Digitization in the pharmaceutical industry offers several key advantages. Not only can it reduce production costs and improve quality, it can also mitigate internal and external risks like intellectual property theft or data breaches.
An effective digital network platform can assist pharma companies with sharing complex data in real time, which is ideal for contact tracing, disease monitoring and patient adherence purposes.
Drug discovery and development
Establishing new pharmaceutical drugs can be an expensive, time-consuming endeavor. On average, the time between drug discovery and market approval for market approval averages 12 years; this may vary depending on the disease being treated. Innovative companies have begun using digital technology to expedite this process while upholding regulatory compliance.
In the basic research phase of drug discovery, scientists first identify a biological target – such as receptors, enzymes or genes involved in specific diseases – before designing and testing small molecules that bind to them to modify activity and stop progression of illness. They can then perform in silico, in vitro and in vivo experiments on these promising molecules before selecting those most likely to move forward to preclinical research phase.
However, technological development may outstrip regulatory change at times, leading to potential compliance issues with data-driven technologies like artificial intelligence (AI). AI has become a popular option within pharmaceutical.
Pharmaceutical manufacturing
Pharmaceutical manufacturers are turning to advanced technology in an effort to boost workflow productivity, leading to major advances in pharmaceutical manufacturing and supply chain management – but also raising regulatory compliance concerns which must be successfully navigated by companies. Complying with national and international regulatory standards means finding a balance between technological progress and adhering to regulatory standards.
Pharmaceutical manufacturing is currently experiencing dramatic transformation, and efficient lab data management will be critical in keeping pace with these shifts. One such innovation is live licensing – an approach to clinical stage transitioning that transforms clinical phases into controlled launches while shortening product lifespans – this new model could transform how pharma organizations develop products as well as interact with stakeholders including PBMs.
Continuous processing setups have also revolutionized the pharmaceutical industry, increasing workflow productivity through rapid shifts of production focus. Due to these shifts, companies need to adapt existing models as well as develop new ones; more on this subject can be found by reading Pharma IQ’s article here.
Pharmacovigilance
At any point during the development of a pharmaceutical drug, any suspected adverse reactions should be reported to regulatory authorities for investigation and to update the Summary of Product Characteristics (SPC), data sheet or Patient Information Leaflet accordingly as new safety signals emerge.
Dependent upon the nature of a drug in question, its monitoring can involve different approaches to pharmacovigilance. Some drugs require clinical trial monitoring while others might benefit from post-marketing pharmacovigilance – both processes require strong knowledge of regulatory requirements and marketing strategies for success.
Pharmaceutical industries face the unique challenge of complying with global regulations while remaining innovative, yet many companies have shown it is possible by adopting an aggressive approach to regulatory compliance – cultivating a culture of compliance, encouraging transparency and creating robust policies and procedures – utilizing regulatory compliance as an opportunity for growth rather than as an impediment to it.
Information technology
Information technology can assist pharmaceutical businesses in streamlining their processes more effectively. It can speed and quality drug development processes while increasing medical treatments’ efficacy; for instance, computer-aided development systems enable researchers to design drugs faster and more accurately than before, as well as help detect production process errors thereby decreasing risks associated with subpar products.
Another use of IT in the pharmaceutical industry is grid computing, a data-sharing platform which enables scientists to collaborate more efficiently. Furthermore, grid computing allows for storage of vast amounts of information and analysis more effectively than before.
Pharmaceutical companies must be able to transmit complex data securely. This is particularly critical since many life-saving drugs require being transported and stored at precise temperatures or else their effectiveness could decrease dramatically; to achieve this effectively requires investing in an advanced digital network infrastructure.