Scientific Program

Conference Series Ltd invites all the participants across the globe to attend International Conference on Pharmaceutical Analysis, Drug Discovery and Designing Chemistry Vancouver, British Columbia, Canada.

Day 2 :

Keynote Forum

Steinar Madsen

Norwegian Medicines Agency, Norway

Keynote: Biosimilar by approval – Biogenerics in practice?

Time : 09:20-10:00

OMICS International Pharmaceutical Analysis  2018 International Conference Keynote Speaker Steinar Madsen photo
Biography:

Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with the safe and cost-effective use of medicines for more than 20 years. He has been working with generics since 2000 and biosimilars since 2006. In 2001, generic substitution at pharmacy level was introduced in Norway. Dr. Madsen is a specialist in internal medicines and cardiology and works part time as a consultant in cardiology.

Abstract:

With an increasing number of biosimilar products entering the market, a discussion on the sustainability of these products is urgent. In Norway, the uptake of monoclonal biosimilars (infliximab, etanercept and rituximab) has been quite rapid owing to the large discounts given in comparison with the originators. Discounts have been up to 70%. So far it has been more or less a one way ticket from originator drugs to biosimilars. Biosimilar infl iximab has a market share of more than 95%, indicating that almost all patients have been switched from the originator to the biosimilar. In fact, this represents a possible transition from one monopoly to another monopoly. In Europe there are now (January 22nd 2018) three approved infl iximab biosimilars, three etanercept biosimilars, three adalimumab biosimilars (marketing will not take place before October 2018) and six rituximab biosimilars. Th e unanswered question is whether the second, third or later biosimilar entrants will have commercial success. In Norway, the fi rst infl iximab biosimilar gained total market dominance in two years. However, in the national tender for 2018 (in force from February 1st 2018), another biosimilar gave the best price – with a very large discount. Economically, all hospitals should switch their patients from the “old” biosimilar to the “new” one. Some physicians in Norway have expressed doubts about switching between biosimilars with the same originator as reference. However, if this way of switching does not take place, the market forces will not be able to secure further price cuts. In October 2017, the Norwegian Medicines Agency issued a statement eff ectively saying the following:
1. Switching from originator to biosimilar is safe.
2. Switching from biosimilar to originator is safe.
3. Switching between biosimilars with the same reference originator is safe.

OMICS International Pharmaceutical Analysis  2018 International Conference Keynote Speaker Yite Robert Chou photo
Biography:

Yite Robert Chou is the Head of High Throughput Analytical Core Facility and the Group Leader of Force Degradation and Impurity Profi ling group in the Biologics and Vaccines Formulation at Merck & Co. Inc. Before joining Merck in 2015, he spent almost 10 years in the Process Development department at Amgen. He has over thirteen years of experience in discovering and developing biotherapeutic products from pre-IND to BLA/commercial stages. Dr. Chou received a B.Sc. degree in Applied Chemistry from Tamkang University, Taiwan, R.O.C., and Ph.D. degree in Biological Chemistry from University of Massachusetts, Amherst, USA.

Abstract:

Statement of the Problem: Th e complexities and subtle distinctions of biologics encounter challenges of implementing quality by design (QbD) concepts in the development and manufacture of biopharmaceutics. A systematic approach of QbD is to design the product that meets patients’ needs and then determine the quality target product profi le (QTPP) and the critical quality attributes (CQAs) within an established design space. The development of appropriate analytical methods is, however, fundamental to establishing the product, process control, and the overall control strategy in a QbD development approach. Recent advances in analytical techniques have enabled the implementation of QbD in biopharmaceutics. Many analytical techniques facilitate QbD early in molecular design and engineering, and during the manufacturing process via process analytical technology (PAT) to achieve real-time quality control and to ensure fi nal product quality.
Methodology: Understanding structural and functional attributes of biopharmaceutics is essential for the selection of desirable quality attributes during molecular design and engineering to ensure the proper bioactivities. Th e disulfi de isoforms of IgG2 have been shown to have diff erent agonistic bioactivities. Many advanced analytical techniques, such as HDX-mass spectrometry, RP-HPLC, and affi nity chromatography have been used to characterize and purify these subtle structural isoforms for maximum clinical impact. Recently the multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LCMS) based method, has been developed and designed to specifi cally monitor and quantify molecular product quality attributes and product/process-related impurities. Although the online chromatographic/HPLC analysis has been one of the major obstacles for the implementation of PAT for biologics, the novel extra-fast HPLC and 2-dimensional HPLC approaches have demonstrated the feasibility to monitor CQAs in a real-time fashion.
Conclusion: Th e implementation of QbD concepts to biopharmaceutical development and manufacturing has been challenging compared to that of small molecules. Th e advances in various analytical technologies during the past decade give bright prospective on building “Quality” in biopharmaceutics.

