Biography:

Dr. Devina Kakar is a Regulatory and Medical Affairs specialist in Tech Observer, Delhi, India. At present, she is working as a Project Manager and Medical Affairs scientist for an upcoming project in GSK Consumer Health, Gurgaon, India and has been acknowledged for leading the same. She did her M. Pharm in Quality Assurance and Ph.D. in Pharmaceutics from Jamia Hamdard, New Delhi, India, and was awarded with the AICTE and Senior Research Fellowship from ICMR during her post-graduation and Ph.D. respectively. Having worked for about 7 years in academic research in the domain of cancer nanomedicine, she has several articles to her credit. Taking forward her keen interest in medical writing, she is actively involved in several projects on regulatory as well as medical affairs.

Abstract:

Effective cancer therapy by an anticancer drug relies on it’s ability to reach the diseased site in its most active form and target multiple cancer hallmarks. However, the insufficiency of the classical anticancer drugs to target multiple pathways of cancer progression and the inability of the conventional delivery systems to carry the payload to the tumor site results in severe side effects and sub-optimal outcome necessitating the exploration of traditional medicine and measures to improve targeted delivery to treat this highly complex disease. The current study aims at utilizing octreotide as the targeting ligand for decorating the PLGA nanoparticle system incorporating a natural bioactive thymoquinone with a well-established anticancer drug, topotecan, to target the somatostatin receptors overexpressed in breast cancer. Topotecan and thymoquinone loaded nanoparticles (TP-TY NPs) were formulated by double emulsion solvent evaporation and decorated with octreotide by carbodiimide chemical conjugation. The optimized particles were the characterized in terms of particle size, zeta potential, reconstitution time, entrapment and loading efficiency. The optimized particles were then evaluated by ex-vivo cytotoxicity analysis in MCF-7, followed by in vivo analysis in Ehrlich ascites tumor model. The optimized Oct-TP-TY NPs had a particles size and polydispersity index of 245.7±3.5 and 0.204± 0.18 respectively, zeta potential of -1.08mV and reconstituted in less than 15 seconds. % loading and entrapment efficiency was 37±1.2 and 2.8±0.65 respectively for topotecan and 62.2±1.2 and 6.2±0.5 respectively for thymoquinone. The decorated particles showed a significantly lower IC 50 (1.9±0.4ug/ml) as compared to its undecorated counterpart (3.5±1.5ug/ml) or free drug solution (16.1±1.8ug/ml). This was further supported by higher cellular uptake of the former. Finally, Oct-TP-TY NPs resulted in marked tumor regression as compared to TP-TY NPs and free drug solution with no or minimal detrimental effect on the haematological profile. In conclusion, the biological evaluation generated proof of evidence in support of the combination of a synthetic and a natural bioactive in an octreotide decorated nanoparticle system for targeted breast cancer therapy. 

Biography:

Gabriela Carrasco Torres is a PhD student in Nanosciences and Nanotechnology at the Center for Research and Advanced Studies of the I.P.N. She has been awarded Honorable Mention in her undergraduate and graduate studies, obtaining outstanding awards. She is the author of international and national publications in indexed journals, in addition to her direct participation in patents that are part of his career in the scientific field

Abstract:

The development of cancer is a set of heterotypic interactions that are intimately connected and with systemic events that favor the formation of solid tumors. Innovative treatments propose the use of the combination of drugs that are driven and released to the tumor. The use of nanoparticles (NPs) as carriers of cancer drugs is a novel strategy due to the ease of being able to bind anticarcinogenic drugs, thus opening the opportunity for low-cost and high-performance treatments. The bioconjugation of NPs with specific antibodies that recognize proteins expressed in tumor cells gives them advantages to conduct drugs with greater selectivity and concentration on the site. We have carried out the evaluation of drugs with antioxidant-prooxidant effect: quercetin and dimaleamilbenzoic acid 3’5 respectively, drugs that in combination, were evaluated in vitro with human cancer cells as in vivo and ex-vivo in animal models, demonstrating their anti-cancer effect without damaging the non-cancerous cells (Patent MX/a/2018/008239). The sum of our previous work and as a corollary encouraged us to develop a targeted treatment using magnetic NPs bioconjugated with the anti-ABCC3, molecule that has been proposed as a tumor marker protein (Patent MX/a/2015/016721). The culmination of this project focuses on undertaking pilot studies for the use of this treatment in patients

Biography:

Asghar Shahbaz has 14 years diversified experience of Pharmaceutical production, Quality Assurance, Registration Affairs, Product development and Process Planning, Method development, Process & Cleaning Validation, and Equipment Qualifications. Certificate Courses on cGMP, ISO Lead Auditor of IRCA, CTD Documents, and 14001-2004, has strong scientific, analytical, statistical, managerial and training skills. Currently he is working as a Quality Assurance Manager and for NEXT Pharmaceutical.

