Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 11th International Conference on Pharmacoepidemiology and Clinical Research Kuala Lumpur , Malaysia.

Day 1 :

Keynote Forum

Abraham G. Hartzema

University of Florida, USA

Keynote: Strenghtening the Clinical Evidence provided by Observational Studies

Time : 10:15-11:15

Conference Series Pharmacoepidemiology Congress 2017 International Conference Keynote Speaker Abraham G. Hartzema photo
Biography:

Abraham G Hartzema is a Professor and Eminent Scholar at the University of Florida in the Department of Pharmaceutical Outcomes & Policy. He is the Perry A Foote Chair in Health Outcomes Research and a Professor of Epidemiology and Biostatistics in the College of Public Health and the College of Medicine. In the year 2007, he was awarded the University of Florida Foundation Research award. He has widely published on various aspects of prescription drug safety, including several books on pharmacoepidemiology. He has served on the scientific board of the FIP from 1988-1996 and on Editorial Boards, including Medical Care, Annals of Pharmacotherapy, Clinical Therapeutics, the International Journal of Pharmacy Practice, Pulmonary Circulation and others. He has been the Chair of Data Safety and Monitoring Boards for several RTCs at the University of Florida. He has also served on the University of Florida Graduate Council and Grant Review Panels for AHRQ, FDA, HealthCanada, DSEN, NASA, NIH and NIHBL. He currently serves on the United States Pharmacopeia: Nomenclature, Safety and Labeling Expert Committee. He was recently appointed as a Senior Advisor to the FDA, Center for Devices and Radiological Health.

Abstract:

Why is the clinical evidence from observational studies in the literature often conflicting and delayed? We will address the efforts undertaken in the US FDA to provide more recent evidence on the safety of newly marketed drugs as mandated by US Congress. The Sentinel system is a distributed data system that allow for the time analysis of emerging drug safety questions. The automation of the safety queries and the large population covered (120 male patients), allows for the timely analysis and provide the statistical power to address safety question in the early uptake of drugs in the marketplace. The second important question is the often conflicting evidence presented in the literature. What is the source of this conflicting evidence? Our group has conducted significant research in the influence of biases, confounding and the interaction of statistical methods and structure and quality of data on the clinical evidence presented. Running statistical methods, including high dimensional propensity scores on 12 different databases we found that self-controlled designs, those observational designs in which the patient serves as its own control are the most powerful designs as these provide the opportunity to control for fixed confounders. These methods do not control for variable confounders and are most suitable when the outcomes follow immediately after drug exposure. Other issues considered are case identification in large databases and formulating search algorithm that have high PPVs to make sure that cases are indeed attributable to the exposure. Recent proposed methods include sensitivity analysis to test the robustness of the clinical evidence identified. Adherence to these practices will assure that the clinical evidence presented is valid and can be incorporated in practice guidelines

Keynote Forum

Swamy KB

Lincoln University College, Malayisa

Keynote: The latest trends of IQ and brain size and effects of life style and environmental factors on cranial capacity

Time : 11:35-12:35

Conference Series Pharmacoepidemiology Congress 2017 International Conference Keynote Speaker Swamy KB photo
Biography:

Swamy K B has been awarded PhD by Andhra University,  his Master’s Degree MS (in Clinical Anatomy) from Andhra Medical College, D M C h (Maternal & Child Health) from IGNOU, New Delhi, his Medical Degree (MBBS) in 1976, from SV University, India. He has expertise in multi medical disciplines, Human Genetics, Reproductive Health & Developmental Anatomy and in Herbal Medicine. He has been the genetic counsellor for many Medical institutions. He possess prestigious grants FRGS,URGS from Malaysia, he has conducted  researches on Herbal Medicine and Diabetes, “Brain size and Intelligence Quotient (IQ)”, He has been the former founder Anatomist, Professor and Head for many Medical Schools in India as well as in Malaysia. He is an International Editorial Board Member for many reputed journals like Anatomical Society of India (ASI). Recently he has been unanimously elected as an Executive Board Member for ASI .

