6^th Asia-Pacific Pharma Congress July 11-13, 2016 Kuala Lumpur, Malaysia

Biography:

Young-Ger Suh is a Professor of College of Pharmacy, Seoul National University, Korea. He graduated from Seoul National University with a B.S. degree in Pharmacy in 1975 and received Ph.D. degree from University of Pittsburgh in 1987. Currently, he is a President of Korean Society of Organic Synthesis, a full member of The Korean Academy of Science and Technology, a Fellow of Asian Federation for Medicinal Chemistry, and a Vice President of The Korean Federation of Science and Technology Societies. He has published more than 150 papers in reputed journals and presented more than 200 papers at Scientific Meetings.

Abstract:

Hypoxia is a special feature occurring in vascular diseases and induces the transcriptional genes involved in glycolysis, haematopoiesis, invasion and angiogenesis. Hypoxia-inducible factor-1α (HIF-1α), which is a key mediator of angiogenesis, is overexpressed under hypoxic condition and transcripts various genes. Our initial studies confirmed that deguelin, a rotenoid, disrupts ATP binding to hsp90 and consequently induces destabilization of HIF-1α. We have identified novel hsp90 inhibitors through the SAR studies including structure truncation of deguelin. The new hsp90 inhibitors exhibited excellent antiproliferative and antiangiogenic activities, which are applicable for treatment of the angiogenesis-related ocular diseases. In particular, two representative hsp90 inhibitors exhibited suppression of hypoxia-mediated retinal neovascularization and vascular leakage in diabetic retina. They effectively suppressed expression of target genes of HIF-1α including vegfa in the retina of oxygen-induced retinopathy (OIR) mice, but do not induce definite toxicity. We will report our recent progress on the development of antiangiogenic agent with detailed discussions.

Biography:

Mervat El-Borhamy has completed her MD at the age of 32 years from Faculty of Medicine, Ain-Shams University and postdoctoral studies from Faculty of Medicine, Ain-Shams University. She is the head of Microbiology Department, Faculty of Pharmacy, Misr International University. She has published more than 20 papers in reputed journals and has been serving as an Infection Control and Clinical Microbiology Consultant in International Medical Center, Cairo.

Abstract:

Antimicrobial stewardship is a multidisciplinary development of evidence-based practice guidelines incorporating local microbiology data and resistance patterns to improve antimicrobial utilization. The objective of the speech is to emphasize on the following crucial points: abuse of antibiotics and development of multidrug resistant bacteria (MDR) versus rational use of antibiotics, statistical data on MDR and how do we get started to implement local antibiotic policy, restricted antibiotic policy, recommendations to improve antimicrobial stewardship and recommendations to minimize the development of MDR.

Biography:

Christina Leung completed two Bachelor degrees in England, Management Sciences degree followed by the Pharmacy degree at the University of Nottingham. Following the registration as a pharmacist, she had worked in different London Teaching Hospitals. In the last 12 years, she has specialised in Paediatrics (especially in PICU and Paediatric Liver), Obstetrics and Gynaecology. She published two articles in the UK magazine relating to drugs use in paediatric liver diseases. Ms Leung is a registered pharmacist in HK and she is currently working as the Senior Pharmacist (Clinical Pharmacy Service) at the HKU-SZH in China. She is also the Honorary Lecturer at the University of Hong Kong. She delivers lectures to the Master and Undergraduate Pharmacy students relating to Paediatrics, Obstetrics and Gynaecology.

Abstract:

HKU-SZH has adopted the good pharmacy practices from the West and has implemented an advanced clinical pharmacy system within Pharmacy Department. We hope to use near-patients and near-doctors approach to provide high quality of clinical pharmacy service to patients and the healthcare professionals to ensure safe and effective of drugs use. The clinical pharmacists join the doctor-led ward rounds regularly on selected clinical areas such as ICU and NICU. For all newly admitted in-patients, the clinical pharmacists take drug histories and carry out medication reconciliation, and the information is recorded in the electronic prescribing system. They also check all the in-patient prescriptions for clinical appropriateness using approved and updated reference sources. In addition, pharmacists involve actively in the warfarin patient counselling service and stroke clinical pathway patient care contributions on the wards. Since early 2015, clinical pharmacists have participated in the smoking cessation clinic, paediatric and adult respiratory out-patient clinics, diabetic clinic to provide patient counselling services. In addition, clinical pharmacists play a role in the cardiac rehabilitation centre to deliver cardiac drugs educational talk. Furthermore, clinical pharmacists have delivered talks to patients regarding drugs use for smoking cessation, safe use of insulin injections, effective use of inhalation devices, and medication safety in children such as use of oral syringes and tablet cutter in the out-patient forum. All these quality improvement plans are to enhance medication safety and optimistation of drugs. Clinical pharmacists in China find this experience rewarding and we think this cannot be achieved without an effective multi-disciplinary teamwork.

Biography:

Abdelmoneim Awad has completed his Ph. D at the age of 31 years from Robert Gordon University, Aberdeen. He is a Professor of Clinical Pharmacy and Chairman of the Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University. He has published 40 peer-review papers and presented 35 abstracts in international conferences, and serving as an editorial board member of reputed journals. Scopus citation overview of his indexed publications in April 2016 is h-Index (12) and total citations (406). Prof Awad is a reviewer of 24 professional journals. He is a member of the American College of Clinical Pharmacy, Gulf College of Clinical Pharmacy, and the European Society of Clinical Pharmacy.

