"6th International Conference and Exhibition on Biologics and Biosimilars"
- Start Date:
- Wednesday, 19 October, 2016
- End Date:
- Friday, 21 October, 2016 4:30pm
- Immunology, Rheumatology, Internal Medicine
6th International Conference and Exhibition on Biologics and Biosimilars Organizing Committee invites you to join us during October 19-21, 2016 at Houston, TX, USA.Biosimilars is a global annual event. The Biosimilars 2016 will bring together scientists, researchers and CROs spanning over the entire globe. Biologics are a highly-effective class of medicines that finds its roots in naturally occurring proteins and produced using living cells.A great share of the biologics are produced using recombinant DNA technology.Pan USA there are around 200 companies of Biologics and Biosimilars with over 35,000 entrepreneurs delving on these topics.
All over the world, there are more than 400 companies producing Biologics and Biosimilars and 55,000 industrialists focussing their research work on Biosimilars and Biologics.The global biosimilars market as expected had exceeded $19.4 billion by 2014 and its Annual Growth Rate (CAGR) has been 89.1% from 2009. By the end of this decade, the global market for Biosimilars is expected to hit the $55 Billion mark. Biologic agents will continue to outpace overall pharma spending growth and are expected to represent 19-20% of the total market value by 2017.
USA still proves to be the leaders in Biologics production and sales followed by European countries. Nevertheless the uptake of Biosimilars is more in European countries followed by China.Track 1: Challenges and Regulatory Approach for BiosimilarsThe generic version of biologicals- "Biosimilars" is the new buzz word in the world of pharmaceutical industry. Biosimilars are highly similar to their licensed reference product not withstanding minor differences as excipients in the formulation; also there are no remarkable differences between the biologicals and the reference product in terms of safety, purity, and potency.
This track includes: Licensing of biosimilars, Biosimilars regulation, Biosimilar Patents, BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars. This World Biosimilar Congress 2016 will provide an excellent opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics.Track 2: Emerging Biosimilars in TherapeuticsBiosimilar insulins are the most expected ones in the class to enter the biosimilar landscape as patents for major branded insulin products start to expire in the next few years.
Biosimilar insulins have the potential to conceivably reduce diabetes treatment costs, increase the accessibility of insulin treatment, and expand the options for available insulin brands in the market. However, they will have to overcome numerous regulatory hurdles, meet a variety of commercial demands, and effectively confront competition from both established and next-generation branded insulin products before they can succeed on the global market.
This biosimilars meeting shall be the perfect bridge between the renowned academicians and industry personalities to pave the way for biosimilar insulins in the market. The main theme of this track is to have sound knowledge in the emerging biosimilar products like Recombinant blood products, therapeutic proteins, vaccines, Growth hormones, Biosimilar peptides, therapeutic proteins, biosimilar antibodies. The sub tracks included in this are Biosimilars in cancer treatment, Biosimilar monoclonal antibodies, Biosimilars interferon, Biosimilars in rheumatic diseases, Biologics in autoimmune disease, Biologics in cardiovascular diseases.Track 3: Clinical Studies and Clinicians Prospects for BiosimilarsAny drug post to its development and formulation into suitable dosage form requires to prove its safety, efficacy and potency over the human population.
Clinical trials are designed in stages I-IV so as to receive a clear picture of the drug candidate in respect to its pharmacokinetics and pharmacodynamics parameters. This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilars, PK/PD studies, Toxicological studies and Aspects of genotoxicity tests.
This track is designed for those who are having sound knowledge on clinical studies and clinicians prospects for biosimilars.Track 4: Emerging Biologics in TherapeuticsThe explorations in the field of biologics has created a new avenue for the clinicians towards better disease management. The emerging biologics has already manifested fruitful outcomes in treatment of ailments like those of the biologics in psoriasis, biologics in rheumatic arthritis, biologics in cancer, biologics in inflammatory bowel disease(IBD) etc.
Biologic agents like Ustekinumab and Secukinumab has already produced promising results. Thus follow-on-biologics have a great prospect to find a prominent space in treatment protocol of these disease and also with better patient compliances. This session focuses on all such biologics products that has laid its footprints in the market. Researchers and scientists who are engaged in the study of these biologics and industries who are into manufacturing and marketing these can find this platform just the most befitting to not only visualise the biologics scenario but also share knowledge about the science that lies behind them.Track 5: Globalization of BiosimilarsThis 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.
Those who can attend the biosimilar exhibition under this track are ones following Biologics/ Proteins/Biosimilar Products, New Biosimilar Development, Process Science, Biosimilar Market, Portfolio Management, Research & Development, Business Development, Business Operations and Scientific Affairs related to Biosimilars.Track 6: Biosimilars Innovator Pharmaceutical ProductsBiosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company.