Abstract:

In the pharmaceutical industry every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in - recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to coordinate, facilitate and improve science-based decision-making with respect to risk. Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects. ICH Q9 - Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making with regard to risk identification, resource prioritization and risk mitigation / elimination, as appropriate.

Biography:

Dr Hugo Albrecht is a Senior Lecturer at the University of South Australia and a member of the Centre for Drug Discovery and Development within the division of Health Sciences. Prior to his appointment to the University of South Australia, he has held various positions in academic and commercial settings in Switzerland and the US, where he gained profound experience in preclinical drug discovery.

Abstract:

For a long time, prostate cancer has been considered chemo-refractory. Only during the last 10-15 years, have good results been achieved in clinic trials with taxane derivatives such as docetaxel (DTX) and cabazitaxel. However, disabling toxicities including fatigue and neuropathy limit optimal dosage and therefore only modest, life prolonging effects have been achieved for prostate cancer patients. Future treatment outcomes might potentially be improved through targeted delivery of chemotherapeutic compounds into cancer cells while reducing the exposure of healthy tissue.

Prostate cancer cells frequently overexpress the gastrin releasing peptide receptor (GRPR) and various strategies have been applied in preclinical settings to target this receptor for the specific delivery of anti-cancer compounds. Recently, it has been proposed that elastin-like polypeptide (ELP)-based, self-assembling micelles with tethered gastrin-releasing peptide (GRP) on the surface might be useful for active targeting of prostate cancer cells. Although poorly soluble chemotherapeutics such as docetaxel have been loaded into the hydrophobic cores of ELP micelles, only limited drug retention times have been achieved. We report the generation of hybrid ELP/liposome nanoparticles which self-assemble rapidly in response to temperature change, encapsulating docetaxel at high concentrations with slow release.  The GRP ligand was displayed on the surface and specifically bound to GRP receptor expressing PC-3 cells as demonstrated by flow cytometry. This novel type of drug nanocarrier was successfully used to reduce cell viability of prostate cancer cells in vitro through the specific delivery of docetaxel.

Biography:

Muhammad Jehangir has 13 years diversified experience of Quality Control, Quality Assurance, Registration Affairs, Product development and Pharmaceutical manufacturing, Process Planning, Method development, Method validation, Statistical Methodology, Process & Cleaning Validation, and Equipment Validation. Certificate Courses on cGMP, cGLP, Process Validation, CTD Documents, ISO 9001:2015, 13485-2016, and 14001-2004, has strong scientific, analytical, statistical, managerial and training skills. Currently he is working as a Senior Manager Quality Control and validation for Novamed Pharmaceuticals. It is toll manufacturing oriented company, manufacturing of companies like Getz Pharma, ICI, SEARLE, Macter, Ray, and for Sanofi-Aventis. He is also looking after the Quality of Novamed Healthcare, the nutraceutical and cosmeceutical manufacturing plant.

Abstract:

The evaluation of pharmaceutical raw materials and finished products for impurities and degradation products is an essential part of the drug development and manufacturing testing process. Additionally, toxicological information must be obtained on any drug-related impurity that is present at a concentration of greater than 0.1% of that of the active pharmaceutical ingredient (API). In pharmaceutical QC and manufacturing, impurity analysis has traditionally been performed by HPLC with UV, PDA, or MS detection. As it is essential to detect and measure all of the impurities in the sample, it is necessary to have a high resolution separation process. This usually involves long analysis times resulting in low throughput. As candidate pharmaceutical compounds become more potent and are dosed at lower and lower levels, ever more sensitive assays are needed to detect and measure impurities. The low throughput of HPLC can become the rate-limiting step in product release testing or process evaluation. Since much of the process of impurity identification involves the coupling of LC to sophisticated MS, any reduction in analysis time will result in a more efficient use of these significant investments. Analytical technology advances such as UPLC and UPC offer significant improvements in throughput and sensitivity, with benefits to the process of product release and identification of drug-related impurities. The most characteristic feature of the development in the methodology of pharmaceutical and biomedical analysis during the past 25 years is that HPLC became undoubtedly the most important analytical method for identification and quantification of drugs, either in their active pharmaceutical ingredient or in their formulations during the process of their discovery, development and manufacturing

