The impact of big data is being felt in every industry, but the impact on pharma is amplified by the convergence of science and technology. There is an emerging transformation fueled by growing transparency in the flow of information between patient, doctor and other providers. Currently, information is siloed by provider—if a patient obtains care from a primary care physician and a specialist, the records of the two providers are not connected or shared. This keeps the patient’s personal medical data fragmented and prevents holistic, optimal care. The digital revolution in conjunction with data integration and artificial intelligence can help to close this gap.
The speed of the technological upgrade of data management in healthcare, however, must consider the highly-regulated environment. For example, using a Clinical Trials Management System (CTMS) must ensure privacy and make certain that patient report forms and summaries are compliant with regulatory requirements. CTMS is a nascent technology and in the early stages, especially for healthcare, there are costs of entry that cannot be compromised. Processes will be transitioned to a digital application but the governance of those processes can be at risk, creating weakness. Though some manual processes have been transferred into technological systems with great success, it is very limited and much more is necessary for both the efficiency and the opportunity to share data to fully become viable and remain compliant. However, if clinical trials are conducted globally, the process will be different based on the requirements of the countries where clinical trial sites are located. Conducting a trial in Eastern Europe is not the same as doing it in Western Europe, the U.S. or China. There are significant differences across those regions, which reflect the need for a process that is consistent and compliant so that data can be audited and consolidated easily. The protection of data as required in the U.S. pursuant to the Health Insurance Portability and Accountability Act (HIPAA) and other statutes, should not result in creating systems that limit your ability to innovate and be creative while you protect the health information of the patient as may be required in other countries. To ensure compliance, some of the standard patient data protection and privacy requirements are patient consent, opt-ins or outs at any time, or redaction of patient data or personal information. Most of the industry has done quite well using these tools and has built-in infrastructures, checks and balances and systems to assure compliance with the various regulations.
"The speed of the technological upgrade of data management in healthcare, however, must consider the highly-regulated environment"
The new trends emerging in the pharma marketplace are focused on specialty products and rare diseases; as well as the challenges in higher need areas like Alzheimer’s disease. Cancer treatment has seen great advances in the past few years as science and technology converge and more effective treatments are expected in the next five years than in the last 50 years. The most exciting trend coming is digital medicine. This advancement is in its very early stages and the concept is the integration of medicine with technology. It’s one of the reasons Apple, Google, Verizon and others are now interested in life sciences—they see the potential in this convergence. Technology titans lack the regulatory wherewithal and healthcare experience, so they will need to partner with pharmaceutical companies in order to do the most good for human health.
The Upward Trajectory for CIOs
It’s very important not to allow your mindset to be conventional, because the methods of the past will not be sufficient in the present and the future. CIOs must be forward-looking and forward-thinking and integrate many different modalities and platforms from drug discovery to commercialization. They mustbe inclusive of all possible contributors to improve the outcomes. And the general trend of business seems to be shifting away from fee for service to fee for outcomes. To facilitate those outcomes, it is essential that the information and data is integrated and relevant to the business–it should not be in isolation or siloed from other relevant data. It’s like the Internet of Things (IoT)–we must bring these capabilities together to optimize outcomes and solve the real challenges we face to achieve the next breakthrough in medicine.