OMICS International Pharmaceutical Analysis  2018 International Conference Keynote Speaker Marika Kamberi photo
Biography:

Marika Kamberi holds a double major in chemical engineering and biochemistry. She received her PhD from Oita University in Oita, Japan and completed postdoctoral studies at Stanford University in Palo Alto, California. Dr Kamberi has over 25 years of pharmaceutical experience/medical devices with increasing levels of responsibility across functional disciplines, including analytical R&D, bioanalytical, pre-clinical research, quality control and stability. She is currently the director of Analytical Chemistry for Medical Devices of Abbott, a worldwide premier medical device organization. Marika is author/co-author of more than 50 papers published in peer-reviewed journals, conference proceedings, and book chapters, and of 15 US/EU patents.

Abstract:

Analytical methods used in the characterization of combination products must be suffi ciently accurate, specifi c, sensitive and precise to ensure quality and reliability of the results, which in turn are crucial for ensuring quality, safety and efficiency of the products. Method validation is the process of proving that an analytical method is acceptable for its intended purpose. Validation is primarily concerned with the identifi cation of the sources of the potential errors in the method and their quantifi cation. It describes in mathematical and quantifi able terms the performance characteristics of a method. Performance is strongly connected with both the requirements and the design of the individual analytical procedure. Consequently, the analyst has to identify relevant parameters, which refl ect the routine performance of the given analytical procedure, to design the method validation studies accordingly and to defi ne acceptance criteria for the results generated. Setting acceptance criteria for the analytical methods used in the characterization of combination products is however much more complex than usually described. Criteria that are too wide may lead to unnecessary and incorrect out-of-specifi cation (OOS) cases, resulting in bad reject decision for the products. Th is study concentrates on analysis, through simulation, of the relation of method variability with specifi cation limits for the total loaded dose of the active substance on the drug eluting stents (DES). Th e fi ndings of this study point towards what levels of precision and accuracy are needed, in other words, what is the magnitude of the allowable total error from all possible eff ects (both systematic and random) in an assay method, in order to to achieve the level of performance required for the methods applied routinely for the evaluation of the total loaded dose of DES as part of lot release/ stability testing

Keynote Forum

Yara Peluso Cid

Federal Rural University of Rio de Janeiro, Brazil

Keynote: Pharmacokinetics of Fipronil and Fipronil-sulfone in dogs after oral administration of Fipronil tablets

Time : 11:40-12:20

OMICS International Pharmaceutical Analysis  2018 International Conference Keynote Speaker Yara Peluso Cid photo
Biography:

Yara Peluso Cid is professor at the Federal Rural University of Rio de Janeiro. Graduation in Pharmacy, Masters in Pharmaceutical Sciences and PhD in Science Technology and Innovation in Agriculture. Has experience in the area of veterinary drug design and pharmaceutical analysis applied to the physical-chemical quality control and studies of Pharmacokinetics, as well as expertise in the area of analytical and bioanalytical methods validation and Quality Assurance.

 

Abstract:

Statement of the Problem: Increased human-pet interaction creates concern for the prevention and treatment of fl ea and tick infestations. Fipronil (FIP) is an insecticide belonging to the class of phenylpirazoles widely used in veterinary medicine. Ectoparasiticides products commercially available for pets are mostly in topical forms, however they are associated with owner’s and environmental damage. Oral pharmaceutical forms for veterinary use have advantages related to convenience of administration, besides safety of human and environment.
Methodology & Th eoretical Orientation: Plasma concentrations of FIP and SULF were analyzed by HPLC-UV aft er solid phase extraction (SPE) procedure using SPE Oasis HBL (Waters) cartridges and methanol as eluent. Chromatographic separation was performed using a Kromasil C18 100 x 4.6 mm x 3.5 μm column, mobile phase acetonitrile: water (60:40) with fl ow rate 1.0 mL/ min. Construction of plasma concentration x time curve and pharmacokinetic parameters was performed using the Microsoft Excel macro PK Solver. Th e study used the non-compartmentalized mathematical model of extravascular administration.
Findings: Th e bioanalytical method was suitable for application in the pharmacokinetic studies, with LQ values of 0.1 μg/ mL for FIP and SULF, which allowed the quantifi cation of both in plasma until AUC0-t was greater than 80% of AUC0-∞. FIP presented a double-peak pharmacokinetic profi le, which probably occurred due to the drug oxidative metabolism. FIP administered orally at the dose of 2 mg/kg reached the systemic circulation (Cmax= 2.17μg/mL) and was fast absorbed (tmax= 2.67h) and metabolized, once its SULF metabolite presented Cmax= 1.32μg/mL in a tmax= 3.5h. Both elimination, FIP and SULF occurred slowly (t1/2= 385.93h) and (t1/2= 385.93h) respectively, maintaining quantifi able plasma levels in the blood for up to 28 days aft er treatment.
Conclusion & Significance: Th e use of fi pronil tablets for the control of ectoparasites in dogs may be a safer alternative for owners and the environment.