How has the pharmaceutical industry been transformed by digitization and automation in the past year?
The pharmaceutical industry is highly dependent on digitization and automation for its research. Examples are computational chemistry, robotic chemistry, imaging techniques, and (ultra) high throughput screening. In addition, digitization and automation are increasingly being used to process already large but still growing datasets for clinical trials. Ultimately, however, the big dossier for a new drug must be submitted to regulatory authorities (like the FDA note). However, these registrars may not have the same ability to efficiently manage the electronic parts of these large files.
When it comes to digitization and automation in pharmaceutical manufacturing, I assume it’s not too different from other factory manufacturing industries. Wherever the pharmaceutical industry can take advantage of digitization and automation in its factories, it will use this technology not only to increase efficiency and accuracy but also to minimize contamination of factory workers. We must not forget that especially large pharmaceutical companies have two types of factories: the raw material factory, the synthesis of active ingredients in the medicine, and the formulation and packaging factory, where the active ingredients are formulated in the form of tablets, capsules, or pills injection fluid. Especially the big pharmaceutical companies have factories in different countries. Each type of factory requires its own digitization and automation.
What changes can we expect in the next five years?
Many pharmaceutical companies, especially large corporations, have expanded their research into oncology and immunology, in part because expensive and time-consuming clinical trials can be shorter for drugs, especially oncology. This is very relevant, since the development of, for example, a new drug molecule can take ten to fifteen years at a cost of more than 2.5 billion dollars. The vast majority of these high costs are related to the later stages of clinical development. The FDA and EMA generally allow cancer drugs to follow an accelerated/alternative development path and also allow some registrations for more than one type of cancer, resulting in lower clinical development costs and faster hospital cancer treatment. . The cancer drug market is already by far the largest and is expected to double by 2024. More than 40% of drugs in development are now in the therapeutic field of oncology. In fact, there have been many successes with monoclonal antibodies (molecules with names ending in … mab), including the recent related class of checkpoint inhibitors, as well as kinase inhibitors (molecules with names ending in … nib).
We may also see more joint therapies, which means that a patient is taking a combination of drugs, even if they come from different pharmaceutical companies. Conjunction therapies are already widely used in oncology and HIV, but they can also be used in other therapeutic areas. However, pharmaceutical companies need to be more open in sharing drug data or even sharing development data.
The pharmaceutical industry is becoming more patient. Patients now have more control over their health, including the drugs they (wish to) take, and patients’ well-being plays an increasingly important role in drug admission, market access, and reimbursement, which is why companies pharmaceutical companies are trying to get involved. More patients at all stages of value creation.
However, technological advancement does not only involve operations but also changes in business models. Digital technologies allow pharmaceutical companies to become drug and data companies, or rather healthcare solutions companies, but talking about digital technology is one thing; It is probably more challenging to change the organization accordingly. Although the pharmaceutical industry has taken serious steps and is slowly changing its conservative nature, it still lags behind other industries in the use of digital technology.
Pharma is lagging behind in innovation compared to other sectors. What prevents the market from innovating?
The pharmaceutical industry is an “old” industry, in the sense that big companies were born long before digitization and modern automation. For typical biotech companies, this is different as most (many) came later. Therefore, the main drugs lack digitization and automation in their genes and are often considered conservative. Furthermore, the pharmaceutical industry would be leaning towards the ‘packaging mentality’: no company tends to move individually unless the others change as well. While typical large pharmaceutical companies are called innovators because they are looking for new patentable molecules, innovation is totally focused on their research. The reflection is: if our pipeline is full of high potential molecules, especially primary molecules, then our future looks bright.
For prescription drugs, the ‘market’ is strange in the sense that consumers (patients) do not choose the product (medicine) themselves (the doctor does) and – to make things even stranger – payment for the product by the government and/or health insurers. Therefore, normal market mechanisms do not work for the pharmaceutical market, at least not for prescription drugs, which in monetary terms certainly make up the vast majority of the market.
The (innovative) pharmaceutical industry spends more money – as a percentage of its gross revenue – on research than any other industry. However, there is still a lot of “trial and error” involved in pharmaceutical research, with a relatively small chance that a drug will reach the market. A good example of this is Alzheimer’s disease: despite spending billions of dollars a year for so many years, the result is still negative.
This shows that the human body – especially at the cellular and molecular level – is still only partially understood and therefore the pharmaceutical industry still relies on the basic science of the Academy (universities and research institutes). While interaction with the Academy is essential for accessing basic science, pharmaceutical companies must pay attention to their intellectual property (IP). Let’s not forget that for a completely new type of technology such as gene therapy or a new class of molecules such as small molecules or proteins (such as monoclonal antibodies), it can take decades between the first molecular concept (idea) and the first class of brand blow molecules. Therefore, we must recognize that its main asset, research, is still too innovative and expensive for innovative pharmaceutical products.
If you compare this “freedom to work” with, say, the auto industry, you’ll see that the auto industry – although it also has limitations like safety and emissions regulations – has more freedom and is much less dependent on the miraculous pursuit of the purely basic as misunderstood as the human body. Despite all the advances in the life sciences, the human body is still so poorly understood that new technologies such as computational chemistry, robotic chemistry, high-throughput (ultra) screening, and even the human genome are fully revealed to a multitude of drugs. truly innovative in the market has not yet been performed.