 1000 more Scientific Societies and distributes 700+ Open Access Journals which contains more than 30000 prominent identities, reputed scientists as editorial board members.

Young Scientist Benefits:

Our conferences provide best Platform for your research through oral presentations.

Share the ideas with both eminent researchers and mentors.

Young Scientist Award reorganization certificate and memento to the winners

Young Scientists will get appropriate and timely information by this Forum.

Platform for collaboration among young researchers for better development

Award should motivate participants to strive to realize their full potential which could in turn be beneficial to the field as whole.

Why to attend?

With individuals from everywhere throughout the world concentrated on getting new ideas concerning Biosimilars, Pharmaceutical and its advances, this is the best chance to accomplish the greatest get-together of people from the Biosimilars and Pharma Innovation groups. Famous speakers, quality presentations, recent frameworks, novel techniques for the innovation in the field of Biosimilars and Pharmaceutics, recent techniques will mark the uniqueness of this conference. It will also pave way for making a good relationship with the Biosimilars and Pharma associates through the B2B meetings and develop better business opportunities.

WHO SHOULD ATTEND

World Biosimilars 2020 invites CEOs | CIOs | VPs | CTOs | Directors |Department Heads |Technical Analysts| Research Engineers | Specialists| Government officers specializing in the field of Biosimilars and Pharma Innovation.

TARGET AUDIENCE

  • Pharmaceutical Companies,
  • Pharma Associations & Societies,
  • Bio- technology Experts/Business Entrepreneurs.
  • R&D, F&D Scientists
  • Intellectual Property Attorneys
  • Ph.D. and Post Doctorate Scholars
  • Directors, CEO’s of Organizations
  • Business Development Managers
  • Chief Scientific Officers
  • R&D Researchers from Biosimilar
  • Bioslogics Industries
  • Professors, Associate Professors, Assistant Professors
  • PhD Scholars
  • Patent Attorneys
  • Intellectual Property Attorneys
  • Association, Association presidents and professionals
  • Noble laureates in Health Care and Medicine
  • Bio instruments Professionals
  • Bio-informatics Professionals
  • Research Institutes and members
  • Manufacturing Companies
  • Business Entrepreneurs
  • Students, Scientists, Researchers, and Faculty of Pharmaceutical Sciences
  • Universities, Medical Colleges, Researchers from Pharmaceutical backgrounds
  • Pharma Industry, Pharmacy Associations and Societies,
  • Business Entrepreneurs, Training Institutes, Software developing companies,
  • Medical Devices Manufacturing Companies, CRO
  • Students, Scientists, Research scholars and Faculties from Pharmacy Universities and Medical Colleges
  • Research scientists from Pharmaceutical Industries
  • Pharmacy associations and societies
  • Medical devices manufacturing companies
  • Clinical Research Organizations
  •  Advances in Biosimilars

 

KEY PRACTICAL LEARNING POINTS OF THE CONFERENCE:

  • An overview of the current biosimilars market
  • Barriers in developing biosimilars
  • Cost of developing biosimilars.
  • A summary of regulatory pathways in various geographic regions
  • How biosimilars are developing in different countries
  • An overview of approved biosimilars in the E.U, U.S, India, South Korea, and Latin America.
  • The market impact of biosimilars on their reference biologics
  • The top ten biologics on the focus of biosimilar developers
  • Ways to commercialize biosimilars
  • Implications of biosimilars inpatient treatment

 

A word to Sponsors /Exhibitors/Collaborators:

Be the first to showcase your research, innovation and brand to gain competitive advantages. Meet your target audience and explore your product and services.

