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13th International Conference on Biosimilars and Biologics, will be organized around the theme “Biosimilars and Biologics: Present Scenario & Future Prospects ”

Biosimilars Congress 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 Congress 2018

Submit your abstract to any of the mentioned tracks.

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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. Analysis of Biosimilars and Biologics forms to be one of the most important aspects towards the Biologics and Biosimilar development process. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry. The market for Biosimilars follow-on-Biologics is expected to grow at an exponential rate for next decade with the expiry of most patented drugs by 2020.The market in the APAC region for Biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for Biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

  • Track 1-1Biosimilar bioanalytical methods
  • Track 1-2Biosimilar Formulation
  • Track 1-3Bioassay for comparability and Potency Testing
  • Track 1-4Biosimilar GMP protein analysis
  • Track 1-5Biosimilar lc/ms analysis for discovery, preclinical, and clinical programs
  • Track 1-6Biosimilar Electrophoresis
  • Track 1-7Biosimilar multimodal techniques
  • Track 1-8Biosimilars companies

This track includes Clinical Studies & Trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Toxicological studies and Aspects of genotoxicity tests. 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. Research estimates that there are 280 Biosimilars in the pipeline, and clinical trials are increasing by 20% per year. Biologics also represent over 40 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

  • Track 2-1Clinical trials on major diseases
  • Track 2-2Risk management, and quality affairs
  • Track 2-3Case studies and clinical models
  • Track 2-4Transgenic Animals
  • Track 2-5Targeted cell line development
  • Track 2-6Clinical PK/PD studies
  • Track 2-7Toxicological studies
  • Track 2-8Aspects of Genotoxicity tests
  • Track 2-9Environmental Monitoring and Microbiological Testing

Biosimilars is a Biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the Biosimilar Exhibitors associated with the field of Biosimilar and Biologics. 2014 was a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorders affecting fewer than 200,000 people in the U.S. A total of 41 new molecular entities (NMEs) and biologics (BLAs) were approved by the FDA in 2014 - 15 of those were approved in December alone (11 in final two weeks.

 

  • Track 3-1Biotechnology medicinal products for different drugs
  • Track 3-2Challenges faced in developing Biosimilars
  • Track 3-3Future of Biosimilars
  • Track 3-4Biopharmaceuticals development
  • Track 3-5Lyophilization of Biosimilars
  • Track 3-6Next generation Biosimilars

The 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. However, there are certain challenges in way of its development and receiving a green signal for launching into the market. Newer biologics also are targeting widespread diseases, with profound implications: a drug that costs $20,000 per year that is useful for 1 person in 100,000 has much less effect on a health plan’s cost structure than a $5,000-per-year drug that is useful for 1 in 100 people.

 

  • Track 4-1Current concepts of drugs and Biologics
  • Track 4-2Unique considerations for Biologics
  • Track 4-3Early clinical development essentials
  • Track 4-4Late clinical development essentials
  • Track 4-5Drug safety essentials
  • Track 4-6Cancer Therapeutics
  • Track 4-7Comparability for Biologics
  • Track 4-8Quality by Design for Biologics and Biosimilars

Biosimilar guidelines for Pharmacovigilance practice and Pharmacoepidemiology are the points that shall be laid emphasis in this session. U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs. In same proportion Pharmacovigilance for Biosimilars has been comparatively more than other pharmaceutical products. Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in Pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

 

  • Track 5-1Current problems in Pharmacovigilance
  • Track 5-2Adverse drug reactions with Pharmaceutical products
  • Track 5-3Detection and evaluation of drug safety signals
  • Track 5-4Improve Pharmacovigilance through Patient and Provider Education
  • Track 5-5Regulatory updates and key drivers for registration approvals in US, EU and China
  • Track 5-6Regulatory requirement for Biosimilar IND filing in the US
  • Track 5-7Role of Pharma industries in the improvement of Pharmacovigilance system

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. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).

The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

For more details about the trending topics, PS Biosimilars Conferences

  • Track 6-1Pharma patent scenario
  • Track 6-2Criteria for patentability and patent claims
  • Track 6-3Critical research issues
  • Track 6-4Patentable subject matter
  • Track 6-5Recent patent disputes and litigations

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6 percent with one generic competitor, but jumps to 48 percent with two generic competitors, 56 percent with three, 61 percent with four and 67 percent with five generic producers in a market. Within two years of the expiration of the patent for the popular drug Zantac in mid-1997, generic versions accounted for 90 percent of the treatment’s total sales, and the price for patients was about 10 percent of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners received EMEA approval for the first European Biogenerics, two products containing human growth hormone.

