The greatest race of the 21st century?
Our healthcare providers are working harder and more bravely than ever before, saving lives while risking their own, as the rest of us are doing our part by staying home and flattening the curve. In parallel, many of the smartest minds in the world are racing to find a vaccine or treatment for the COVID-19 virus - the greatest race of the 21st century to date.
As of April 16, there are 79 companies driving toward a solution, but who will win and what is needed to get the metaphoric checkered flag that is a cure for this deadly virus?
The intermediate line is often defined as time-to-clinic while the finish-line is often identified as time-to-market. In this race, however, the true victory is when efficient time-to-patient is reached. When trying to get drugs from ideation to the patient, knowledge management is a critical component.
Product and process knowledge should be managed from development through the commercial life of the product, up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented), pharmaceutical development studies, technology transfer activities, process validation studies over the product life-cycle, manufacturing experience, innovation, continual improvement, and change management activities. With such a varied breadth of sources, effectively storing, disseminating, and analyzing said knowledge is critical to the drug development process.
What is the result of solid knowledge management?
With effective knowledge management, companies have been able to reach markets faster than before while simultaneously reducing their cost of production by 80% compared to normal for monoclonal antibodies (mAb). Behind this impressive cost reduction are several factors: high yield and productivity, significantly fewer exceptions (which can cause costly out-of-specification investigations), and the use of advanced analytics for advanced process control. Combined with golden batch technology and multivariate prediction and prescriptive data analytics, firms can get drugs to market faster and more efficiently, while improving their processes. This is all enabled by knowledge management and data - specifically, easy access to information that can be used in a proactive rather than reactive manner to increase throughput and quality simultaneously.
The greatest race will not be over until a vaccine or treatment for the COVID-19 virus has been evaluated to be safe and effective. When that product can be transferred to many production plants releasing high quality products at minimal cost in the shortest possible time, the race will truly be won. To our brave healthcare workers and to everyone in the race, we are cheering for you.