Abstract:

Intelligence quotient (IQ) is widely used to assess different aspects of mental ability. Development in mental ability initiates from conception and continues through adulthood. Various environmental factors affect IQ. The aim of this study was to assess the correlation between IQ and environmental characteristics on cranial capacity in children and adolescents in Malaysia. This cross sectional study was performed on primary and secondary school students in Kuala Terengganu, Malaysia. Students, who were aged between 6 to 16 years and did not have any mental or physical disabilities, participated in this study. Measurements including weight, height, body mass index and cephalometry were performed for each subject. The Wechsler Abbreviated Scale for Intelligence- Second Edition (WASI-II) questionnaire was used for each subject to evaluate the subtests of IQ. A total of 419 subjects with the mean age of 12.51 ± 2.82 years had participated in this study.  Boys were taller (p=0.04), had higher IQ (p=0.01) and cranial capacity (p<0.001) as well as block design score (p=0.02) when compared with girls. There was a significant mean effect for age (p=0.03), gender (p=0.04), paternal education (p=0.04), family income and block design (p=0.03) on cranial capacity. This study revealed different patterns of brain growth, function and IQ amongst male and female subjects as well as defining the environmental factors that can affect cranial capacity and that the IQ and cranial capacity may be improved by tuning up the lifestyles and economic conditions of the families in developing countries.  (It is an original research conducted in Malaysia)

 

  • Pharmacokinetics and Pharmacodynamics | Pharmacoepidemiology and Clinical Research | Clinical Pharmacology and Therapeutics | Pre-Clinical and Clinical Trials |Case Reports in Clinical Trials | Clinical Drug Development
Location: Bilik seraya
Speaker

Chair

Swamy KB

Lincoln University College, Malayisa

Session Introduction

Surendra Lalwani

Metro College of Health Sciences & Research, India

Title: Photodynamic Therapy: An emerging treatment modality for melanoma

Time : 12:35-13:00

Speaker
Biography:

Surendra Lalwani has completed his PhD, MPharm, BPharm and PGDMM from Dr. H. S. Gour Central University, India. He has more than 18 years of teaching and research experience with keen interest and expertise of research in photodynamic therapy. He is presently working as Principal, Metro College of Health Sciences and Research, Metro College of Pharmacy, India. He is the Member of Indian Association for Cancer Research, The Association of Pharmaceutical Teachers of India, Indian Science Congress Association, Indian Chemistry Teachers Association and International Society for Infectious Disease. He is also an Editorial Board Member of Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry.

Abstract:

Cancer is known to occur in all societies and in all parts of the world. It affects animals as well as humans. However, the types of cancer most prevalent in a community will vary with the age, sex distribution and race of people in the community, as well as the geographical situation, the economic and environmental situation and habits of the people including their diets. In developed countries, cancer is responsible for about 25-30% of deaths. Skin cancer is one of the most widespread tumors. However, despite the progress achieved in all clinical diagnostic techniques, the most severe of different tumors is cutaneous melanoma, whose frequency continues to climb. Photodynamic therapy (PDT) is a modality of cancer treatment based on light-induced killing of cells after administration of a photosensitizer. It gives good cure rates for superficial skin tumors. The results of PDT in the treatment of hyper-proliferative diseases, especially in the skin are most encouraging and have the potential of becoming the treatment of choice. Porphyrins are powerful photodynamic agents that render cells vulnerable to light. Hematoporphyrin (Hp) is one of the most widely used PSs in PDT of tumors. It is widely reported in literature that the hematoporphyrin (Hp) accumulate preferentially in tumor tissues. The Hp has cytotoxic and antitumor actions which is light and oxygen dependent. Four to six weeks old female BALB/c mice (20-25 g) was used for implanting B16F10 melanoma tumor model. Melanoma cell line (B16F10) was maintained by serial transplantation in female BALB/c mice. The cells were subcutaneously injected (50 μL, 0.5×106 cells per mice) in the previously shaved right flank of female BALB/c mice under general anesthesia (ketamine hydrochloride i.p., 80 mg/kg). After 10-15 days, the mice developed black tumor having around 100±10 mm3 of volume. The tissue homogenates and supernatants from tumor-bearing mouse were prepared and the cell viability was checked by trypan blue exclusion test using trypan blue stain. Approximately 100 cells were counted at various fields in hemocytometer for each experiment. Melanoma cells (1×106) were suspended in PBS (50 μL) and injected subcutaneously into previously shaved right flank of adult female BALB/c mice (4-6 weeks old), through a gauge no.18 needle under general anesthesia (ketamine hydrochloride i.p., 80 mg/kg). Tumor cells were injected in healthy mice in the laminar air flow bench. After 10-15 days, the mice developed black tumors having around 100±10 mm3 of volume. After development of tumor, mice were randomly sorted into different groups: The group-1 which served as control group having no tumor and received vehicle (5 mL/kg), Group-2 also received vehicle (5 mL/kg), Group-3 received PDT (630±10 nm), Group-4 received Hp in dark, and Group-5 received Hp along with PDT. Each mouse was placed underneath an aperture that controlled the area of light illumination on the tumor site. Each mouse was received a total dose of 150 J/cm2. Individual tumor volumes were measured and effectiveness of the treatment was compared among the groups on alternate day. It may be concluded that after PDT treatment, a remarkable damage of tumor vasculature and secondary necrosis of tumor tissue was observed along with a significant inhibition of tumor growth in presence of photodynamic treatment. It indicates that Hp has more efficacies the presence of PDT.

Biography:

Nusrat Shafiq is currently working as an Additional Professor at Department of Pharmacology, Postgraduate Institute of Medical Education and Research, India.

Abstract:

Conducting clinical trials in developing countries is associated with several challenges which are not limited to constraints of resources. The process of informed consent, reporting of adverse events and quality of data generated are often circumspect. Though several clinical trials sponsored by multinational pharmaceutical companies are being undertaken in these countries, the procedures followed with regards to above mentioned aspects of clinical research are found lagging in several instances. It is a common belief that a relatively uneducated population particularly those in lower income groups, the informed consent process was not adequately administered. We developed informed consent comprehension forms and evaluated the comprehension of participants in an exploratory first in human study and a confirmatory phase-3 study. We identified the informed consent comprehension tool very useful in addressing specific doubts of potential participants. Further, we identified factors which were associated with a low comprehension score. Reporting of adverse events, serious adverse events have been subject to a lot of debate. Regulations regarding reporting of serious events and compensation were laid down. In order to meet these requirements mechanisms were set up by sites for meeting the needs of timely reporting. The current presentation would like to share the lessons learnt and way forward. Trials sponsored by pharmaceutical companies are often monitored by a monitor appointed by the sponsor or the contract research organization. It is now required of ethics committees in India to undertake onsite monitoring of clinical trials. The mechanism initiated to meet this regulatory requirement has proven to be very useful. It was interestingly noted that the focus of regulator’s monitors on documentation to meet the requirements of GCP, took the attention away from clinical and ethical aspects with regards to patient’s well-being. An additional monitoring mechanism could be helpful in working towards ensuring participant’s well-being and his/her rights. In conclusion, with the new awakening with regards to ethics of clinical trials, sites in developing country would need to initiate endeavors such as above to reinstill the confidence in clinical trials conducted there.

 

 

Afreen Banu

Lincoln University College , Malaysia

Title: Green synthesis of monodispersed silver nanoparticles and its applications

Time : 14:25-14:50

Speaker
Biography:

Afreen Banu is currently working as an lecturer at Department of Pharmacology, at Lincoln University College , Malaysia . Research interest includes: pharmacology, medicine, nanotechnology.

