Call for Abstract
14th International Conference on Biologics and Biosimilars, will be organized around the theme “A new doorway to novel yet affordable medicines”
Biosimilars 2019 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Biosimilars 2019
Submit your abstract to any of the mentioned tracks.
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Biosimilars being referred to as follow on Biologics calls for overcoming many challenges while it’s development. As comparisons are being drawn from the initial stages, it is very important to have proper scientific as well as strategic approached taken for the successful development of these Biosimilars. This need for overcoming the challenges continues till the late clinical steps, drug safety factors and labeling requirements.
- Track 1-1Current concepts of drugs and biologics
- Track 1-2Biopharmaceuticals development
- Track 1-3Advertising, promotion and labeling essentials
- Track 1-4Unique considerations for biologics
- Track 1-5Comparability for biologics
- Track 1-6Drug safety essentials
- Track 1-7Late clinical development essentials
- Track 1-8Early clinical development essentials
- Track 1-9Biologics in genetic disorders
- Track 1-10Current concepts of drugs and biologics
- Track 1-11Late clinical development essentials
- Track 1-12Cancer therapeutics development
With the effectiveness of biosimilars and its cheap price, biosimilars is in huge demand in the pharmaceutical market. With the advancement of Biosimilars, disease management has become comparatively easier. It is currently being used in the treatment of ailments like psoriasis, rheumatic arthritis, cancers, inflammatory bowel disease (IBD) etc. Biosimilars are also being used as monoclonal antibodies, growth hormones, peptides, therapeutic proteins etc.
- Track 2-1Recombinant blood products
- Track 2-2Biosimilars interferon
- Track 2-3Biosimilar monoclonal antibodies
- Track 2-4Biosimilars in cancer treatment
- Track 2-5Recombinant therapeutic proteins
- Track 2-6Biosimilar peptides
- Track 2-7Insulin Biosimilars
- Track 2-8Growth hormones
- Track 2-9Recombinant vaccines
- Track 2-10Biosimilars in rheumatic diseases
- Track 2-11Recombinant therapeutic proteins
- Track 2-12Biologics in autoimmune disease
As the demand of Biosimilars is ever increasing in the pharmaceutical market, it is very important to check them properly before releasing it to the mass. That is why there is a stepwise approach towards clinical trials of Biosimilars. It has various levels such as Extensive Molecular characterization Program, Pre-Clinical, Phase 1, Phase 3, Phase 4 and so on.
- Track 3-1Biosimilars Clinical Studies
- Track 3-2Biosimilars Toxicological studies
- Track 3-3Targeted cell line development
- Track 3-4Transgenic animals
- Track 3-5Case studies and clinical models
- Track 3-6Risk management and quality affairs
- Track 3-7Clinical trials on major diseases
Cancer is something which if treated properly is not hard to beat. Most of the medicines that we currently have for Cancer are way too costly for any common human being, but Cancer being one of the largest cause of death needs proper treatment. This is where Biosimilars come handy. Biosimilars being cheaper can increase access worldwide to potentially life saving biologics.
Drug development is the process of bringing a new pharmaceutical drug to the market once the led component has been identified through the process of drug discovery. It further has pre-clinical and clinical development procedure. Once the drug has been developed, it is important to check its mode of function, this is termed as the drug delivery. Once this has been done, the drug can be qualified for usage. This session will be looking on the such following topics.
- Track 5-1Research & Development in Drug Designing
- Track 5-2Drug Designing Docking
- Track 5-3Types of Drug Design
- Track 5-4ADME(T)
This session of the Biosimilars 2019 will be looking 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 6-1Current problems in biosimilar pharmacovigilance
- Track 6-2Adverse drug reactions with biologics and biosimilar products
- Track 6-3Detection and evaluation of drug safety signals
- Track 6-4Role of pharma industries in the improvement of pharmacovigilance system
- Track 6-5Good pharmacovigilance practice and pharmacoepidemiology
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 7-1Strategies for the bioequivalence assessment of topical dosage forms
- Track 7-2Bioequivalence approaches for transdermal dosage forms
- Track 7-3Bioequivalence assessment of respiratory dosage forms
- Track 7-4Evaluation of highly variable drugs and drug products
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 8-1Biotechnology medicinal products for different drugs
- Track 8-2Future of next generation biosimilars
- Track 8-3Biopharmaceuticals development
- Track 8-4Biotechnology medicinal products for different drugs
- Track 8-5Future of next generation biosimilars
- Track 8-6Biopharmaceuticals 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 9-1Biopharmaceutical Research
- Track 9-2Recombinant Protein Expression
- Track 9-3Monoclonal Antibodies
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 10-1Pharma Patent Scenario
- Track 10-2Criteria for Patentability and Patent Claims
- Track 10-3Critical research issues
- Track 10-4Patentable subject matter
- Track 10-5Evaluation 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 11-1BCS biowaivers
- Track 11-2Preclinical and clinical testing for oral drug delivery
- Track 11-3Waiver for In vivo bioavailability or bioequivalence
- Track 11-4Consideration of biowaiver extensions for BCS class III drugs
- Track 11-5In vitro diffusion cells for dissolution testing in formulation development
- Track 11-6Dissolution testing in drug formulation
- Track 11-7In vitro preclinical ADME/BCS testing
- Track 11-8In vitro drug product research
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 12-1Implementation of the BPCI Act
- Track 12-2Patent protection and infringement issues
- Track 12-3Patent negotiation and litigation phase
- Track 12-4Market exclusivities
- Track 12-5Patent protection and infringement issues
- Track 12-6Patent negotiation and litigation phase
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 13-1Licensing of biosimilars
- Track 13-2Biosimilars regulation
- Track 13-3BLA filing for biosimilars
- Track 13-4Regulatory prospects of BRIC countries
- Track 13-5A paradigm of traditional generics to biosimilars
- Track 13-6Biowaiver approval for Biosimilars
- Track 13-7Generic Biosimilars
- Track 13-8BLA filing for biosimilars
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 14-1Global impact of biosimilars over generics
- Track 14-2Economic aspect towards biosimilars
- Track 14-3Biosimilars in global market
- Track 14-4Investment and returns on biosimilars
- Track 14-5Cost and risk management
- Track 14-6Adopting innovative mechanisms such as risksharing arrangement
- Track 14-7Global P&R models for the biosimilars and generics market