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Theme: Developmental Strategies & New Horizons in Biosimilars through a Decade

Pharma Biosimilars 2020

Tentative Program

Renowned Speakers

Insang Lee
Divine Lab Co Ltd
South Korea

Kunihiko Furuzaw
GMP Consultant
Japan

Mathew George
Pushpagiri College of Pharmacy
India

Suliman Al-Fayoum
Al-Fayoumi Consulting
USA

Jia-You Fang
Chang Gung University
Taiwan

Lincy Joseph
Pushpagiri College of Pharmacy
India

Ming-Cheng Chang
Institute of Nuclear Energy Research
Taiwan

Jaganmohan Somagoni
ClinSync Clinical Research Private Limited
India

Pharma Biosimilars 2020

PHARMA BIOSIMILARS 2020, February 12-13, 2020 Auckland, New Zealand

Conference Series LLC Ltd, Scientific Event Organizer and the World Class Open Access Publisher invites all the participants from all over the world to attend “2nd International Conference on Biosimilars & Pharmaceuticals” (Pharma Biosimilars 2020) slated on February 12-13, 2020, Auckland, New Zealand which covers on all aspects of the pharmaceutical sciences, manufacturing, quality with strong emphasis on originality and scientific quality. This Pharma Formulations 2020 setting a platform for all the budding Scientists and Researchers to present their real-time work and share their views and aspects related to the theme of the Conference. The Organizing committee is gearing up for an exciting and informative Conference program including plenary Lectures, Symposia, Workshops on a variety of topics, Poster presentations and various programs for participants from all over the World.

Pharma Biosimilars 2020 conveys recent developments in Pharma drug marketing and production of Pharma drugs and contract manufacturing. A complete knowledge of a scientific discipline that described the effects of Biosimilars drug marketing and Biosimilars Pharma now explores the Scope of Biosimilars drug marketing in industry & provides detailed market, technology, and industry analyses to help readers quantify and qualify the market for prescription generic drugs. Important trends are identified and sales forecasts by product categories and major country markets these are based on industry sources and considered assessment of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the generic drug market. The wider economic environment is also considered.

Why attend Pharma Biosimilars 2020:

Attending Pharma Biosimilar 2020 is an opportunity for you to meet new people in the field of Pharmaceutical Science.

This Conference enable you to expand your network, you meet people from all walks of life in the same industry. It widens your reach and gets referrals from these people, which can help your business in one way or another. From this perspective, conferences expand your current network and you are bound to build another one.

In Pharma Biosimilar 2020 event, most of the topics talk about the current problems and the long-term solution to it. It does not just talk about the now, but what’s in store for the upcoming years in Pharmaceutical Science field. This event gives you several ideas on the current trends and how to utilize them to your own advantage.

Keynote presentation along with interactions to galvanize the scientific community.
Workshop and symposiums to reach the largest assemblage of participants from the Pharma/Biotech community.
A wide track of exhibitors to showcase the new and emerging technologies.
Platform to global investment community to connect with stakeholders in Pharma/Biotech sector.
Young Scientist/ Investigators Award geared towards best budding young research.
Links to the political marketing resources to expand your business and research network.
Triumph of Awards, Certificates recognizes your commitment to your profession to encourage the nascent research.

â€‹Pharma Biosimilars 2020 Objective:

Open panel discussions: Providing an open forum with experts from academia and business to discuss on current challenges in Biosimilars & Biologics, where all attendees can interact with the panel followed by a Q&A session.

Speaker and poster presentations: Providing a platform to all academicians and industry professionals to share their research thoughts and findings through a speech or a poster presentation.

Editorial board meeting: Discussing on growth and development of open access Bio-analysis & Biomedicine International Journals and recruiting board members and reviewers who can support the journal.

Round table meetings: Providing a platform where industry professionals meet academic experts.

Over 50+ organizations and international pavilions will be exhibiting at the Pharma Biosimilars 2020 event. Exhibitors will include equipment manufacturers and suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies.

In addition to the products and services you will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.

The Pharma Biosimilars 2020 has everything you need, all under one roof, saving you both time and money. It is the event you cannot afford to miss!!!

A two-day gathering that examines the future market patterns, creative business methodologies and open doors for development of moderate medications. Pharma pioneers want the substance and roundtable examinations yet remain for the systems administration and air. This meeting is formally the biggest key nonexclusive gathering in the business and will give members a thorough survey of business methodology for moderate meds.

Break into the lucrative Generic Medicines industry

Position your organization as an industry pioneer

Make deals leads and convey an arrival on venture

Connect with your objective market in the locale.