Abstract:

Identification of individuals with metabolic syndrome (MetS) and those who are at risk of developing coronary heart disease (CHD) and type 2 diabetes (T2D) is vital to delay or even prevent the development of T2D and modify the CHD risk levels. The present study was designed to determine the prevalence of MetS, and to estimate the 10-year risk for developing T2D and CHD among the general population in Kuwait. A descriptive, cross-sectional survey was undertaken in 1800 individuals without diabetes or a history of cardiovascular disease. The questionnaire was developed using the Finnish Diabetes Risk Score, Framingham Risk Score and the 2009 Joint Statement criteria for diagnosis of MetS as a framework. The response rate was 89.4%. Sixty one percent of responders were either overweight or obese. Twelve percent had BP ≥ 140/90 mm Hg. Twenty eight percent had fasting plasma glucose levels ≥ 5.6 mmol/l, of whom 86.0 % and 14.0% had impaired fasting glucose and screen detected T2D, respectively. MetS was present in 31.8%. Almost 30% were at moderate, high, or very high risk of developing T2D, while 17.6% were at moderate/high risk of developing CHD. Almost 9% were at moderate/high/very high risk of developing both T2D/CHD. T2D risk was higher for females compared to males (p < 0.001); however, the pattern was reversed in terms of the risk of developing CHD or T2D/CHD. The risk of developing T2D, CHD, or T2D/CHD was greater among those aged ≥ 45 years, and those having MetS (p<0.001). The current findings highlight the need for multifaceted interventions for prevention.

Biography:

Namrata Singh graduated as a MBBS in 1996 and got trained as a pediatrician from one of the premium hospitals in India, Sir Ganga Ram Hospital. She has a rich clinical experience of handling patients, patients’ data and contributing to research. She has been working as a medical writer for 8 years in different roles as an employee, as freelancer and currently as head of a team of medical writers at Turacoz Healthcare Solutions. Being on both sides of the table makes her an expert on the requirements of both authors and journals. She has written for all major therapies and provided support for all publication documents like original research, review, case reports, case series, systematic reviews and meta-analysis.

Abstract:

Background: Disclosure and publishing of results is critical for advancement of science whether the trial results are positive or negative. The disclosures are important because they are the legal requirements, ethical responsibilities, industry commitments, impacts ability to publish, supports research and avoids duplication of research. Currently the disclosures are voluntary and the scene is changing every day to accommodate and streamline the requirements and execution by healthcare, pharmaceutical companies, clinical research organizations and medical communication companies. The current presentation enumerates all the documents that are required in this rapidly changing space and what are the recent advancements in this area which can expedite the documentation and transparency methods. Role of a Medical Communication Company. This changing atmosphere and surroundings has contributed to an additional responsibility for the medical communication companies to develop medical and regulatory documents which can support the regulatory bodies, pharmaceutical and biotech companies to fulfil the disclosure requirements and maintain the required transparency. The key documents that fall under this category are: 1. Clinical trial registration and status reporting 2. Trial results posting 3. Redaction of confidential company information 4. Publication of trial results in journals 5. Lay summaries for public 6. Clinical overview and clinical summary Way Forward: Automatic Authoring and Artificial Intelligence If all this documentation is done manually, then the amount of time and resource required is magnanimous. There are some new technologies available like automatic authoring and artificial intelligence which can play a great role in expediting these document requirements and reaching the goals of complete transparency and public disclosures globally and regionally. Now is the time for the whole research community to join hands and contribute in this ambitious endeavor to gain the best from the drug research and development and contribute to improved patient care and quality of life.

Biography:

Gnanaprakash is 37 years old and completed his M. Pharm (Pharmaceutics), graduated from Tamil Nadu Dr M.G.R Medical University, Chennai (TNMMU). He is having 8 years of experience in training and peer education and has developed professional capabilities by facing inspections, attending conferences & organizing inter-college events etc.

Abstract:

The pulmonary route, owing to a noninvasive method of drug administration, for both local and systemic delivery of an active pharmaceutical ingredient (API) forms an ideal environment for APIs acting on pulmonary diseases and disorders. Isoniazid is an antibiotic utilized as a first-line specialist for the prevention and treatment of both latent and active tuberculosis. Low levels of isoniazid obtain entrance into plasma following oral administration because of its high aqueous solubility, low permeability and rapid first pass hepatic metabolism with small t1/2 of 1–4 hrs demonstrates its short stay in plasma and the requirement for repetitive or high doses which may subsequently result in hepatotoxicity and neurotoxicity connected with its utilization. The PLGA nanoparticles (NPs), known for their superb oral bioavailability and furthermore in other route of administration they are chosen to conquer the above obstacle in medication achieving the blood plasma. Poly (lactic-co-glycolic acid) (PLGA) is a standout amongst the most effectively created biodegradable polymers. It has pulled in extensive consideration because of its biodegradability and biocompatibility, defense of drug from degradation and sustained release, target and focus the effect to specific organs and cells. The preparation of Isoniazid PLGA Nanoparticle conditions were optimized by varying the formulation and process variables , to get a stable Nanoparticle with less particle diameter of 178.5 nm, PI of 0.856 and zeta potential of -36.1mV, which shows best stable nanoparticle. The encapsulation efficiencies and drug content were around 80.56 ± 2.54 % and 86.92 ± 3.42 %. According to structural and morphological analysis by SEM studies the particle demonstrates spherical, smooth surfaced multilamellar nanoparticles. Furthermore, in vitro diffusion studies shows desired release characteristics. From the above results it was inferred that the emulsion solvent evaporation technique was an optimized formulation for Isoniazid PLGA Nanoparticle.

Biography:

Aref Alabed graduated as a qualified Dentist in the Ukraine during 2005, setting up his own dental clinic in Jordan that he operated for 3 years. He was then offered a position in a Dental clinic in KSA. He held two roles there; in the evening he worked as a dentist and during the day as the center manager. The 5 years spent in the management role gave him an opportunity to begin to understand business operation and he decided to study for a Master’s in Business Administration. He was awarded my MBA with Merit from the University of Northampton in England. Then he moved to Jordan to work as a Director for Marketing for the largest chains of pharmacies in Jordan (105 pharmacies) and during his trips all over the world he opened the International Medical Training Academy based in London which focus at the interpersonal skills for the healthcare professionals with a wide range of courses for the Pharmacists.