  • To Meet Experts
  • Learning In a New Space
  • New Tips & Tactics
  • Certification
  • Global Networking
  • Rebuild New Customer Base
  • Brand Establishment

 Target Delegates:

  • Students, Scientists, Research scholars and Faculties from Pharmacy Universities and Medical Colleges
  • Research scientists from Pharmaceutical Industries
  • Pharmacy associations and societies
  • Business Entrepreneurs Training Institutes
  • Software developing companies
  • Medical devices manufacturing companies
  • Clinical Research Organizations
  • Data Management Companies.
  •  Advances in Biosimilars

       

 

 

 

Sessions


Track 1: Chemical and Analytical Strategies for Biosimilars:

Biosimilar products are required by regulatory authorities to have appropriate and comparable quality, safety and efficacy with a reference biologic product .Analysis of biosimilars and biologics structures to be a standout amongst the most critical angle towards the biologics and biosimilar advancement process. Bio-analytical strategies for process advancement and approval and also utilization of generation innovations, for example, disposables and store network co-ordinations can enable organizations to build up office adaptability. This biosimilars worldwide occasion additionally incorporates Bio-analytical strategies, Formulation, Bioassay for equivalence and power testing, GMP protein examination, LC/MS investigation for revelation, preclinical, and clinical projects. While small changes in these parameters can impact the various chemical permutations for a given biotherapeutic, innovators can, under certain circumstances, change the host cell, fermentation process, purification process, and even manufacturing site, but the product can be validated without undertaking a complete new product development review.

Track 1-1 Biochemical and Biosimilar Characterization

Track 1-2 Biosimilars multimodal techniques

Track 1-3 Biosimilars bioanalytical methods

Track 1-4 Bioassays for comparability and potency testing

Track 1-5 Biosimilars LC/MS analysis for discovery, preclinical and clinical programs

Track 1-6 Biosimilars GMP protein analysis

Track 1-7 Biosimilars electrophoresis

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Track 2: Pharmaceutics

Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. The largest pharma market globally is for musculoskeletal drugs. The segment accounted for 14% of the global total in 2017. Cardiovascular, oncology and ant-infective drugs are the second third and fourth largest markets.

  • Drug delivery
  • Pharmaceutical formulation
  • Pharmaceutical manufacturing
  • Physical pharmacy
  • Pharmaceutical jurisprudence
  • Dispensing pharmacy
  • Pharmaceutical technology

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Track 3: Drug Formulation

Pharmaceutical formulation is defined as the process in which different chemical substances are combined to produce a final medicinal product which can be either solid, semisolid or liquid formulations. This session is ventured around topics like, Drug Delivery design, versatile polymer in drug delivery and Controlled Drug Delivery, Novel Drug interactions, improvement of pharmaceutical product, Sustained Drug Delivery Systems, may be a distinct architecture session that plays an important role in the fields of drug formulation and development.

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Track 4: Biological Medicine:

A biologic medicine is defined as a medicine that contains one or more active substances made by or derived from a biological source. In the broadest sense, biological medicines include any substance made in the laboratory from a living organism. This broad definition includes vaccines, immunotherapies, biosimilars, gene therapy, and stem cell or tissue therapy. Bio medicine can also be defined as a medicine whose active substance is made by a living organism.

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Track 5: Emerging Biosimilars in Therapeutics

In the field of biologics, the new avenue has created towards clinicians because explorations have created for better disease management. In the treatment of elements like psoriasis, rheumatic arthritis, certain cancer inflammation, bowel diseases etc. Showed some good outcomes because of using biologics. Biosimilar insulin which are newly formed are likely to enter the insulin landscape as patents for major branded insulin products ready to expire in the next few years. The emerging biosimilar like filgrastim, pegfilgrastim, recombinant blood products, therapeutic products vaccine biosimilar, anti-bodies growth hormones, biosimilar peptide, all these are used to sound knowledge on biosimilars development on drugs.