Target Audience 2020:

Directors/Senior Directors/Executive Directors and Vice Presidents/Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of

· CROs and CMOs

· Pharma Research Sites

· Pharma/Biotech and Medical Device industries

· Hospitals, Associations

· Directors, CEO’s of Organizations

· Business Development Managers

· Chief Scientific Officers

· R&D Researchers from Biosimilar and Biologics Industries

· Professors, Associate Professors, Assistant Professors

· PhD Scholars

· Patent Attorneys

· Intellectual Property Attorneys

· Investment Analysts

· Association, Association presidents and professionals

· Noble laureates in Health Care and Medicine

· Bio instruments Professionals

· Bio-informatics Professionals

· Software development companies

· Research Institutes and members

· Supply Chain companies

· Manufacturing Companies

· CRO and DATA management Companies

· Training Institutes

· Business Entrepreneurs

Track 1: Biosimilars/Biologic – A Biologic Drug Revolution

Biosimilars/Biologic medicines are large, complex molecules that are made in living cells grown in a laboratory. Biologic medicines are often 200 to 1,000 times the size of a small molecule or chemical drug such as aspirin. Due to both their large molecular size and fragile molecular structure, biologic medicines are almost always injected into the patient’s body.

It is approved based on demonstrating that it is highly similar to a FDAâ€approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Track 2: Globalization of Biosimilars

These track discuses about the generic drugs impact on global biosimilar market, Cost and risk management, adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars. The worldwide market situation with the dispatch of first biosimilar in the market gauges some radical changes. This will look upon such key concerns which are seen by the worldwide Pharma advertise and that are thinking of the consequent dispatch of alternate biosimilars and biologics. Despite these rising offices, bio therapeutic designers are most agreeable off-shoring to set up business sectors—the US and Europe. As far as the outsourcing goals that are most-referred to as no less than a probability for outsourcing amid the following five years, the main markets are: USA (78% are at any rate considering) Germany (76%) Singapore (74%) United Kingdom (73%).

Track 3: Bio-Pharmaceuticals

Bio-Pharmaceuticals are class of therapeutic protein produced by modern biotechnological techniques, especially via genetic engineering or in the case of monoclonal antibodies by Hybridoma technology.

The Pharmaceuticals industry, as we know it is barely 60years old and now Bio-pharmaceuticals are among the most sophisticated and elegant achievements of modern science, the top 15 biopharma products each enjoy annual revenue of more than $2 billion, with some, such as the anti-inflammatory drug Humira, generating sales of more than $10 billion a year. For many players, the biggest challenge has been simply making enough products to sell. It’s no surprise that major pharmaceutical companies around the world are increasingly shifting their R&D and sourcing focus to large-molecule products.

Track 4: Pharmaceutical Research and Development

Pharmaceutical Research and Development (R&D) is crucial for the growth and future success of research-based Pharma companies. To maintain their R&D organisations efficient, pharmaceutical companies started to hedge the potential of open innovation to cut R&D costs and to access external knowledge. These new strategies could be divided into several categories: open source, innovation centres, crowd sourcing and virtual R&D.

A variety of approaches is employed to identify chemical compounds that may be developed and marketed. The current state of the chemical and biological sciences required for pharmaceutical research & development dictates that 5,000–10,000 chemical compounds must undergo laboratory screening for each new drug approved for use in humans. The overall process from discovery to marketing of a drug can take 10 to 15 years. As the product takes shape, the process that began with R&D divides into relevant areas necessary to bring the research product to the market. Regulatory aspects are assessed and work begins to meet all the criteria for approvals and launch.

Track 5: Development Strategies for Biosimilar Drug

The goal in biosimilar drug development is to leverage as much information as possible in a stepwise fashion starting with the analytical characterization of the biosimilar compared to the reference product.

The Pharma industry is rapidly changing, which provides a unique set of challenges for those developing and manufacturing biosimilars. Gain true insight on winning development, manufacturing, clinical and commercialization strategies for biosimilars in the global market. Navigate the challenges in the clinic, and the manufacture and development of biosimilar medicines as well as explore the commercial hot topics in the industry. This is your best chance to find out where the true biosimilar industry growth opportunities lie and what role they can play in your portfolio.

Track 6: Interchangeable Biologic/Biosimilars

An “interchangeable” biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. To be approved as interchangeable, research must show that the biosimilar drug produces the exact same results in an individual patient, that a person can take either drug and expect the same symptom reduction and same side effects. To date, no biosimilars have been approved as interchangeable.

Interchange ability standards:

1. The biological product is biosimilar to the reference product;

2. It can be expected to produce the same clinical result as the reference product in any given patient; and

3. For a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

Track 7: Biosimilars Pipeline

The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved the current biosimilars development pipeline and update the industry’s progress. Quite a lot has changed in just one and a half years, and it still is early in the evolution of biosimilars, with more progress and changes coming.

