6th International Conference and Exhibition on Biologics and Biosimilars Organizing Committee invites you to attend the largest assemblage of biologics and biosimilars researchers from around the globe during October 19-21, 2016 at Houston, TX, USA.
Biosimilars 2016 is a global annual event. This Biosimilars Congress 2016 brings together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. The passage of approval for biosimilars Inflectra finds much requirement for discussion also focussing the latest developments in the field of biologics and biosimilars. A comprehensive approach for the discussion has been taken up as listed below under several tracks and sub-tracks below:
The development of biologics calls for overcoming lot 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 labelling 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 multiple 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 2: Emerging Biosimilars in Therapeutics
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.
Track 3: Biosimilars Analytical Strategies
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 4: Regulatory Approach for Biosimilars
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 2016 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: Legal Issues and BPCI Act
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. The Europe biosimilars, US biosimilars, Australian biosimilars, Canada origin biosimilars and UK biosimilars are expected to take control over the biosimilar market around the globe by 2017.
Track 6: Biosimilars Research Pipeline
Biosimilars 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. 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: Globalization of Biosimilars
This track discuses about the generic drugs impact on global biosimilar market and Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, LATAM market for biosimilars.
Those who can attend the biosimilar meeting 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.
Track 8: Clinical Development Of Biosimilars
This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx 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. Biosimilar guidelines on the above mentioned topics are also to be thrown light upon at this biosimilars conference.
Track 9: Intellectual Property Rights
Needless to mention differentially that any pharma product has to successfully pass through the regulatory affairs' scanners before being launched in the market. Biosimilars and biologics are no exceptions. Apart from regulatory aspects the companies developing these biosimilars and biologics tend to enjoy monopoly over their product. Intellectual Property Rights (IPR) and patents are ultimate tools to the biosimilar manufacturers for safeguarding their interests. 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 10: Bioequivalence Assessment
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 also includes Strategies for the bioequivalence assessment of topical dosage forms, Bioequivalence assessment of respiratory dosage forms, Bioequivalence approaches for transdermal dosage forms.
Track 11: BCS and IVIVC Based Biowaivers
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. 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. The Biosimilars Congress 2016 aims at addressing all such challenges of the pharma formulation sector for biobetters, biologics, biosimilars and biowaivers.
Track 12: Biosimilar Companies and Market Analysis
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. Market researchers, market analysts, industrialists would be the apt participants for this session at Biosimilars 2016.
This session of the Biosimilars 2016 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 14: Entrepreneurs Investment Meet
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 endeavours. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile. The best technological knowhow, economical aspects, regulatory red tapes and profit shares involving biosimilars and biologics shall be discussed at this Biosimilars Global Event.
The Biosimilars 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, the 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.