  • Rapid screening methods
  • Environmental Monitoring
  • Particulate matter

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Track 6: Innovative Clinical Approach in Biosimilars:-

Clinical trials for biosimilars should exhibit much identical security what is a lot of, viability to the reference item, together with consecutive PK/ metallic element and viability/security trials. Controllers expect PK/PD similarity info from a phase I clinical trial trial can bolster encourage viability/ successfulness evaluations in crucial phase III clinical trial trials. Stay solitary phase III clinical trial investigations or joined section I/III outlines while not supporting PK info area unit most likely not attending to be acknowledged. Clinical similarity stipulations might fluctuate on a item-by-item premise subject to a risk primarily based approach. Three-arm phase I clinical trial trials area unit more and more getting used to point out equivalence between the biosimilars and 2 licensed diversifications of the same reference item which will exist in numerous markets, permitting developers to proceed with crucial trials employing a single version of the reference product.

  • Biosimilars clinical trials
  • Clinical PK/PD studies
  • Toxicological studies
  • Risk management and quality affairs
  • Targeted cell line development
  • Case studies and clinical models
  • Biologics product life cycle and sustainable market returns

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Track 7: Current Challenges in Developing Biosimilars

The development of biologics necessitate overcoming ton several challenges. With initial steps of ideas of biologics, their issues, necessities for early clinical developments it's a great deal required that correct scientific and strategic approaches area unit taken for the winning development of follow-on-biologics. Moreover, the requirement for overcoming the challenges continues within the late clinical steps, drug safety factors and labelling needs. Conjointly it's a lot of needed currently to develop a drug product in accordance to quality intentionally (QbD).This monetary unit biosimilars conference can explore the multiple sides of current challenges in Biosimilars development. This biosimilars conference can specialise in multiple aspects of biosimilars development to with success deliver safe, potential and efficacious life product to the market.

  • Biopharmaceuticals development
  • Quality by Design for Biologics and Biosimilars
  • Implimentation of the BPCI Act
  • Advertising, promotion and labelling essentials
  • Unique considerations for biologics
  • Comparability for biologics
  • Drug safety essentials
  • Late clinical development essentials
  • Early clinical development essentials
  • Biologics in genetic disorders
  • Biopharmaceuticals development

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Track 8. Formulation of R&D

The drug subjected to drug development undergoes range of trials and area unit screened at totally different stages to provide a final potent drug supposed for the treatment of varied diseases. throughout this method numerous properties area unit checked to check whether or not the drug is non-toxic to living system and is therapeutic or not. victimisation appropriate excipients and technological preparations the active substances area unit developed into final indefinite quantity type. The last product is that the Actual composition of preparation, producing specification. Drug formulation will have a considerable impact on nearly each quality characteristic of Associate in Nursing API together with efficiency, bioavailability, solubility, dosage, route of administration and stability. In immune offers epithelial duct drug formulation R&D services for primary stage and diagnosing candidates with a special prominence in nanoparticle based mostly drug delivery technology.

  • Sources of Drug Formulation
  • Electrochemical Methods

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Track 9: Biosimilar Market and Cost Analysis

The global biosimilars market is growing at an exponential rate. The CAGR from 2015 to 2020 is projected at over 22%. The biosimilars market is predicted to be around $6.2 billion by 2020 from only $2.3 billion in 2015. By the top of this decade the biosimilars would surely occupy 27% of the entire pharmaceutical market. Moreover, with the worldwide rise in concern for more accessible-improved- cost effective healthcare, biosimilar drugs would be a more apt choice to the payers, end users, manufacturers over the costly reference biologics. Originator biologics are as costly as about $100,000 per annum per patient. Biosimilars on the contrary are often offered at a 30-40% lower cost than that of the reference product. However, with all the success stories and opportunities there also lies a sobering 50% failure rate in developing and obtaining license towards marketing of biosimilars. The biosimilars market is categorized into mainly four zones – North America(USA and Canada); Europe(UK, Germany, Spain, Italy, France and Rest of Europe); Aisa-Pacific( China, India, Japan, South Korea) and remainder of the planet ( LATAM and MENA). Key players of the biosimilars market include Amgen, Hospira, Teva, Sandoz International GmbH, Dr. Reddy’s Laboratory, Biocon, Roche, Celltrion, Catalent, Mylan and Merck. There are also certain other companies which are gaining importance in biosimilar de velopment like LeanBio Pro-Spain, PPD-USA, SGS Life Sciences-UK, Therapeutic Proteins International-USA. The biosimilars development is especially concentrated within the therapeutic domains of oncology, blood disorders, autoimmune disorders, endocrine disorders and infectious diseases.

