Have specific questions?
Talk with Expert
Soneil Guptha, M.D. FACC FESC FCCP AFPM
Senior Medical Director, Medical and Scientific Affairs, Cardiovascular and Metabolic Diseases
Over 40 Years' Experience
Dr. Guptha has 40 years of combined experience in clinical development, medical and regulatory affairs experience (US EU APAC) in cardiology; nephrology, lipids, diabetes, thrombosis, drug eluting stents and asthma/COPD as medical monitor to departmental head since graduating in 1976. Prior to joining Worldwide Clinical Trials, he worked as an independent consultant utilizing his expertise as an academician, clinician (interventional cardiologist) and drug & device developer in the USA, Europe, and Asia Pacific. He is very experienced in clinical (Cardiovascular & Metabolic) medicine; pharmaceutical medicine (clinical, epidemiological and drug & device P2-4 development, research operations, medical affairs and regulatory affairs) and basic research methodologies.
Dr. Guptha has a track record of translating organizational strategy in medical affairs and clinical development function in USA, EU and AP regions. He demonstrates the ability to develop relationships internally and long-term external relationships by successful engagement of stakeholders and enacting the strategies requiring extensive buy-in in a complex organization, built over time and on the basis of reciprocal trust, engage in positive dialogues; and an innate ability to call on balance of fact and feeling in decision making. He has also developed departments from scratch, supervised functional or cross functional multidisciplinary teams and managed departmental and or research budgets
Specifically, Dr. Guptha has created strategies for clinical development, medical affairs and has grown US & International MA Activities; utilizing – optimal regional medical director support for business, build/manage strategic publications & scientific communications, KOL identification/management, internal education. He also has overseen medical strategy, operations and investigator initiated study programs, medical advocacy and training of MSL, and launch medical operations with external education-CME. Operationally, he is experienced in protocol development, outcome trials, clinical trial strategy, filing (IDE IND NDA sNDA); pharmacovigilance, medical communications.
Dr. Guptha’s therapeutic experience (different indications); supports to the business development; supervision and management. He developed and marketed new chemical entities (Simvastatin, Enalapril, Losartan, Aggrastat, Singulair Caspofungin, Fenoldopam and Drug Eluting Stents); including pediatric exclusivity. Much of his work that he has been associated with, has been published in peer review journals and has led to step change in treatment paradigm/guideline changes in the therapeutics.
Dr. Guptha continues to volunteer in local universities in developing and execution (with local peers) online education in cardiology, pharmaceutical medicine, epidemiology and statistics. Internationally, he maintains a close relationship in educational activities of the pharmaceutical faculty at Royal College of Physicians in UK and the IFAPP Academy. He has published in peer review journals an author of thesis; 51 published articles; 33 invited lectures and presentations; 1 book chapter; 5 book reviews; and been 1 course director.
In 1999 he was awarded – 20th Century Achievement Award – for admirable career achievements and contributions, USA and in 1998 he was awarded – Outstanding People of the 20th Century – for exceptional contributor to Cardiology, Lipids and Pharmaceutical Medicine, UK.