How Digital Technology Will Transform Every Part of Life Sciences in 2020
Contributed Commentary by Ferdi Steinmann
March 9, 2020 | Achieving a single view of the patient has been a key challenge for the life sciences industry, given the inherently siloed nature of organizations in the sector. However, as patient centricity increasingly becomes the crux of all life science organizations, the pace of digitization within the industry has picked up significantly.
Organizations have been quick to understand the need to implement transformative technologies such as AI, analytics, IoT, blockchain and cloud platforms, to create a world of patient centricity and personalized, value- based medicines. Here are eight ways digital technologies will shape each stage of the drug lifecycle.
Research and development
Like many other areas of life sciences, research and development (R&D) organizations have lagged behind their stakeholders—especially patients—in their pace of embracing digital technologies. However, 2020 will mark the year R&D organizations in the life sciences industry begin to catch up.
Patients often discuss their conditions on online forums and social networks, providing a wealth of real-world evidence. The integration of assessment devices such as MRI scans, laboratory equipment, and even smart pills, provide far more accurate and granular information on each patient. Digital technologies provide improved collaboration between biotech companies with other life sciences organizations and academic institutions.
This year, R&D organizations will begin to adopt interoperable data platforms that enable effective collecting, synthesizing, analyzing and communicating of information to move from volume- to value-based research that drives better patient outcomes.
Clinical trials
Digital technologies are now beginning to make a transformational impact on the way pharmaceutical and other life sciences companies recruit for, and operate, clinical trials. The application of AI-driven analytics is honing patient recruitment by crawling through patient records to identify the most suitable candidates.
These same technologies are boosting retention and adherence by using individual-level targeted insights and trigger-based digital media to manage patient needs more proactively. Physicians can monitor and prompt to ensure treatment regimens are being followed. AI technologies allied to IoT platforms are facilitating the biggest change in the sector towards virtual trails. The improvement to patient convenience and the ability to remote monitor should help reduce the number of people quitting the trials.
Manufacturing and the supply chain
The pharmaceutical industry is experiencing a period of rapid innovation. Even as Good Manufacturing Process (GMP) compliance remains the foremost concern, manufacturers are finding new and creative ways to create value in highly regulated contexts.
As the industry moves towards personalized medicines, production must also move from large bulk runs to more precise and targeted batches. An interoperable data platform will be required to capture the data needed to facilitate this transition to a made-to-order approach that allows for the production of many product variants.
Pharmaceutical manufacturers will also have to more carefully manage supply chains to maintain profitability with smaller production runs and shorter drug lifecycles. In addition, supply chain security remains a key priority, and the need to prove chain of custody has never been higher. Pharmaceutical manufacturers will increasingly use AI, IoT and blockchain within the supply chain to add visibility and transparency with full product traceability—including monitoring the condition of sensitive drugs in transit.
Quality
For a few years now, there has been interest in applying the connected technologies of Industry 4.0 to manage quality performance, including the costs of both good and bad quality. Many companies have begun to increase the resolution of the data they collect using IoT and analytics. This no longer stops at the factory wall. Instead of inspecting parts as the primary quality activity, companies are beginning to inspect their suppliers’ quality and processes to address downstream quality issues.
It is still early days for Quality 4.0 and, again, the key is likely to be the adoption of an interoperable data platform across production and supply chain processes to enable new levels of trust and cooperation among all parties working along the life sciences value chain.
Commercialization
The enterprise-wide shift to a focus on patients and greater collaboration among all stakeholders is perhaps most keenly felt in commercialization. As patients become more empowered, the life sciences industry is beginning to better serve them not only through the medicines it produces, but also through services which smooth the road for access—from diagnosis to therapy to reimbursement.
In addition to empowering patients, pharmaceutical companies must look for ways to empower the physician with the right information and support to improve diagnosis and drug prescription. This is yet another reason the major technology trend across all life sciences sectors will be the move towards the interoperable data platform that will form the basis to enable the secure data flows the industry needs.
Marketing and packaging
As patient centricity takes precedence, life sciences organizations are being provided with a vastly greater amount of patient data. Leveraging this data, organizations and healthcare providers are able to create a single comprehensive view of the patient. This can help with treatment and also delivers insight needed to personalize marketing.
However, these outcomes can only occur where patients have the trust to share their information. Data privacy is core to developing compliant global marketing communications for life sciences. As patient-centricity increases and the impact of personalized medicines grows, global pharmaceutical companies will be faced with developing many thousands of separate digital marketing assets that must meet regulatory standards and be delivered at the right point in the patient journey.
As such, implementing enterprise marketing communications management platforms will help organizations meet the compliance, cost and complexity challenges of global marketing and packaging requirements.
Regulation and submissions
The FDA has the stated aim of cutting submission and approval times, especially to address drug monopolies. To achieve this goal, regulators, not just the FDA, expect a much greater level of collaboration with all the parties involved.
For instance, the European Medicines Agency (EMA) is implementing standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) and FDA representatives have mentioned using structure data and content to make future submissions fully digital and not just in PDF formats. This will place a greater focus on enterprise data and content management to take control of information and simplify the submissions process.
Post-market monitoring
The use of Fitbit or other connected health wearables continues to increase, and patients are more willing to share their data with physicians and other parties they trust. Research shows that people are beginning to select healthcare providers based on whether the providers offer telemedical and remote monitoring devices.
While physician-supplied medical devices—such as pacemakers—are FDA regulated, most personal IoT-enabled devices are not. In many cases, the IT security teams in healthcare are unaware when new devices join their networks or begin to share data. Organizations will look towards identity-driven IoT platforms to gain the value of real world data from connected health wearables while minimizing the security and data privacy risks.
Ferdi Steinmann is a global industry strategist, life sciences, at OpenText. With over two decades of experience in the healthcare, life sciences and pharmaceutical industries, Ferdi has tremendous insight into the way technology helps companies become successful. He can be reached at fsteinmann@opentext.com.