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International Conference on Biosimilars & Pharmaceuticals, will be organized around the theme “Essential innovation in pharma biosimilars.”
Pharma 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 Pharma Biosimilars 2019
Submit your abstract to any of the mentioned tracks.
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Biologics and Biosimilar analysis make the one of the most important aspect on the development on biological products. The use of production technologies such as disposable and supply chain logistics can help companies such establish flexibility facility involved in biosimilar analytical methods.
Bioanalytical methods include in all global events of biosimilars for example: GMP protein analysis, pre-clinical and clinical program, Bioassay for comparability and potency testing.
- Track 1-1Biosimilar bioanalytical methods
- Track 1-2Bioassay for comparability and potency testing
- Track 1-3Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
- Track 1-4Biosimilar GMP protein analysis
- Track 1-5Biosimilar electrophoresis
- Track 1-6Biosimilar Formulation
- Track 1-7Bioassay for comparability and potency testing
- Track 1-8 Licensing of biosimilars
- Track 1-9Biosimilar multimodal techniques
In the field of biologics, the new avenue has created towards clinicians because explorations have created for better disease management. In the treatment of ailments like psoriasis, rheumatic arthritis, certain cancer inflammation, bowel diseases etc. showed some good outcomes because of using biologics. Biosimilar insulins which are newly formed are likely to enter the insulin landscape as patents for major branded insulin products ready to expire in the next few years. The emerging biosimilar like filgrastim, peg filgrastim, recombinant blood products, therapeutic products vaccine biosimilar, anti-bodies growth hormones, biosimilar peptide, all these are used to sound knowledge on biosimilars development on drugs.
- Track 2-1Biosimilars in rheumatic diseases
- Track 2-2Recombinant therapeutic proteins
- Track 2-3Insulin Biosimilars
- Track 2-4Growth hormones
- Track 2-5Recombinant vaccines
- Track 2-6Biosimilars in cancer treatment
- Track 2-7Recombinant blood products
For the development of biological calls many changes may occur. Concepts of biologics with considerations at initial stages, clinical developments are essential at early. For the successful development of biologics follow on proper scientific and strategic approaches are need. Most probably, the drug safety factors and labelling requirements are the overcoming challenges and important in continue of late clinical steps. And now it is much required to develop a drug product in according to quality by design.
- Track 3-1Current concepts of drugs and biologics
- Track 3-2Cancer therapeutics development
- Track 3-3Drug safety essentials
- Track 3-4Biopharmaceuticals development
- Track 3-5Advertising, promotion and labeling essentials
- Track 3-6Unique considerations for biologics
- Track 3-7Late clinical development essentials
biosimilars is likewise called as nonspecific adaptation of biosimilars. The clinically idle compound is not withstanding with biosimilars but rather minor contrasts and profoundly like authorized item; additionally, there Presently a-days in pharmaceutical industry biosimilars is shaped has another buzz. Furthermore, these are no clinically important contrasts between the biologicals and the reference item as far as intensity, wellbeing and immaculateness. The worldview of customary generics to biosimilars, and different parts of Biosimilar endorsements. Also, these Biosimilars 2019 will give a phenomenal and overall chance to the researchers, accomplices and pharma pioneers from Biopharmaceutical and Biotechnology businesses to improve and to investigate the key market for Biosimilars and Biologics with an unmistakable photo of the administrative approach for biosimilars and biologics. The US biosimilars, European biosimilars, Canada biosimilars, UK biosimilars take a noteworthy part in cross the globe by 2019.
biosimilars development. And these biosimilar conferences will mainly focus on bio similar product development to deliver safe and successfully.