Biosimilars are officially approved versions of original biosimilar innovator products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Also includes Biotechnology medicinal products for different drugs, Future of next generation biosimilars, Biopharmaceuticals development. This session shall be highly beneficial for the biosimilar manufacturers.
This session also finds place for all the biosimilar exhibitors' associated with the field of biosimilar and biologics.Track 7: Biosimilar Analytical StrategiesAnalysis of Biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. Analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility.
Effective management of a current good manufacturing practice (GMP) facility requires a strict eye on all those factors. This also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.Track 8: Bioequivalence AssessmentBioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation.
This also includes Strategies for the bioequivalence assessment of topical dosage forms, Bioequivalence assessment of respiratory dosage forms, Bioequivalence approaches for transdermal dosage forms.This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar.Track 9: BCS & IVIVC Based BiowaiversBiopharmaceutics Classification System and invitro and invivo classification discusses about ADME pathways of different drugs.
This also includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro preclinical ADME/BCS testing. The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs. This biosimilar conference aims at addressing all such challenges of the pharma formulation sector.Track 10: Plant Produced Biosimilar ProductsBiosimilar products are also produced from plants.
Plants are the richest store house of diverse class of phytochemicals. Production of biosimilars from tobacco plants is on the verge of completion of the first step in their research. These also includes Transgenic plants, Post translational genetics, Fermentation culture, Molecular farming. For biosimilar manufacturers this session has the potential to bring up new avenues in their product range. Biosimilars conference is expected to be the best platform for the scientists to share scientific knowledge amongst those biosimilar companies and research institutes who are engaged in biosimilar development pertaining to plant source biosimilars .Track 11: Pharmacovigilance and its ChallengesThis session of the Biosimilars 2016 will look into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies and ADR related issues.
Current challenges in pharmacovigilance, Adverse drug reactions with biosimilar and biologic products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.Track 12: Regulatory Affairs and Intellectual Property RightsThe safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR.
It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. Pharma patent scenario, Criteria for patentability and patent claims, Patentable subject matter, biosimilar guidelines, biosimilar patent issues are key points of discussion in the segment.
Patent analysts, law firms and legal authorities dealing with biosimilar regulatory affairs would find this conference a perfect platform to put forward their views on the topic.Track 13: Current Challenges in Advancement of BiologicsDevelopment of identical products of licensed ones without any access to the original product is ought to be challenging. But the recent years in the pharmaceutical research has seen this challenge been conquered in the form of biosimilars and biologics.
Nevertheless these biosimilars and biologics have come through lots of challenges in respect to their development, process parameters, biosimilars analytical strategies, regulatory considerations and many more. Probably these are one of the chief reasons that they have taken a long time to find place in the market.Current concepts of drugs and biologics, Unique considerations for biologics, Early clinical development essentials, Cancer therapeutics, Comparability for Biologics, Biosimilar approvals are the points of discussion in this session.Track 14: Biosimilar Companies and Market AnalysisOver the past decade, biologics have been the darlings of the pharmaceutical industry, with sales growing at twice the rate of the market as a whole.
The global biologics market had reached $170 billion in sales value in 2012, accounting for 18 percent of the overall market. The five top 10 global products in terms of sales volume are biologics, wherein 2008 it was just two.The U.S. takes the lion's share (49 percent) of the global biologics market value and generates half of the sales value growth as well. The EU accounts for 22 percent of the market's sales value and 14 percent of its value growth.
In contrast, emerging markets represent just a sliver of the sales pie, with 7.5 percent share. Thus, biologics market growth is still largely driven by mature markets. Biosimilars and non-original biologics will represent nearly 10 percent of the $250 billion market total by 2020 (equating to $10 - 25 billion), depending upon the number of new biosimilars introduced -- and most especially on the number available in the U.S.
Congressional Budget Office estimated that a Senate bill creating a regulatory pathway for biosimilars would cut spending on prescription drugs in the United States by $25 billion between 2009 and 2018.Track 15: Entrepreneurs Investment MeetEntrepreneurs who arte willing to put in hard work and invest in the field of biologics and biosimilars will find this meeting the best place to properly shape their drive for the new endeavours.
Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile.The biologics conference 2016 is owned to bring together the worldwide top pharmaceuticals, biotechnology and regulatory representatives under one roof that will provide them the best platform to update and share knowledge related to biosimilars and biologics. Hence, 6th International Biosimilar Conference will unfold the multiple facets of biosimilars, ranging from the evolving regulatory landscapes, biosimilar guidelines to the legal and economic aspects and the then current challenges in biosimilar development, .
This biosimilar conference will focus on a variety of aspects of biosimilar product development to successful delivery of safe, efficacious and potent biosimilar products to the market. By attending this biologics conference one will gain a comprehensive outlook on the key issues surrounding biosimilars. An important platform for Biosimilars stakeholders to discuss and share best practices in expediting development in the field of Biologics and Biosimilars is ought to be Biosimilars 2016.
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