  • Return on Investment(ROI) for Biosimilars
  • Biosimilars Pharmacoeconomic Modelling
  • CAGR of biologics and biosimilars
  • Future of next generation biosimilars
  • SWOT Analysis of Biosimilars
  • Challenging potential & Competing Vs Generics
  • Penetration and uptake of biosimilars in different disease sectors
  • Pharmacoeconomic Modelling of Biosimilars
  • Risk management plan (RMP) for Biosimilars

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Track 10: Intellectual Property Rights

The safeguarding of product secret, its formulations and other process parameters by law is typically covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance within the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. The very name Biosimilars involves the occurrence of property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel. Currently, the US provides 12 years of exclusivity for brand spanking new biological products under the Biologics price war and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of the many who need them. Prices frequently exceed $100,000.

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Track 11: Regulatory Updates on Biosimilars

Competitions and/or success at intervals this company business square measure determined by the winning patent strategy that principally pertains to the generic market entry. Generic and branded drug makers each the patent strategy proximally belongs to the Hatch-Waxman Act statutory theme and ANDA litigations. The Hatch-Waxman Act enacted in 1984 with modification in 2003 expedited the entry of generics at associate early stage-thereby finishing the battle of branded generic ANDA of blockbuster medication. All constant the Biologics price struggle and Innovation (BPCI) Act has maximized the branded-generic patent duel at intervals the biologics realm by imposing a litigated framework on follow-on-biologics.

An bureau analysis of drug costs from 1999 to 2004 found that the discount from generic competition was simply 6 June 1944 with one generic competition, however jumps to forty eighth with 2 generic competitors, fifty six with 3, sixty one with four and sixty seven with 5 generic producers throughout a market. at intervals a pair of years of the expiration of the patent of the favored drug alkaliser in 1997, generics of alkaliser accounted ninetieth of the treatment’s total sales, and thus value the worth|the value} for patients was concerning 100% of its pre-generic price. European patents on biological treatments began to expire in 2000, and in Gregorian calendar month 2006, Sandoz and Biopartners with success received EMEA approval for the first European biogenerics, 2 products containing human somatotrophic hormone.

  • Licensing of biosimilars
  • BLA filing for biosimilars
  • Regulatory prospects of BRIC countries
  • Biowaiver approval for biosimilars

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Track 12: Biosimilars Development in Markets.

A Biosimilars bio therapeutic item is comparative (but not identical) as so much as quality, wellbeing, Associate in Nursing viability to an effectively licensed reference item. Not within the least like nonspecific very little particles, it’s arduous to send such naturally complicated things in lightweight of convoluted grouping forms. The worldwide biosimilars advertise is developing quickly as licenses on blockbuster life medications terminate and alternative healthful services elements centre on drop-off of expenses. Biologics square measure among the foremost elevated price medicines on the worldwide market nowadays, that suggests the necessity for stripped-down effort decisions. In developing markets, biosimilars formally supply a lot of moderate prices, that square measure tempting, additionally as crucial to economies wherever expensive medications are not monetarily realizable

Track 8-1Biosimilars China and Asia Pacific

Track 8-2Biosimilars India

Track 8-3Biosimilars USA

Track 8-4Biosimilars USA

Track 8-5Biosimilars Europe

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Track 13: Biosimilars Approval to Biogenerics in Clinical Practice

Biological medicines are far more structurally complex and very sensitive to manufacturing conditions and thus harder to characterize and produce than small molecule drugs. Even minor changes in manufacturing may cause significant variations of the cellular systems used for biological production, also on differences within the structure, stability, or other quality aspects of the top product, all of which have the potential to affect tolerability and/or efficacy and increase the danger of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there's some disagreement on which studies got to be implemented to approve a biosimilars. According to current literature, the subsequent points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to permit physicians to realize confidence in biosimilars.

