Satish Chandra-Nair
Accepted Abstracts: Pharmaceut Reg Affairs
Recent reports indicate that up to 31% of the world's clinical trials are currently being conducted outside of the US and 25% of the investigational new drug applications include data from clinical trials conducted at international study sites. The need for diverse patient population for research, decreased trial costs, improved subject accrual, and, access to rare diseases are additional driving forces for the expansion of international clinical research. The high population growth, demand for medication, improved life expectancy, increased prevalence of life-style related disease and access to rare diseases in the MENA countries should drive the conduct of clinical trials in these countries; yet the region hosts only about 0.5% of global clinical trial sites. Many factors, including the regulatory environment, patient protection, physician-preparedness, type of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical challenges and opportunities for the effective pursuit of clinical trials in the MENA region. Regulatory challenges and oversight issues can be overcome through strategic planning by the local CRO. Risk-based monitoring and education and cross training of healthcare professionals in the region can overcome barriers related to trial quality and subject protection. Population characteristics, growing healthcare infrastructure, and the state-of-the-art communication technologies provide clear advantages for clinical trial subject recruitment in the region. Low physician salaries, lower operating costs and the expected increase in pharmaceutical sales in the region are significant incentives for the future conduct of clinical trials.
Satish Chandra-Nair is the Senior Specialist and Head for Clinical Research at Tawam Hospital- Johns Hopkins Medicine International Affiliate, and Clinical Assistant professor at the Faculty of Medicine and Health Sciences, UAE University, Al Ain in the UAE. He has served as a faculty member both in US Medical Schools and in India and later as a member of senior management for pharmaceutical companies in the USA. He is a primary inventor (Immunophilin) and primary investigator and has published over 40 international peer reviewed scientific papers and presented significant number of abstracts at conferences. He has been rewarded with professional achievement awards such as the Global Leadership Award for Clinical Research by the Academy of Clinical Research, USA, Union of International Cancer Control, Japanese Cancer Foundation, and Society for Cell Differentiation young investigator award, and has been the invited reviewer for the Susan G. Komen Cancer Foundation breast cancer grants. Additionally, he is on the Editorial Advisory Board of several USA journals such as Journal of Diabetes Technology and Therapeutics, Clinical Research and Regulatory Affairs and Editor-in-Chief of Applied Clinical Trials and Clinical Research, USA. He has chaired several sessions and delivered lectures on Molecular drug discovery, Signaling pathways, Receptors and small molecule targets, Clinical Trials etc; very recently he was invited to speak at the prestigious ?Evolution Summit 2011? for Clinical Trial and Pharmaceutical Leaders in Montreux, Switzerland (2011). He is also the Chair of the Gulf Cooperation Council Chapter for the ACRP (USA).
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
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