 

  • Track 7-1Biosimilars regulation
  • Track 7-2Biosimilars regulation
  • Track 7-3BLA filing for Biosimilars
  • Track 7-4Regulatory prospects of BRIC countries
  • Track 7-5Aparadigm of traditional generics to Biosimilars
  • Track 7-6Biowaiver approval for Biosimilars
  • Track 7-7Generic Biosimilars
  • Track 7-8Regulatory Prospects in BRIC countries

The objective of this track is 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 track also includes BCS biowaivers, in vitro diffusion cells for dissolution testing in formulation development, in vitro preclinical ADME/BCS testing. Until in vitro in vivo correlation achieves the required degree, the Biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

 

  • Track 8-1BCS biowaivers
  • Track 8-2Preclinical and clinical testing for oral drug delivery
  • Track 8-3Waiver for In vivo Bioavailability or Bioequivalence
  • Track 8-4Consideration of Biowaiver extensions for BCS class III drugs
  • Track 8-5In vitro diffusion cells for dissolution testing in formulation development
  • Track 8-6Dissolution testing in drug formulation
  • Track 8-7In vitro preclinical ADME/BCS testing
  • Track 8-8In vitro drug product research

Biopharmaceutical are also called medical product these Biopharmaceuticals includes blood, blood components, gene therapy, Recombinant therapeutic protein. Biopharmaceutical informatics is used in information technology, molecular modeling and biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence

 

  • Track 9-1Applications of computation in Biologic drug development
  • Track 9-2Protein sequence-structural contexts and degradation reaction mechanisms
  • Track 9-3Creation of databases and data mining
  • Track 9-4Pre-clinical immunogenicity risk assessment of Biotherapeutics
  • Track 9-5Monoclonal antibodies (Various)
  • Track 9-6Blood components
  • Track 9-7Vaccines
  • Track 9-8Biopharmaceutical Research
  • Track 9-9Pharmaceutical Microbiology

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Disease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

 

  • Track 10-1Advances in Biological products
  • Track 10-2Biological drugs
  • Track 10-3Generic Biological drugs
  • Track 10-4Biotechnology medicinal products for different drugs
  • Track 10-5Future of next generation Biosimilars
  • Track 10-6Biopharmaceuticals development

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 11-1Strategies for the bioequivalence assessment of topical dosage forms
  • Track 11-2Bioequivalence assessment of respiratory dosage forms
  • Track 11-3Bioequivalence approaches for transdermal dosage forms
  • Track 11-4Evaluation of highly variable drugs and drug products

Biosimilars are surmounting pharmaceutical business division from most recent three decades and deals appear to extend coherently. Advances in the biotechnology prompt to change and exposure of new natural items (biosimilars) to treat diverse life-debilitating illnesses. Biosimilars are organic medications that are conveyed after expiry of the patent of affirmed pioneer and include Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

 

  • Track 12-1Key Aspects in Technical Development
  • Track 12-2Analysis of the Biosimilar Development Pipeline
  • Track 12-3Legal Issues and Implementation of the BPCI Act

The "Generic Drugs Market: 2015 - 2030 - Opportunities, Challenges, Strategies & Forecasts" report presents an in-depth assessment of the generic drugs and Analysis of key therapeutic areas and leading generic drugs  pufecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, Pharmaceutical Industry  opportunities, future road map, Following key trends, market drivers, challenges, Analysis of key therapeutic areas and leading generic trends ,value chain, ecosystem player profiles and strategies and  Regulatory landscape of global trends  throughout the globe The report also presents market size forecasts for generic drugs from 2017 through to 2030. The forecasts are segmented for over 10 therapeutic areas, 3 brand classifications, 5 regions and 25 leading countries.

 

  • Track 13-1Clinical development strategies for Biosimilars
  • Track 13-2Advances in Biosimilar Production & Technologies
  • Track 13-3Scale Up of Biosimilars
  • Track 13-4Business Development in Biosimilar
  • Track 13-5Major market trends & Featured regional market trends

Globalization of Biosimilars is 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. A growing global market for Biosimilars is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Thus, according to Research and Markets, the global biosimilar market, valued at $2 billion in 2012 is projected to reach $19.4 billion by 2018.

 

  • Track 14-1Global impact of Biosimilars over generics
  • Track 14-2Economic aspect towards Biosimilars
  • Track 14-3Biopharmaceuticals developmentBiosimilars in global market
  • Track 14-4Investment and returns on Biosimilars
  • Track 14-5Cost and risk management
  • Track 14-6Adopting innovative mechanisms such as risk-sharing arrangement
  • Track 14-7European market for Biosimilars
  • Track 14-8Global P&R models for the Biosimilars and generics market

Good Manufacturing Practice is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and Quality Control. Fact about Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Over the previous decade, a developing offer of the business' R&D yield has comprised of incremental enhancements to existing generic medications instead of new sub-atomic substances. Execution measures that consider just altogether new medications, for example, the quantity of NME endorsements every year miss that move and underestimate the business' R&D Field

 

  • Track 15-1New Product Development
  • Track 15-2Cost and risk managementPatent innovations
  • Track 15-3The Global R & D and Regulatory Landscape
  • Track 15-4Regulatory landscape of generic drugs throughout the globe
  • Track 15-5Facts about Current Good Manufacturing Practices (cGMPs)
  • Track 15-6Current GMP guidelines
  • Track 15-7Good clinical practices & Good Laboratory Practices
  • Track 15-8Current regulations and quality Standards
  • Track 15-9International Regulatory Affairs

A biosimilar is an organic item very like an affirmed natural item, known as a kind of perspective item, with no clinically significant contrasts as far as wellbeing and viability. In the U.S., if a natural compound exhibits practically identical information to a U.S. Nourishment and Drug Administration (FDA)- authorized item from expository, preclinical and clinical reviews, it will be acknowledged as a biosimilar after termination of trend-setter licenses through a curtailed course. Tradable natural items are likewise Biosimilars, however should meet extra criteria to coordinate the reference item. Interchangeable can be substituted for the reference item without a medicine from a social insurance supplier.

 

  • Track 16-1Biosimilar Product Reimbursement and Pricing
  • Track 16-2Biosimilar Regulatory Updates and Legal Implications
  • Track 16-3Biosimilar Market Access and Commercialization

Biosimilar Engineers and their outsourcing accomplices must know about the picked nation's administrative scene, and have broad information of any current Biosimilar endorsement pathway and the most recent administrative organization rules. Furnishing administrative experts with endorsements of investigation (CoA) for a U.S. - advertised comparator could challenge. As opposed to European practice, U.S. makers tend not to make CoAs accessible to parties required in the production network or bolster the improvement of a contender by discharging CoAs for clumps acquired for clinical trials. Giving family proclamations to the reference item more often than not is acknowledged as an option.

 

  • Track 17-1Product Similarity for Biosimilars & Analytical Challenges
  • Track 17-2Role of Medical Affairs in Biosimilars
  • Track 17-3Regulatory strategy for generics and Biosimilars

Pharmacology is the branch of solution and science worried with the investigation of medication action where a medication can be comprehensively characterized as any man-made, characteristic, or endogenous (from inside body) particle which applies a biochemical and additionally physiological impact on the cell, tissue, organ, or living being (once in a while the word Pharmacon is utilized as a term to envelop these endogenous and exogenous bioactive species). Sedate improvement is the way toward conveying another pharmaceutical medication to the market once a lead compound has been distinguished through the procedure of medication revelation. It incorporates pre-clinical research on microorganisms and creatures, petitioning for administrative status, for example, by means of the United States Food and Drug Administration for an investigational new generic medication to start clinical trials on people, and may incorporate the progression of acquiring administrative endorsement with another medication application to showcase the medications and Increase Global Pharma Market

 

  • Track 18-1Clinical pharmacology and Drug addictions
  • Track 18-2Characterization of biologically active compounds
  • Track 18-3Recent advancements in research and developments
  • Track 18-4Recent advances in computer aided drug design
  • Track 18-5Novel Approaches in drug discovery

Biosimilar products are also produced from plants. Plants are the richest store house of diverse class of phytochemicals. Production of Biosimilar products in 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. Pharmacognosy researchers would find this track highly interesting and informative towards their research work. Proportion of plant produced Biosimilars are comparably low. However, an increased level of plant sourced biologics ~25% is owned to be seen in the market. Especially biologics derived from the plant sources are expected to occupy about more than 20% of all biologics.

 

  • Track 19-1Transgenic plants
  • Track 19-2Post translational genetics
  • Track 19-3Fermentation culture
  • Track 19-4Molecular farming

Biotherapeutics more often than not alludes to helpful materials created utilizing organic means, including recombinant DNA innovation. Biotherapeutics are fundamentally operators, used to treat and maintain a strategic distance from human malady by interrelating with the microbial environment of the host. Biotherapeutics can target particular particles inside the human body, and have a decent reputation with patient wellbeing. Fabricating biotherapeutics is mind boggling, as they are bigger mixes in both size and structure, and can be touchy to ecological conditions.

 

  • Track 20-1Advancements in Biotherapeutics
  • Track 20-2Biotech and Biosimilar Products
  • Track 20-3Antibody based therapeutics
  • Track 20-4Therapeutic Antibodies and Fc Fusion Proteins