Track 9-1Monoclonal antibody

Track 9-2Fusion protein

Track 9-3Biologic drug

Track 9-4Anti–tumor necrosis factor

Track 9-5Biotechnologic drug

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Track 14: Biopharmaceutical Informatics

Biopharmaceutical information processing endeavors to use info technology, sequence-and structure-based bioinformatics analyses, molecular modelling and simulations, and applied math knowledge analyse towards biological drug development. Development of knowledge bases containing the experimental data on biophysical stability, safety along with molecular sequence

Track 10-1 Applications of computation in biologic drug development

Track 10-2 Physics-based molecular modelling

Track 10-3 Protein sequence-structural contexts and degradation reaction mechanisms

Track 10-4 De risk biopharmaceutical development

Track 10-5 Creation of databases and data mining

Track 10-6 Pre-clinical immunogenicity risk assessment of biotherapeutics

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Track 15: Consequences of Brexit on Biosimilars

With Europe that made-up because of the uptake of biosimilars over a decade agone, the results of Brexit would be doubtless tougher on UK. Presently UK isn't to any extent further guaranteed to follow the foundations of EMA. Additionally analysis grants from Innovative Medicines Initiative and Horizon 2020 would no a lot of be offered to UK. All the same, EMA has its headquarters in London, UK. The so arising complications would positively have sure consequences on the Biosimilars state of affairs in UK and EU.

Track 11-1Brexit- Pros and Cons to European pharma market

Track 11-2Post Brexit changes in biosimilars regulation in UK

Track 11-3Fate of biosimilars clinical trials in UK

Track 11-4Research funding from European organizations to UK based research laboratories

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Track 16: BCS and IVIVC Based Biowaivers

The objective of this work was to counsel the biowaivers potential of biopharmaceutical arrangement that are noted to increase the solubility, dissolution, oral absorption of water insoluble medication. Biopharmaceutics arrangement and invitro and invivo classification discusses concerning ADME pathways of varied medication. This additionally includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro presymptomatic ADME/BCS testing. Till in vitro and in vivo correlation achieves the desired degree, the biosimilars drug will not be able to meet the wants of the primary drug candidate. Hence the proportion of BCS and IVIVC based mostly biowaivers ar fairly low ~0.5-1% of total pharmaceutical product.

Track 16-1 BCS biowaivers

Track 16-2 Preclinical and clinical testing for oral drug delivery

Track 16-3 Waiver for In vivo bioavailability or bioequivalence

Track 16-4 Consideration of biowaiver extensions for BCS class III drugs

Track 16-5 In vitro diffusion cells for dissolution testing in formulation development

Track 16-6 Dissolution testing in drug formulation

Track 16-7 In vitro preclinical ADME/BCS testing

Track 16-8 In vitro drug product research.

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Track 17: Challenges in Biosimilars Pharmacovigilance:

This session of the Biosimilars 2018 can verify the long run and Food and Drug Administration initiatives that have already been proclaimed to include increased following and follow-up of post selling police investigation problems, planned enhancements in AERS, and pilots of latest post market drug-monitoring ways and ADR connected problems. Biosimilar tips for pharmacovigilance follow and pharmacoepidemiology are the points that shall be set stress throughout this session. U.S. average annual defrayal growth from 2002 to 2007 was Sixteen Personality Factor Questionnaire for biologics, compared with three.7% for medicine. In same proportion pharmacovigilance for biosimilars has been relatively quite different pharmaceutical merchandise.