Abstract:

It is a known fact that Pharmacists are largely encouraged to develop the scientific areas of their career, adding value and new benefits to our lives. Less encouragement, however, is given to their personal development; understanding how to connect, build valuable relationships with others and manage the team, the communication in the pharmacy. Management and interpersonal skills are rarely included in the Pharmaceutical curriculum at universities and yet these skills are crucial when faced with the responsibility of managing teams. Systems and processes have to be implemented to lead a team successfully and without an understanding of leadership and communication skills this can be extremely challenging. A very well know that: " In order to be a good professional, a pharmacist should possess “a combination of comprehensive therapeutic knowledge, experience, problem-solving skills, and judgment” (Burke, et al., 2008). And in a recent survey soft skills were rated as more important than the hard skills (Aasheim & Williams, 2009). And lastly Hewitt Sean (2008) and Tobin (2006), quoted in (John, 2009), state that soft skills are non-technical, intangible, personality specific skills which determines an individual's strength as a leader, listener and negotiator, or as a conflict mediator. Soft skills are the traits and abilities of attitude and behaviour rather than of knowledge or technical aptitude. Here in the UK, the NHS is aware of the importance of the soft skills, that's why the requirements for the pharmacist's job is to have an excellent communication skill, good customer skills, willing to supervise others, team work, have leadership skills, able to deliver knowledge to the new employees. And all these skills have to be up to date with annual continuing professional development ( CPD). I believe that the balance between technical excellence and interpersonal skills is what truly makes a difference in the experience for service users and staff.

Biography:

Gopal Natesan has completed his Doctoral degree (PhD) in Pharmaceutical Chemistry from Hamdard University (Jamia Hamdard) New Delhi, India in 2000 and currently serving as Professor of Medicinal Chemistry & Deputy Dean of Research & Innovation and Students Affairs in Faculty of Pharmacy, MAHSA University, Kuala Lumpur, Malaysia. His research focuses on the synthesis of newer small chemical entities, quinazolinones heterocyclic pharmacophore and their preliminary screening in both in-vivo and in-vitro models mainly focusing on pain & inflammation and also for newer microbial agents. He has published >40 articles in indexed journals and presented >80 papers in conferences and invited speaker at international scientific meetings and conferences and serves as reviewer for several scientific international journals and also as Editorial/Advisory board of various journals.

Abstract:

Antibacterial resistance is one of the major global health issues and many infectious organisms have adapted to the drugs designed to kill them, making the products less effective. In view of these emerging resistance problems, there is an urgent need for new anti-resistance compounds. Benzimidazole is a heterocyclic aromatic organic compound and is a constituent of many bioactive compounds that are of wide interest, because of their diverse biological and clinical applications. A series of novel schiff base of Benzimidazole derivatives were synthesised and evaluated for antibacterial property. The title compound, 1-[(1H-benzo[d]imidazole-1-yl) (4’-substituted phenyl) methylene]-2-[4”- substituted benzylidene] hydrazine derivatives were synthesised by condensing benzimidazole with substituted benzoyl chloride followed by hydrazonation, further the final Schiff base was prepared by reacting with different substituted aromatic aldehydes and the structure of newly synthesised compounds were characterised by using 1H NMR & MASS spectral data. The antibacterial activity of the newly synthesized benzimidazole hydrazine derivatives (IIIa, IIIb) and schiff bases (IVa-h) were evaluated against the gram positive (S. aureus and B. cereus) and gram negative bacteria (P. aeruginosa and E. coli) by using the agar well diffusion method at a concentration of 100μg/mL using Norfoloxacin as reference drug. From the study, it has been observed that substitution on the parent hydrazine derivative alter the antibacterial activity and the parent hydrazine derivatives showed very lower degree of activity against S. aureus and B. cerus. Among the benzimidazole Schiff base derivatives, 1-[(1H-benzo[d]imdiazol-1-yl) (4-methoxyphenyl) methylene]-2-(2,3,4-trimethoxy benzylidene) hydrazine (IVb) showed better antibacterial activity against gram positive bacteria and while remaining all the synthesized compounds showed moderate in action. None of the compounds showed any activity against gram negative bacteria.

Biography:

Professor Yu Zong Chen obtained his PhD in University of Manchester (UK) in 1989. He then worked at Purdue University as a postdoc and at Ionis pharmaceuticals to conduct antisense drug design, Since 1997, he has been working at the National University of Singapore as a lecturer, senior lecturer, Associate Professor, Department head, and Professor. He pioneered the inverse docking method for target discovery, led the development of the popular therapeutic target database, revealed the distribution patterns of drug productive species in nature, and is among the first few scientists who explored machine learning methods for predicting protein function, drug target, ADME-Tox, bioactive compounds and multi-target agents.

Abstract:

The discovery of Artemisinin by Tu YouYou gives a good example of drug discovery based on the clues from the traditional medicines. A question is whether Tu’s miraculous discovery tale can be repeated by the modern informatics analysis of the traditional medicines. We investigated this question by examining to what extent the known drug-productive herbs in the traditional Chinese medicine (TCM) can be indicated by comparative analysis of the traditionally described medicinal functions with respect to the targeted therapeutic symptoms. We found that the drug-productive herbs may be indicated at lower false rate by coupling the analysis of the TCM functions together with the knowledge of the phylogenetically clustered distribution patterns of drug-productive species. Traditional medicines also offer new therapeutic approaches based on synergistic combination of low-potency natural products. We quantitatively studied the potency gaps between the approved drugs and the natural products of the same therapeutic classes, and evaluated the questions of whether, at what probability, and by what mechanisms these potency gaps can be overcome by the synergistic combinations of the natural products.

