Digital transformation and emerging opportunities

As biopharma research and advanced research disciplines transform into more data-rich operations, pharma professionals must be equipped with the skills to distill actionable insights from the vast clinical and patient-generated health data sets. Expertise in analytics, risk-based approaches, patient-centric knowledge and advanced data science capabilities are becoming highly attractive in biopharma industries. Regardless of the combination, strong communication, management skills, operational knowledge, strategic thinking, agility, risk-based approach, patient centricity, and the ability to operate in diverse teams will continue to be indispensable for the drug development professionals of today and tomorrow.

Digital transformation is advancing rapidly, and the focus today has shifted from adopting specific technologies to the broader prospect of rapidly establishing and embracing new operating models and adopting new solutions that allow drawing maximum advantage of what data can offer. Drug development stands to benefit greatly from the increased exchange of knowledge and improved best practices for collecting, organising, storing, sharing, exchanging, analysing, interpreting and communicating data. Such a transformation requires a high degree of adaptability at the levels of individuals, organisations, and the entire industry. Innovations such as robotics, Artificial Intelligence (AI), Machine Learning (ML)/Natural Language Processing (NLP), Internet of Things (IoT), In-Silico Clinical Trials (ISCTs), as well as blockchain-based trials and digital health are expected to improve productivity and resource optimisation.

Recent digital technology advancements have brought an innovative evolution in the field of medical sciences. Digital health has become crucial to daily patient-centered care and drug development. Consequently, a novel subsection of digital technology has emerged called Digital Therapeutics (DTx). The US FDA approved the first Prescription Digital Therapeutic (PDT) in 2017 for treating Substance Use Disorder (SUD) across a de novo submission for classification as a class-II medical equipment. With the recent FDA approval of the first game-based DTx used to treat ADHD, it demonstrates the expanding scope of DTx beyond patient monitoring.

Digital enablement is probably one of the most significant general progresses in the healthcare landscape. With the arrival of the digital therapeutics, a new era opens up in which patients can receive therapy itself through digital health tools. Digital therapeutics strengthen the patient engagement for their therapeutic pathway under guidance of a healthcare professional.

Various terminologies like digital health, telehealth, and e-health can be interchanged and are  expounded as the purpose for healthcare services reinforced by digital technology to improve healthcare services. e-health solutions can be part of every step of the healthcare process, such as treatment, diagnosis, symptoms, decision-making and monitoring, et al. Telemedicine describes medical services provided remotely by physicians using telecommunication provisions. Healthcare operations like patient evaluation, treatment and monitoring are performed without the requirement of in-patient consultation. However, the legalities of these operations range as per jurisdiction. Tele-monitoring is using digital technology that consistently monitors the critical signs of patients.

Below is a list of broad areas related with emerging opportunities:

◆ Clinical monitoring: risk-based monitoring, remote monitoring, centralised monitoring, hybrid monitoring, Decentralised Clinical Trials (DCTs), virtual trials, remote project management support, trend and risk analysis, review of key metrics and key indicators such as KPI, KRI and KQI.
◆ Clinical Trial Management Software (CTMS), cloud-based operational systems, Electronic Data Capture (EDC), electronic Trial Master File (eTMF), randomisation -IWRS/IVRS or IRT,
trial supply management, synthetic arm, digital twins, etc.
◆ Patient recruitment and retention services, translation services, imaging vendors, investigator/site payment systems
◆ Patient-centric technologies: eConsent, eSource, eDiaries, digital pills, virtual site operations, Electronic Medical Records (EMRs), telemedicine, home visits, apps, portals and surveys
◆ Clinical outcome assessment (COA), Patient-Reported Outcome (PRO); Clinician Reported Outcome (ClinRO); Observer Reported Outcome (ObsRO); or Performance Outcome (PerfO) instruments
◆ Digital therapeutics, digitalnendpoints, diagnostics, wearable devices/sensors (e.g., health-tracking wristbands, smart watches, mobile devices, wearable glucose patches, blood glucose monitor, blood pressure monitor, oximeter, wearable sensors, etc.)
◆ Quality of life index scales and questionnaires: rating scale development/validation, scale translation/cultural adaptation
◆Real-World Data (RWD), Real World Evidence (RWE), Clinical Trial Disclosure, medical writing, training, remote investigators meeting management, remote KOL management, patient
advocacy, diversity and inclusion, data disclosure and privacy.

COVID-19 has allowed businesses to implement profound changes to the way we work, from digitalising processes and re-shaping clinical trials.

In the near term, as the impact of digital transformation becomes evident, drug development organisations must retain flexibility to act nimbly and redeploy or reconfigure the workforce.

The following roles are expected to gain greater currency in coming years
◆ Data scientists and statisticians who can handle large data settings using advanced analytics
◆ AI systems, big data and Machine Learning (ML) experts
◆ Clinical trial experts, who could perform holistic review of efficacy and safety data involved in the execution of clinical trials
◆ Patient-centricity and diversity adaptation involving technologies
◆ Technology navigators who could provide technology support to research ecosystem

Digital technologies hold an intriguing theoretic benefit to health, particularly in terms of supporting patient self-management of common, chronic conditions. The combined ubiquity of consumer electronic devices (cell phones, tablets, computers, etc.) with a growing body of knowledge surrounding the use of administrative and patient-reported outcome data to identify, target and tailor interventions to specific patients, provides virtually limitless ways in which to improve how patients manage their health.

Furthermore, there is an extensive investment in this sector because of the level of innovation within the pharma research field. Digital solutions provide opportunities to address various unmet needs in preventing and managing disease-related adverse events. It involves increased communication amongst patients, educating patients and care providers, standard clinical assessment integration with Patient Reported Outcomes (PROs) during daily clinical practice, assisting patients in surveillance of their conditions, improvised empowerment of patients, self-management and enhanced evidence for clinical trials based on PRO endpoints in research analysing treatments and evaluations of supportive care interventions.