Abstract:

This topic focuses on the production of silver nanoparticles and its antimicrobial activity. Research in nanotechnology highlights the possibility of green chemistry pathways to produce technologically important nanomaterial. Synthesis and characterization of newly synthesized nanoparticles was made by UV–visible absorption spectroscopy, scanning electron microscope (SEM), transmission electron microscope (TEM), Fourier transform infrared (FTIR) spectroscopy and atomic force microscope (AFM). The  extracellular  synthesis  of  nanoparticles  and  its  efficacy against  multidrug  resistant  (MDR)  strains  isolatedfromburntcasesfromhospitals at Gulbarga region, Karnataka, India is reported here. Two MDRstrains ofPseudomonas aeruginosa (P1and P2) from burnt patients were selected for the antibacterial study with nanopartilces. The anticancer activity of the synthesized compound was carried out on two cancer cell lines namely HT-29 (colon cancer) and EAC cell lines which were obtained from National Center for Cell Science (NCCS), Pune, India.The biosynthesized silver nanoparticles (AgNPs) showed excellent antibacterial activity against ESBL-strains. The silver nanoparticles (AgNPs) from Rhizopus stolonifer showed excellent anti-cancer activity against HT-29 (colon cancer) and EAC cancer cell lines. The Nanosilver also showed potent activity against pathogenic fungi and an excellent anti-cancer activity against HT-29 (colon cancer) and EAC cancer cell lines.The development of nanosilver and their use in wide array of applications such as antibacterial, antifungal, anti-cancer, on living organisms has recently attracted the attention of researchers towards nanobiotechnology.

Speaker
Biography:

Mansour Tobaiqy is an Assistant Professor of Clinical Pharmacology in the Faculty of Medicine, University of Jeddah, KSA. He is also the General Supervisor of the Human Resources Development Centre in the same university and he has completed his PhD in Medicine and Therapeutics from the School of Medicine, University of Aberdeen, UK. He is also a Visiting Professor at RGU, UK. He has done several researches on the safety medicines in children and pharmacovigilance in general

Abstract:

Fever in children is the most common symptoms managed by health care professionals. Fever concerns the parents to an extent that even a minimal rise in temperature prompts them to administer antipyretics to their children that if not used optimally can lead to adverse drug reactions (ADRs).To determine whether in retrospect, parents had witnessed any ADRs related to use of antipyretics and analgesics in their children and to assess parents’ experiences toward antipyretics and analgesics use.A cross-sectional survey was conducted in four specialized and tertiary hospitals in Jeddah City, Kingdom of Saudi Arabia. A questionnaire was issued to all the parents who had signed the consent and agreed to take part in the study anonymously.661 parents provided information on the occurrence of ADRs in their children, 31.5% of children had experienced ADRs, loss of appetite (23%) and stomach ache (20.3%) were the most commonly reported symptoms, from all ADRs reported. 71.8% parents described them as slight, however 18% agreed that these symptoms were annoying, 6.7% of children had experienced significant symptoms, 16.6% had stopped taking the medication and 26.3% went to the hospital. 40% of parents believed that the medication used has caused these adverse symptoms and in their opinion Paracetamol (Acetaminophen) was responsible for these ADRs, 26.5% of parents obtained these medications without prescription, 14% consulted family and friends before using the medications.One-third of parents believe that analgesics and antipyretics caused ADRs in their children, although the majority of ADRs were mild, however a significant number of harmful ADRs were occurred. This study adds further weight to the call for increase awareness of parents for safe and optimal use of antipyretics and analgesics in children.

 

 

 

 

 

Speaker
Biography:

Dr Sahar Hassain Khan is pursuing her Phd at Lincoln College University, Malaysia. Her area of research includes pharmacology, clinical research, medicine.