Biography:

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin. She has also held a variety of senior level positions at Dyax (now Shire), MGI Pharma (now Eisai), AstraZeneca, and Dey Pharma (now Mylan). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd) and has worked in review divisions at the FDA. In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Abstract:

Having a solid, global regulatory affairs strategy is essential to efficient and effective approval and commercialization of pharmaceutical products. This presentation will review similar and divergent regulatory strategies in key areas around the world and provide practical advice on managing a timely and high quality program to achieve success.

Biography:

Dr Hetal Shah is a Pharmacologist with over 12 years of first-hand experience in the field of Medical writing and Clinical Research Project Management. A Gold medalist and PhD awarded by the Gujarat University, she has 20 odd publications to her credit including book chapters, research papers and review articles in national as well as international journals. A medical writing expert with high standards for quality and work ethics, Dr Shah is extensively involved in developing scientific and regulatory documentation & publications for various international and national Pharmaceuticals & CROs. Dr Shah’s writing sphere currently ranges from preparation of clinical trial documents to clinical study reports; compilation of clinical modules for marketing authorization dossiers to Scientific Publications for Journals. Dr Shah is also an experienced trainer with practical approach to coaching, and conducts medical writing workshops customized for various topics and audiences’ needs. She is a member of the executive committee of All India Medical Writers Association (AIMWA) and the DIA Medical Writing group of India.

Abstract:

In the field of research, it is always emphasized that either Publish or Perish!. As important it is to conduct a research activity, so it is to have the findings of your work informed to others via the means of a publication. Original research article or manuscript, is by far, one of the most common type of article being published in journals. Unlike other article formats like narrative review articles, short communications, or case reports, research manuscripts traditionally have a systematic and structured format. The body of a manuscript follows the ‘IMRAD’ pattern – Introduction, Methods, Results and Discussions. A manuscript should also have a proper title to its start and conclusion to its end. Other important aspects are Abstract, Keywords, acknowledgements and References. In this presentation, salient features of all these sections of the manuscript mentioned above, will be discussed in details and how to draft each of them will be demonstrated. Common errors involved in manuscript development and steps to avoid them will also be discussed. Overall, the presentation will provide A to Z step-wise approach for drafting an original research paper.

Biography:

Muhammad Abdul Qadir has completed his PhD at the age of 30 years from University of the Punjab, Lahore, Pakistan. He is working as Professor of Analytical Chemistry, University of the Punjab, Lahore. His main field of research is Drug designing, drug delivery and Imaging, Environmental Analytes and Agriculture. He has more than 70 research publications in the journals of international repute.

Abstract:

Gemifloxacin, a novel, 4th generation fluoroquinolone derivative, was labeled with99mTc; its freeze dried kits were prepared and used for infection imaging. Kits showed great stability with higher labeling efficiency. Kits were synthesized through a simple method; developed at room temperature without HCl and heating with low colloidal content. Reaction conditions were optimized in order to get maximum radiochemical purity. Highest labeling efficiency (99 ±0.05)% was achieved when 1.0 mg gemifloxacin was labeled with 10 mCi sodium pertechnetate in the presence of 50 lg SnCl2 and 300 lg D-penicillamine at room temperature. Radiolabeled antibiotic kits were preclinically assessed such as in-vitro stability, lipophilicity, protein binding, in-vitro binding with bacterial strains and pharmacokinetic investigations in animals. Kits were found highly stable for 6 h both at room temperature and at 37 _C in serum. Biodistribution showed excellent uptake of activity at infection site (in Pseudomonas aeruginosa, Salmonella typhi and Klebsiella pneumoniae). Biodistribution data showed that 99mTc-gemifloxacin has the potential and may be used for infection imaging.

Biography:

Maha Al draimly is an Ambulatory care clinical pharmacist at national guard comprehensive specialized clinic, Riyadh. She did her bachelor degree of pharmacy from KSU, Master degree of clinical pharmacy, KSU. She is a Cpd coordinator, member of family medicine research committee, established CDC clinic. She has participated in more than 160 international symposiums as a speaker. She is an Assistant Professor at King Saud University and Prince Noura University, Saudi Arabia.

Abstract:

Hypertension and dyslipidemia are main complications of diabetes. Hypertension prevalence 28.7% in US, Diabetes prevalence 7%, while prevalence of diabetes in SA is 27% and HTN is 26%. Clincal pharmacist is health science discipline in which pharmacist provide patient care that optimizes medication therapy and promotes health, wellness and disease prevention. Intervention of clinical pharmacist with Family medicine physician in managing and education of uncontrolled hypertensive, diabetic, dyslipidemic patients is expected to improve compliance with drug therapy, chronic disease outcome parameters and patient quality of life. 300 patients of uncontrolled hypertensive, diabetic and dyslipidemic are enrolled in this observational cohort study held in 3 ambulatory care centers at King Abdulaziz Medical city in Riyadh, 200 patients as sample, 100 as control. Quality of life measured at the base line and at the end of study for sample patients. Hba1c measured for each patients with BP and LDL with follow up with clinical pharmacist every 3 to 4 month for 5 visits, during this visit clinical pharmacist revise all of lab parameters for patients with medications file, doing education for patients, after finishing all visits of patients BP, Hba1c and LDl will be measured to measure the outcome and improvement of quality of life, to show the effect of clinical pharmacist intervention and education on upper parameters.

Biography:

Zayed Nama Alsulami is a paediatric clinical pharmacologist working for Alkharj Military Hospital in Alkharj City, Saudi Arabia. Zayed has completed his PhD from University of Nottingham in 2013. His main role is to conduct research into paediatric drug therapy and medication errors including the medication errors in the Middle East countries, Nurses adherence to double check process and medication administration errors in children.

