Day 1 :
Keynote Forum
Akwete Lex Adjei
Rhodes Pharmaceuticals L.P., USA
Keynote: Steady-state bioavailability of extended-rel ease Methylphenidate capsule vs. immediate-release Methylphenidate tablets in health y adult volunteers
Time : 10:20 - 10:50
Biography:
Akwete (Lex) Adjei, PhD has a wealth of experience in drug design and drug delivery technology. After receiving his PhD from the University of Texas, Austin, Lex did his postgraduate work on complexation of xanthine drugs in non-ideal sovent systems. Lex has held positions at several pharmaceutical companies and currently is Executive Director of R&D at Rhodes Pharmaceuticals, L.P. He has been the author/co-author of 38 published peer-reviewed articles and 15 books or book chapters and he has almost 50 patents for his work in this area. He is an experienced presenter with more than 25 presentations by special invite.
Abstract:
A novel formulation of extended-release (ER) methylphenidate hydrochloride that utlizes multiple layers of coatings on microbeads for encapsulation into hard gelatin capsule shells (Aptensio™, MPH-MLR) was evaluated to determne the relative bioavailability vs. immediate-release methylphenidate tablets (IR, Ritalin®) as single and multiple doses in the fed state. A single-center, 4-day, multiple-dose, randomized, open-label, 2-period crossover study design assessed the relative bioavailability of MPH-MLR 80 mg once daily versus Ritalin® IR 25 mg 3 times daily (TID) in 26 healthy adults. Serial blood samples were collected at pre-specified time points over the 4-day dosing period for determination of methylphenidate concentration and pharmacokinetic analyses. Relative bioavailability of MPH-MLR versus Ritalin (75 mg total daily dose normalized to a single dose of MPH-MLR) as a single dose under fed conditions, and at steady state under fed conditions, was determined based on AUC0-t, AUC0-inf and Cmax of methylphenidate. MPH-MLR administration produced a rapid initial peak, a moderate decline until ~5 hours postdose, and a gradual increase until ~7 hours postdose. Cmax was lower for MPH-MLR 80 mg than methylphenidate IR 25 mg on Day 1. Exposure was similar with 90% CI limits for the geometric mean ratios of log-transformed AUC0-t that were within the 80%-125% equivalence range. Day 4 partial AUC0-4 (74.49±15.23) for MPH-MLR exceeded Ritalin IR 25 mg 3 times daily (66.01±17.41), and therefore was not bioequivalent. MPH-MLR capsules administered once daily or methylphenidate IR administered TID provides comparable maximum methylphenidate concentrations and systemic exposure in the fed state.
- Track 6: Pharmacovigilance & Risk Management
Track 11: Challenges in Pharmacovigilance
Track 13: Pharmacovigilance Market
Track 20: Growth Strategies in Pharma
Session Introduction
Madeeha Malik
Hamdard University, Pakistan
Title: Role of pharmacist in ADR reporting in Pakistan: A myth or reality?
Time : 13:50-14:15
Biography:
Madeeha Malik has completed her PhD in 2013 from University Sains, Malaysia and her Post-doc in 2015, in Pharmacy Practice from North West University, South Africa. She is currently serving as Director and coordinator for MPhil Pharmacy Practice at Faculty of Pharmacy, Hamdard University Islamabad, Pakistan. She is also serving as an appointed MPhil and PhD supervisor for Higher Education Commission of Pakistan. She has published more than 50 papers in reputed journals and serving as an Editorial Board Member of repute.
Abstract:
A cross-sectional study design was used to explore the perceptions’ and attitudes of pharmacists regarding ADR reporting in Pakistan. The study was approved by ethical committee of Hamdard University and Ministry of Health, Pakistan. A validated semi-structured questionnaire was used to collect data. Data was cleaned, coded and analyzed using SPSS vs. 16.
Nermine El-Maraghy
Suez Canal University, Egypt
Title: Pattern of hospital-acquired pneumonia in intensive care unit of Suez Canal University Hospital
Time : 14:15-14:40
Biography:
Nermine El-Maraghy is Associate Professor of Medical Microbiology & Immunology. She completed Master’s degree and PhD in Medical Microbiology & Immunology from Facuulty of Medicine Suez Canal University, Ismailia, Egypt. She is a member of tumor oncology unit, clinical epidemiology units at Faculty of Medicine Suez Canal University. She had great experience in the era of clinical immunology, allergy skin prick test, immunotherapy, diagnostic microbiology and infection control. She has several international publications on PubMed and Google Scholar. She is the reviewer of the Infectious & Non-Infectious Diseases (online), Suez Canal University Medical Journal and Eastern Mediterranean Health Journal (online).
Abstract:
Hospital acquired pneumonia occurs more than 48 h after hospital admission and was not present at the time of admission, while ventilator associated pneumonia occurs after 48–72 h of endotracheal intubation or within 48 h of extubation.HAP is the second most common nosocomial infection and accounts for approximately 25% of all infections in the Intensive Care Unit worldwide.
Hayam Ateyya
Cairo University, Egypt
Title: Amelioration of Cyclosporine Induced Nephrotoxicity by Dipeptidylpeptidase Inhibitior Vildagliptin
Time : 14:40-15:05
Biography:
Hayam Ateyya has completed her MBBch degree in Medicine & Surgery from Cairo University, Faculty of Medicine and MD Degree in Pharmacology from Cairo University, Faculty of Medicine. She is working now as Assistant Professor at Taibah University in KSA.
Abstract:
Cyclosporine A (CsA) is an immunosuppressive drug used in organ transplantation and autoimmune diseases but its clinical uses may be limited due to its dose-related nephrotoxicity. This study was carried out to evaluate the possible protective effects of vildagliptin (VLD) against CsA-induced nephrotoxicity in rats. Animals were divided into four groups treated as follows: control group (CsA & VLD vehicle); VLD group (10 mg/kg/day, orally); CsA group (20 mg/kg in sunflower oil, S.C.); and CsA-VLD group (CsA &VLD). Induced nephrotoxicity was evidenced by a significant elevation of serum creatinine, blood urea nitrogen (BUN), lactate dehydrogenase (LDH) and urinary micro total proteins (MTP), while serum albumin and urinary creatinine clearance were significantly decreased compared to control group. Moreover, renal dysfunction was further confirmed by a significant increase in renal lipid peroxide that was measured as renal malondialdehyde (MDA). Renal reduced glutathione (GSH) and superoxide dismutase (SOD) were significantly decreased. Nephrotoxicity was further confirmed by renal tissues histopathology. Also, a high protein expression of Bax with decreased Bcl-2 was revealed in renal tissue of CsA treated group. Administration of VLD significantly ameliorated the nephrotoxic effects of CsA suggesting antioxidant, anti-inflammatory and anti-apoptotic benefits of VLD in CsAinduced nephrotoxicity.
Khaudeja Bano
AbbVie Inc , Chicago, IL – USA
Title: Combination Products – The Paradigm Shift
Time : 15:05-15:30
Biography:
Khaudeja is a Physician with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, an Oracle DBA, and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and certified coach. Khaudeja has more than 25 years professional experience, including clinical practice. She has held several global safety positions at Abbott Vascular, Abbott Diagnostics, Abbott Established Pharma Division and now AbbVie Inc. Her career in safety includes global leadership roles in devices, diagnostics, pharmaceuticals and combination products.
Abstract:
Combination products present a unique challenge globally for industry and the regulators regardless if you consider pharmaceuticals or biologics, devices or diagnostics. As the US and Japan have expressed their views in the form of draft guidance and regulations, organizations are working towards a streamlined process that best meets their needs. Combination products present challenges that need to be evaluated to better prepare for the future and to demonstrate an organization’s compliance. Let us consider how to develop integrated cGMP and Regulatory Strategies for combination products. With two or more components; two Quality Systems; two or more databases; one or more Postmarketing Safety Report(s) what Is an Organization to do? How does the organization set up the right culture? Some best practices to consider. Risk based safety assessments may be a solution.
- Track 1: Drug Safety
Track 2: Adverse Drug Reactions
Track 3: Pharmacovigilance Significance & Scope
Track 15: Case Report in Clinical Trials
Session Introduction
Ehab Darwish
TopLab, Egypt
Title: A preliminary report of successful cleavage after calcium ionophore activation at ICSI in cases with previous arrest at the pronuclear stage
Time : 17:05-17:30
Biography:
Ehab Darwish founded TopLab co. For IVF (In vitro fertilization) labs consultations in 2014. He did many researches in ART (Assisted reproductive techniques). He got his Master’s degree in Health Care Management in 2013, after his Post-graduate studies from University of Bristol, United Kingdom in 2009. He is a medical school graduate, Ain Shams University, Egypt. He is running many IVF labs in Egypt and UAE. His consultations company is running national and international training courses for ART techniques. His years of expereinces gave him the ability to set up labs., and improve others’ performances through his company’s services.
Abstract:
Artificial oocyte activation (AOA) has been previously suggested as a means to overcome the problem of total fertilization failure, which affects about 1–3% of the intracytoplasmic sperm injection (ICSI) cycles. A preliminary study on the application of chemical AOA was conducted using A23187 Ca2+ ionophore to improve embryonic development in four women with a history of complete fertilization arrest and inability to transit to cleavage stage during previous ICSI trials. Data indicated that activated oocytes resulted in better fertilization, embryonic development and clinical pregnancy in one of the four couples. Therefore, ICSI combined with AOA using Ca2+ ionophore may be useful in selected patients with cleavage failure, and may help the zygotes to reach more advanced developmental stages. I have to say that this is a novel usage to Ca2+ ionophore in treating embryo cleavage block
Sangameshwar Mahangaonkar
IMS Health, Dubai, United Arab Emirates
Title: Drug safety assessment using Dubai Real World Claims Database (DRWD)
Time : 17:30-17:55
Biography:
With over 16 years of experience spanning clinical practice, medical education, public health research and pharmaceutical consulting, Sangameshwar currently leads the practice of Real World Evidence Solutions at IMS Health based in Dubai. At IMS Health, in addition to outcomes research, his work interests include post-authorization safety and effectiveness studies. A trained physician with specialization in epidemiology and public health, Sangameshwar obtained his MBBS from Bangalore Univesrity, his MD in public health. He is also an adjunt professor of Public Health in the Department of Community Medicine at PES Institute of Medical Sciences & Research, Kuppam, India.
Abstract:
The large databases of health insurance claims often contain information on potential adverse events (AE). If investigated further, this information could complement other methods of drug safety assessments. The Dubai Real World Claims Database (DRWD) is an anonymized longitudinal patient level database of all insurance claims generated from private healthcare sector in the Emirate of Dubai. Covering over 1.9 million lives, the DRWD currently represents about 15% of the total UAE national population and is available since January 2014. Major data fields available are: patient demographics, physician specialty, provider, details of prescriptions, clinical diagnosis (ICD10), few lab test results, procedures and hospitalizations, which ultimately generate an insurance claim. DRWD is a rich source of healthcare data in UAE that may be valuable for epidemiological and outcomes research. We are conducting a retrospective observational study to evaluate the suitability of using the DRWD adverse event reporting. We have considered all categories of lipid-modifying drugs for this exercise, given that these drugs are amongst the 5 most prescribed drugs in the United Arab Emirates. We are thereby confident of securing a robust sample of patient records with lipid modifying therapy. Those patient records currently existing within the database, aged 18 years or above and receiving 2 or more prescriptions for lipidmodifying drugs between January 1, 2014 and September 30, 2015 will be included in the study. Hospitalizations with diagnosis codes (ICD-10) related to common and known adverse drug reactions of lipid modifying therapy such as muscle, kidney, and liver affections will be determined for patients receiving statins, fibrates, cholesterol absorption inhibitors, or combination therapy. The key criteria to be considered for suitability of DRWD for this exercise, would be two fold. First would be an attribute of the DRWD itself – the availability of actual data on the four elements of adverse event reporting – suspected drug, actual adverse event, identifiable patient and an identifiable physician. The second criterion is the consistency of findings from DRWD with reported rate of adverse events in real world clinical practice. The latter will be confirmed through a survey among clinical experts.
Biography:
Samira Saleh, PhD, Cairo University and Post-doctoral studies from Strathclyde University, UK, is currently the Head of the Department of Pharmacology, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University. She is a Board member of The Egyptian Society of Pharmacology and Experimental Therapeutics and the Editor-in-Chief of the Egyptian Journal of Basic and Clinical Pharmacology. She makes evaluation of Science and Technology Development Fund (STDF) projects. She has published around 85 papers, supervised more than 50 thesis and gave presentations at more than 60 conferences. She received many awards from the Supreme Council of universities for publishing papers in international journals.
Abstract:
In the 1960’s, the thalidomide disaster led to limb deformities in the newborns of those mothers who took the drug while pregnant. This implies that premarketing evaluation of drug safety, in animal experiments and in phase 1-3 clinical trials, provides insufficient evidence of safety. Accordingly, it is vital to monitor safety of all medicines throughout their marketed life because adverse drug reaction-related cost to the country may exceed the cost of the medications themselves. The study of ADRs is the concern of the field of pharmacovigilance which is gaining importance as the number of stories of drug recalls increases. The WHO international drug monitoring program started in 1968; it is located in Uppsala, Sweden. In Egypt, the Egyptian PV Centre was established in 2009 and is linked to the global PV system. The program is based on voluntary ADR reporting and monitoring and is vital for maintaining drug safety. Voluntary reporting by physicians and other health providers and consumers may alert the authorities and pharmaceutical companies to possible adverse effects of drugs. It aims in reducing the risks associated with drug prescribing and administration and improving patient care, safety and treatment outcome. The Yellow Card Scheme was founded in 1964 after the thalidomide disaster. It receives more than 20,000 reports of possible side effects each year. To conclude, pharmacovigilance is a dynamic clinical and scientific discipline. It provides reliable, balanced information for the effective assessment of the risk/benefit profile of medicines. Under-reporting remains the corner stone that hinders pharmacovigilance activities.