IQ Regulatory Advisory Committee (RAC) publishes white paper on collaboration in the age of COVID-19
From Drug Discovery to Commercialization: Industry Collaboration in the Age of COVID-19 and Beyond
The pharmaceutical industry has been under tremendous pressure to produce novel life-saving therapies and to accelerate their development in partnership with regulatory agencies. The global public health emergency due to the COVID-19 pandemic that started in early 2020 has highlighted these challenges. In these times, the medical needs are enormous and addressing them requires unprecedented innovation as well as collaboration across international borders among manufacturers and regulators. The global ramifications on the speed of development and approvals both for preventative and curative treatments are far-reaching. The resulting operating efficiencies in many cases have the potential to extend beyond the immediate application to COVID-19 therapies.
With these considerations in mind, companies in the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium or IQ) have been working in a collaborative manner on approaches to facilitate efficiencies during the development and lifecycle management of drugs in the age of COVID-19 and beyond. The nine topics summarized in this paper span the development lifecycle including pre-clinical and clinical research, product development, shelf-life projections, and post-approval life cycle management. The reports all converge on one central theme that not only focuses on the science of how we bring important medicines to patients but how these can be brought to patients with speed, efficiency, and continued patient safety as the drivers. These efforts provide an important framework and foundation that will prepare the industry to effectively apply the lessons learned from drug discovery and development during COVID-19 to support future pandemic or unmet medical needs for the patients we serve.