Track 17-1 Current problems in biosimilars Pharmacovigilance

Track 17-2 Adverse drug reactions with biologics and biosimilar products

Track 17-3 Detection and evaluation of drug safety signals

Track 17-4 Role of pharma industries in the improvement of pharmacovigilance system

Track 17-5 Good pharmacovigilance practice and pharmacoepidemiology

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Track 18: Legal Issues and BPCI Act

The legal problems regarding the follow-on-biologics associate degreed biosimilars are one of the foremost aspects that want an open discussion. Before the actual advent of biosimilars to the market legal problems have up in numbers in their biological process stages. Known organizations have filed cases against alternative 2 claims their rights and for other legal allegations related to the product. This track is dedicated to discussion of all such cases that has been argued among the court of law.

By 2002, the authority had approved thirty six new biologics, followed by thirty seven additional in 2003, another forty in 2004 and thirty-nine additional in 2005. By 2006, the leading class of biological treatment, the red corpuscle attention recombinant glycoprotein (EPO), generated $14 billion in sales revenues, or forty p.c quite the popular ancient pharmaceutical, Lipitor. quite three hundred therapeutic antibodies presently are in clinical development and trials, compared to solely thirteen that already are wide accessible because of legal problems.

Track 15-1Implimentation of the BPCI Act

Track 15-2Patent protection and infringement issues

Track 15-3Patent negotiation and litigation phase

Track 15-4Market exclusivities       

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Track19. Drug Delivery Technology:

Pharmaceutical drug delivery technologies enhance drug absorption, efficacy, and patient expertise. style maskers increase the business viability of your pharmaceutical merchandise by neutralizing the sturdy, bitter tastes of bound oral medical formulations. Bioavailability of medicines at intervals the system square measure typically achieved by increasing the dissolution rate with specialised drug delivery sweetening merchandise. Enhancing the drug delivery technology of final pharmaceutical formulation will increase its business success. The most routes of drug delivery square measure oral, injection/infusion, and percutaneous. Drug-eluting stents and different implantable drug delivery devices square measure conferred, conjointly as outwardly applied devices. Once combined with applicable targeting moieties, drug-coated nanoparticles, drug-encapsulating liposomes and nanotubes, and tree-like dendrimers alter organ and tissue targeting.

The use of applied science in drugs and a lot of specifically drug delivery is close to unfold apace. presently several substances square measure underneath investigation for drug delivery and a lot of specifically for cancer medical care. Curiously pharmaceutical sciences square measure mistreatment nanoparticles to reduce toxicity and aspect effects of medication and up to recently did not notice that carrier systems themselves could impose risks to the patient. the type of hazards that square measure introduced by mistreatment nanoparticles for drug delivery square measure on the far side that exhibit by standard hazards obligatory by chemicals in classical delivery matrices

These biotechnology derived medicine were at one time administered by injection alone, but today, solutions for inhaled, percutaneous, and even oral delivery square measure obtainable or underneath investigation for several established merchandise .Super molecule delivery technologies, since unprotected or untargeted delivery of sequence therapies or RNAi is unthinkable. We have a tendency to then advance to developments in percutaneous delivery technology, which includes active systems wherever delivery is driven by micro needles or energy applied via ultrasound or lasers.

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Track 20. Pharmacogenomics:

 Pharmacogenomics is that the study could be a few person’s genes response to specific medication. this is {often |this can be} often the somewhat new field that mixes medication (the science of drugs) and genetics (the study of genes and their functions) to develop productive, safe medication and doses that will be tailored to a person’s genetic makeup. This session plans to bolster the novel drug administration by intermixture medication and modifying in light-weight of hereditary varieties in placid reaction.

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Track 21. Pharmaceutical Chemistry

Pharmaceutical chemistry encompasses drug design, drug synthesis, and the evaluation of drug efficacy and drug safety. Drug discovery is the core of pharmaceutical chemistry.