- Track 4-1BLA filing for biosimilars
- Track 4-2Patent issues
- Track 4-3Biosimilars regulation
- Track 4-4 Licensing of biosimilars
- Track 4-5Generic Biosimilars
- Track 4-6 Regulatory prospects of BRIC countries
- Track 4-7A paradigm of traditional generics to biosimilars
Same proportion pharmacovigilance for biosimilars has comparatively more different from other products. Biosimilars 2019 session mainly look that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, and on FDA initiative planned different changes in AERS, pilots of new developed post market strategies of drug-monitoring and ADR related problems. The guidelines of biosimilars for pharmacovigilance and pharma epidemiology are the points that shall be laid emphasis in the session In USA average annual income mostly spend on biologics comparing to generic drugs for example:16% on biologics and 3% on other drugs.
- Track 5-1Good pharmacovigilance practice and pharmacoepidemiology
- Track 5-2Detection and evaluation of drug safety signals
- Track 5-3Adverse drug reactions with biologics and biosimilar products
- Track 5-4Current problems in biosimilar pharmacovigilance
- Track 5-5Current problems in biosimilar pharmacovigilance
These Mainly discusses about different types of drugs and adsorption distribution metabolism excretion pathways. And This biosimilars includes, In vitro diffusion cells for dissolution testing in formulation development, The preclinical testing of ADME in INVITRO. The primary moto of this work was to suggest the biosimilars potential of biopharmaceutical classification system which are known to increase the dissolution. These insoluble drugs which is orally absorbed. These Aims at addressing all such challenges of the pharma formulation sector at biologics and biosimilars at 2019 conference. The solubility includes in biopharmaceutical classification.
- Track 6-1In vitro drug product research
- Track 6-2In vitro preclinical ADME/BCS testing
- Track 6-3Dissolution testing in drug formulation
- Track 6-4In vitro diffusion cells for dissolution testing in formulation development
- Track 6-5Consideration of biowaiver extensions for BCS class III drugs
- Track 6-6Waiver for In vivo bioavailability or bioequivalence
- Track 6-7Preclinical and clinical testing for oral drug delivery
These tracks mainly deal with biosimilar meetings those who can attend by following biologics/protein/biosimilar product process science, New biosimilar development, portfolio Management, Reasearch&development, biosimilar market, business operations, scientific affairs. This track mainly discusses about Risk-sharing arrangement LATAM market for bio-similar adopting innovative mechanism for generic drugs impact on global bio similar market and cost and risk.
- Track 7-1Global P&R models for the biosimilars and generics market
- Track 7-2Adopting innovative mechanisms such as risksharing arrangement
- Track 7-3Cost and risk management
- Track 7-4Biosimilars in global market
- Track 7-5Economic aspect towards biosimilars
- Track 7-6Global impact of biosimilars over generics
Risk Management, quality affairs, Case studies, clinical models, Transgenic animals Targeted cell-line development, clinical biosimilar tracks are major diseases of clinical trials. The pkd/docx studies toxicological studies and Aspects of genotoxicity tests. And These tracks are designed especially for those who are having more knowledge on clinical studies and clinicians’ prospects for biosimilars. These guidelines on the above-mentioned topics are also to be thrown effect upon at this biosimilars conference
- Track 8-1Biologics Product Life Cycle and Sustainable Market Returns
- Track 8-2Toxicological studies
- Track 8-3Clinical PK/PD studies
- Track 8-4 Targeted cell line development
- Track 8-5Transgenic animals
- Track 8-6Clinical trials on major diseases
- Track 8-7Clinical trials on major diseases
- Track 8-8Case studies and clinical models
- Track 8-9Aspects of genotoxicity tests
The active ingredient from the pharma product and its absorption into the systemic circulation is mainly focus on equivalence release. Bioequivalence assessment includes strategies of topical dosage forms and bio equivalence approaches for transdermal dosage form and assessment of respiratory dosage form.
- Track 9-1Bioequivalence assessment of respiratory dosage forms
- Track 9-2Strategies for the bioequivalence assessment of topical dosage forms
- Track 9-3Bioequivalence approaches for transdermal dosage forms
- Track 9-4Evaluation of highly variable drugs and drug products
The biological medical product is a biosimilar manufactured by a different company by the copy of an original product. The original biosimilar innovator products are officially approved biosimilar can be manufactured when the originally product patient expire. This session shall be highly useful for the biosimilar industry researchers to update themselves on the latest research updates from all over the world. Not only these sessions and also there are many ways to find the exact place for all the biosimilar exhibitions associated with present generation of biosimilars and biologics.