Biosimilars in the pipeline are still robust, having grown at an average of greater than 20% annually in the past one and a half years. This sustained growth is remarkable, given that over the past five and a half years the pipeline has expanded at an average of 27% annually.

Track 8: Bio-equivalence Assessment

Bioequivalence Assessment studies are used to compare the expected in vivo biological equivalence of two formulations of a drug and this study is to assure therapeutic equivalence of generic products to innovator products. In the bioequivalence study, bioavailability should be compared for innovator and generic products. If this is not feasible, pharmacological effects supporting therapeutic efficacy or therapeutic effectiveness in major indications should be compared (These comparative tests are hereafter called pharmacodynamics studies and clinical studies, respectively). For oral products, dissolution tests should be performed, since they provide important information concerning bioequivalence.

Bioequivalence assessment includes strategies of topical dosage forms and bio equivalence approaches for transdermal dosage form and assessment of respiratory dosage form.

Track: 9 BCS and IVIVC Based on Biosimilars

These mainly talks about various kinds of medications and adsorption dissemination digestion discharge pathways. Also, This biosimilars incorporates, In vitro dissemination cells for disintegration testing in plan advancement, The preclinical testing of ADME in INVITRO. The essential moto of this work was to recommend the biosimilars capability of biopharmaceutical order framework which are known to expand the disintegration. These insoluble medications which is orally consumed. These Aims at tending to every such challenge of the pharma definition part at biologics and biosimilars at 2019 meeting. The dissolvability incorporates into biopharmaceutical order.

Track: 10 Pharmacovigilance & Regulatory Affairs

An administrative undertaking (RA), likewise called government issues, is a calling inside controlled enterprises, for example, pharmaceuticals, medicinal gadgets, agrochemicals (plant insurance items and manures), vitality, banking, telecom and so forth. Administrative issues additionally has a quite certain importance inside the social insurance ventures (pharmaceuticals, therapeutic gadgets, biologics and practical foods).Regulatory undertakings (restorative issues) experts (otherwise known as administrative experts) more often than not have duty regarding the accompanying general areas Ensuring that their organizations conform to the majority of the guidelines and laws relating to their business.

Track: 11 Drug Delivery Devices: Approaches and Manufacturing

Medication conveyance advances change medication discharge profile, assimilation, appropriation and disposal to support improving item adequacy and security, just as patient comfort and consistence. Medication discharge is from: dissemination, corruption, growing, and fondness based mechanisms. Some of the basic courses of organization incorporate the enteral (gastrointestinal tract), parenteral (by means of infusions), inward breath, transdermal, topical and oral routes. Many prescriptions, for example, peptide and protein, counter acting agent, antibody and quality based medications, as a rule may not be conveyed utilizing these courses since they may be powerless to enzymatic debasement or cannot be retained into the foundational flow proficiently because of sub-atomic size and charge issues to be remedially successful. Consequently numerous protein and peptide medications must be conveyed by infusion or a Nano needle exhibit. For instance, numerous vaccinations depend on the conveyance of protein medicates and are regularly done by infusion.

Track: 12 Healthcare Common Procedure Coding System (HSPCS)

The abbreviation HCPCS initially represented HCFA Common Procedure Coding System, a medicinal charging procedure utilized by the Centers for Medicare and Medicaid Services (CMS). Preceding 2001, CMS was known as the Health Care Financing Administration (HCFA). HCPCS was built up in 1978 to give an institutionalized coding framework to depicting the particular things and administrations gave in the conveyance of human services. Such coding is essential for Medicare, Medicaid, and other health care coverage projects to guarantee that protection cases are handled in a deliberate and reliable way. At first, utilization of the codes was deliberate, yet with the execution of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) utilization of the HCPCS for exchanges including medicinal services data ended up obligatory

Track: 13 Medicare Reimbursement & Biosimilars

A biosimilar is repaid at its very own ASP in addition to 6% of the reference item's ASP. This gives suppliers a little yet vital motivator to utilize a biosimilar. ... In 2018, new repayment to 340B offices for all items is ASP less 22.5%, a takeoff from the repayment of 106% ASP.

Track: 14 Advances in Pharmaceutical Sciences

Drug store is the science and method of getting ready, administering, and investigating drugs and giving extra clinical administrations. It is a wellbeing calling that connections wellbeing sciences with pharmaceutical sciences and plans to guarantee the protected, viable, and moderate utilization of medications. The expert practice is winding up more clinically situated as the majority of the medications are currently fabricated by pharmaceutical businesses. In light of the setting, the drug store is named a network or institutional drug store. Giving direct patient consideration in the network of institutional drug stores are viewed as clinical pharmacy.The extent of drug store practice incorporates progressively conventional jobs, for example, intensifying and administering of prescriptions, and it likewise incorporates increasingly current administrations identified with medicinal services, including clinical administrations, exploring meds for wellbeing and adequacy, and giving medication data. Drug specialists, in this manner, are the specialists on medication treatment and are the essential wellbeing experts who upgrade the utilization of prescription to help the patients.