  • Design of safer chemicals and products
  • Process Chemistry Considerations
  • Structure-activity relationships of drug Moiety
  • Synthetic chemistry including combinatorial methods
  • Invivo and in vitro bio transformation of drugs
  • Modelling and designing of small compounds
  • Physico chemical and biological factors that contribute to drug action
  • Medicinal Radio compounds or Radiopharmaceuticals
  • Global Pharmaceutical Policy
  • Impurities and Impurity Profile Significance in API

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Track 22. Digital Pharma

Pharmaceutical companies can play a paramount role in the digital revolution of healthcare. But grabbing this opportunity requires identifying the right actions. Pharmaceutical companies are running hard to keep measure with changes brought about by digital technology. Mobile communications, the cloud, advanced analytics, and the Internet of Things are among the new innovations that are starting to transform the healthcare industry in the ways they have already transformed the media, retail, and banking industries. Pharma executives are well aware of the disturbing potential and are examining with a wide range of digital enterprise. Yet many find it hard to determine what initiatives to scale up and how, as they are still unclear what digital success will look like five years from now. This article aims to remedy that. The digital pharma market is relied upon to reach $ 11.2 billion in 2013. This market is further anticipated that would develop up to $23.5 billion in 2018 with a compound yearly development rate (CAGR) of 16.1%.

  • Pharma: just trying to start something new with the help of Digital.
  • Digital Pharma: A New Culture
  • Digital Pharma & Customer Service
  • Digital Pharma Opportunities & Challenges
  • Digital’s Increasing Impact on Pharma Communications.

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Track 23: Advanced Drug Delivery System:

1. Vaccine Drug Delivery System

Vaccine is a material that activates an immunologically mediated resistance to a disease but not necessarily an infection.  Vaccines generally consist of killed or attenuated organisms or subunits of organisms or DNA encoding antigenic proteins of pathogens. Delivery of antigens from oil-based adjuvants such as Freund's ancillary lead to a reduction in the number of doses of vaccine to be administered but due to toxicity concerns such as inductions of granulomas at the injection site, such ancillary is not widely used.  Search for safer and potent ancillary resulted in the formulations of antigen into delivery systems that administer the antigen in particulate form rather than solution form.

  • Cancer vaccines
  •   Human vaccines
  •   HIV/AIDS vaccines
  • HPV vaccines
  • Therapeutic vaccination for autoimmune diseases
  • Novel vaccines
  • Clinical trials     

2. Sustained Release Drug Delivery system

Sustained-release drug delivery dosage forms are designed to release a drug at a prearranged rate by maintaining a fixed drug level for a particular period of time with minimum side effects. It basically optimizes the biopharmaceutical, pharmacokinetic and pharmacodynamics properties of a drug in such a way that its utility is maximized, side-effects are reduced and the cure of the disease is achieved.

3. Prolonged Release Drug Delivery System

Prolonged-release drug delivery system makes a simple cylindrical device with a small release hole which is investigated by a dynamic mathematical simulation model based on the two-dimensional Fick's law of diffusion. Effects of the release hole radius, height, and radius of the device and hydrodynamic diffusion boundary layer formed on the device, the surface is numerically evaluated. It releases the active ingredients through a hole slowly so that it can release for an extended period of time.

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Track 24: Encapsulated Drugs

It is a very advanced approach in which the drug/small molecules are nanoencapusaluted in nanocarriers (NCs). The basic idea about encapsulate drug is it allows efficient loading of drug molecules inside the NCs which in further reduces systemic toxicity associated with drugs.

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Track 25. Pharmaceutical Manufacturing

Pharmaceutical manufacturing, Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

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Market Analysis

The World biosimilar 2020 market in Europe reached a value of US$ 2,934.6 Million in 2018. The market is further projected to reach a value of US$ 11,663.1 Million by 2024, growing at a CAGR of 24.9% during 2019-2024.

The European biosimilar market represents the most mature in the world and continues to rally momentum. This market is expected to grow robustly in the next five years, as a number blockbuster biologics are scheduled to lose patent protection in Europe.

