Title: Quality risk management in pharmaceutical industry

Abstract:

Recently the application of Quality Risk Management (QRM) in the pharmaceutical industry has evolved and become a mandatory regulatory requirement. QRM is a continuous process of minimizing risks to product quality throughout its life cycle in order to optimize a product’s benefits and outweigh the risks. It is a systematic process for the assessment, control, and review of risks to the quality of the pharmaceutical product. ‘Risk’ is defined as the combination of the probability of occurrence of harm and the severity of that harm. ICH Q9 Guideline, Quality Risk Management illustrates core principles and tools of quality risk management to aid in efficacious and persistent risk-based decisions to both the industries viz. Regulatory and Pharmaceutical in regard to the quality of the drug substance as well as drug product from the patient’s perspective. A few examples of QRM systems that require practical decision-making are Validation, Documentation, Training, Inspection etc. Risk ranking and filtering is one of the widely used basic tools to identify and categorize the potential threat and risk is ranked using risk descriptors such as high, medium or low. Further, a risk score can also be used to define risk descriptors in risk ranking. Usually, an initial risk assessment analysis is conducted followed by final risk assessment analysis to either confirm the low risk or confirm the reduced risk. In conclusion, effective QRM system can facilitate better risk identification and subsequent risk control to improve scientific decisions.

Biography:

Prachi V. Atre has completed her Master’s in Industrial Pharmacy Practice from St.John’s University, Queens, NY, 11439. She has 3+ years of experience in injectables and is currently working as a Formulation Scientist II at Nexus Pharmaceuticals, Inc. She has published poster abstracts and presentations at Annual Meetings and Expositions such as American Asociation of Pharmaceutical Scientists (AAPS) and Controlled Release Society (CRS). She has good written and communication skills and has published review article on injectables recently.

Title: Metallacarborane derivatives effective against pseudomonas aeruginosa and yersinia enterocolitica

Abstract:

Pseudomonas aeruginosa is an opportunistic human pathogen that has become a nosocomial health problem worldwide. The pathogen has multiple drug removal and virulence secretion systems, is resistant to many antibiotics, and there is no commercial vaccine against it. Yersinia pestis is a zoonotic pathogen that is on the Select Agents list. The bacterium is the deadliest pathogen known to humans and antibiotic-resistant strains are appearing naturally. There is no commercial vaccine against the pathogen, either. In the current work, novel compounds based on metallacarborane cage were studied on strains of Pseudomonas aeruginosa and a Yersinia pestis substitute, Yersinia enterocolitica. The representative compounds had IC50 values below 10 µM against Y. enterocolitica and values of 20–50 mM against P. aeruginosa. Artificial generation of compound-resistant Y. enterocolitica suggested a common mechanism for drug resistance, the first reported in the literature, and suggested N-linked metallacarboranes as impervious to cellular mechanisms of resistance generation. SEM analysis of the compound-resistant strains showed that the compounds had a predominantly bacteriostatic effect and blocked bacterial cell division in Y. enterocolitica. The compounds could be a starting point towards novel anti-Yersinia drugs and the strategy presented here proposes a mechanism to bypass any future drug resistance in bacteria.

Biography:

Swietnicki is a scientist working on antibacterial strategies. The work is focused on novel vaccines and therapeutics targeting bacterial virulence systems. Swietnicki obtained his Ph.D. in Biochemistry and Molecular Biology from the University of Florida, Gainesville, FL, USA, in 1995 for his work on Hepatitis A Virus 3C protease. Later he worked on human prion proteins at CWRU, Cleveland, OH, USA before starting work on Select Agents at USAMRIID, Ft. Detrick, MD, USA, and ECBC, APG, MD, USA. In 2011 he moved to Poland to work on virulence blockers of enteropathogenic E. coli at EIT+ and later on novel vaccines against periodontitis at the Institute of Immunology and Experimental Therapy of PAS in Wroclaw, PL.

Title: Assay development of hight content metabolic stability and aldehyde oxidase benchmarking tool for drug discovery

Abstract:

Understanding the metabolism of new chemical entities at an early stage has become common practice in the pharmaceutical industry.

An automated, high throughput, in vitro assay for evaluation of the intrinsic clearance in liver microsomes, Cytochrome P450 (CYP) contribution, and metabolic soft spot identification, was developed.  This assay utilizes a combination of technologies and methods including automated liquid handling, acoustic sampling, in silico prediction, and hybrid quadrupole -orbitrap mass spectrometry, to efficiently generate and deliver data both in a high throughput manner, and in a reasonable time frame early in the drug discovery process.

Aldehyde oxidase (AO) has become an important clearance pathway in recent years. Due to the subcellular location of this enzyme, first tier discovery metabolic stability assays using human liver microsomes fail to identify the contribution of AO-mediated metabolism in new chemical entities. An automated, high throughput, in vitro assay was developed as a benchmarking tool for an in vitro - in vivo correlation of intrinsic clearance using commercial drugs known to be metabolized by AO using in vitro systems (human liver cytosol, liver S-9 fractions and human hepatocytes). This work provides a relative scale that can be used for an in vitro - in vivo correlation of AO clearance and can provide acceptance criteria as to when a potential new drug candidate that is metabolized by AO will have acceptable human clearance. This assay allows for quick structure activity relationships to guide further structural modifications for new chemical entities predicted to have AO mediated metabolism.

Biography:

Marina Slavsky has completed her M.S. from Moscow State University of Fine Chemical Technologies, Russia. She is the senior scientist in AstraZeneca DMPK group. Marina has extensive experience in high throughput assay development, automation, validation, and implementation for drug discovery and development.

Title: Fatty acid based vesicular systems: a novel strategy for topical treatment?

Abstract:

Topical administration of active pharmaceutical ingredients remains to be the most efficient and cost effective strategy for the treatment of superficial infections. The early infection can be well treated with topical formulations while more invasive infection can be dealt with oral treatment. However, a newer approach would be the use of topically administered flexible formulations which can deliver their contents to the systemic circulation.The common topical formulations like creams and ointments are limited in their efficacy because of lack of local pharmacological activity.  The various vesicular systems have been gaining attention because they not only act as depot for delivery of contents but also act as penetration enhancers. Carrier systems like liposome and noisome had to be overshadowed because of stability concerns. Investigation of other carrier system revealed fatty acids to self-assemble into vesicles which could carry the potential of drug delivery. The present work is focused on preparation and characterization of various vesicular systems and their comparison. In this work we focused on the treatment of superficial fungal infection as model disease to prove the effectiveness of fatty acid based vesicular systems. Superficial fungal infection is known to be the most widespread mycoses prevalent not only in   developing but also in developed countries. We found out that the pharmaceutical performance of the model drug was improved by using fatty acid based vesicle system in comparison to other conventional lipid and surfactant based vesicles. Therefore the use of fatty acid vesicles as a novel delivery system can be explored for topical treatment.Keywords: Fatty acid vesicle, topical delivery, vesicle delivery systems

Biography:

Zakir has completed her PhD from Jamia Hamdard (NIRF rank 1), India.  Dr. Zakir is currently working as an Asst. Prof., Delhi Pharmaceutical Sciences and Research University (India’s First Pharmacy University and second in the world). She has more than 20 referred articles in high impact journals >4 (h-index=10, >400 citations). She has authored numerous book chapters by Elsevier and Bentham publishers. She has published more than 50 conference proceedings and abstracts. She has also received various awards such as Young Rearcher Award, Award for Academic Excellence, best poster and oral presentation awards.