Abstract:

Background: Children are more susceptible to medication errors than adults [1]. Medication administration process is the last stage in the medication treatment process and most of the errors occurred in this stage [2]. Little research has been undertaken about medication errors in children in the Middle East countries [3]. Aim: To evaluate how the paediatric nurses adhere to the medication administration policy and also to identify any medication preparation and administration errors. Method: This was a prospective direct observational study of medication administration process, from when the nurses preparing patient medication until administration in the patient room in the paediatric ward (May to August 2014). Also, the observers were documented any medication administration errors occurred during the study period. Main outcomes were adherence rate of each step of preparation and administration process, number of errors and associated risk factors. All data collected was anonymous and was recorded on a data collection form which was designed specifically for this purpose. Results: Fourteen paediatric nurses serving for 90 paediatric patients were observed. 456 drug administered doses were evaluated. Seven steps out of 16 steps with lower adherence rate. Patient allergy information, dose calculation, drug expiry date were the steps in medication administration with lowest adherence rate. 63 medication preparation and administration errors were detected with error rate 13.8% of medication administration. No potentially life-threating errors were witnessed. Few technical and administrative factors were identified. Conclusion: Medication administration policy and procedure need an urgent revision. Nurses’ knowledge and skills regarding to the medication administration process should be improved.

Biography:

D. Ayman K.M. Hassan has completed his interventional cardiology Ph.D. at the age of 33 years from Leiden University Medical Center, The Netherlands after finishing this Master studies from Assiut University School of Medicine. He was nominated as the vice director of Assiut University Hospitals and the head of a new health care quality unit. He has published more than 20 papers in reputed journals and has been serving as an editorial board member of repute. He is the founder of E-learning courses for under-and post-graduate students. Also as an experienced interventional cardiologist he pushed the field forward by practicing difficult cases.

Abstract:

The objective of this study was to investigate the effect of polypharmacy and high doses of amoxicillin/clavulanate on warfarin response in hospitalized patients. This was a prospective cross-sectional observational study on 120 patients from July 2013 to January 2014. Potentially interacting drugs were classified according to their tendency of increasing international normalized ratio (INR) or bleeding risk. The 87.5% of patients prescribed high-dose amoxicillin/clavulanate (10–12 g daily) compared with 28.9% of patients prescribed a normal dose (up to 3.6 g daily) had INR values ≥ 4 during the hospital stay (P≤.001). Increased number of potentially interacting drugs that are known to increase INR was a significant predictor of having INR values ≥ 4 (OR, 2.5; 95%CI, 1.3–4.7), and increased number of potentially interacting drugs that are known to increase bleeding risk was a significant predictor of experiencing bleeding episodes (OR, 3.1; 95%CI, 1.3–7.3). High doses of amoxicillin/clavulanate were associated with a higher risk of over-anticoagulation when combined with warfarin than were normal doses. Increased risk of having INR ≥4 and bleeding events was associated with increased numbers of potentially interacting drugs prescribed, indicating that polypharmacy is a problem of concern. Frequent monitoring of warfarin therapy along with patients’ medications is necessary to avoid complications.

Biography:

Rashid mahmood has 13 years diversified experience of Quality Control, Quality Assurance, Registration Affairs, NDA, ANDA, BLA, GMP Requirements, Drugs Laws, Statistical Methodology, Method Validation, Process & Cleaning Validation, Equipment Validation etc. Currently he is working as a Senior Executive Manager Quality Assurance & Quality Management Representative for Surge Labs.

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 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 co-ordinate, 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. Barna Ganguly completed M.B.B.S (1987) from Calcutta University & M. D - Pharmacology (1994) from Aligarh Muslim University, Aligarh. She has also done PG Diploma – Bioethics (2012-13) IGNOU, supported by ICMR – NIH (USA). Presently she is working as Professor and Head, Department of Pharmacology and Head, UNESCO Bioethics Unit of Gujarat under UNESCO Chair in Bioethics, (University of Haifa), in P.S. Medical College, Karamsad, Gujarat, India. She has got total teaching experience of 23 years (approx) with several publications at various national and international level with authorship in chapter of book in CRC publication. She has presented posters and papers at all levels of conference getting scholarships from PRIM & R Conferences and 12th World Congress with full scholarships from NIH. She is a life member of six associations, was President of Society of Pharmacovigilance, India for 2014-2015 and reviewer of many journals. She is a member of International Forum of Teachers of Bioethics, UNESCO. Her area of interest is Clinical Pharmacology and Bioethics.

Abstract:

Origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisted of 12 regional centers, each covering a population of 50 million. India is a hub for clinical trials flooded with more than 6,000 licensed drug manufacturers and 60,000 branded formulations. Though Pharmacovigilance is plays a significant role in clinical research and practice, yet there is an immense gap in understanding its importance in such areas. The Pharmacovigilance Programme of India was launched with an objective to safe guard the health of people of India. While major advancements in this discipline have taken place in Western countries, implementation and compliance still remain as challenge in India. So, it is important to address various challenges of pharmacovigilance. In India, the events are not properly reported due to lack of time, low motivation, ignorance. Lack of continuing medical education on pharmacovigilance and dearth of drug information and updates particularly at the level of primary health centres and private practitioners lead to underreporting of ADR. The practice of self-medication and use of traditional medicines pose other challenges as adverse events in such cases often go unreported. In addition, there are lacunae like lack of communication among healthcare professionals, shortage of trained personnel and inadequate training on pharmacovigilance at undergraduate level. Another challenging area of ADR monitoring is with that of clinical trials where there are always certain risks for the participants in such trials, which involve healthy volunteers and patients. The safety of the trial subjects is the sole responsibility of the investigator. S/he should conduct the trial strictly abiding by Indian GCP guidelines and ICH-GCP Guidelines if the requirement is by USFDA or EU regulatory agencies. Different kinds of research (epidemiological studies, post marketing surveillance, other pharmacovigilance studies, clinical trials, product development) have their own particular scientific requirements and specific ethical challenges. These can be addressed by incorporating changes like making pharmacovigilance reporting mandatory at all levels and introducing pharmacovigilance inspections. Intensive training should be given in all aspects of pharmacovigilance to various stake holders including the patients, efficient system of communication, creating a clinical trial database for SAEs and ADRs for signal detection and access to relevant data for various stakeholders. Thus it can help in proper implementation and compliance of the programme.

