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13th International Conference on Biologics and Biosimilars, will be organized around the theme “”
Biosimilars 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Biosimilars 2018
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The development of biologics calls for overcoming many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labeling requirements. Also it is much required now to develop a drug product in accordance to Quality by Design (QbD).
This biosimilars conference will look at the facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.
- Track 1-1Current concepts of drugs and biologics
- Track 1-2 Late clinical development essentials
- Track 1-3 Current concepts of drugs and biologics
- Track 1-4 Biologics in genetic disorders
- Track 1-5 Early clinical development essentials
- Track 1-6Late clinical development essentials
- Track 1-7 Drug safety essentials
- Track 1-8 Comparability for biologics
- Track 1-9 Unique considerations for biologics
- Track 1-10 Advertising, promotion and labeling essentials
- Track 1-11 Biopharmaceuticals development
- Track 1-12 Cancer therapeutics development
A biopharmaceutical is also known as a biologic(al) medical product. It is any pharmaceutical drug product which is manufactured in, extracted from, or semisynthesized from biological sources. They are different from totally synthesized pharmaceuticals. They include vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.
- Track 2-1Biopharmaceutical Research
- Track 2-2Recombinant Protein Expression
- Track 2-3Monoclonal Antibodies
Analysis of biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. Biosimilars 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.
This biosimilars global event also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.
- Track 3-1 Biosimilar multimodal techniques
- Track 3-2 Biosimilar bioanalytical methods
- Track 3-3Bioassay for comparability and potency testing
- Track 3-4 Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
- Track 3-5Biosimilar GMP protein analysis
- Track 3-6 Biosimilar electrophoresis
- Track 3-7 Biosimilar Formulation
- Track 3-8 Bioassay for comparability and potency testing
- Track 3-9 Biosimilar GMP protein analysis
The explorations in the field of biologics have created a new avenue for the clinicians towards better disease management. The emerging biologics have already manifested fruitful outcomes in treatment of ailments like those of psoriasis, rheumatic arthritis, certain cancers, inflammatory bowel disease (IBD) etc. Emerging Biosimilar insulins are likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. The main theme of this track is to have sound knowledge in the emerging biosimilars like Filgrastim, Pegfilgrastim, Recombinant blood products, therapeutic proteins, vaccines, Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments and their impacts.
- Track 4-1 Recombinant blood products
- Track 4-2Recombinant therapeutic proteins
- Track 4-3 Biosimilars in rheumatic diseases
- Track 4-4 Recombinant vaccines
- Track 4-5 Growth hormones
- Track 4-6Insulin Biosimilars
- Track 4-7 Biosimilar peptides
- Track 4-8 Recombinant therapeutic proteins
- Track 4-9 Biosimilars in cancer treatment
- Track 4-10 Biosimilar monoclonal antibodies
- Track 4-11 Biosimilars interferon
- Track 4-12 Biologics in autoimmune disease
Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars regulatory prospects of BRIC countries, a paradigm of traditional generics to Biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. Biosimilars 2018 will provide an excellent and global 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 with a clear picture of the regulatory approach for biosimilars and biologics.
- Track 5-1 Licensing of biosimilars
- Track 5-2 Biosimilars regulation
- Track 5-3 Patent issues
- Track 5-4 BLA filing for biosimilars
- Track 5-5 Regulatory prospects of BRIC countries
- Track 5-6 A paradigm of traditional generics to biosimilars
- Track 5-7 Biowaiver approval for Biosimilars
- Track 5-8 Generic Biosimilars
- Track 5-9BLA filing for biosimilars
The Patient Protection and Affordable Care Act (PPAC Act) was signed into law in March 2010 in addition to the amendments in the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biosimilars and follow on biologics. These new statutory provisions are often referred as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This track concentrates upon such legal bindings and the aspects of the BPCI Act that pertain to the biosimilars and biologics. This session on legal issues shall be very beneficial to research scientists from both academic backgrounds and also those from industry R&D.
- Track 6-1 Implimentation of the BPCI Act
- Track 6-2 Patent protection and infringement issues
- Track 6-3 Patent negotiation and litigation phase
- Track 6-4 Market exclusivities
- Track 6-5 Patent protection and infringement issues
- Track 6-6 Patent negotiation and litigation phase
- Track 6-7 Market exclusivities
Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. There are some specific scientific consideration for criteria, design and analysis regarding development of Biosimilars. Biosimilars are officially approved versions of original biosimilar innovator products, and can be manufactured when the original product's patent expires.
This session shall be highly beneficial for the biosimilar industry researchers to update themselves on the latest research updates from around the world. This session also finds place for all the biosimilar exhibitions associated with the field of biosimilars and biologics.
- Track 7-1 Biotechnology medicinal products for different drugs
- Track 7-2 Future of next generation biosimilars
- Track 7-3 Biopharmaceuticals development
- Track 7-4 Biotechnology medicinal products for different drugs
- Track 7-5 Future of next generation biosimilars
- Track 7-6 Biopharmaceuticals development
This 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 global market scenario with the launch of first biosimilar in the market forecasts some radical changes. This track will look upon such key concerns which are witnessed by the global pharma market and that are coming up with the subsequent launch of the other biosimilars and biologics. Despite these emerging facilities, biotherapeutic developers are most comfortable off-shoring to established markets—the US and Europe.
