Business
Ministry of Economy, Trade and Industry has esti- mated the Japanese robot industry alone will grow to 400 billion yen ($3.8 billion) by 2035, by which point a third of Japan’s population will be 65 or older46. Today, pharma, healthcare and digital have
become deeply intertwined47. Working with other industry verticals has become critical and those with the business skills to do so are highly valued. Care delivery has significantly improved under the influence of AI/ML, robotics, automation, break- through services and adjunct
therapies.
Regulatory-approved digital therapeutics48 now contribute substantially, especially in addictive and cognitive diseases, with organisations such as the Digital Therapeutics Alliance established to sup- port such work49. The social costs of an ageing population related to care delivery are no longer rising unchecked and governmental intervention has been required to ensure affordability is no longer an issue. l Blockchain: In recent years, blockchain technol- ogy has transformed healthcare, placing the patient at the centre of the healthcare ecosystem and increasing the security, privacy and interoperability of health data. This technology provided a new model for Health Information Exchanges (HIE) by making EMRs more efficient, disintermediated and secure. While not a panacea, this rapidly-evolving field provided fertile ground for experimentation, investment and proof-of-concept testing50. l Cloud computing: The adoption of cloud com- puting by biopharma R&D has been steady but slow. The PRISME Forum – the de facto R&D IT leadership group of the biopharmaceutical indus- try – explored this topic as long ago as 201051, yet by 2019 some biopharma companies were still ner- vous of the unstoppable encroachments of this widespread technology, not least in the implemen- tation of GxP solutions52. The implementation of Life Science Clouds to
support R&D continued to make slow progress during the 2020s. Vested interests within pharma were an obstacle to progress but senior manage- ment eventually grasped the nettle and forced through cloud implementation on a global scale. By 2030 the cloud has been accepted as the plat- form of choice for the life science ecosystem, signif- icantly improving the efficiency and effectiveness of biopharma R&D. Furthermore, cloud computing increased the
security of computer-based transactions in signifi- cant part due to cloud companies, whose core busi- ness was to supply high-performance and secure computing, employing the best talent and tech-
Drug Discovery World Fall 2019
nologies. This expertise went a considerable way to bringing the wave of low-level cyber-crime under control. l Devices: Advances in medical devices, wearables and multi-dimensional imaging53 led to diagnostic insights in numerous, previously-untreatable con- ditions. The increase in reliability and accuracy of implantable monitoring devices for serious dis- ease54 in the general population, and for most of the common health-related issues, meant that real- time monitoring of patients undergoing therapy was possible. Further, outcomes data was used rou- tinely to demonstrate the health-economic value of drugs, procedures and devices. One of the challenges of such implantable mon-
itoring devices was the risk of causing infection in patients – not least due to difficult-to-eradicate biofilms. Thankfully, this has largely been over- come55 by new nanomaterials with superhy- drophobic properties that could repel blood on common materials leading to self-cleaning biosen- sors56. As a result, clinical trials were transformed by
researchers employing digital solutions; with com- panies such as Science 37 working effectively with big pharma57 to exploit wearables and simplify the clinical trial patient experience. CROs such as PAREXEL also developed platforms that securely capture, transmit and visualise medical device data; such platforms have been specifically built to support the volumes of data collected by modern sensors58. In 2017, more than 320,000 mobile digital
health apps were in use and had proven particular- ly useful in the treatment of diabetes, asthma, car- diac and pulmonary rehabilitation, with estimated savings to the US health system of $7 billion per year. However, the lack of a clear regulatory frame- work for such innovation was a risk to both doc- tors and their patients, and was yet another exam- ple of how the regulatory agencies were struggling to keep up with the pace of innovation59. The evo- lution of adaptive clinical trial design, and the reg- ulators’ acceptance to adaptive studies, accelerated due to the widespread availability of sensors, wear- ables and software as a medical device. These hardware and software devices also
enabled secure, physician-approved, direct-to- patient clinical trial recruitment, and thus changed drug and device clinical studies dramatically. Clinical trial protocols moved to favour continuous streaming of data from these devices to cloud-based data collection systems. This change had the posi- tive impact of speeding up clinical trials and reduc- ing clinical trial costs as the number of protocol
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