New legislation requiring pharmaceutical companies to implement 'serialization' is now coming into force. This means that no counterfeit product should enter the supply chain and no legitimate product is diverted from its intended destination. To work effectively, serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. The application of track and trace principles can help to avoid counterfeit medicines from entering the supply chain. To be effective, digital technologies such as blockchain and RFID-enabled tag and trace systems need to be embraced.
Pharmaceutical industry trends
The digital transformation of biopharmaceutical manufacturing is continuing at a rapid pace as companies attempt to mine the sources of data available. Innovations include predictive analytics, big data analytics, and creating the digital plant. Digital transformation offers a mechanism to revise its business model, to improve production processes, to design new drugs faster by using artificial intelligence to screen compounds and to increase responsiveness to customers. Furthermore, the volume of data processed by pharmaceutical firms shows no sign of slowing down. This means pharmaceutical companies must act quickly in terms of building core internal digital capabilities and moving beyond their traditional IT functions to all areas of the business.
There is a plethora of analytics reports, including ones by Deloitte, DKV Global, and Ernst and Young, all pointing out to a declining business performance of the pharmaceutical industry. They all convey a similar bottomline message: the decline is not due to a lack of innovation (the innovations are growing). And not because sales are falling or markets are shrinking (revenues are growing in general, and the markets are expanding with the expanding and ageing population). The key reason of the declining financial performance is the fact that research and development (R&D) costs are growing substantially faster over an average investment period, than the actual revenues over the same period. This kills operational profits, leading to a decline in the overall business gain. A direct consequence of that -- an increasingly stagnating industry, cutting sometimes promising R&D programs, jobs etc.
There are two more relevant questions here:
1) why R&D costs are growing faster than revenues, considering that technological progress is seemingly providing more and more optimal and powerful technologies to pharma companies at a constantly decreasing specific price (e.g. costs of computation, sequencing, screening and many other things are falling), and
2) what to do about it to reverse the decline in pharma industry performance?
In a seminal work published by McKinsey & Company – The Granularity of Growth, a detailed study of the performance of the 100 largest US corporations over the two most recent business cycles – a key finding emerged: top-line growth is vital for survival.
To dig a bit deeper, the study found that a company whose revenue increased slower than the growth of U.S. GDP was five times more likely to falter in the next cycle than a company that expanded more rapidly. Companies have a “Growth Imperative,” which is to either “grow or go,” the authors concluded; in other words, companies must grow faster than their peers or else be left behind.
Computer-aided drug design (CADD) is a central part of so-called “rational drug design”, pioneered in the last century by companies like Vertex. Over the last decades, CADD had great influence on the way new therapeutics are discovered, however, it also showed limitations due to modest accuracy of computational tools.
The majority of software tools used for computational chemistry and biology rely on molecular mechanics -- a simplified representation of molecules, essentially reducing them down to “balls and sticks”: atoms and bonds between them. In this way it is easier to compute, but accuracy suffers greatly.
In order to gain adequate accuracy, one has to account for the electronic behavior of atoms and molecules, i.e. consider subatomic particles -- electrons and protons. This is what quantum mechanical (QM) methods are all about -- and the theory is not new, dating back to the early decades of the 20th century.