Biography:

Muhammad Lutafullah has 20 years diversified experience of Pharmaceutical production, Quality Assurance, Registration Affairs, Product development and Process Planning, Method development, Process & Cleaning Validation, and Equipment Qualifications. Certificate Courses on cGMP, ISO Lead Auditor of IRCA, CTD Documents, and 14001-2015, has strong scientific, analytical, statistical, managerial and training skills. Currently he is working as a General Manager Plant Operations in NEXT Pharmaceutical.

Abstract:

The risk has been and will remain one of the main problems any company is put to trial during its activity, regardless of its type. Whether we are talking about a financial activity, a production activity, a management activity, etc ... the risk is a matter which should not be neglected. The motivation behind a detailed analysis of risks lies in the complexity and their multiple effects, in the need for security, in the desire for a safe development of the activity of the company, a development of safe and cost-effective projects, the implementation of performance and safe technologies etc.

Depending on the field of activity, the risk is dealt with in different ways. Whether we are talking about a transaction, a project, an organization, an asset, a monetary flow, the risk is composed of two elements: the probability of occurring of an event that could affect one of the units of analysis mentioned above and the effect that this has on the unit of analysis. Therefore, the manifestation of risk leads the analysis to a difficult situation to which the management of the organization is supposed to find viable solutions for surpassing.   

In the specialized literature there many methods and techniques in managing the emergence and the manifestation of risks, and one of these is the fishbone technique.

Researches in the field have led to the gathering and analysis of items of information regarding this analytical tool.  The results of the theoretical and practical research have resulted in a multitude of studies and research papers on such analysis tools that help improve understanding and identify the underlying causes of certain problems.

The purpose of this presentation is to achieve a representation of the relationships between the possible effects and possible causes that can influence a process, a phenomenon, an action.

Biography:

TSABANG Nole has received his Ph.D in 2008 at the University of Yaounde 1. He is a retired researcher of the Journal Institute of Medical Research and Medicinal Plants Studies. Now he serves as Adjunct lecturer at the Faculty of

Medicine and Biomedical Sciences, at the University of Dschang and at the Higher Institute of Environmental Sciences.

Tsabang Nole is an editorial member and Reviewers of reputed journals including OMICS Groups International. Indian Journal of Natural Products and Resources, International of Biological and Chemical Sciences. He worked as an Independent Consultant with Heifer Project International and Global Water Partnership. Dr. Tsabang is investigator of about 47 publications and 17 reports of ESIA, ethnobotanical and ethnoveterinary studies and co-presenter in conferences including 13th International Conference on Ethnobiology and 10th world conference on animal production. He is involving in the publication of five books and establishing collaboration with the University of Jackson State, Mississippi, USA.

Abstract:

The world needs, as in the past, synergistic drugs more effective in the treatment of diseases and even the most complicated ones such as diabetes, hypertension, cancer, sickle cell anemia, etc. A majority of Africans rely on synergistic traditional medicine as the primary form of healthcare. Yet most traditional medicine products have a short shelf life, especially for water-based formulations such as macerations, infusions and decoctions. Indeed, many of these water extracts become unfit for human consumption after five to seven days of conservation either because of the degradation or toxicity of active components, and/or the growth of pathogenic organisms. The purpose of this study was to develop a new approach for an improved traditional medicine (ITM) which is cheap, efficient, safe, available, affordable and easy to produce, and that can be conserved for a longer time. Hence, Laportea ovalifolia was selected from an ethnopharmacological survey in Cameroon, and was used to prepare an oral antihyperglycemic ITM. This preparation required 9 steps which permitted to a multidisciplinary team of scientists to  realized it standardization. Four galenic formulations of this antihyperglycemic ITM were produced. From October 2007 date of their preparation to 2018 they still undamaged. A relationship between these four formulations was described as follow: One spoon of oral suspension (10 ml) = one sachet of powder=2 tablets=3 capsules. Hence, our research provides new insight into a drug discovery approach that could alleviate the major problems affecting traditional medicine and enhance its effectiveness in addressing health care in developing and undeveloped countries.