- Track 8-1 Global impact of biosimilars over generics
- Track 8-2 Economic aspect towards biosimilars
- Track 8-3 Biosimilars in global market
- Track 8-4 Investment and returns on biosimilars
- Track 8-5 Cost and risk management
- Track 8-6 Adopting innovative mechanisms such as risksharing arrangement
- Track 8-7 Global P&R models for the biosimilars and generics market
Drug Delivery Companies and Market session is beginning to change for small, medium, and large scale pharmaceutical Companies. Biopharmaceutical Manufacturer and Industries and generic drugs companies contract drug delivery companies which can manifest from development to manufacturing. Addressing these instabilities is a great challenge, because of the complexity of the Clinical bio therapeutics themselves.
- Track 9-1New approaches to enhance drug performance
- Track 9-2Drug Delivery technologies
- Track 9-3Drug Delivery Companies and Markets
- Track 9-4Drug Delivery Companies and Markets
- Track 9-5Recent Advances in Drug Delivery
This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, PK/PD studies, Toxicological studies, ethics maintained in clinical and preclinical studies, development difficulties and Aspects of genotoxicity tests. Biosimilar guidelines on the above mentioned topics are also to be thrown light upon at this biosimilars conference.
- Track 10-1 Biosimilars Clinical Trials
- Track 10-2 Case studies and clinical models
- Track 10-3 Aspects of genotoxicity tests
- Track 10-4 Biosimilars Clinical Studies
- Track 10-5 Clinical trials on major diseases
- Track 10-6 Case studies, and clinical models
- Track 10-7 Transgenic animals
- Track 10-8 Targeted cell line development
- Track 10-9 Clinical PK/PD studies
- Track 10-10 Toxicological studies
- Track 10-11 Biologics Product Life Cycle and Sustainable Market Returns
The 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.
The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel.
- Track 11-1 Pharma Patent Scenario
- Track 11-2 Criteria for Patentability and Patent Claims
- Track 11-3 Critical research issues
- Track 11-4 Patentable subject matter
- Track 11-5 Recent Patent disputes and litigations
- Track 11-6 Evaluation of highly variable drugs and drug products
This track covers all the current trends that are coming up in the Pharmaceutical industries to provide better pharmaceutical products.
- Track 12-1Regulatory Requirements for Pharmaceuticals
- Track 12-2Purpose and Principles of GMP
- Track 12-3R&D Advancement: Road to New Medicines
- Track 12-4Pharmaceutical Process Validation
Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. 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 drug.
Of all attempts towards developing a follow on biologics or a biosimilar drug the main detection point stands at the bioequivalence assessment. Once the bioequivalence has been obtained it can be 70% ascertained the drug qualifies to be a suitable biologics or biosimilars.
- Track 13-1 Strategies for the bioequivalence assessment of topical dosage forms
- Track 13-2 Bioequivalence assessment of respiratory dosage forms
- Track 13-3 Bioequivalence approaches for transdermal dosage forms
- Track 13-4 Evaluation of highly variable drugs and drug products
The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics 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.
- Track 14-1 BCS biowaivers
- Track 14-2 Preclinical and clinical testing for oral drug delivery
- Track 14-3 Waiver for In vivo bioavailability or bioequivalence
- Track 14-4 Consideration of biowaiver extensions for BCS class III drugs
- Track 14-5 In vitro diffusion cells for dissolution testing in formulation development
- Track 14-6 Dissolution testing in drug formulation
- Track 14-7 In vitro preclinical ADME/BCS testing
- Track 14-8 In vitro drug product research
This track is concentrated towards the different reviews and forecasts regarding the scenario of Biosimilars market and follow on Biologics. The present status and future scenario of the market are best to be discussed during this session. Market researches from the first launching of biosimilar to the newest one till date prospects for a radical change in the pharmaceutical market.
- Track 15-1 Biosimilars Pharmacoeconomic Modelling
- Track 15-2 Return on Investment(ROI) for Biosimilars
- Track 15-3 CAGR of biologics and biosimilars in USA
- Track 15-4 Penetration and uptake of biosimilars in different disease sectors
This session of the Biosimilars 2018 looks into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.
- Track 16-1 Current problems in biosimilar pharmacovigilance
- Track 16-2Adverse drug reactions with biologics and biosimilar products
- Track 16-3 Detection and evaluation of drug safety signals
- Track 16-4 Role of pharma industries in the improvement of pharmacovigilance system
- Track 16-5 Good pharmacovigilance practice and pharmacoepidemiology
The Brexit effect on Biosimilars tends to be negative. Not only would it be a major setback towards approval and launch of biosimilars to the market but also it would be hindrance towards the cost cutting approach taken up by NHS. With Britain being among principal clinical trial centers is owned to see a decrease in the willingness of the manufacturers and researchers to carry out any further trials in Britain. Also Brexit will cause the principal motive of British Biosimilars Association (BBA) to fall back- which aimed at increasing the use of biosimilars.
Entrepreneurs who are 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 endeavors. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile.