The track category is the heading under which your abstract will be reviewed and later published in the conference printed matters if accepted. During the submission process, you will be asked to select one track category for your abstract.
The development of biologics calls for overcoming lot many challenges. 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. The need for overcoming the challenges continues till 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).
- Approval Process for Biosimilar Products
- Clinical Trial Design
- New Trends in Delivery Systems
- Improving the Drug Performance
Biosimilars Market is experiencing a growth at an exponential rate. Presently around 700 biologics are making progress in the research pipelines of nearly 250 biopharma companies. 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. Biosimilar insulin’s have already started revolutionizing the future drug development in the realm of diabetology. Biosimilars are also being used as monoclonal antibodies, growth hormones, peptides, therapeutic proteins etc.
- Biosimilars for Cancer Treatment
- Biosimilars for Immune Disorder Treatment
- Monoclonal Antibody Biosimilars
- Erythropoietin Biosimilars
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.
- Aspects of Genotoxicity Tests
- Biosimilars Clinical Studies
- Toxicological Studies
- Transgenic Animals
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 causes of death needs proper treatment. This is where Biosimilars come handy. Biosimilars being cheaper can increase access worldwide to potentially lifesaving biologics.
- Trastuzumab biosimilars
- Biological drugs
- Cancer Therapy
Monoclonal antibodies (mAbs) are natural specialists that are broadly used to treat malignancies including non-Hodgkin's lymphomas and ceaseless lymphocytic leukaemia. They are compelling however costly. The licenses for some, mAbs are lapsing, so Biosimilar solutions, which contain an adaptation of the dynamic element of the first medication, are being produced. The first mAb biosimilars to be approved in Europe and elsewhere was the infliximab biosimilars (Inflectra and Remsima), which originator is Remicade.
- Monoclonal Antibodies in Oncology
- Lymphatic Disorder Treatment
- Rheumatoid Arthritis Treatment
- Guidelines for Monoclonal Antibody Production
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 such following topics.
- New Approaches to Enhance Drug Performance
- Drug Delivery Companies and Markets
- Drug Delivery Companies and Market Strategies
- Drug Delivery Technologies
A biopharmaceutical is also known as a biologic or biological medical product. It is any pharmaceutical drug product which is manufactured in, extracted from, or semi synthesized from biological sources. They are different from totally synthesized pharmaceuticals. They include vaccines, blood and blood components, allergenic, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be made out of sugars, proteins, or nucleic acids or complex blends of these substances, or might live cells or tissues.
- Biopharmaceutical Research
- Recombinant Protein Expression
- Monoclonal Antibodies
- Biologic Drug Development
Biosimilars is a Biologic therapeutic item which is duplicate of a unique item that is made by an alternate organization. Biosimilars are formally affirmed creative adaptations of unique items, and can be made when the first item's patent terminates. Reference to the innovator product is an integral component of the approval. This session also finds place for all the biosimilars exhibitors associated with the field of biosimilars and biologics. Biosimilars innovative products are on the rise.
- Economic Aspects Towards Biosimilars
- Cost and Risk Management
- Global Impact of Biosimilars Over Generics
- Monitoring the Production of Biological Products
Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the therapeutic management of inflammatory rheumatic diseases with dramatic clinical improvement and reduction in systemic inflammation in arthritis.
- Reasons of Switching
- Switching of bDMARD to its Biosimilars
- Switches in Clinical Trails
Biological Products means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein or analogous product, or arsphenamine or derivative of arsphenamine, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
- Biosimilar Biological Products
- Conceptual Development of Biosimilars
- Drug Designing
- Drug 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 most extreme significance in setting to the way that lone an appropriately bioequivalent sedate competitor that adjusts the outcomes in all regards to the first authorized item can be called as Biosimilar tranquilize.
- Strategies for the Bioequivalence Assessment of Topical Dosage Forms
- Evaluation of Highly Variable Drugs and Drug Products
- Bioequivalence Approaches for Transdermal Dosage Forms
- Bioequivalence Assessment of Respiratory Dosage Form
This session of the Biosimilars 2020 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.
- Role of Pharma Industries in the Improvement of Pharmacovigilance System
- Current Problems in Biosimilar Pharmacovigilance
- Detection and Evaluation of Drug Safety Signals
- Pharmacoepidemiology and GMP
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.
- Critical Research Issues
- Patentable Subject Matter
- Criteria for Patentability and Patent Claim
- Pharma Patent Scenario
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.
- Licensing of biosimilars
- Biosimilars Regulation
- Patent issues
- Bio waiver approval for Biosimilars
Globalization of Biosimilars tells us about the generic drugs impact on global biosimilars market, Cost and risk management, and Adopting innovative mechanisms such as risk-sharing arrangement, and European market for biosimilars. The global market scenario with the launch of first biosimilars in the market forecasts some radical changes. Globalization of Biosimilars 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.
- Biosimilar Multimodal Techniques
- Biosimilar Electrophoresis and Formulation
- Biosimilar GMP Protein Analysis
- Supply Chain Challenges Before Biosimilars
A Biosimilars bio therapeutic item is comparative (but not identical) as far as quality, wellbeing, and viability to an effectively authorized reference item. Not at all like nonspecific little particles, it’s hard to institutionalize such naturally complex items in light of convoluted assembling forms. The worldwide biosimilars advertise is developing quickly as licenses on blockbuster biologic medications terminate and other medicinal services parts centre on lessening of expenses. Biologics are among the most elevated cost medicines on the worldwide market today, which suggests the requirement for minimal effort choices. In developing markets, biosimilars officially offer more moderate costs, which are alluring, as well as crucial to economies where costly medications are not monetarily achievable.
- Contribution of Biosimilars in Global Market
- Growth of Erythropoietin Biosimilar Drug Market
- Cloning of Genes for Erythropoietin Biosimilars
- Rise in Biosimilar Use