Otsuka Pharmaceutical Development & Commercialization

Deborah Profit

The healthcare industry, since outset, has been home to some of the most cutting-edge and forward-looking science, whether in biology, chemistry or genetics. Adoption of new technologies, however, has proceeded less quickly. While many healthcare organizations lead as early adopters of new technologies that assist medical professionals in advancing care and improving outcomes, profitably utilizing the vast data that new technologies can provide is still rife with challenges. The biggest challenge is how medical firms will deal with the ever growing volume and velocity of data collected, considering that Electronic Medical Records systems (EMRs) alone are collecting huge amounts of data. Data integration is changing health care decision-making on every level. Healthcare Providers (HCPs), patients, payers, and regulators have visibility and access to such data like never before, resulting inpatient-centric and personalized approaches to medicine. Patients can now possess months of data— from a blood pressure cuff at their local pharmacy, weight from their digital scale, food diaries from smart phone apps, number of steps taken each day and sleep patterns from wearable digital devices, blood sugar data from digital testing devices—all at their fingertips to share in literally one second.

One of the earliest uses of big data to generate new insights has been in predictive analytics. With big data in the picture, a lot of innovation has been made possible just by using the available data and discovering useful insights from it. The most exciting innovation is the ever growing and improved use of technology in clinical research that is capable of providing timelier and cleaner data. Embracing recent digital platforms, study subject data can be captured in real time, unlike the past, when researchers were waiting on a paper diary to be collected and were dependent on a patient’s memory. This has had a huge impact on clinical investigators’ decision-making and the speed and efficiency of clinical trials. Opportunities now exist to examine the patient journey during the span of a clinical trial by accessing their updated and archived data.

Beyond the speedier availability and deeper analysis of more and more data, the uptake of cloud-based solutions across all pharmaceutical domains has also opened up a multitude of possibilities. Certainly in the R&D space, the advent of eSolutions to capture real-time data and share it promptly with appropriate stakeholders using the cloud is significant, as the clinical trial process today is quite slow and antiquated.

Fortunately, the accession of eConsent, eScanning (e.g., investigational product), eSource (e.g., study data), and other digital platforms can drive greater efficiencies in the clinical trial process, allowing real-time insights during the conduct of the trial. Until recently, data and resulting insights were not available for months. This will ultimately result in trials being completed earlier and new treatment options becoming available sooner to the patients in need.

Looking beyond R&D, into the commercial space, greater collaboration with payers, HCPs and regulators to leverage real world data and non-interventional studies will potentially strengthen market and patient access opportunities in critical therapeutic areas. The need continues for industry to be extremely diligent with data security and most especially patient and consumer data. Regulatory authorities, globally, are not only asking for protection of personal data, but mandating it. In addition, the health care industry also has a responsibility to allow patients to have access to their data and to manage their data, in terms of how they want to use it and who they want to grant access to it. Developing secure ways to do so is a critical path initiative for all of industry.

For a faster—adoption of new technologies, agility and unconventional thinking are key. The speed at which technology is changing requires all of industry to rethink today’s processes, but also to contemplate how best to optimize and automate. If a patient app can be built in 3 weeks, but it takes several months to deploy it due to a paper driven process for testing and validation, then the competitive advantage is gone; automation is key. A heads-up for upcoming leaders—IT needs to be in the room and have a voice in helping the business solve problems and make decisions, not just implementing a decision via technology after the decision is made. Be creative, focus on the essentials, and do not be afraid to challenge the norm. Lastly, we are all patients and consumers of healthcare–we owe it to ourselves to make it better for all of us.