- Track 10-1Biotechnology medicinal products for different drugs
- Track 10-2Future of next generation biosimilars
- Track 10-3Biopharmaceuticals development
- Track 10-4Biotechnology medicinal products for different drugs
That any pharma product has successfully pass through the regulatory affairs scanners before launched in the market need less to mention. Biosimilars and biologics are no exceptions. The companies developing these biosimilars and biologics apart from regulatory aspects tend to enjoy monopoly over their product. Intellectual Property Rights (IPR) and patents are ultimate tools to the biosimilar manufacturers for safeguarding their interests. 2016 was a record year for development of Biosimilars & biologics in US. In this year 16 IPR petition was filed. So, expected scenario of 2017 would be a boom in Biosimilar and biologics field
- Track 11-1Pharma Patent Scenario
- Track 11-2Criteria for Patentability and Patent Claims
- Track 11-3Critical research issues
- Track 11-4Patentable subject matter
- Track 11-5Recent Patent disputes and litigations
- Track 11-6Evaluation of highly variable drugs and drug products
The negative tendency of biosimilars Brexit impact. The hindrance towards the cost cutting approach taken by the NHS is a major setback towards approval and launch of biosimilars in market. With Britain being among foremost clinical preliminary focuses is claimed to see a diminishing in the eagerness of the makers and specialists to do any further preliminaries in Britain. Additionally, Brexit will cause the primary rationale of British Biosimilars Association (BBA) to fall back-which went for expanding the utilization of Biosimilars..
Medication Delivery Companies and Market session is starting to change for little, large, and medium scale pharmaceutical, Co biopharmaceutical Manufacturing and Industries, bland medications organizations, contract sedate conveyance organizations which can show from improvement to assembling. Tending to these dangers is an extraordinary test, because of the many-sided quality of the Clinical bio therapeutics themselves.
- Track 13-1New approaches to enhance drug performance
- Track 13-2Drug Delivery technologies
- Track 13-3Drug Delivery Companies and Markets
- Track 13-4Drug Delivery Companies and Markets
- Track 13-5Recent Advances in Drug Delivery
Biosimilars are a generally new subset of biopharmaceuticals, with the biotechnology business at last developing to such an extent that off-patent nonexclusive compose items progressively will enter real markets. Up until now, more than 20 biosimilars for a set number of reference items have been affirmed in real markets, principally the European Union. Just two items have been formally endorsed as biosimilars in the United States. The parent field of biopharmaceuticals itself keeps on displaying a poor supporting framework of data assets. Those biopharmaceutical and biosimilar data assets that do exist for the most part are restricted in number, assorted variety, and advancement
- Track 14-1Regulatory Requirements for Pharmaceuticals
- Track 14-2Purpose and Principles of GMP
- Track 14-3R&D Advancement: Road to New Medicines
- Track 14-4Pharmaceutical Process Validation
Organic Medicine works with the science of the body and its regular recuperating capacities and in addition the otherworldly, passionate and physical parts of malady. Sickness implies that the body's direction isn't working legitimately and should be brought once again into its normal powerful state where the invulnerable framework is in full control. It in this manner searches for main drivers for the showing side effects of sickness the hidden elements making a man give a specific disease. These underlying drivers may comprise of a few elements which have developed after some time and can incorporate; consume less calories, sustenance sensitivities, intestinal unsettling influences, family history, push, ecological elements, substantial metals, dental issues, hyperacidity, injury, introduction to microscopic organisms or infections or electromagnetic aggravation
- Track 15-1Biological medicines in rheumatoid arthiritis, cancer, chronic kidney diseases
- Track 15-2Biological Medicine and the healing effects
- Track 15-3Biological pharmacotherapies in biological medicines.
- Track 15-4Biological Medicine is a science