Abstract:

Health of a mother and newborn depends not only on the health care received during pregnancy and Intra partum but also during postpartum period.A cross-sectional study was conducted on Gadaba and Konda Dora Tribal populations at random from 95 tribal villages in Vizianagaram district, Andhra Pradesh.Data were collected from 300 lactating women from each Tribe who were Aged between 15-45 years through in-depth and face to face interview method.Nearly one fifth (18.0%-20.0%) of the present Tribal women reported that the Umbilical cord was cut after the delivery of the placenta, and majority of the respondents were not sure/unaware of the time of removing the umbilical cord. Most of the Gadaba (80.3%) and Konda Dora (82.3%) Tribes used the new shaving blade to cut the umbilical cord. After cutting the Umbilical cord, new thread was tied to the stump to arrest the blood flow in 80.3% of Gadaba and 83.0% of Konda Dora newborns. About 96.0% of Gadaba and 95.3% of Konda Dora newborns were applied with variety of oils or ash of vegetative origins and also used different powders to the wound for healing.Some of the present study Tribal women have adopted certain unhygienic Practices in cutting the umbilical cord with unsterilized unsafe instruments, tying the wound with available material and also applying the cord stump with different substances which are considered as unhealthy practices.

 

Biography:

Dr. Sunil Shrestha is a Researcher-Academician-entrepreneur-social worker from the beautiful city Kathmandu of Nepal which is located landlocked between India and China. He is the founding member and works in capacity of Founder President and Research Director at Nepal Health Research and Innovation Foundation (NHRIF), an NGO Located at Kathmandu, Nepal. He earned his Bachelor in Pharmacy Degree (2012) from Asian College for Advanced Studies which isaffiliated to Purbanchal University, Nepal. He is Registered Pharmacist of Nepal Pharmacy Council (NPC). After bachelor he received his Doctor of Pharmacy, Pharm.D (Post Baccalaureate) from Kathmandu University (2015). He is working in pharmaceutical sector, he is social activist working against Domestic violence in Nepal. He had done many photo exhibitions on domestic violence on major cities of Nepal like Kathmandu, Lalitpur, Birgunj etc. and other group exhibitions. He is also Honoree member of Biotechnology Society of Nepal.He is also Editorial Board Member at Medplus International Journals and Editorial Board Member at International Journal of Pharmacovigilance

 

Abstract:

Adverse Drug Reactions (ADRs) are inevitable risk factors associated with the use of anticancer drugs. A great emphasis is needed for their detection, assessment, monitoring, reporting and prevention. A prospective cohort study was carried out at oncological ward of three different hospitals in Kathmandu, Nepal with objectives to study the incidence and pattern of ADRs; and to assess the causality, severity and preventability using different types of scales like Naranjo Algorithm, modified Hartwig and Siegel and modified Shumock and Thornton scale. Females and age greater than 60 years were found to have the risk factors for getting ADRs. Alkylating agents were responsible for the ADRs in 32.51% followed by antimetabolites (29.62%). Carboplatin was responsible for 14.40% of the ADRs followed by gemcitabine (13.58%) and fluorouracil (13.16%). Paclitaxel, Docetaxel, Cisplastin and Doxorubicin were found to be other drugs identified for causing ADRs. Anemia (42.6%) was the most commonly encountered ADRs followed by fever, neutropenia. ADRs of the suspected drug continued in 36.9%, stopped in 21.3%, discontinued in 16.4%, dose reduced in 13.9% and drug changed in 11.5%. Most of the reactions were probable (66%) in causality, moderate (72.4%) in severity and probably preventable (52.2%) in nature. ADRs increased cost of illness due to added therapy for management of ADRS, clinical investigations and prolongation of hospital stay. ADRs are still of a great problem in cancer patient care. All involved in management of a cancer person have to play a great role in detection, monitoring and prevention of ADR to provide the better pharmaceutical care to patients.