ETHICS, RISK AND COMPLIANCE IN PHARMACEUTICAL R&D: CURRENT PERSPECTIVES AND A GLIMPSE TO THE FUTURE
From a pharmaceutical perspective, the past few months have been nothing short of dazzling when it comes to the reimagining of science. Academic and research centres, small biotech companies and big pharma players are all making an unprecedented effort, both jointly and separately, to fight the COVID-19 pandemic. This struggle is encompassing and uniting all science and technology disciplines. The industry is using data and analytics to understand patterns of spread, new technologies for rapid diagnosis and the latest scientific understanding to conduct multiple clinical trials focused on prevention and treatment. These remarkable efforts are being advanced by clinicians on top of their daily heroic struggle to save lives.
The public is now well aware of the global efforts of the healthcare sector. Prior to the pandemic, despite many recent breakthroughs in medicine, pharmaceutical companies have not gained much in popularity or reputation. Now, however, it seems that people have started to give the industry a second look with the expectation that it will stop the pandemic, save lives and rescue both the global economy and humankind.
Even before the COVID-19 outbreak, society entrusted the most precious and sensitive populations into the care of the pharmaceutical industry. Both healthy and sick people (and animals) alike are exposed to novel therapeutics for which we have limited understanding. The industry is expected to be fair and fast, and to do things right. To this end, we hope for the best but continuously prepare for the worst. Collecting high-quality data from clinical trials requires interactions with investigators, researchers and other third-party vendors. These complex activities are conducted under the highest ethical standards for clinical research, as well as animal welfare, and in compliance with all applicable international guidelines and internal corporate policies, all designed to protect patient rights and their safety. This is the reason why the role of ethics and compliance professionals in supporting pharmaceutical research and development (R&D) is extremely important.
Jul-Sep 2020 Issue
Novartis Research & Development (NIBR & GDD)