Day 1 :
Keynote Forum
Nipom Deka
Amgen Holdings Inc., China
Keynote: Biologics versus biosimilars: Are they similar molecules? Do they share similar drug safety profile?
Time : 10:15-11:15
Biography:
Nipom Deka is a Physician with 7 years of valuable experience in various Departments of Medicine, Surgery, Accident & Emergency and Orthopedics in India & abroad. In 2007, he started his career in Pharmaceutical Industry as a Clinical Investigator for a Phase II trial. Eventually, he moved into Pharmacovigilance joining as a Pharmacovigilance Physician. Over a period of time, he had the opportunity to lead and manage teams of Medical Reviewers & Drug Safety Associates (DSA). Besides working on streamlining & process improvement initiatives, he was actively involved in delivering training on Pharmacovigilance to DSA’s & Physicians in various Organizations, he has been associated with. He was also involved in setting up of Pharmacovigilance units in various country offices in Asia, Africa & Middle East for multiple pharmaceutical companies. Having worked in Pharmacovigilance for more than 10 years, he has gained experience in areas including signal detection, benefit-risk assessment, risk management plan and various process improvement initiatives. In his current role in Amgen, he is providing leadership to the Pharmacovigilance teams in various affiliate offices in Asia Pacific region. As a member of Strategic Leadership Team, he contributes to develop and maintain compliant safety systems working closely with cross functions.
Abstract:
Biologics are medicines made from living cells through highly complex manufacturing processes. Biologics are important treatments for a number of cancers or chronic diseases. Biosimilars are highly similar to an already approved biologic molecule with differences (may be minor) in clinically inactive components. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. Although comparative studies are needed to generate substantive evidence in terms of quality, safety and efficacy, stringent pharmacovigilance procedures are required to detect potential differences in safety signals between biosimilars and their reference products. Unlike small molecule generics, a biosimilar approval requires clinical studies to ensure that small manufacturing changes have not altered the therapeutic efficacy of the biological drug. Post-marketing pharmacovigilance becomes even more critical in case of biosimilars as there is limited information available regarding them. Additionally, the effect of such biosimilars on diverse patient populations with respect to the dosage and duration of therapy needs to be closely monitored. Due to these reasons, biosimilars are required to undergo same pharmacovigilance regulations as its reference product. In my presentation, I would like to present before the audience the risks that the biosimilars could potentially bring in terms of immunogenicity and interchangeability of small molecules compared to the innovator’s biologic molecule. Since biosimilars are many times cheaper than innovator’s biologic molecules, we should not be discouraged in developing biosimilars but should be cautious with its characteristics and requires thorough evaluations. This would ultimately help the needy patient population.
Keynote Forum
Swamy KB
MAHSA University, Malaysia
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
Biography:
Swamy K B has been awarded with PhD from Andhra University, his Master’s degree in Clinical Anatomy from Andhra Medical College, DMCh in Maternal & Child Health from IGNOU, New Delhi and MBBS in 1976 from SV University, India. He has expertise in human genetics, reproductive health & developmental anatomy and in herbal medicine. He has been the Genetic Counselor for many medical institutions. 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).
Abstract:
Introduction: 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.
Objectives: The aim of this study was to assess the correlation between IQ and environmental characteristics on cranial capacity in children and adolescents in Malaysia.
Methods & Materials: 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.
Results: 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.
Conclusions: 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.
- Adverse Drug Reactions | Drug Safety | Challenges in Pharmacovigilance | Pre-Clinical and Clinical Trials
Chair
Swamy KB,
MAHSA University, Malaysia
Session Introduction
Tetsufumi Koga
Daiichi Sankyo Co. Ltd., Japan
Title: Consideration of antimicrobial resistance in Campylobacter spp. in cynomolugs monkeys from Asian countries
Biography:
Tetsufumi Koga is currently a Senior Scientist at the Laboratory Animal Care & Management Group of Daiichi Sankyo Co., Ltd., Japan. He has presented more than 10 papers regarding the evaluation of antibiotics, mechanisms of antibacterial agents and animal infection models.
Abstract:
Campylobacter spp. are zoonotic pathogens and a major cause of gastroenteritis for humans. The transmission of Campylobacter infection is due to consumption of animal products and water and through contact with animals and environments such as soil and rivers. Consequently, Campylobacter infection is of great importance to public health. We have performed the isolation of Campylobacter spp. in cynomolgus monkeys that were purchased from China (more than 2 animal producers), Cambodia, Indonesia (more than 1 animal producer), Philippines and Vietnam. From 1 animal producer of China, Cambodia and Indonesia, Campylobacter spp. were isolated from the feces of monkeys. Prevalence rates of each country were different and the pattern of antimicrobial resistance was also varied. Multi-resistant isolates (isolates simultaneously resistant to more than three or more different classes of antimicrobials) of C. coli were found in monkeys from all 3 countries and an isolate simultaneously resistant to five different antimicrobials (Penicillin, Tetracycline, Chloramphenicol, Aminoglycoside and Quinolone) was isolated from Indonesia. Although only limited information from humans and animals is available on the antimicrobial resistance of Campylobacter spp., similarly patterned resistance profiles, which had been previously reported, were observed in each country. We did not characterize these isolates with molecular typing techniques; however, these geographic areas would be contaminated with these pathogens. Antibiotic resistance is a growing global public health threat and a particularly serious problem in Asia due to the historic overuse and misuse of antimicrobials in human health and animal agriculture. We should conduct global surveillance on drug resistance in bacteria of not only human origin but also animal origin. This surveillance is also included in pharmacovigilance. In addition, antimicrobial stewardship initiatives and infection control programs should be instituted for both human and animal therapy.
Biography:
Abhay Chimankar is a Physician by profession, Global Leader with expertise in Drug Safety and Pharmacovigilance Regulatory Affairs with additional experience in Medical Writing, Clinical Trials, BA/BE Monitoring and Auditing. He is well-versed in Global Regulatory Guidelines and Speaker at international conferences and is known as a keen planner, strategist, and implementer with solid track record of results that deliver business value through streamlined PV operations. His areas of PV expertise include: Pharmacovigilance guidelines in key areas of the globe, with in-depth knowledge on patient safety, practical implications of EU GVP, particularly all effective modules, establishing PV operations, Argus implementation and electronic gateway setup and compliance with quality standards, SOPs, ICH-GCP and/or other guidelines. He has experience previously working in Cipla Ltd, TCS and Novartis. He is currently working with Pharmaviz Pvt. Ltd. as the CEO.
Abstract:
With the ever-increasing requirement from various regulatory authorities across the globe, the marketing authorization holders (MAHs) are required to comply with these requirements. To meet the expectations from multiple regulators, it becomes difficult for MAHs to sustain the team, resources and also to manage the global team within the budget. One of the challenges is to have global compliance in terms of regulatory reporting, identification, assessing, reviewing the ICSRs and reporting them on-time. At the same time, the ICSRs are to be exchanged with the global partners. Right at the start and sustain the rightness through various processes including the risk based audits of various functions is the key to this compliance. Well trained and experienced resources and retention strategy play important role in the PhV system. Automation processes which are validated and compliant to the requirements help MAH to minimize the manual inputs wherever possible e.g., literature imports, identification of key index term, using auto mails for follow up communications, generating various reports like KPI dashboard and compliance reports. The safety databases to be used to its fullest capabilities, right IT partners (in-house or outsourced) helps in this to align.
Delphine Bertram
Xendo B.V., Netherland
Title: Adverse drug reaction reporting by patients in 50 countries
Time : 15:10-15:30
Biography:
The aim of this work is to review the current patient Adverse Drug Reaction (ADR) reporting system in 50 countries and to analyze its implication on pharmacovigilance system. National Competent Authorities (NCA) is surveyed and a literature review was conducted in fifty countries across five continents. Of the 50 countries included in this study, patient report ADR to NCA in 44 countries (88%) were taken. Twenty-six countries (59%) have created a patient-specific ADR reporting form. Depending on the country, the way to declare an ADR is more or less easy to find from the NCA website but on the average 3 clicks are requested to access the ADR form. The total number of fields to complete per ADR form varies from 6 (Brazil) to 59 (Austria) with a mean of 36 items. Reports from patients represent an average 9% of total ADR reports compared to HCP reports received by NCAs but a fairly large disparity can be observed. Efforts are still to be made in the field of pharmacovigilance to encourage patients to report ADR especially in developing countries. However, the majority of the 50 countries surveyed in this study really began to implement a patient ADR reporting system (16 countries began in 2012 or 2013), which can explain the fact that the patient reporting is fairly low compared to HCP. When NCA implemented an online ADR reporting form, the rate of reporting is increasing. Means to report should be extended for the development of applications in mobile devices enabling faster return at any time. Only few countries have currently implemented a mobile application. Each country should promote ADR reporting system using all means of communication included Internet and social networks.
Abstract:
The aim of this work is to review the current patient Adverse Drug Reaction (ADR) reporting system in 50 countries and to analyze its implication on pharmacovigilance system. National Competent Authorities (NCA) is surveyed and a literature review was conducted in fifty countries across five continents. Of the 50 countries included in this study, patient report ADR to NCA in 44 countries (88%) were taken. Twenty-six countries (59%) have created a patient-specific ADR reporting form. Depending on the country, the way to declare an ADR is more or less easy to find from the NCA website but on the average 3 clicks are requested to access the ADR form. The total number of fields to complete per ADR form varies from 6 (Brazil) to 59 (Austria) with a mean of 36 items. Reports from patients represent an average 9% of total ADR reports compared to HCP reports received by NCAs but a fairly large disparity can be observed. Efforts are still to be made in the field of pharmacovigilance to encourage patients to report ADR especially in developing countries. However, the majority of the 50 countries surveyed in this study really began to implement a patient ADR reporting system (16 countries began in 2012 or 2013), which can explain the fact that the patient reporting is fairly low compared to HCP. When NCA implemented an online ADR reporting form, the rate of reporting is increasing. Means to report should be extended for the development of applications in mobile devices enabling faster return at any time. Only few countries have currently implemented a mobile application. Each country should promote ADR reporting system using all means of communication included Internet and social networks.
Rajvir Singh
Hamad Medical Corporation, Qatar
Title: Patient safety culture in Hamad Medical Corporation (HMC), Doha, Qatar
Time : 16:15-16:50
Biography:
Abstract:
Unsafe medication practice and medication errors are a leading cause of patient safety incidents across the world. Patient safety culture is an essential element of universal health coverage and affects the sustainability of a health care system through decreasing errors and providing an optimal service. Many publications on patient safety exist but the organizational climate within Qatar has not been studied and can be compared to other non-Western countries where a few studies have been done. Patient safety can be defined as the avoidance and prevention of patient injuries or adverse events resulting from the process of health care delivery.
Aim: The aim of this study is to describe patient safety culture at HMC Qatar.
Design/Method: A validated questionnaire was used to conduct a web-based cross-sectional survey amongst health professionals; doctors, nurses and pharmacists in HMC. HMC includes seven different hospitals in Doha Qatar. The start date was Feb 2015 until July 2016. Study was approved by IRB, medical Research Center, HMC, Doha, Qatar and funded by the National Priority Research Program (NPRP) cycle 7.
Results: A total of one thousand, six hundred and four responses were received over the study period. Most responses (67.9%) were received from nurses followed by doctors (13.3%) and pharmacists (12.9%) Around three quarters (70.9%) were female and aged less than 40 years (76.0% and almost half (48.1%) had more than ten years of experience as a health professional in secondary care. The percentage agreement (strongly agree and agree) for each statement and the mean percentage agreement for each domain were calculated. Those domains with the lowest levels of agreement were: non-punitive response to errors (24.0%); staffing (36.2%); communication openness (50.5%); handoffs and transitions (53.1%); and supervisor/manager expectations and actions promoting patient safety (56.5%). The highest levels of agreement were: organizational learning – continuous improvement (85.1%); team working within unit (82.1%); and management support for patient safety (75.4%).
Conclusions: Most responses were derived from female Nurses comprising of 3/4 of the population aged less than 40 years. Continuous improvement, team working in unit, and management support were found more prominent factors in patient’s safety culture.