Biosimilars are biotherapeutic products which are similar to already licensed reference biologics, in terms of quality, safety and efficiency. Biosimilar manufacturers wait till the patent of the reference product expires and then seek approval from the regulatory authorities in order to produce their biosimilar versions. These manufacturers use the state-of-the-art technology for comparing the characteristics, such as purity, chemical identity and bioactivity, of the proposed biosimilar to its reference product.

In 2005, a science-based regulatory framework was established in the European Union (EU) for ensuring the production of high-quality biosimilars. Later in 2006, the European Medicines Agency (EMA) approved the first biosimilar medicine, Omnitrope. Since then, a number of biosimilars belonging to various therapeutic classes have been approved in Europe.

Biosimilars Market in Europe: Drivers

Biosimilars are less expensive than their branded counterparts as they do not require extensive research and testing which saves both money and time; thereby lowering the costs. Moreover, they also have short marketing times as launching a biosimilar does not require extensive marketing as the safety and efficacy profile of their branded counterparts have already been established.

Several blockbuster biologics are expected to lose their patent protection over the next 5 to 10 years. This expiration of patents and other intellectual property rights is expected to create huge opportunities for biosimilar manufacturers.

The European population is ageing with around one fifth of the total EU population above 65 years of age. There has resulted in a significant increase in the burden of lifestyle diseases in the region. The prevalence of diseases such as diabetes, autoimmune diseases, oncology, etc. has been increasing rapidly in Europe. This is also expected to propel the market growth during the next few years.As a result of rising healthcare costs, governments across a number of European countries have formulated policies incentivising physicians, pharmacists and patients in favour of biosimilars over branded biologics.

Market Summary:

Country-wise, the market has been segmented into Italy, Germany, United Kingdom, France, Spain and Others. In 2018, Italy represented the largest market for biosimilars in Europe.

The report has analysed the market on the basis of molecule. In 2018, Infliximab dominated the market, accounting for the highest sales. Other major molecules include Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, etc.

The report has also analysed the market on the basis of indication. Autoimmune diseases represented the biggest indication for biosimilars in 2018. Other major indications include oncology, autoimmune diseases, blood disorders, growth deficiency, diabetes, etc.

On the basis of manufacturing type, the report has segmented the market into in-house manufacturing and contract manufacturing. In 2018, in-house manufacturing accounted for a higher share.

Some of the leading players operating in the European biosimilars market include:

  1. Novartis
  2. Pfizer
  3. Teva
  4. Celltrion
  5. Samsung Bioepis
  6. Amgen
  7. Apotex
  8. Ratiopharm
  9. Mylan
  10. Merck Sharp & Dohme
  11. Eli Lilly
  12. Accord Healthcare Ltd
  13. Boehringer Ingelheim
  14. Hexal Ag
  15. Stada Arzneimittel Ag

About Pharma Industry

By the year 2000, pharmaceutical sales within the region of eastern Europe comprising Bulgaria, the Czech Republic, Hungary, Poland, Romania, the Slovakia and therefore the Ukraine will almost double in value to reach $6.23 billion, with Poland increasing its share to 43% of the seven countries' total, according to a new report (Eastern Europe - Prospects for the Pharmaceutical Industry) from IMS International's Pharma Strategy Group.

US dollar growth in pharmaceuticals over the 1994-2000 period in each of the markets is expected to be faster than Gross Domestic Product growth, with the exception of the Ukraine, the only market forecast to decline in size. Bulgaria, the Czech Republic and Poland are all expected to show much higher growth rates than the regional average of 12.6% per annum over the forecast period.

The Czech Republic is predicted to possess the very best per capita sales in 2000 of $112, but the figure remains much less than the ecu Union's average of around $190 in 1994. Although Poland remains the largest market in terms of US dollar sales, with the highest growth rate over the forecast period, per capita sales will still trail those of the Czech Republic and Hungary, at just $70 by 2000.

Expected Biosimilars and Pharma market in the upcoming years .

 

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