Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 3rd International Conference on Biopharmaceutics and Biologic Drugs Philadelphia, USA
(10 Plenary Forums - 1Event).

Day :

Biopharma 2017 International Conference Keynote Speaker Mallikarjun Narayan Dixit photo
Biography:

Dixit (graduate from University of Illinois) is a scholastic personality with several patents and publications to his credit and with more than 25 years of rich experience
in pharmaceuticals, biopharmaceutical and CRO industries in the area of drug discovery and bio-analytical services. He has extensively worked on method development
and validation of various assay platforms such as LC-MS, ELISA, MSD, SPR, RIA/RIPA and Cell based assays for Immunogenicity and pharmacokinetics
evaluation of non-clinical and clinical study samples under GLP and GCLP compliant practices for regulatory submission studies. As a test facility management and
head of bioanalytical laboratory he has successfully faced multiple sponsor’s and regulatory audits. Dr. Dixit with his expertise is currently guiding the team biologics
in the delivery of quality compliant bioanalytical and Characterization services for biologics and biosimilars for submission studies

Abstract:

The global prescription drug market is expected to grow by 6% to reach nearly USD 1.05 trillion by 2022. Th e top 20 drugs are
manufactured by 14 companies and account for a total 10% of global prescription drug market in 2016. Th e total revenue
generated by top 20 products was estimated to be USD 0.128 trillion. Biologic drugs are cost eff ective opportunity for patients
in the area of oncology, diabetes, infl ammatory disorders, Autoimmune diseases, cardiovascular diseases and represent a total
market value of more than $50 billion. Th ere are 150 marketed biologic products worldwide, with almost 500 products under
development. About 21 important biologics will loose patent protection by the year 2019. Th e biopharmaceuticals show much
greater effi cacy and effi ciency when compared to conventional pharmaceuticals. Th e use of biopharmaceuticals is continuously
increasing and has resulted in a huge market demand. Biological drug products including Biosimilars, are larger in size and
more complex than conventional small molecule drugs and the majority of these originate from living organisms. During
the product development phase, some of the process changes are inevitable such as Cell line change, Critical Raw Material
change, Primary packaging components change, Scale up/ down, Process parameter change, Formulation, Presentation,
Device and Form Change Site Change or Critical Equipment change. Multiple complex manufacturing processes involved
in biologics drug product development may signifi cantly aff ect the product quality attributes, product development process
and the product safety and/or effi cacy. Th ese may also aff ect the other quality attributes such as physical, chemical, biological,
or microbiological property of the biologic drug product. Th ere are multiple challenges at every stage of development of
high quality biologics drug products. Th ese include the initial clone development, clone expression, product development,
processing, purifi cation, characterization, post translation modifi cations, sensitive bioanalytical methods and stringent
regulatory expectations. Similarly, there are several challenges in the clinical development phase also. Th ese include Study
Indication, Study Design, reference product, regulatory approvals, patient recruitment, Inclusion and Exclusion Criteria,
Statistical consideration, Immunogenicity, Safety assessment and Post marketing study requirement. Th e advancement in
the technology and availability of scientifi c approaches have helped to a great extent in eff ectively combating the challenges
andkeep the biologics drug development process at a rapid pace. Th e presentation on challenges in developing Biologics and
Biosimilars gives an overview of scope for Biologics and Biosimilars drugs, various challenges and methods to overcome many
of these challenges.