Biography:

Sergey Altarev has completed his PhD from Kemerovo State Medical Academy, Kemerovo, Russian Federation. He is now a senior staff researcher of Rehabilitation Laboratory in Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation, and works as a Subinvestigator in clinical trials in a field of cardiology. He has published more than 10 papers in reputed journals and had an opportunity to orally present his research in Russian and international conferences.

Abstract:

Aim: The aim of the study was to elaborate on motivational profile of doctors actively engaged in industry-sponsored clinical research. Methods: The study participants comprised clinicians of 4 hospitals from the different parts of Russia. The doctors were invited to complete a questionnaire comprising questions on the number of simultaneously managed clinical trial patients during the previous year and on what attracts them to take part in clinical research. Answers to the latter were summarized into 9 different motivational factors. We conducted a factor and a discriminant analyses to describe the relationship between motivation factors and doctors’ engagement in clinical trials. Results: The factor analysis allowed us to reduce the number of motivational factors to 4 groups of factors (Bartlett's Test’s of Sphericity p=0.038). The first one included having new responsibilities and liking the investigational process per se, the second financial aspect and being not independent, the third being able to travel and to communicate with people, and the fourth having scientific/professional interest and having an opportunity to help patients. Discriminant analysis was applied to describe the relationship between each of the 4 groups of factors and the number of simultaneously managed clinical trial patients during the previous year. The final model included only Factor 4 (Wilks' Lambda=0.806, p=0.002) with area under the curve of 0.712 (p=0.013). Conclusions: The analysis of doctors’ motivations to take part in clinical trials showed that only the desire to help patients and/or having professional/scientific interest in a trial could increase doctors’ engagement in clinical research.

Biography:

Irfan Bashir is working in The Islamia University of Bhawalpur, Pakistan. He is the Chairman of Foundation for Young Researchers and also Author & Chief Editor for Concise & Conceptual Series of Books.

Abstract:

Hypertension is a most common cardiovascular disease and a precursor to other major diseases like brain stroke, heart attack, kidney failure as well as myocardial infarction etc. Limited studies have been carried out to check the prevalence of hypertension among student community who are in striving phase of their life. So information about prevalence and risk factors for hypertension among student community is desirable. With a clinically validated sphygmomanometer and stethoscope, resting blood pressure values were measured in 400 respondents. The study population consisted of boys and girls of age 15 to 25 years, who participated in the survey conducted in various educational institutes. Survey was based upon various questions to evaluate dietary habits, obesity factor, routine blood pressure values, and socioeconomic status and personality factors. During the study period, there was an upward trend in B.P. among students community in the locality of Lahore, Pakistan. After adjustment for gender, age and weight status, the prevalence of pre-hypertension and hypertension was found to be 19%. Being overweight was strongly associated with pre-hypertension and hypertension in comparison with those having normal weight. A considerable rise in cases of hypertension in students can be attributed to their lifestyle, habits and attitude which usually affect them in the form of abnormally high weight and mental stress. Blood pressure can be kept under control by maintaining normal BMI, adapting a healthy lifestyle and having positive reaction to critical circumstances.

Biography:

Namrata Singh is an INSPIRE fellow of the DST (India). She is currently associated with CSIR-Indian Institute of Chemical Biology, Kolkata aiming for Ph.D. from the University of Calcutta. She is involved in characterizing an immune-stimulatory drug. She participated in the 7th HOPE meeting with Nobel Laureates as JSPSFellow in Japan, 2015. She is a recipient of several national awards and also been felicitated for excellence in academic background. Publication of 4 papers with good citations has initiated her research career and a reviewer of applied medical research.

Abstract:

An ether extract of nine different bacterial metabolites combined with two step (ether followed by ethanol) extract of bovine bile lipid is used as an immune stimulatory drug. While characterizing the drug, we observed fibrinolytic activity in the extract through fibrinogen plate assay and fibrin zymography.Background literature emphasized major role of fibrinolytic enzymes in activating immune systems. This increased our curiosity to understand the role of these enzymes in this drug in human physiology. This fibrinolytic enzyme/s has no similarity with plasmin in terms of cross reactivity in immunoblotassay and hydrolysis of the specific substrate S-2251. In RP-HPLC analysis, the lipid extract was fractionated into several components. Interestingly, fibrinolytic activity was confined to all the fractions. To purify the enzyme, it was extracted from the lipid by aqueous buffer extraction and applied to CNBr activated fibrinogen substrate affinity column. Purified enzyme was tested for activation of complement system and wound healing through C3 binding andin-vivo wound healing assay respectively. The enzyme will be identified by mass-spectrometric analysis. Also, we propose to finger-print protein components present in bile lipid by MS analysis to have a better insight of the functionality of the lipid component of the drug.

Biography:

Abstract:

Prostate cancer is the most common fatal cancers in men, and exposure to toxic elements is the most important factor in the aetiology for prostate cancer. Selected elements (Cd, Cr, Cu, Fe, Mn, Ni, Pb and Zn) were analyzed in the blood, scalp hair and nails of prostate cancer patients and counterpart healthy donors by atomic absorption spectrometry. Average concentrations of Cd, Mn, Ni and Pb were found to be significantly higher (p<0.05) in the blood, scalp hair and nails of the patients compared with those of the healthy subjects who exhibited significantly higher concentrations of Zn. The correlation study revealed significantly diverse relationships of the elements in the blood, scalp hair and nails of the two donor groups. Variations in the elemental concentrations were also noted for various types of prostate cancer (adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma and small cell carcinoma), as well as for different stages of the cancer. Multivariate apportionment of trace elements in the blood, scalp hair and nails of the patients was also significantly different than that in the healthy donors. The study evidenced considerably divergent variations in the elemental concentrations in prostate cancer patients in comparison with healthy subjects.