Biography:

Presenting author is a Professor inDepartment of Pharmaceutical Technology, Meerut Institute of Engineering & Technology, Meerut. He has done Post Doctorate from  Institute of Nuclear Medicine and Allied Sciences, Delhi under a SERB funded proposal. He has completed his doctorate from JNT University Hyderabad in 2015. He has approximate 13 years of teaching and research experience in various organizations. More than 18 national and international research publications are in his account along with 02 patents applied. His area of interest is polysaccharide based drug delivery system such as oral, nano and hydrogels.

Abstract:

In the present study, an attempt was made to develop vitamin-D₃loaded nanoemulsion formulation for effective treatment of cerebral ischemia through nose to brain targeting. Tween 20 and polyethylene glycol (PEG-400) were chosen as surfactant/co-surfactant, while oleic acid as oil phase in nanoemulsion. The formulation was characterized for several in-vitro studies and further targeting efficiency of radiolabelled vitamin D₃nanoemulsion (^99mTc-Vitamin D-Nanoemulsion) was investigated through radiometry and gammascintigraphy. Efficacy of Vitamin D-Nanoemulsion was studied in transient middle cerebral artery occlusion rat model using Magnetic resonance images (MRI). Prepared Vitamin D-Nanoemulsion showed mean size range 49.29±10.28 nm and zeta potential 13.77. Gamma scintigraphy static images revealed brain deposition through nasal delivery of prepared formulation. Radiometry assay confirms approximate 4 fold increased biodistribution of ^99mTc-Vitamin D-Nanoemulsion into brain compare to oil solution of ^99mTc-Vitamin D. MRI of rat ischemic model confirmed better efficacy of Vitamin D-Nanoemulsion. Further elevated serum levelof MDA and decreased SOD, GSH and catalase activities confirm neurological deficits.

Biography:

Rashid Mahmood has Master Degree in Analytical Chemistry and MS in Total Quality Management. He has 15 years of experience of Pharmaceutical Quality Operations and has participated in many international conferences as a keynote speaker.  He has presented various talks in USA, Canada, UK  & UAE on Cleaning Validation, cGMP Guidelines, Quality Risk Management, Role of Mass Spectrometry in Pharmaceuticals and on new Drug Delivery Systems.

Currently he is working as a General Manager Technical Operations for Surge Lab.(Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company of Pakistan.

Abstract:

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique  for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. It is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in pharmaceutical industry continues to grow and recent success of this technique have made it a useful tool of consideration as a drug delivery solution.

The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability.

Biography:

Bushra ALQuadeib has completed her PhD from Newcastle university, UK School of Engineering and Advanced Materials, United Kingdom. I am a assisstant professor in pharmaceutical department, pharmacy college, king saud university had published more than 10 papers in reputed journals.

Abstract:

Amphotericin B (AMB) is used most commonly in severe systemic life-threatening fungal infections. There is currently an unmet need for an efficacious (AMB) formulation amenable to oral administration with better bioavailability and lower nephrotoxicity. Novel PEGylated polylactic-polyglycolic acid copolymer (PLGA-PEG) nanoparticles (NPs) formulations of AMB were therefore studied for their ability to kill Candida albicans (C. albicans). The antifungal

activity of AMB formulations was assessed in C. albicans. Its bioavalability was investigated in nine groups of rats (n¼6). Toxicity was examined by an in vitro blood hemolysis assay, and in vivo nephrotoxicity after single and multiple dosing for a week by blood urea nitrogen (BUN) and plasma creatinine (PCr) measurements. The MIC of AMB loaded to PLGA-PEG NPs against C. albicans was reduced two to threefold compared with free AMB. Novel oral AMB delivery loaded to PLGA-PEG NPs was markedly systemically available compared to Fungizone_ in rats. The addition of 2% of GA to the AMB formulation significantly (p50.05) improved the bioavailability from 1.5 to 10.5% and the relative bioavailability was4790% that of Fungizone_. The novel AMB formulations showed minimal toxicity and better efficacy compared to Fungizone_. No nephrotoxicity in rats was detected after a week of multiple dosing of AMB NPs based on BUN and PCr, which remained at normal levels. An oral delivery system of AMB-loaded to PLGA-PEG NPs with better efficacy and minimal toxicity was formulated. The addition of glycyrrhizic acid (GA) to AMB NPs formulation resulted in a significant oral absorption and improved bioavailability in rats .