Track: 15 Drug Design Theory

Medication configuration, frequently alluded to as sane medication plan or essentially sound structure, is the creative procedure of finding new prescriptions dependent on the learning of a natural target.[1] The medication is most generally a natural little atom that initiates or restrains the capacity of a biomolecule, for example, a protein, which thus brings about a remedial advantage to the patient. In the most fundamental sense, medicate configuration includes the plan of atoms that are integral fit as a fiddle and charge to the biomolecular focus with which they communicate and in this manner will tie to it. Medication structure every now and again however not really depends on PC demonstrating techniques.[2] [3] This sort of displaying is in some cases alluded to as PC supported medication plan. At long last, tranquilize plan that depends on the information of the three-dimensional structure of the biomolecular target is known as structure-based medication design.[3] notwithstanding little atoms, biopharmaceuticals including peptides[4][5] and particularly helpful antibodies are an inexorably significant class of medications and computational techniques for improving the proclivity, selectivity, and soundness of these protein-based therapeutics have additionally been created.

Track: 16 Clinical Development of Biosimilars

A biosimilar (otherwise called pursue on biologic or consequent passage biologic) is a biologic therapeutic item that is very nearly an indistinguishable duplicate of a unique item that is fabricated by an alternate company.] Biosimilars are authoritatively affirmed variants of unique "pioneer" items and can be made when the first item's patent lapses. Reference to the trend-setter item is a necessary part of the endorsement. Not at all like with conventional medications of the more typical little particle type, biologics by and large display high atomic intricacy and might be very delicate to changes in assembling forms. In spite of that heterogeneity, all biopharmaceuticals, including biosimilars, must keep up steady quality and clinical execution all through their lifecycle. Pursue on makers don't approach the originator's atomic clone and unique cell bank, to the accurate aging and refinement process, or to the dynamic medication substance, yet they approach the popularized trailblazer item. Generally speaking, it is more enthusiastically to determine fungibility among generics and trend-setters among biologics than it is among completely incorporated and semi combined medications.

Track: 17 Futures of Biosimilars

All in all, biosimilars are nonexclusive results of biopharmaceuticals. Not the same as generics, they are "comparable" and in this manner require endorsement strategies like new marked medications. In spite of the fact that there are around 25 affirmed biosimilars in Europe, they didn't get a similar treatment in the United States. Regardless of 11 medications are endorsed in the United States, just around 3 sorts can be used in patients for marked pharmaceutical organizations are utilizing business systems to forestall biosimilar drugs from vieing for their present expensive biopharmaceuticals. The US FDA propelled a biosimilar medication activity plan in July 2018 to support the advancement of biosimilar drugs. FDA Director Scott Gottlieb stated, "Just under 2% of Americans use biologics, however biologics represent 40% of all out professionally prescribed medication consumptions and 70% of medication spending development in 2010-2015.

Track 18: Biological Medicine:

Natural Medicine works with the study of the body and its customary recovering limits and moreover the supernatural, enthusiastic and physical pieces of disease. Affliction infers that the body's course isn't working really and ought to be brought by and by into its ordinary ground-breaking state where the insusceptible system is in full control. It as such scans for primary drivers for the demonstrating symptoms of disorder the shrouded components making a man give a particular malady. These hidden drivers may involve a couple of components which have created after some time and can fuse; devour less calories, sustenance sensitivities, intestinal agitating impacts, family ancestry, push, biological components, generous metals, dental issues, hyperacidity, damage, prologue to minute life forms or contaminations or electromagnetic exacerbation

The Growing Pharmaceuticals Science Market :

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 expected to be around $6.2 billion by 2020 from only $2.3 billion in 2015. By the end of this decade the biosimilars would surely occupy 27% of the total pharmaceutical market. Moreover, with the global 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 year per patient. Biosimilars on the contrary can be offered at a 30-40% lower price 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 rest of the world ( 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 deâ€‹velopment like LeanBio Pro-Spain, PPD-USA, SGS Life Sciences-UK, Therapeutic Proteins International-USA. The biosimilars development is mainly concentrated in the therapeutic domains of oncology, blood disorders, autoimmune disorders, endocrine disorders and infectious diseases.

Biosimilars pharmacoeconomic modelling
Return on Investment(ROI) for biosimilars
CAGR of biologics and biosimilars in Europe
Penetration and uptake of biosimilars in different disease sectors

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Conference Date	February 12-13, 2020
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2^nd International Conference on Biosimilars & Pharmaceuticals February 12-13, 2020 Auckland, Newzealand

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