Biography:

Sravan Kumar Gunda completed Masters in Analytical chemistry at Teesside University. He started his career as a Pharmacist technician in 2012 and moved on to Product Market programmer by the end of 2012. He is a registered Pharmacist at Andhra Pradesh pharmacist council (India). He worked at Synowledge as Drug Safety Associate from Mar 2013 to Jul 2015. From Aug 2015, he started with Quintiles as Operational Specialist till the end of the 2015. Currently, he is working as Team lead at Jeevan Scientific technology from Feb 2016.

Abstract:

Pharmacovigilance plays a major impact on public health, reducing patients, increasing quality of life and decreasing risk factors of the drugs. Under current conditions the Adverse Drug Reactions (ADR) are reported less than 5 %, when compared to the occurrence of the ADR’s. According to many surveys conducted by NGOs, it was reported that about 95% of the health care professionals (HCP) are not interested to report any ADR’s due to lack of time & facilities, poor reporting systems, lack of proper laws, lack of knowledge on pharmacovigilance and its importance in public health and etc. In order to make reporting for more user friendly, quick and translucent, iCURE adverse event mobile application was developed and this application was live in android play store from 25, Nov 2015. This mobile application would really help the HCP’s for reporting ADR’s. Page 1: New complaint, verification of your compliant and suggestions to the company Page 2: Reporter Identification Page 3: Patient details Page 4: Drug information Page 5: Event description and document attachment When a user raises a complaint, it first reaches to the common mail box which is controlled by the application (iCURE) holder and from there it will be distributed to the individual company folders (like GSK, Pfizer, Ranbaxy etc. based on the product manufacture). This complaint will be then distributed to the concerned MAH or manufacturing company of the country where the drug was manufactured, along with a duplicate copy to the concerned health authority. Currently we had around 50 plus downloads and around 25 users who had registered in our application database. In future, this mobile interface will be contacted to eCRF (electronic case report form). By this, usage of paper form will be reduced, timelines for reporting and be met more efficiently.

Biography:

Priyanka Karolia obtained her M.Sc Degree in Environmental Chemistry in 2010. She has submitted her thesis to School of Studies in Chemistry, Jiwaji University, Gwalior at the age of 28 years. She is a recipient of Junior Resarch Fellowship from Department of Science and Technology, Govt. of India for excellent academic. She has published three papers in the journals of international repute. At present, she is involved in research and teaching.

Abstract:

Voltammetric sensor is an effective tool for pharmaceutical analysis due to its simplicity, specificity, sensitivity, fast, cost-effective and repetitive measurements. A highly sensitive and selective sensor is fabricated based on polyaniline modified glassy carbon electrode (PANI/GCE). It is demonstrated that this sensor can be used for determination of a pharmaceutically important compound tinidazole (TNZ) using square wave voltammetry (SWV), cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS). The electrode surface was characterized by scanning electron microscopy (SEM). The developed sensor also exhibited good reproducibility and long-term stability. Polyaniline nanofibers are expected to be promising material for sensing applications because of the ease of fabrication, excellent electrochemical performance, and high electroactive surface area.

Biography:

Vishnu Vardhan Reddy Beeram pursuing PhD from Vignan’s University at Vadlamudi, Guntur in Andhra Pradesh, India. He has Completed Master of pharmacy in Pharmaceutics from Rajiv Gandhi University of Health and Sciences at Bengaluru in Karnataka, India. He has published more than 10 papers in reputed scientific journals.

Abstract:

Inhalable anti Tubercular therapy is gaining interest in day to day research. Rifampicin PLGA nanoparticle was formulated in order to decrease the dose, adverse effects and to enhance the target-ability to desired organ. The aim of the current study is to select an optimized method for design of Rifampicin loaded PLGA Nanoparticles by altering the product and process variable in the formulation. Optimization of method was done by Box Behnken Design by investigating the effect of independent variables like polymers, surfactant and sonication time on dependent variables like particle size, entrapment efficiency, drug release profile and zeta potential etc. Based on the obtained results it has been concluded that the trial formulation RIFPG013 with their independent variable shows desired effect on dependent variable i.e. particle size 200nm, entrapment efficiency 80%, sustained drug release above minimum inhibitory level up to 48 hours and better zeta potential -32.3mV with Poly dispersibility index of 0.279, which shows good stability of nanospheres. Thus it was concluded that the emulsion solvent evaporation technique with 7.5% w/w of polymer, 2% w/w surfactant and 30min of sonication time was found to be a best technique for the formulation of Rifampicin loaded PLGA nanospheres.

Biography:

Abdul Hafeez has completed his M Pharm in Pharmaceutics from Teerthankar Mahaveer University, Moradabad and pursuing doctoral studies from Glocal Unversity, Saharanpur in Pharmaceutics department ,Glocal School of Pharmacy, a premier rising university. He has published more than 5 papers in reputed journals and has been serving as an editorial board member of repute.

Abstract:

The objective of the present study was to optimize Cefpodoxime proxetil microsphere in order to achieve an extended retention in the upper GIT which may result in enhanced absorption and thereby improved bioavailability. Cefpodoxime proxetil microspheres were prepared using hydroxy propyl methyl and ethyl cellulose in different ratios taking into account emulsion solvent diffusion method. The formulations were characterized for various physicochemical studies and in vitro drug release mechanism. The morphology of the particle was visualized using photoelectric microscope adjusted with micrometer tools and scanning electron microscopy (SEM). The particle size was found to be in the range of 228.80µm - 296.21µm, percentage yield between 65.92 - 79.20%, drug entrapment efficiency 50.91- 79.42% and buoyancy percentages 52.59- 64.69%, respectively. The maximum release was achieved in formulation composition HPMCK15M: Ethylcellulose in the ratio of 0.5:0.25:0.75 with release of 70.45% with diffusion mechanism. Finally, it could be concluded that the Cefpodoxime proxetil microsphere accentuates the floating efficiency of Cefpodoxime proxetil and could be used as a carrier for effective floating delivery.

