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The pharmaceutical industry is one of the most regulated sectors in the world. It's no wonder - mistakes or oversights in the process of manufacturing and distributing drugs can have serious consequences for people's health and lives. Learn how technology helps modern representatives of this industry in managing risk.
Fundamentals of Risk Management in the Pharmaceutical Industry
In the pharmaceutical industry, several types of risk are distinguished.
- Clinical risk - associated with clinical trials and the potential adverse effects of drugs. It includes the risk to participants as well as the risk of study failure.
- Regulatory risk - refers to compliance with regulations and regulatory requirements. This includes, among other things, the registration and approval of drugs for the market.
- Operational risk - associated with the company's day-to-day operations, such as manufacturing, distribution, and the supply chain.
- Financial risk - potential losses that arise from financing expensive research and development of new drugs.
Before the era of digitalization in the pharmaceutical industry, traditional, paper-based risk management systems were dominant. These included:
- manual control and monitoring of production;
- paper documentation and reports on regulatory compliance;
- periodic internal and external audits;
- statistical analyses of data intended to detect irregularities.
Such systems were less efficient and more prone to human error. However, then came the advancement of digital technologies, which simplified and automated many processes.
Overview of Digital Technologies in the Pharmaceutical Industry
Modern digital technologies streamline research, production, and logistics processes in many different ways. Thanks to them, efficiency increases, and pharmaceutical companies can more effectively control risk. What solutions are most commonly used?
Big Data and Data Analysis
The pharmaceutical industry is data-driven - at every stage of work, huge amounts of information are generated. Modern business intelligence systems can analyze terabytes of data in a few seconds, detecting worrying trends or anomalies. This allows for swift reactions to threats and the implementation of appropriate preventive measures.
Artificial Intelligence and Machine Learning
AI and deep learning algorithms learn from rich datasets from the past. As a result, they can predict with high accuracy the likelihood of various types of risk that may emerge in the future. This facilitates accurate decision-making and threat management.
Blockchain
The distributed blockchain provides a very high degree of data security. Thanks to the mechanism of independent transaction verification, it is practically impossible to modify recorded information without authorization. This technology allows for full control over the flow of data: both within the organization and externally.
Internet Rzeczy (IoT)
In pharmacy, smart sensors are used, for example, to continuously monitor the conditions of storage and transportation of drugs. In this way, companies can ensure the high quality of medicines and take care of patient safety.
IoT devices instantly signal any worrying deviations in parameters - for example, temperature or humidity. This significantly reduces the risk of sensitive preparations spoiling.
Computer Simulations
Modern mathematical models and computer simulations allow for "testing" the effects of new drugs in a virtual world before they proceed to trials. This enables, among other things:
- to examine their toxicity levels;
- to check how they interact with other substances;
- to select the appropriate dosage for the human body.
Such virtual tests accelerate research and development efforts and make them safer.
The Impact of Digital Technologies on Risk Management
Digital technologies revolutionize the way the pharmaceutical industry identifies, assesses, and manages risk. How do they do it?
Improving prediction accuracy
Modern technology allows for analyzing data at a highly advanced level. Innovative algorithms can accurately predict potential issues, which is why artificial intelligence-based systems quickly detect subtle patterns and dependencies in data and respond to threats earlier.
Increasing reaction speed
Digitization of processes enables immediate response to detected risks. Thanks to automation, personnel responsible for risk management can quickly take preventive actions, mitigating the negative effects of problems.
Automation and process efficiency
We have robotic drug packaging, production quality monitoring systems - digital technologies significantly contribute to better risk management at every stage of production. Removing human factors from production processes improves the quality and safety of products.
Transparency and tracking
Digital technologies allow for full transparency of the entire drug supply chain. Blockchain enables monitoring every stage of drug production, distribution, and sale in real-time. This not only increases patient safety by avoiding counterfeits but also facilitates rapid response in case of quality issues detection.
Challenges and limitations
Unfortunately, introducing new technologies in the pharmaceutical industry is not always a straightforward task. What are the problems facing this industry today?
Privacy and data security
Collecting and analyzing large amounts of data requires caution. The risk associated with protecting information in the digital age is very real. Therefore, the industry should be aware that ensuring security is its responsibility to all patients.
Complexity and implementation costs
Considering the level of regulation and the impact of potential errors, introducing new technologies in pharmacy can be difficult and costly. This requires significant financial and time investments related to high-quality IT systems, infrastructure, specialists, training, and technical support.
Resilience to change
It is not always easy to adapt and implement employees to new technologies. Companies should be prepared to change their organizational culture to encourage employees to learn new tools. Without this approach, new technologies will not be a benefit but an additional burden.
Case Studies
Pfizer is a pioneer in digital strategies in the pharmaceutical market. Thanks to supercomputers and artificial intelligence, the company was able to shorten the time of some processes by as much as 80-90%. This resulted in the creation of PAXLOVID - an oral drug for Covid-19 - in just four months.
On the other hand, the Swiss pharmaceutical company Novartis is conducting over 150 projects using artificial intelligence throughout the company. The brand has signed contracts for IT technology development with tech giants such as Microsoft and NVIDIA.
AbbVie - an innovative biopharmaceutical corporation with a global reach - actively engages in digitization and automation processes using IT. The company utilizes advanced technologies, including AI and deep learning, throughout the research and development process, from early experiments to the discovery of new assets and the development of late-stage programs. The company also implements digitization in other areas, such as the collaboration with WebMakers, a knowledge compendium for healthcare workers, improving the collection and distribution of medical knowledge.
Use data to make better business decisions.
However, attempting to introduce innovative solutions does not always end in success. An example from which lessons can be learned is the situation of GE HealthCare.
The company tried to create the Predix platform, which was supposed to be a universal solution for analyzing data from medical devices. However, it encountered many technical, organizational, and market problems, which resulted in delays and losses. The reasons included:
- too large scale and complexity of the project;
- lack of clear vision and goals;
- low quality and consistency of data;
- difficulties in integration with existing systems and equipment;
- competition from other tech companies.
The Future of Risk Management in the Pharmaceutical Industry
Forecasts clearly indicate significant development of innovative technologies such as data analysis, AI, the Internet of Things (IoT), or blockchain. These modern tools have the potential to revolutionize production, research, and logistics processes in the pharmaceutical sector.
Investments in digital transformation in pharmacy are huge - by 2030, they are expected to reach around USD 4,5 million. With the application of artificial intelligence, traditional drug discovery methods can be accelerated, significantly shortening the process of creating a new drug, which currently takes 10-12 years.
The New Era of the Pharmaceutical Industry
Modern technology has a huge impact on risk management in the pharmaceutical industry. Already, the industry is investing massive amounts in digital transformation, and year by year, the amounts and engagement are increasing.
Pharmaceutical companies should continue to research and implement digital solutions. In this way, they will ensure competitiveness in the market and improve risk management in their organizations.
In WebMakers, we specialize in projects for the pharmaceutical industry, so if you want to realize your project, do not hesitate to write to us.