Biography:

Hassan Saeiahan is the last semester student of animal biology (B.Sc.) in University of Tabriz. He is 20 years old and is the member of talented students of the University. He has several articles under review in reputed journals about diabetes and herbal treatment. He has attended several international congress such as 13 Iranian International congress of Toxicology, 6th International Conference of Cognitive Science.

Abstract:

Methotrexate (MTX) is an antineoplastic drug. Some of the best-known side effects of MTX are hepatotoxicity and kidney failure. Therefore, the current study was designed to investigate the probable therapeutic effects of Cornus mas fruit extract (CMFE) in MTX-induced acute toxicity in liver and kidney of rats. Male wistar rats were divided into six groups; Control, CMFE, MTX (single dose 20mg/kg) and three MTX (20mg/kg) + CMFE (300, 700, 1400mg/kg) groups. After termination of experimental days, liver and kidney tissue dissected to measure activity of some antioxidant enzymes such as superoxide dismutase (SOD), catalase (CAT) and lipid peroxidation (MDA) by spectrophotometer. The levels of Urea, Creatinine, Total- Direct and indirect bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), alkaline phosphatase (ALP), Lactate dehydrogenase (LDH) were measured in a biochemistry auto analyzer. The levels of Uric acid were measured enzymatically and the content of albumin in blood sample were measured by electrophoresis (ELCIA) method and the levels of Na/K were measured by Ion Selective electrode (ISE) method. This study revealed that administration of CMFE (700 and 1400mg/kg) significantly prevented MTX-induced alterations in these biochemical parameters, that is, AST, ALT, ALP, Direct bilirubin and LDH activity (P<0.05) and significantly prevented MTX-induced alterations in Serum concentration of Urea, Uric acid, Creatinine, K (P<0.05) and kidney and liver lipid peroxidation level was significantly decreased compared to MTX group (P<0.05). The present study indicated the nephroprotective and hepatoprotective effect of CMFE against methotrexate induced liver and kidney injury.

Biography:

Muhammad Majid Aziz has completed his Bachelor of pharmacy at the age of 22 years from Gomal University and Master studies from The Islamia University of Bhawal pur, Department of pharmacy. He is the PhD candidate at Xi'an Jiaotong University, a top ranked univeristy in P.R.China. He has published more than 6 papers in reputed journals and has been serving as pharma industry and academia in pakistan.

Abstract:

It had been reported that in many developing and under developed economically deprived countries most episodes of illness are treated by self-medication and is common practice due to quality concerns related to healthcare delivery systems. However, there are few studies in Pakistan which has explored the health seeking behavior, medicinal use and self medication in rural and urban areas. Our study aims to explore the public opinion about the control of self medication. Current study was conducted in Multan; Pakistan in March 2016.This was a qualitative study. The data from purposefully selected community was collected by in-depth interviews. The sample size was limited by applying the saturation criteria. All interviews were audio taped and transcribed verbatim. Inductive thematic content analysis was applied to analyze the data and draw conclusions. Out of the total 16 participants, 2 were female, and 5 were illiterate. Analysis of the data yielded 8 themes; Prevent the supply of medicines without prescription, Awareness and education regarding implications of self-medication, Enforcing strict rules regarding misleading pharmaceutical advertising, Working towards making health care facilities easily available, Availability of health care provider, Control toward rational diagnostic tests, Control of prescriber’s consultation fee, Control on laboratory fee for tests.

Biography:

S Poonguzhali is a post graduate student currently pursuing her M Phil (Pharmacy) at Taylor’s university lakeside campus, Malaysia. She has experienced in working in the management as well as working as a lecturer at a well-known university in Malaysia. She has also got the experience of developing “Diploma in pharmacy programme” at the Higher Education Institution.

Abstract:

The present study is aimed to prepare and evaluate the supersaturated self nanoemulsifying drug delivery (S-SNEDDS) system of a poorly water soluble drug dutasteride in order to achieve a better dissolution rate which would further help in enhancing oral bioavailability compared to the SNEDDS. The present research work describes SNEDDS and S-SNEDDS of dutasteride using Capryol PGMC, Cremophor EL, PEG400 and HPMC as precipitation inhibitors. The pseudo-ternary phase diagrams with presence and absence of drug were plotted to check for the emulsification range and also to evaluate the effect of dutaseride on the emulsification behavior of the phases. The mixtures consisting of oil (Capryol PGMC) with surfactant (Cremophor EL), co-surfactant (PEG 400) in 2:3 ratios were found to be optimum formulations. HPMC 0.5 mg was added in the S-SNEDDS preparation along with the above mentioned oil, surfactants and co-surfactants. Prepared formulations were evaluated for its particle size distribution, nanoemulsifying properties, robustness to dilution, self-emulsification time, drug content and in-vitro dissolution. The optimized formulations were further evaluated for heating cooling cycle, centrifugation studies, freeze thaw cycling, particle size distribution and zeta potential were carried out to confirm the stability of the formed S-SNEDDS formulations. The prepared S-SNEDDS formulation revealed some excellent physicochemical characteristics such as mean particle size of <100 nm and percentage of drug dissolved within 5 min, >90% in dissolution media of pH 1.2 and 6.8. The preliminary results from our study suggest that the dutasteride-loaded self-nanoemulsifying formulation shown a significant improvement in terms of the drug dissolution as compared with raw drug. Thus, this greater dissolution of dutasteride from formulations could lead to higher absorption and higher oral bioavailability in clinical application.